Page last updated: 2024-11-10

cholecalciferol

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Description

Cholecalciferol: Derivative of 7-dehydroxycholesterol formed by ULTRAVIOLET RAYS breaking of the C9-C10 bond. It differs from ERGOCALCIFEROL in having a single bond between C22 and C23 and lacking a methyl group at C24. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

calciol : A hydroxy seco-steroid that is (5Z,7E)-9,10-secocholesta-5,7,10(19)-triene in which the pro-S hydrogen at position 3 has been replaced by a hydroxy group. It is the inactive form of vitamin D3, being hydroxylated in the liver to calcidiol (25-hydroxyvitamin D3), which is then further hydroxylated in the kidney to give calcitriol (1,25-dihydroxyvitamin D3), the active hormone. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID5280795
CHEMBL ID1042
CHEBI ID28940
SCHEMBL ID3126
MeSH IDM0004229

Synonyms (186)

Synonym
provitina
vitamin d (cholecalciferol)
vitamin d assay system suitability
ak r215 component colecalciferol
CHEMBL1042
colecalciferolum
ak-r215 component colecalciferol
vitamin d3 (as cholecalciferol)
vitamin d3; cholecalciferol
(+)-vitamin d3
delta-d
(3s,5z,7e)-9,10-secocholesta-5,7,10(19)-trien-3-ol
CHEBI:28940 ,
(3beta,5z,7e)-9,10-secocholesta-5,7,10(19)-trien-3-ol
oleovitamin d3
colecalciferol
cc
(5z,7e)-(3s)-9,10-secocholesta-5,7,10(19)-trien-3-ol
vigantol
cholecalciferol (jp17/usp)
D00188
colecalciferol (inn)
delta-d (tn)
quintox
PRESTWICK_63
BPBIO1_000460
ACON1_001997
delsterol
nsc375571
nsc-375571
(5z,7e)-(3s)-9,10-seco-5,7,10(19)-cholestatrien-3-ol
LMST03020001
BSPBIO_000418
MEGXM0_000458
NCGC00091072-01
trivitan
feracol
UPCMLD-DP152:001
deparal
vigorsan
ricketon
9,10-secocholestra-5,7,10(19)-trien-3-ol, (3beta,5z,7e)-
vitinc dan-dee-3
einecs 200-673-2
arachitol
rampage
9,10-secocholesta-5,7,10(19)-trien-3-ol, (3beta,5z,7e)-
epa pesticide chemical code 202901
einecs 215-797-2
irradiated 7-dehydrocholesterol
d3-vicotrat
colecalciferolo [dcit]
colecalcipherol
9,10-secocholesta-5,7,10(19)-trien-3-beta-ol
7-dehydrocholesterol, irradiated
cholecalciferolum
cholecalciferol, d3
duphafral d3 1000
vi-de-3-hydrosol
neo dohyfral d3
nsc 375571
colecalciferolum [inn-latin]
ccris 6286
hsdb 820
ebivit
ccris 5813
d3-vigantol
9,10-seco(5z,7e)-5,7,10(19)-cholestatrien-3-ol
67-97-0
calciol
cholecalciferol
C05443
vitamin d3
cholecalciferol, meets usp testing specifications
cholecalciferol, >=98% (hplc)
cholecalciferol (d3), analytical standard
cholecalciferol, analytical standard
DB00169
NCGC00159331-02
UPCMLD-DP152
vitamin d-3
PRESTWICK3_000429
(1s,3z)-3-[(2e)-2-[(1r,3as,7ar)-1-[(1r)-1,5-dimethylhexyl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1h-inden-4-ylidene]ethylidene]-4-methylene-cyclohexanol
9,10-secocholesta-5(z),7(e),10(19)-trien-3(.beta.)-ol
NCGC00159331-04
SMP1_000068
vitamin d3 emulsifiable
1406-16-2
9,10-seco(5z,7e)-5,7,10(19)-cholestatrien-3beta-ol
vitamin d 3
BMSE000507
()-vitamin d3
(1s,3z)-3-[(2e)-2-[(1r,3ar,7as)-7a-methyl-1-[(2r)-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1h-inden-4-ylidene]ethylidene]-4-methylidene-cyclohexan-1-ol
HMS2096E20
(1s,3z)-3-[(2e)-2-[(1r,3as,7ar)-7a-methyl-1-[(2r)-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1h-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol
9vu1ki44gp ,
unii-9vu1ki44gp
dtxcid306294
dtxsid6026294 ,
micro-dee
AKOS015950641
S4063
HY-15398
CS-1179
vi-de3
colecalciferol [inn]
1c6v77qf41 ,
colecalciferolo
colecalciferol d3
unii-1c6v77qf41
dp-r206
cyclohexanol, 3-((2e)-2-((1r,3as,7ar)-1-((1r)-1,5-dimethylhexyl)octahydro-7a-methyl-4h-inden-4-ylidene)ethylidene)-4-methylene-, (1s,3z)-
cholecalciferol [usp:ban:jan:iso]
cholecalciferol [usp-rs]
cholecalciferol [hsdb]
colecalciferol [who-ip]
cholecalciferol [jan]
cyclohexanol, 3-[(2e)-2-[(1r,3as,7ar)-1-[(1r)-1,5-dimethylhexyl]octahydro-7a-methyl-4h-inden-4-ylidene]ethylidene]-4-methylene-, (1s,3z)-
cholecalciferol [usp monograph]
vitamin d3 [fcc]
dp-r206 component vitamin d3
9,10-secocholesta-5,7,10(19)-trien-3-ol, (3.beta.,5z,7e)-
vitamin d3 [mi]
cholecalciferol [iso]
cholecalciferol [inci]
colecalciferolum [who-ip latin]
vitamin d assay system suitability [usp-rs]
cholecalciferol [ep monograph]
cholecalciferol [orange book]
colecalciferol [who-dd]
colecalciferol [mart.]
vigantoletten
(3.beta.,5z,7e)-9,10-secocholesta-5,7,10(19)-trien-3-ol
cholecalciferol [vandf]
fosamax plus d component cholecalciferol
colecalciferol [ema epar]
cholecalciferol component of fosamax plus d
SCHEMBL3126
Q-201931
9,10-secocholesta-5,7,10(19)-trien-3?-ol
vidde-3-hydrosol
mfcd00078131
bdbm50030475
cholecalciferol, european pharmacopoeia (ep) reference standard
cholecalciferol for system suitability, european pharmacopoeia (ep) reference standard
AC-8884
cholecalciferol, united states pharmacopeia (usp) reference standard
vitamin d3 (cholecalciferol)
cholecalciferol (vitamin d3), pharmaceutical secondary standard; certified reference material
(5e,7e)-9,10-secocholesta-5,7,10-trien-3-ol
cholecalciferol d3
devaron
9,10-secocholesta-5,7,10(19)-trien-3-ol
3-beta,z,7e-9,10-secocholestr-5,7,10(19)-trien-3-ol
(3beta,z,7e)-9,10-secocholesta-5,7,10(19)-trien-3-ol
videkhol
granuvit d3
colecalciferol, british pharmacopoeia (bp) reference standard
9,10-secocholesta-5,7,10(19)-trien-3beta-ol
vitamin d3 10 microg/ml in acetonitrile
Q139347
9,10-secocholesta-5,7,10(19)-trien-3-ol, (3b,5z,7e)-
CCG-268466
(s,z)-3-(2-((1r,3as,7ar,e)-7a-methyl-1-((r)-6-methylheptan-2-yl)octahydro-4h-inden-4-ylidene)ethylidene)-4-methylenecyclohexan-1-ol
BS-42465
(1s,3z)-3-[(2e)-2-[7a-methyl-1-(6-methylheptan-2-yl)-2,3,3a,5,6,7-hexahydro-1h-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol
cholecalciferol; 67-97-0
cholecalciferol for system suitability
usepa/opp pesticide code: 202901
colecalciferol (mart.)
colecalciferolum (inn-latin)
(1s,3z)-3-((2e)-2-((1r,3ar,7as)-7a-methyl-1-((2r)-6-methylheptan-2-yl)-2,3,3a,5,6,7-hexahydro-1h-inden-4-ylidene)ethylidene)-4-methylidene-cyclohexan-1-ol
cholecalciferol (ep monograph)
5,7-cholestadien-3-betal-ol
osteo-vit3
growth supportpatch, hautuki
a11cc05
cholecalciferol (usp:ban:jan:iso)
cholecalciferol (usp monograph)
novel-d3
cholecalciferol (usp-rs)
(5e,7e)-9,10-secocholesta-5,7,10(19)-trien-3beta-ol
cholecalciferol impurity a (ep impurity)
decalcitrol
vitaminum d3
vita-desic

Research Excerpts

Overview

Cholecalciferol (VIT-D) is a known modulator of oxidative stress and angiogenesis. It is an essential steroid produced in the skin by solar ultraviolet B radiation (UVB 290-315nm) CholecalCiferol is a common dietary supplement as a precursor of active vitamin D.

ExcerptReferenceRelevance
"Cholecalciferol (VIT-D) is a known modulator of oxidative stress and angiogenesis."( Vitamin-D3 (α-1, 25(OH) 2D3) Protects Retinal Pigment Epithelium From Hyperoxic Insults.
Anandula, VR; Carpentier, G; Chevour, P; Das, D; Firoz, A; Ghosh, A; Jayadev, C; Jeyabalan, N; Krishna, L; Kumaramanickavel, G; Murali, S; Murugeswari, P; Shetty, R; Vinekar, A, 2020
)
1.28
"Cholecalciferol was shown to be an effective, tolerable, inexpensive pharmacotherapeutic option to overcome vitamin D deficiency, with a possible modulating effect on fetuin-A, among hemodialysis patients. "( The impact of cholecalciferol on markers of vascular calcification in hemodialysis patients: A randomized placebo controlled study.
Alshahawey, M; El Borolossy, R; El Wakeel, L; Elsaid, T; Sabri, NA, 2021
)
2.42
"Cholecalciferol is an essential steroid produced in the skin by solar ultraviolet B radiation (UVB 290-315nm). "( Vitamin D production after UVB exposure - a comparison of exposed skin regions.
F Holick, M; Gillstedt, M; Krogstad, AL; Landin-Wilhelmsen, K; Larkö, O; Osmancevic, A; Sandström, K; Wennberg Larkö, AM, 2015
)
1.86
"Cholecalciferol (CCF) is a common dietary supplement as a precursor of active vitamin D. "( Cholecalciferol inhibits lipid accumulation by regulating early adipogenesis in cultured adipocytes and zebrafish.
Choi, HS; Jung, YN; Kang, S; Kim, JH, 2016
)
3.32
"Cholecalciferol (100,000 IU) is a safe, effective, and simple way to increase calcidiol concentrations. "( Pharmacokinetics of a single, large dose of cholecalciferol.
Armas, LA; Heaney, RP; Ilahi, M, 2008
)
2.05

Effects

Cholecalciferol has potential, as a clinical drug, to protect renal function in I/R-induced AKI through reducing ROS production. deficiency has been associated with stress-related psychiatric disorders, particularly depression.

ExcerptReferenceRelevance
"Cholecalciferol therefore has potential, as a clinical drug, to protect renal function in I/R-induced AKI through reducing ROS production, NF-κB activation and GSDMD-mediated pyroptosis."( Cholecalciferol pretreatment ameliorates ischemia/reperfusion-induced acute kidney injury through inhibiting ROS production, NF-κB pathway and pyroptosis.
Li, J; Liu, D; Ma, J; Qian, W; Wang, D; Wu, W; Yu, D; Zhang, T; Zhang, Z; Zhao, Y, 2022
)
2.89
"Cholecalciferol deficiency has been associated with stress-related psychiatric disorders, particularly depression. "( Involvement of serotonergic neurotransmission in the antidepressant-like effect elicited by cholecalciferol in the chronic unpredictable stress model in mice.
Camargo, A; Dafre, AL; de Almeida, GRL; de O Dalsenter, Y; Engel, WD; Moretti, M; Neis, VB; Platt, N; Rodrigues, ALS; Rosa, PB; Rosado, AF; Selhorst, I; Werle, I, 2022
)
2.38
"Cholecalciferol has effects similar to those of calcitriol on growth, MMP activity, and VDR."( Cholecalciferol (vitamin D3) inhibits growth and invasion by up-regulating nuclear receptors and 25-hydroxylase (CYP27A1) in human prostate cancer cells.
Tokar, EJ; Webber, MM, 2005
)
2.49

Actions

ExcerptReferenceRelevance
"Cholecalciferol, vitamin D3, plays an important role in bonemetabolism by regulating extracellular levels of calcium. "( Multifunctional hydroxyapatite and poly(D,L-lactide-co-glycolide) nanoparticles for the local delivery of cholecalciferol.
Ajduković, Z; Ignjatović, N; Uskoković, D; Uskoković, V, 2013
)
2.04

Treatment

Cholecalciferol treatment reduced the median concentration of soluble Klotho (from 438.73 pg/ml; interquartile range, 257.99-865.51 pg/ML; to 370.94 pg/ ml; 181.72-710.91 pg/ ML; P <0.05) Cholecal ciferol also increased concentrations of serum 25(OH)D by (19.3 ± 8 ηg/mL, P = .001; 12.2 ± 9ηG/L), and 24,25( OH)2D (1.14 ± 0.89ηL), but returned these values to the controls.

ExcerptReferenceRelevance
"Cholecalciferol treatment increased 25OHD levels and reduced parathormone, total cholesterol, and low-density lipoprotein cholesterol levels in C-cohort patients, whereas no significant changes in these parameters were observed in P-cohort patients."( Vitamin D Status, Cardiovascular Risk Profile, and miRNA-21 Levels in Hypertensive Patients: Results of the HYPODD Study.
Abate, V; Buondonno, I; D Amelio, P; D Elia, L; De Filippo, G; Fallo, F; Faraonio, R; Martinelli, F; Muscariello, R; Rebellato, A; Rendina, D; Strazzullo, P; Succoio, M, 2022
)
1.44
"Cholecalciferoltreated rats had increased acetyl CoA carboxylase 2 protein expression and decreased expression of malonyl CoA decarboxylase."( Cholecalciferol affects cardiac proteins regulating malonyl-CoA availability and intracellular calcium level.
Culafic, T; Ivkovic, T; Koricanac, G; Kostic, M; Romic, S; Stanisic, J; Stojiljkovic, M; Tepavcevic, S, 2023
)
3.07
"Cholecalciferol treatment resulted in stable calcium concentrations and a substantial increase in calcitriol."( High doses of cholecalciferol alleviate the progression of hyperparathyroidism in patients with CKD Stages 3-4: results of a 12-week double-blind, randomized, controlled study.
Dezfoolian, H; Elvarson, F; Isaksson, E; Linde, T; Ljunggren, Ö; Sterner, G; Westerberg, PA, 2018
)
1.56
"Cholecalciferol treatment effectively increased 25(OH)D concentrations, but surgery resulted in a decrease in 25(OH)D concentrations at day 3 in both arms."( Vitamin D to Prevent Lung Injury Following Esophagectomy-A Randomized, Placebo-Controlled Trial.
Cooper, MS; D'Souza, VK; Dancer, RCA; Fraser, WD; Gao, F; Howells, PA; Mahida, RY; Martineau, AR; Parekh, D; Perkins, GD; Scott, A; Tan, L; Tang, JCY; Thickett, DR; Tucker, O, 2018
)
1.2
"Cholecalciferol treatment reduced the median concentration of soluble Klotho (from 438.73 pg/ml; interquartile range, 257.99-865.51 pg/ml; to 370.94 pg/ml; 181.72-710.91 pg/ml; P <0.05)."( Cholecalciferol supplementation reduces soluble Klotho concentration in hemodialysis patients.
Brzósko, S; Goździkiewicz, J; Hryszko, T; Koc-Żórawska, E; Myśliwiec, M; Rydzewska-Rosołowska, A; Zelazowska-Rutkowska, B, 2013
)
2.55
"Cholecalciferol treatment increased concentrations of serum 25(OH)D by (19.3 ± 8 ηg/mL, P = .001; 12.2 ± 9 ηg/mL, P = .0001) and 24,25(OH)2D (1.14 ± 0.89 ηg/mL, P = .0024; 1.0 ± 0.72 ηg/mL P = .0002), and reduced serum PTH (-11 ± 21 pg/mL, P = .0292; -42 ± 68 pg/mL, P = .0494) in normal and CKD subjects, respectively. "( Activation of FGF-23 mediated vitamin D degradative pathways by cholecalciferol.
Alshayeb, H; David, V; Gyamlani, GG; Quarles, LD; Showkat, A; Wall, BM, 2014
)
2.08
"Cholecalciferol treatment, 2000 vs 800 IU/d, did not reduce falls (28%; 95% CI, -4% to 68%), but reduced the rate of hospital readmissions by 39% (95% CI, -62% to -1%)."( Effect of high-dosage cholecalciferol and extended physiotherapy on complications after hip fracture: a randomized controlled trial.
Bischoff-Ferrari, HA; Bretscher, B; Can, U; Dawson-Hughes, B; Egli, A; Looser, S; Minder, E; Mueller, NJ; Orav, EJ; Platz, A; Stähelin, HB; Theiler, R; Vergopoulos, A; Willett, WC, 2010
)
1.4
"Cholecalciferol treatment reduced perseverative behavior that is associated with developmental alcohol exposure in a dose-dependent manner."( Cholecalciferol attenuates perseverative behavior associated with developmental alcohol exposure in rats in a dose-dependent manner.
Happer, JP; Idrus, NM; Thomas, JD, 2013
)
2.55
"Cholecalciferol treatment returns these values to the controls which might be due mainly to the increased number of Ca2+ pump units."( Effect of vitamin D deficiency on lipid composition and calcium transport in basolateral membrane vesicles from chick intestine.
Alisio, A; Cañas, F; de Bronia, DH; Pereira, R; Tolosa de Talamoni, N, 1997
)
1.02
"Cholecalciferol treatment (500 IU at 72 h) significantly enhanced selenite uptake, a response that decreased when the vesicles were stored at room temperature for 2.5 h prior to the uptake measurement."( Relationship of membrane-bound sulfhydryl groups to vitamin D-stimulated uptake of [75Se]Selenite by the brush border membrane vesicles from chick duodenum.
Mykkanen, HM; Wasserman, RH, 1990
)
1
"Treatment with cholecalciferol is effective for the normalization of 25(OH)D, demonstrating a beneficial effect on the calcium-tropic axis in other populations; however, its effect on the PTH/vitamin D/calcium and FGF23/klotho/phosphorus axis in RTR has not been reported."( [Vitamin D and its positive effect on the PTH/vitamin D/calcium-FGF23/klotho/phosphorus axis in kidney transplant recipients].
Balcázar-Hernández, L; Basurto, L; González-Virla, B; Jiménez Martínez, MDC; Manuel-Apolinar, L; Martínez Ordaz, JL; Mendoza-Zubieta, V; Reza-Albarrán, AA; Vargas Ortega, G, 2023
)
1.25
"The treatment with cholecalciferol also normalized the smooth muscle cell membrane potential of de-endothelialized mesenteric arteries of SHR and their hyperpolarizing responses to alpha 2-adrenergic agonists, which were depressed in untreated SHR."( Recovery of impaired K+ channels in mesenteric arteries from spontaneously hypertensive rats by prolonged treatment with cholecalciferol.
Borges, AC; Feres, T; Paiva, TB; Vianna, LM, 1999
)
0.83
"Treatment with cholecalciferol or 1,25-dihydroxyvitamin D3 (1,25(OH)2D3) increases activity and changes electrophoretic mobility of alkaline phosphatase (alkPase) from duodenal brush border of vitamin D-deprived chicks. "( Changes of intestinal alkaline phosphatase produced by cholecalciferol or 1,25-dihydroxyvitamin D3 in vitamin D-deficient chicks.
Asteggiano, CA; Blanco, A; Cañas, FM; Cortes, CS; Moreno, J; Pereira, R; Tolosa, N, 1985
)
0.87

Toxicity

Cholecalciferol supplementation with 10,400 IU daily is safe and tolerable in patients with MS and exhibits in vivo pleiotropic immunomodulatory effects. In patients with COVID-19 pneumonia, who are vitamin D deficient, administration of large doses of cholecalCiferol for few days can be a safe option to treat mild to moderate pneumonia.

ExcerptReferenceRelevance
" On the basis of both renal calcification and body weight, the present studies would suggest that 25(OH)D3 is 5 to 10 times more toxic than vitamin D3."( Safety of 25-hydroxycholecalciferol as a source of cholecalciferol in poultry rations.
Gray, RW; Hollis, BW; Quarles, CL; Yarger, JG, 1995
)
0.61
"1 alpha,25-Dihydroxyvitamin D3 (1 alpha,25(OH)2D3) has recently been reported to exert a toxic effect on both rat and human glioma cell lines."( Cytotoxic effects of 1 alpha,25-dihydroxyvitamin D3 and synthetic vitamin D3 analogues on a glioma cell line.
Baudet, C; Binderup, L; Brachet, P; Chevalier, G; Naveilhan, P; Wion, D, 1996
)
0.29
" dose of TPA, but these adverse effects became less intense or disappeared when a lower dose of TPA was used."( Effect of intravenous infusions of 12-O-tetradecanoylphorbol-13-acetate (TPA) in patients with myelocytic leukemia: preliminary studies on therapeutic efficacy and toxicity.
Cao, GS; Chang, RL; Conney, AH; Han, ZT; Liu, XJ; Newmark, HL; Sun, JZ; Tian, GF; Yang, RY; Zhu, XX, 1998
)
0.3
" Moreover, 45,000 IU/kg of dietary vitamin A ameliorated the potential toxic effects of feeding high levels of vitamin D3, 25-(OH)D3 and 1,25-(OH)2D3 to young broiler chickens."( The influence of vitamin A on the utilization and amelioration of toxicity of cholecalciferol, 25-hydroxycholecalciferol, and 1,25 dihydroxycholecalciferol in young broiler chickens.
Aburto, A; Britton, WM; Edwards, HM, 1998
)
0.53
" Excessive exposure, as in sunbathing, only contributes to the adverse effects, like sunburn and suppression of cellular immunity in the short term, and 'photoaging' and skin cancer in the long term."( [Adverse effects of sunlight on the skin].
de Gruijl, FR, 1998
)
0.3
" These results indicate that 25-OH-D3 is safe for use in laying hen feed as a source of vitamin D3 at 82."( Safety of 25-hydroxyvitamin D3 as a source of vitamin D3 in layer poultry feed.
Lanenga, M; McNaughton, JL; Stark, LE; Terry, M, 1999
)
0.3
"The Food and Nutrition Board of the National Academy of Sciences states that 95 microg vitamin D/d is the lowest observed adverse effect level (LOAEL)."( Efficacy and safety of vitamin D3 intake exceeding the lowest observed adverse effect level.
Chan, PC; MacFarlane, GD; Vieth, R, 2001
)
0.31
"The 100-microg/d dosage of vitamin D3 effectively increased 25(OH)D to high-normal concentrations in practically all adults and serum 25(OH)D remained within the physiologic range; therefore, we consider 100 microg vitamin D3/d to be a safe intake."( Efficacy and safety of vitamin D3 intake exceeding the lowest observed adverse effect level.
Chan, PC; MacFarlane, GD; Vieth, R, 2001
)
0.31
" Since both H(2)O(2) and 6-OHDA may injure cells via free radical and reactive oxygen species, the neuroprotection seen here may operate via a reversal of such a toxic mechanism."( Vitamin D(3) attenuates 6-hydroxydopamine-induced neurotoxicity in rats.
Borlongan, CV; Chen, HH; Cherng, TL; Hoffer, BJ; Wang, JY; Wang, Y; Wu, JN, 2001
)
0.31
"The drug is safe and has potential benefits at serum concentrations where effects begin to be noted in vitro."( Pharmacokinetics and safety of ILX23-7553, a non-calcemic-vitamin D3 analogue, in a phase I study of patients with advanced malignancies.
Bonate, P; Bryan, M; Camastra, D; Chanel, SM; Harrison, J; Hollis, BW; Novick, SC; Owusu, K; Pliner, L; Saunders, T; Soignet, S; Wieder, R; Williams, T, 2003
)
0.32
" Safety was assessed through concomitant medications, adverse events, laboratory evaluations, and physical examinations."( A multicenter, double-blind, safety study of QR-333 for the treatment of symptomatic diabetic peripheral neuropathy. A preliminary report.
Farez, C; Khodabandehlou, T; Le Devehat, C; LeFante, C; Richard, JL; Rosenbloom, RA; Valensi, P,
)
0.13
" Eleven patients in the QR-333 group reported 23 adverse events (all mild or moderate); 4 in the placebo group reported 5 events (all moderate)."( A multicenter, double-blind, safety study of QR-333 for the treatment of symptomatic diabetic peripheral neuropathy. A preliminary report.
Farez, C; Khodabandehlou, T; Le Devehat, C; LeFante, C; Richard, JL; Rosenbloom, RA; Valensi, P,
)
0.13
" Safety was monitored based on adverse events recorded during the treatment period and on the results of laboratory tests, including measurement of creatinine and uric acid levels."( Clinical and laboratory safety of one year's use of a combination calcium + vitamin D tablet in ambulatory elderly women with vitamin D insufficiency: results of a multicenter, randomized, double-blind, placebo-controlled study.
Brazier, M; Fardellone, P; Grados, F; Kamel, S; Maamer, M; Mathieu, M; Morel, A; Sebert, JL, 2005
)
0.33
" Treatment-related adverse events were reported in 21 (22."( Clinical and laboratory safety of one year's use of a combination calcium + vitamin D tablet in ambulatory elderly women with vitamin D insufficiency: results of a multicenter, randomized, double-blind, placebo-controlled study.
Brazier, M; Fardellone, P; Grados, F; Kamel, S; Maamer, M; Mathieu, M; Morel, A; Sebert, JL, 2005
)
0.33
" However, topical agents can be associated with unwanted and potentially toxic side effects that make physicians reluctant to prescribe them, and patients intentionally discontinue treatment with these topical agents."( The roles of safety and compliance in determining effectiveness of topical therapy for psoriasis.
Corvari, L; Stein Gold, L, 2007
)
0.34
" The data support the feasibility of pharmacologic doses of vitamin D3 for clinical research, and they provide objective evidence that vitamin D intake beyond the current upper limit is safe by a large margin."( Safety of vitamin D3 in adults with multiple sclerosis.
Kimball, SM; O'Connor, P; Ursell, MR; Vieth, R, 2007
)
0.34
"Vitamin D(3) at doses equivalent to 2000 IU/d for 1 yr is safe in adolescents and results in desirable vitamin D levels."( Short- and long-term safety of weekly high-dose vitamin D3 supplementation in school children.
El-Hajj Fuleihan, G; El-Rassi, R; Kimball, S; Maalouf, J; Mahfoud, Z; Nabulsi, M; Vieth, R, 2008
)
0.35
"Short-term, high-dose oral cholecalciferol treatment of vitamin D deficiency in hemodialysis patients appears to be effective and with no evidence of toxic effects."( Efficacy and safety of a short course of very-high-dose cholecalciferol in hemodialysis.
Huang, R; Long, Q; Raggi, P; Singapuri, S; Tangpricha, V; Wasse, H, 2012
)
0.92
"6%) developed hypercalciuria, no significant adverse events were observed."( Efficacy and safety of high dose intramuscular or oral cholecalciferol in vitamin D deficient/insufficient elderly.
Basaran, S; Guzel, R; Seydaoglu, G; Tellioglu, A, 2012
)
0.63
" Eighty-four adverse events (AEs) were reported in 24 of 32 subjects receiving DP-R206, and 14 AEs were reported in 8 of 29 subjects receiving the vitamin D3 24,000-IU tablet."( Comparison of the pharmacokinetics, safety, and tolerability of vitamin D3 in DP-R206 (150-mg ibandronate/24,000-IU vitamin D3 tablet) and as monotherapy (24,000 iu) in healthy male Korean adults.
Chae, SW; Im, YJ; Jeon, JY; Jun, H; Kim, EY; Kim, MG; Kim, Y; Lee, JW; Lee, SY; Lee, TW; Park, TS, 2014
)
0.4
" Their combined use has made it possible to increase an overall survival but they are still penalized by adverse effects and toxicity."( Evaluation of the safety and efficacy of the first-line treatment with somatostatin combined with melatonin, retinoids, vitamin D3, and low doses of cyclophosphamide in 20 cases of breast cancer: a preliminary report.
Colori, B; Di Bella, G; Mascia, F; Ricchi, A, 2013
)
0.39
"To the best of our knowledge, adverse effects of SMF from MRI devices on the bone health of MRI workers were detected for the first time."( [Are there any adverse effects of static magnetic field from magnetic resonance imaging devices on bone health of workers?].
Akkaya, N; Akkaya, S; Güngör, HR; Ok, N, 2014
)
0.4
" In addition, vitamin D3 did not significantly increase the incidence of adverse effects, including total adverse effects, gastrointestinal adverse effects and fluctuation of blood pressure."( Efficacy and safety of vitamin D3 in patients with diabetic nephropathy: a meta-analysis of randomized controlled trials.
Dong, J; Liao, L; Shang, H; Wang, H; Zhang, D; Zhao, J, 2014
)
0.4
" And it does not increase any adverse effects than control, even in combination therapy with angiotensin converting enzyme inhibitors/angiotensin receptor blockers."( Efficacy and safety of vitamin D3 in patients with diabetic nephropathy: a meta-analysis of randomized controlled trials.
Dong, J; Liao, L; Shang, H; Wang, H; Zhang, D; Zhao, J, 2014
)
0.4
" No adverse clinical symptoms were noted."( Pharmacokinetics and safety issues of an accidental overdose of 2,000,000 IU of vitamin D3 in two nursing home patients: a case report.
Drabbe, M; Fleuren, H; van den Ouweland, J; Vollaard, H, 2014
)
0.4
"We previously reported that the intensive cholecalciferol treatment (100 000 IU every 2 weeks for 2 months) was safe in RTR."( VITamin D supplementation in renAL transplant recipients (VITALE): a prospective, multicentre, double-blind, randomized trial of vitamin D estimating the benefit and safety of vitamin D3 treatment at a dose of 100,000 UI compared with a dose of 12,000 UI
Alberti, C; Colas, S; Courbebaisse, M; Prié, D; Souberbielle, JC; Thervet, E; Treluyer, JM, 2014
)
0.67
"To determine whether supplementation with vitamin D improves resilience to the adverse effects of earthquakes."( Effect of monthly vitamin D3 supplementation in healthy adults on adverse effects of earthquakes: randomised controlled trial.
Camargo, CA; Chambers, ST; Florkowski, CM; Jennings, LC; Livesey, JH; Murdoch, DR; Priest, PC; Scragg, R; Slow, S; Stewart, AW, 2014
)
0.4
" The primary endpoint in the current analysis was the self reported effects and overall adverse impact of the Christchurch earthquakes as assessed by questionnaire four months after the most destructive earthquake on 22 February 2011, which was used as the index event."( Effect of monthly vitamin D3 supplementation in healthy adults on adverse effects of earthquakes: randomised controlled trial.
Camargo, CA; Chambers, ST; Florkowski, CM; Jennings, LC; Livesey, JH; Murdoch, DR; Priest, PC; Scragg, R; Slow, S; Stewart, AW, 2014
)
0.4
" There was no significant difference in the number of self reported adverse effects between those receiving vitamin D supplementation and those receiving placebo."( Effect of monthly vitamin D3 supplementation in healthy adults on adverse effects of earthquakes: randomised controlled trial.
Camargo, CA; Chambers, ST; Florkowski, CM; Jennings, LC; Livesey, JH; Murdoch, DR; Priest, PC; Scragg, R; Slow, S; Stewart, AW, 2014
)
0.4
"In this trial, vitamin D supplementation did not reduce the adverse impact of earthquakes in healthy adults."( Effect of monthly vitamin D3 supplementation in healthy adults on adverse effects of earthquakes: randomised controlled trial.
Camargo, CA; Chambers, ST; Florkowski, CM; Jennings, LC; Livesey, JH; Murdoch, DR; Priest, PC; Scragg, R; Slow, S; Stewart, AW, 2014
)
0.4
"The IR was safe and effective in obtaining sufficient levels of vit."( A 24-month prospective study on the efficacy and safety of two different monthly regimens of vitamin D supplementation in pre-menopausal women with systemic lupus erythematosus.
Andreoli, L; Cutolo, M; Dall'Ara, F; Piantoni, S; Piva, N; Tincani, A; Zanola, A, 2015
)
0.42
" After 12 weeks supplementation, both D3 doses were safe and well tolerated."( Safety and Efficacy of High-dose Daily Vitamin D3 Supplementation in Children and Young Adults With Sickle Cell Disease.
Bertolaso, C; Dougherty, KA; Schall, JI; Smith-Whitley, K; Stallings, VA, 2015
)
0.42
" As part of a randomized placebo-controlled trial, we determined if supplementation with 7000-IU/d vitD3 for 12 months in human immunodeficiency virus (HIV)-Infected subjects was safe and/or associated with metabolic outcomes."( Comprehensive Safety Monitoring of 12-Month Daily 7000-IU Vitamin D3 Supplementation in Human Immunodeficiency Virus-Infected Children and Young Adults.
Hediger, ML; Rutstein, RM; Schall, JI; Stallings, VA; Zemel, BS, 2016
)
0.43
" Safety was defined by a low incidence (<5%) of the study-defined serious adverse events-that is, elevated serum calcium plus 25(OH)D >160 ng/mL-and no changes in hematologic, liver, renal, metabolic, lipid, or inflammatory status."( Comprehensive Safety Monitoring of 12-Month Daily 7000-IU Vitamin D3 Supplementation in Human Immunodeficiency Virus-Infected Children and Young Adults.
Hediger, ML; Rutstein, RM; Schall, JI; Stallings, VA; Zemel, BS, 2016
)
0.43
" No subject experienced a serious adverse safety event; none had 25(OH)D >80 ng/mL at any time."( Comprehensive Safety Monitoring of 12-Month Daily 7000-IU Vitamin D3 Supplementation in Human Immunodeficiency Virus-Infected Children and Young Adults.
Hediger, ML; Rutstein, RM; Schall, JI; Stallings, VA; Zemel, BS, 2016
)
0.43
" Cholecalciferol substitution was well tolerated without adverse effects."( Efficacy and safety of body weight-adapted oral cholecalciferol substitution in dialysis patients with vitamin D deficiency.
Lhotta, K; Mündle, M; Sprenger-Mähr, H; Zitt, E, 2015
)
1.58
" None of the subjects in either group developed any adverse events during the supplementation protocol."( Bioavailability and Safety of Vitamin D3 from Pizza Baked with Fortified Mozzarella Cheese: A Randomized Controlled Trial.
Al-Khalidi, B; Chiu, W; Rousseau, D; Vieth, R, 2015
)
0.42
"Vitamin D3 is safe and bioavailable from fortified mozzarella cheese baked on pizza."( Bioavailability and Safety of Vitamin D3 from Pizza Baked with Fortified Mozzarella Cheese: A Randomized Controlled Trial.
Al-Khalidi, B; Chiu, W; Rousseau, D; Vieth, R, 2015
)
0.42
" Adverse events were minor and did not differ between the 2 groups."( Safety and immunologic effects of high- vs low-dose cholecalciferol in multiple sclerosis.
Baynes, M; Bhargava, P; Calabresi, PA; Eckstein, C; Gocke, A; Mowry, EM; Ntranos, A; Sotirchos, ES; Steinman, L; Van Haren, K, 2016
)
0.68
"Cholecalciferol supplementation with 10,400 IU daily is safe and tolerable in patients with MS and exhibits in vivo pleiotropic immunomodulatory effects in MS, which include reduction of interleukin-17 production by CD4(+) T cells and decreased proportion of effector memory CD4(+) T cells with concomitant increase in central memory CD4(+) T cells and naive CD4(+) T cells."( Safety and immunologic effects of high- vs low-dose cholecalciferol in multiple sclerosis.
Baynes, M; Bhargava, P; Calabresi, PA; Eckstein, C; Gocke, A; Mowry, EM; Ntranos, A; Sotirchos, ES; Steinman, L; Van Haren, K, 2016
)
2.13
"This study provides Class I evidence that cholecalciferol supplementation with 10,400 IU daily is safe and well-tolerated in patients with MS and exhibits in vivo pleiotropic immunomodulatory effects."( Safety and immunologic effects of high- vs low-dose cholecalciferol in multiple sclerosis.
Baynes, M; Bhargava, P; Calabresi, PA; Eckstein, C; Gocke, A; Mowry, EM; Ntranos, A; Sotirchos, ES; Steinman, L; Van Haren, K, 2016
)
0.95
"Currently available evidence suggests that active vitamin D3 is effective in treating secondary hyperparathyroidism, renal osteodystrophy, and improving malnutrition and microinflammation in MHD patients, without obvious adverse events."( [Efficacy and safety of active vitamin D3 supplement in maintenance hemodialysis patients: a meta-analysis].
Gao, P; He, L; Li, M; Lin, M; Zhao, T, 2015
)
0.42
" No adverse effects were observed."( Safety and Efficacy of Banaba-Moringa oleifera-Green Coffee Bean Extracts and Vitamin D3 in a Sustained Release Weight Management Supplement.
Kaats, GR; Preuss, HG; Stohs, SJ, 2016
)
0.43
"VD replenishment is safe and can be effectively achieved by means of the employed cholecalciferol dosage in the majority of patients."( Efficacy and safety of vitamin D supplementation in patients with chronic lymphocytic leukemia.
Bednarek, A; Chudek, J; Karwasiecka, D; Kubeczko, M; Nowara, E; Spychałowicz, W; Wdowiak, K; Wojnar, J, 2016
)
0.66
" Individual administration of vitamin A or vitamin K with a toxic dose of vitamin D improved the biochemical and histopathological abnormalities of hypervitaminosis D3."( Comparison between the protective effects of vitamin K and vitamin A on the modulation of hypervitaminosis D3 short-term toxicity in adult albino rats.
El-Kenawy, Ael-M; Elshama, SS; Osman, HE; Youseef, HM, 2016
)
0.43
" Treatment was well tolerated with no product associated adverse events (AE) and only a few mild and expected side effects."( An open-label clinical trial assessing the efficacy and safety of Bend Skincare Anti-Aging Formula on minimal erythema dose in skin.
Morse, NL; Reid, AJ; St-Onge, M, 2018
)
0.48
"Recent randomized controlled trials (RCTs) provide evidence for a possible beneficial impact of vitamin D supplementation on health outcomes beyond bone health, but there are few reviews of noncalcemic adverse effects from long-term supplementation."( Noncalcemic adverse effects and withdrawals in randomized controlled trials of long-term vitamin D2 or D3 supplementation: a systematic review and meta-analysis.
Malihi, Z; Mm Lawes, C; Scragg, R; Wu, Z, 2017
)
0.46
"The aims of this systematic review of vitamin D supplementation in RCTs were as follows: to determine whether all adverse effects, when combined, are reported equally between treatment arms; to identify the most common noncalcemic adverse effects reported; and to ascertain whether withdrawal rates, as a marker of clinical adverse effects, differ between treatment arms."( Noncalcemic adverse effects and withdrawals in randomized controlled trials of long-term vitamin D2 or D3 supplementation: a systematic review and meta-analysis.
Malihi, Z; Mm Lawes, C; Scragg, R; Wu, Z, 2017
)
0.46
"Overall, these findings suggest that vitamin D, by itself, does not increase the risk of noncalcemic adverse effects."( Noncalcemic adverse effects and withdrawals in randomized controlled trials of long-term vitamin D2 or D3 supplementation: a systematic review and meta-analysis.
Malihi, Z; Mm Lawes, C; Scragg, R; Wu, Z, 2017
)
0.46
"8%) taking placebo reported ≥1 adverse event."( Monthly high-dose vitamin D3 supplementation and self-reported adverse events in a 4-year randomized controlled trial.
Camargo, CA; Huang, Y; Khaw, KT; Lawes, CMM; Malihi, Z; Scragg, R; Toop, L; Waayer, D; Wu, Z, 2019
)
0.51
"3 years did not affect participant-reported adverse events."( Monthly high-dose vitamin D3 supplementation and self-reported adverse events in a 4-year randomized controlled trial.
Camargo, CA; Huang, Y; Khaw, KT; Lawes, CMM; Malihi, Z; Scragg, R; Toop, L; Waayer, D; Wu, Z, 2019
)
0.51
" Incidence rate of adverse effects was 19."( Efficacy and safety of cholecalciferol-augmented anti-tuberculosis therapy for treatment of naïve patients with pulmonary tuberculosis: A randomized, controlled, clinical study.
Abd-Ellatief, RB; Hasanain, AFA; Nafee, AMA; Zayed, AAH, 2019
)
0.82
" In addition, adding vitamin D3 to ATT provides extra protection against the hepatic and muscular adverse effects of ATT."( Efficacy and safety of cholecalciferol-augmented anti-tuberculosis therapy for treatment of naïve patients with pulmonary tuberculosis: A randomized, controlled, clinical study.
Abd-Ellatief, RB; Hasanain, AFA; Nafee, AMA; Zayed, AAH, 2019
)
0.82
"High-dose oral Vitamin D3, 5000 IU/day was safe and well tolerated in subjects with epilepsy."( Safety and tolerability of Vitamin D3 5000 IU/day in epilepsy.
Curtis, A; DeGiorgio, CM; Hertling, D; Markovic, D; Murray, D, 2019
)
0.51
" These results support stoss therapy as an effective and safe alternative therapy for the treatment of paediatric vitamin D deficiency."( Safety and effectiveness of stoss therapy in children with vitamin D deficiency.
Biggin, A; Fiscaletti, M; Gunasekera, H; Hayes, E; Kilo, T; Munns, C; Tannous, P; Wood, N; Zurynski, Y, 2020
)
0.56
" None of the included studies reported severe adverse events associated with vitamin D supplementation."( Efficacy and Safety of Vitamin D Supplementation in Patients With Systemic Lupus Erythematosus: A Meta-analysis of Randomized Controlled Trials.
Gonzalez, A; Gui, L; Huang, L; Qiu, M; Wu, X; Yue, J; Zheng, R; Zhu, S, 2019
)
0.51
" The most common adverse events were injection site pain and swelling."( A comparative study of the efficacy and safety of intralesional measles, mumps, and rubella vaccine versus intralesional vitamin D3 for the treatment of warts in children.
Gautam, U; Jain, SK; Kushwaha, RK; Mohta, A; Nyati, A; Sharma, P, 2020
)
0.56
"Lead (Pb) is a known toxic heavy metal which accumulates in different tissues and causes oxidative stress (OS) and inflammation."( Protective Effect of Vitamin D3 Against Pb-Induced Neurotoxicity by Regulating the Nrf2 and NF-κB Pathways.
Afsharzadeh, N; Hoseinrad, H; Moosazadeh Moghaddam, M; Mousazadeh, A; Shahrestanaki, JK; Yadegari, P, 2021
)
0.62
" Regarding serious adverse effects, none was reported in both groups."( Efficacy and safety of weekly vitamin D
Díaz-Niño de Rivera, R; Esquivel-Valerio, JA; Galarza-Delgado, DA; Garza-Elizondo, MA; Garza-Guerra, AJ; Lozano-Plata, LI; Serna-Peña, G; Sifuentes-Ramírez, J; Silva-Luna, K; Vega-Morales, D, 2021
)
0.62
" In patients with COVID-19 pneumonia, who are vitamin D deficient, administration of large doses of cholecalciferol for few days can be a safe option to treat mild to moderate COVID-19 pneumonia."( Vitamin D (Cholecalciferol) with Low Dose Vitamin C as a Safe and Effective Therapeutic Modality in an Adult with COVID-19 Pneumonia.
Khan, ST; Siddiqui, E; Subhani, F; Waheed, S; Zahid, RO, 2021
)
1.23
" Adverse effects were observed through the presence of hypercalcemia/hypercalciuria."( Safety and effectiveness of vitamin D mega-dose: A systematic review.
Ataide, FL; Carvalho Bastos, LM; Freire de Carvalho, J; Skare, TL; Vicente Matias, MF, 2021
)
0.62
"The study demonstrated that vitamin D mega-dose therapy is effective in normalizing serum vitamin levels, and the toxicity assessed through adverse effects was low, with no expressive clinical significance."( Safety and effectiveness of vitamin D mega-dose: A systematic review.
Ataide, FL; Carvalho Bastos, LM; Freire de Carvalho, J; Skare, TL; Vicente Matias, MF, 2021
)
0.62
" Calcifediol, as well as cholecalciferol (vitamin D3), is efficient and safe in the general population, although calcifediol has certain advantages over cholecalciferol, such as its rapid onset of action and greater potency."( Treatment of Vitamin D Deficiency with Calcifediol: Efficacy and Safety Profile and Predictability of Efficacy.
Pérez-Castrillon, JL; Pludowski, P; Usategui-Martín, R, 2022
)
1.02
"Study outcomes will determine what dose of baclofen is safe to prescribe to those receiving methadone, to inform a subsequent proof-of-concept trial of the efficacy baclofen to facilitate opiate detoxification."( FORWARDS-1: an adaptive, single-blind, placebo-controlled ascending dose study of acute baclofen on safety parameters in opioid dependence during methadone-maintenance treatment-a pharmacokinetic-pharmacodynamic study.
Barker, D; Cro, S; Lingford-Hughes, AR; Mozgunov, P; Nahar, L; Paterson, LM; Paterson, S; Phillips, R; Smith, C, 2022
)
0.72
"Calcifediol is a safe and efficacious alternative for oral Vitamin D supplementation in young adults."( Efficacy, safety, and dose-response effects of calcifediol supplementation on 25-hydroxyvitamin D, parathyroid hormone, and 1,25-dihydroxyvitamin D levels in healthy adults: An open-label, interventional pilot study.
Bhadada, SK; Das, L; Dutta, P; Holick, MF; Marwaha, RK; Sachdeva, N; Singhmar, S; Thakur, N,
)
0.13

Pharmacokinetics

A mild degree of pharmacokinetic interaction was observed when bazedoxifene and cholecalciferol were administered concomitantly to healthy male volunteers. Pharmacokinetic analysis of 25-hydroxycholecalCiferol in affected lambs following intramuscular injection of 1,000,000 IU vitamin D3 indicated that transport of vitaminD3 from the site of injection to the liver was rapid.

ExcerptReferenceRelevance
" After 3 mo of oral steroid therapy (Norinyl, 2 mg; norethindrone + mestranol), the antipyrine half-life was increased in 3 of 6 subjects, phenylbutazone half-life was not consistently altered, and vitamin D3 half-life was increased in 3 of 4 patients."( Effect of oral contraceptives on plasma clearance.
Bressler, R; Carter, DE; Christian, D; Haussler, MR; Heine, MW; Hughes, MR, 1975
)
0.25
" Pharmacokinetic analysis of 25-hydroxycholecalciferol in affected lambs following intramuscular injection of 1,000,000 IU vitamin D3 indicated that transport of vitamin D3 from the site of injection to the liver and its metabolism to 25-hydroxycholecalciferol were rapid."( Pharmacokinetics and amounts of 25-hydroxycholecalciferol in sheep affected by osteodystrophy.
Hidiroglou, M; Ivan, M; Williams, CJ, 1979
)
0.79
" The half-life of the injected vitamin D3 was about 6 min."( Plasma clearance, transfer, and distribution of vitamin D3 from intestinal lymph.
Berg, T; Drevon, CA; Dueland, S; Helgerud, P; Pedersen, JI, 1983
)
0.27
"The objective of this study was to evaluate the pharmacokinetic parameters of 45Ca administered intravenously at a dose of 50 microCi in young lambs."( Pharmacokinetic study of 45Ca administered intravenously following intramuscular injection of vitamin D3 or 25-hydroxyvitamin D3 in early weaned lambs.
Hidiroglou, M; Raffy, S; Toutain, PL; Zhao, X, 1999
)
0.3
"We present here the first pharmacokinetic model describing the time-course of 25(OH)D."( Determination of optimal cholecalciferol treatment in renal transplant recipients using a population pharmacokinetic approach.
Benaboud, S; Courbebaisse, M; Friedlander, G; Hirt, D; Legendre, C; Prié, D; Souberbielle, JC; Thervet, E; Treluyer, JM; Urien, S, 2013
)
0.69
" To inform the design of prenatal vitamin D3 trials, we conducted a pharmacokinetic study of single-dose vitamin D3 supplementation in women of reproductive age."( Pharmacokinetics of a single oral dose of vitamin D3 (70,000 IU) in pregnant and non-pregnant women.
Al Mahmud, A; Baqui, AH; Black, RE; Raqib, R; Roth, DE, 2012
)
0.38
" The primary pharmacokinetic outcome measure was the change in serum 25-hydroxyvitamin D concentration over time, estimated using model-independent pharmacokinetic parameters."( Pharmacokinetics of a single oral dose of vitamin D3 (70,000 IU) in pregnant and non-pregnant women.
Al Mahmud, A; Baqui, AH; Black, RE; Raqib, R; Roth, DE, 2012
)
0.38
" The pharmacokinetic analysis was performed using a non-compartmental approach."( A simple and sensitive method for determination of vitamins D3 and K1 in rat plasma: application for an in vivo pharmacokinetic study.
Darlington, JW; Gershkovich, P; Ibrahim, F; Sivak, O; Wasan, KM, 2014
)
0.4
" The pharmacokinetic parameters of vitamin D3 following intravenous administration were: AUC0-∞ = 11323 ± 1081 h × ng/mL, Vd = 218 ± 80 mL/kg, CL = 8."( A simple and sensitive method for determination of vitamins D3 and K1 in rat plasma: application for an in vivo pharmacokinetic study.
Darlington, JW; Gershkovich, P; Ibrahim, F; Sivak, O; Wasan, KM, 2014
)
0.4
" A higher dose of vitamin K1 should be used in future studies for accurate estimation of pharmacokinetic parameters."( A simple and sensitive method for determination of vitamins D3 and K1 in rat plasma: application for an in vivo pharmacokinetic study.
Darlington, JW; Gershkovich, P; Ibrahim, F; Sivak, O; Wasan, KM, 2014
)
0.4
"A pharmacokinetic study was conducted to assess the biochemical dose-response and tolerability of high-dose prenatal vitamin D3 supplementation in Dhaka, Bangladesh (23°N)."( Pharmacokinetics of high-dose weekly oral vitamin D3 supplementation during the third trimester of pregnancy in Dhaka, Bangladesh.
Akhtar, E; Al Mahmud, A; Baqui, AH; Black, RE; Raqib, R; Roth, DE, 2013
)
0.39
" Pharmacokinetic parameters were calculated, and the 90% CIs of the ratios of the geometric means of the parameters were determined from the logarithmically transformed data by using ANOVA."( Comparison of the pharmacokinetics, safety, and tolerability of vitamin D3 in DP-R206 (150-mg ibandronate/24,000-IU vitamin D3 tablet) and as monotherapy (24,000 iu) in healthy male Korean adults.
Chae, SW; Im, YJ; Jeon, JY; Jun, H; Kim, EY; Kim, MG; Kim, Y; Lee, JW; Lee, SY; Lee, TW; Park, TS, 2014
)
0.4
" Concentration of these two agents was determined in rat plasma after simultaneous subcutaneous administration in free form or when loaded into SLNs thus establishing pharmacokinetic application of the developed procedure."( Development of a validated UPLC method for simultaneous estimation of both free and entrapped (in solid lipid nanoparticles) all-trans retinoic acid and cholecalciferol (vitamin D3) and its pharmacokinetic applicability in rats.
Chauhan, AS; Kaur, IP; Kumar, M; Sahwney, S; Sharma, G; Singh, G; Singh, S; Singla, D, 2014
)
0.6
" A total of 171 25(OH)D concentrations were used to perform a population pharmacokinetic analysis."( Determination of optimal vitamin D3 dosing regimens in HIV-infected paediatric patients using a population pharmacokinetic approach.
Benaboud, S; Blanche, S; Bouazza, N; Chappuy, H; Foissac, F; Frange, P; Friedlander, G; Meyzer, C; Souberbielle, JC; Tréluyer, JM; Urien, S, 2014
)
0.4
" The objective of this study was to evaluate the pharmacokinetic properties of oral supplementation versus a single intramuscular injection of cholecalciferol in healthy individuals."( Pharmacokinetic Evaluation of a Single Intramuscular High Dose versus an Oral Long-Term Supplementation of Cholecalciferol.
Dölle, S; Drozdenko, G; Heine, G; Krannich, A; Worm, M; Wylon, K, 2017
)
0.87
" The current work describes a population pharmacokinetic (PK) model for D2 and 25OHD2 and the use of a previously developed D3-25OHD3 PK model [1] for comparing D3 and D2-related exposures."( Model-based meta-analysis for comparing Vitamin D2 and D3 parent-metabolite pharmacokinetics.
Gastonguay, MR; Ocampo-Pelland, AS; Riggs, MM, 2017
)
0.46
" This study developed a physiologically based pharmacokinetic (PBPK) model utilizing published human data on the metabolic cascade of orally derived, low-concentration (placebo, 5 μg and 10 μg) supplementation of vitamin D over the course of 28 days in the absence of sunlight."( A physiologically based pharmacokinetic model of vitamin D.
Evans, MV; Sawyer, ME; Tran, HT, 2017
)
0.46
"A randomized, double-blind crossover trial was performed in 6 malabsorptive patients and 10 healthy participants who were given 900 µg of either vitamin D3 or 25(OH)D3 orally followed by a pharmacokinetic study (PKS)."( A pilot-randomized, double-blind crossover trial to evaluate the pharmacokinetics of orally administered 25-hydroxyvitamin D3 and vitamin D3 in healthy adults with differing BMI and in adults with intestinal malabsorption.
Apovian, CM; Charoenngam, N; Desai, S; Holick, MF; Kalajian, TA; McCarthy, A; Shirvani, A; Yoon, GH, 2021
)
0.62
"Comparative pharmacodynamic (PD) analyses on different dosing schedules for cholecalciferol supplementation are limited."( Pharmacodynamics of Oral Cholecalciferol in Healthy Individuals with Vitamin D Deficiency: A Randomized Open-Label Study.
Adami, G; Benini, C; Bertoldo, E; Fassio, A; Fracassi, E; Gatti, D; Gatti, M; Milleri, S; Rossini, M; Viapiana, O, 2021
)
1.15
" This study aimed to examine the pharmacokinetic interactions between these two drugs and the tolerability of their combined administration in healthy male subjects."( Pharmacokinetic Interactions Between Bazedoxifene and Cholecalciferol: An Open-Label, Randomized, Crossover Study in Healthy Male Volunteers.
Bae, KS; Cho, YS; Han, S; Hong, SH; Jung, J; Kim, H; Lee, MH; Lee, SH; Lim, HS; Yoon, SK, 2023
)
1.16
" Pharmacokinetic parameters were calculated using the non-compartmental method."( Pharmacokinetic Interactions Between Bazedoxifene and Cholecalciferol: An Open-Label, Randomized, Crossover Study in Healthy Male Volunteers.
Bae, KS; Cho, YS; Han, S; Hong, SH; Jung, J; Kim, H; Lee, MH; Lee, SH; Lim, HS; Yoon, SK, 2023
)
1.16
"A mild degree of pharmacokinetic interaction was observed when bazedoxifene and cholecalciferol were administered concomitantly to healthy male volunteers."( Pharmacokinetic Interactions Between Bazedoxifene and Cholecalciferol: An Open-Label, Randomized, Crossover Study in Healthy Male Volunteers.
Bae, KS; Cho, YS; Han, S; Hong, SH; Jung, J; Kim, H; Lee, MH; Lee, SH; Lim, HS; Yoon, SK, 2023
)
1.39

Compound-Compound Interactions

The other patch was treated with microneedling combined with topical cholecalciferol. To our knowledge, this is the first study to evaluate the effect of topical vitamin D (cholecalCiferol) combined with micronesia.

ExcerptReferenceRelevance
"Previous experiments have shown that a variety of agents that interfere with the activity of the transcription factor NF-kB significantly enhanced the differentiation of HL-60 leukemia cells when combined with low levels of the monocytic/macrophagic differentiating agent vitamin D3."( Induction of the differentiation of HL-60 promyelocytic leukemia cells by nonsteroidal anti-inflammatory agents in combination with low levels of vitamin D3.
Sartorelli, AC; Sokoloski, JA, 1998
)
0.3
"In the first oftwo experiments, 123 calf-fed steers were used over a 2-yr period to evaluate the effects of trenbolone acetate (TBA)-based implants administered alone or in combination with zeranol implants on fresh beef muscle quality, color, and physiological maturity of the carcass."( Effects of implant regimens (trenbolone acetate-estradiol administered alone or in combination with zeranol) and vitamin D3 on fresh beef color and quality.
Johnson, DD; Reiling, BA, 2003
)
0.32
" The pyrolysis product were separated With an HP-5 column and identified by the NIST mass spectral search program in combination with the correlation of boiling point and retention time (BP-RT)."( Study of thermal behavior of vitamin D3 by pyrolysis-GC-MS in combination with boiling point-retention time correlation.
Liu, B; Sun, Y; Wang, G; Xie, B; Zhang, R,
)
0.13
" Therefore, we performed the treatment of pigmented lesions with NF1 by intense pulsed-radio frequency (IPL-RF) in combination with topical application of vitamin D(3) ointment."( Treatment of pigmented lesions of neurofibromatosis 1 with intense pulsed-radio frequency in combination with topical application of vitamin D3 ointment.
Furumura, M; Nakayama, J; Sato, N; Yoshida, Y, 2007
)
0.34
" The aim of this study was to investigate the possible influence of 1alpha,25-dihydroxyvitamin D(3) (calcitriol) and 1alpha,24(R)-dihydroxyvitamin D(3) (tacalcitol) in monotherapy and in combination with budesonid R (BR) on NP fibroblast proliferation."( Influence of vitamin D(3) analogues in combination with budesonid R on proliferation of nasal polyp fibroblasts.
Fraczek, M; Gawron, W; Latocha, M; Rostkowska-Nadolska, B, 2009
)
0.35
" In the present study, we investigated the effects of all-trans retinoic acid (ATRA), vitamin D₃ and resveratrol alone and in combination with adenosine analogues, 2-chloro-2'-deoxyadenosine (2CdA) and 9-β-d-arabinosyl-2-fluoroadenine (F-ara-A), on the methylation and expression of phosphatase and tensin homologue (PTEN) tumour suppressor gene in MCF-7 and MDA-MB-231 breast cancer cells."( Comparative effects of retinoic acid, vitamin D and resveratrol alone and in combination with adenosine analogues on methylation and expression of phosphatase and tensin homologue tumour suppressor gene in breast cancer cells.
Bednarek, A; Fabianowska-Majewska, K; Salamé, P; Stefanska, B, 2012
)
0.38
"To evaluate the effects of different doses of phytoestrogen (genitein) combined with calcium and vitamin D3 on preventing osteoporosis in ovariectomized (OVX) mice."( [Effects of phytoestrogen, genistein combined with calcium and vitamin D3 on preventing osteoporosis in ovariectomized mice].
Gao, L; Wang, Q; Xue, Y; Zhang, Y, 2011
)
0.37
"It was lower stimulative effect of low dose of phytoestrogen (genitein) combined with calcium and vitamin D3 on elevating uterine weight in ovariectomized mice."( [Effects of phytoestrogen, genistein combined with calcium and vitamin D3 on preventing osteoporosis in ovariectomized mice].
Gao, L; Wang, Q; Xue, Y; Zhang, Y, 2011
)
0.37
"We assessed the effects of progressive resistance training (PRT) combined with a protein-enriched diet facilitated through lean red meat on lean tissue mass (LTM), muscle size, strength and function, circulating inflammatory markers, blood pressure, and lipids in elderly women."( Protein-enriched diet, with the use of lean red meat, combined with progressive resistance training enhances lean tissue mass and muscle strength and reduces circulating IL-6 concentrations in elderly women: a cluster randomized controlled trial.
Daly, RM; Dunstan, DW; Grimes, CA; Mundell, NL; Nowson, CA; O'Connell, SL, 2014
)
0.4
"5 μg/day) for 4 weeks, and then they were given pegylated interferon (Peg-IFN)-α2a plus ribavirin therapy in combination with either vitamin D3 for 48 or 72 weeks according to the response-guided manner."( Randomized study comparing vitamin D3 and 1α-Hydroxyvitamin D3 in combination with pegylated interferon/ribavirin therapy for chronic hepatitis C.
Asabe, S; Funyu, J; Hashimoto, Y; Hosoda, Y; Inao, M; Koshima, Y; Mochida, S; Nakayama, N; Nishikawa, K; Omori-Mizuno, Y; Tanaka, M; Tomita, K; Yakabi, K, 2015
)
0.42
" In conclusion, vitamin D3 supplementation in combination with weight-loss of at least 5% of baseline weight was associated with significant reductions in levels of IL6."( Effect of Vitamin D3 Supplementation in Combination with Weight Loss on Inflammatory Biomarkers in Postmenopausal Women: A Randomized Controlled Trial.
de Dieu Tapsoba, J; Duggan, C; Imayama, I; Korde, L; Mason, C; McTiernan, A; Wang, CY, 2015
)
0.42
" Our aim in this research was to study the effects of vitamin D3 combined with metformin on the apoptosis induction and its mechanisms in the human breast cancer cell line MDA-MB-231."( Synergistic antitumor activity of vitamin D3 combined with metformin in human breast carcinoma MDA-MB-231 cells involves m-TOR related signaling pathways.
Chen, J; Gao, JM; Gao, MT; Guo, LS; Li, CY; Li, HX; Liang, JQ; Wang, QL; Wu, YJ; Zhang, SY, 2015
)
0.42
" Vitamin D compounds have been shown to exert synergistic effects when used in combination with different agents used in anticancer therapies in different cancer models."( Vitamin D derivatives potentiate the anticancer and anti-angiogenic activity of tyrosine kinase inhibitors in combination with cytostatic drugs in an A549 non-small cell lung cancer model.
Filip-Psurska, B; Kutner, A; Maj, E; Milczarek, M; Psurski, M; Wietrzyk, J, 2018
)
0.48
" Individuals from each group completed a 12-week NW training program (3 times a week/2 hours) combined with randomized Vitamin D supplementation (HD = high dose: 4000 IU/day or LD = low dose: 800 IU/day)."( The Effect of Nordic Walking Training Combined with Vitamin D Supplementation on Postural Control and Muscle Strength in Elderly People-A Randomized Controlled Trial.
Antosiewicz, J; Gmiat, A; Kochanowicz, A; Kortas, J; Mieszkowski, J; Niespodziński, B; Prusik, K; Ziemann, E, 2018
)
0.48
" An ultralow concentration of the local anesthetic agent bupivacaine reduced 5-HT-evoked intracellular Ca2+ release, and an ultralow concentration of the phosphodiesterase-5 inhibitor sildenafil in combination with vitamin D3 reduced ATP-evoked intracellular Ca2+ release."( Anti-inflammatory effects induced by ultralow concentrations of bupivacaine in combination with ultralow concentrations of sildenafil (Viagra) and vitamin D3 on inflammatory reactive brain astrocytes.
Hansson, E; Skiöldebrand, E, 2019
)
0.51
" The current study aimed to determine whether the allogenic response of adoptively transferred memory T cells in mice was suppressed by vitamin D3 monotherapy alone or in combination with monoclonal antibody treatment."( Vitamin D3 combined with antibody agents suppresses alloreactive memory T-cell responses to induce heart allograft long-term survival.
Dai, H; Di, A; Luo, X; Ma, Y; Qi, Z; Wang, C; Xi, Y; Xie, B; Xu, S; Yan, G, 2021
)
0.62
" Recipient mice were administered vitamin D3 alone or in combination with monoclonal antibodies (anti-CD40L/ anti-LFA-1)."( Vitamin D3 combined with antibody agents suppresses alloreactive memory T-cell responses to induce heart allograft long-term survival.
Dai, H; Di, A; Luo, X; Ma, Y; Qi, Z; Wang, C; Xi, Y; Xie, B; Xu, S; Yan, G, 2021
)
0.62
"Vitamin D3 efficiently protected allografts from memory T-cell allo-responses when combined with anti-CD40L/anti-LFA-1 antibodies therapy."( Vitamin D3 combined with antibody agents suppresses alloreactive memory T-cell responses to induce heart allograft long-term survival.
Dai, H; Di, A; Luo, X; Ma, Y; Qi, Z; Wang, C; Xi, Y; Xie, B; Xu, S; Yan, G, 2021
)
0.62
"In the present study, we assessed the adjunct effect of vitamin D3 in combination with Fluconazole (FLZ) against Vulvovaginal Candidiasis (VVC) in mice."( Prophylactic and Therapeutic Role of Vitamin D3 in Combination with Fluconazole Against Vaginal Candidiasis in a Murine Model.
Allemailem, KS, 2021
)
0.62
" To our knowledge, this is the first study to evaluate the effect of topical vitamin D (cholecalciferol) combined with microneedling in the treatment of depigmented patches of vitiligo."( Efficacy of topical vitamin D combined with microneedling in the treatment of vitiligo: A comparative study.
Adel Abd El Azim, A; Galal, SA; Salem, MW, 2023
)
1.13
" The other patch was treated with microneedling combined with topical cholecalciferol."( Efficacy of topical vitamin D combined with microneedling in the treatment of vitiligo: A comparative study.
Adel Abd El Azim, A; Galal, SA; Salem, MW, 2023
)
1.14
"Topical cholecalciferol is a relatively effective and safe alternative in the treatment of stable vitiligo and its combination with microneedling increases its efficacy."( Efficacy of topical vitamin D combined with microneedling in the treatment of vitiligo: A comparative study.
Adel Abd El Azim, A; Galal, SA; Salem, MW, 2023
)
1.34

Bioavailability

The amount of fat with which vitamin D is ingested does not seem to significantly modify the bioavailability of vitamin D3. The food matrix has apparently little effect on vitamin D bioavailability. sucrose polyesters (Olestra) and tetrahydrolipstatin (orlistat) probably diminish vitamin D absorption.

ExcerptReferenceRelevance
" In both the jejunum and the ileum a linear relationship was found between the absorption rate of the vitamin and its intraluminal concentration."( Vitamin D-3 intestinal absorption in vivo: influence of fatty acids, bile salts, and perfusate pH on absorption.
Hollander, D; Muralidhara, KS; Zimmerman, A, 1978
)
0.26
"Oral vitamin D3 was poorly absorbed by 4 out of 6 patients with primary biliary cirrhosis; absorption was negatively correlated with faecal fat excretion."( Absorption, hydroxylation, and excretion of vitamin D3 in primary biliary cirrhosis.
Grundman, MJ; Krawitt, EL; Mawer, EB, 1977
)
0.26
" These results are interpreted to indicate that, in Finland, the commonly used amounts of dietary vitamins A and E or their bioavailability in vitamin-mineral concentrates are not sufficient to maintain serum concentrations in winter even close to the levels found in horses on pasture."( Vitamin A, E and D nutrition in mares and foals during the winter season: effect of feeding two different vitamin-mineral concentrates.
Koskinen, E; Mäenpää, PH; Pirhonen, A, 1988
)
0.27
" The average rate of absorption of 1,25-dihydroxyvitamin D3 [1,25(OH)2D3] was two- and fivefold higher than that of 25-hydroxyvitamin D3 [25(OH)D3] and vitamin D3 (D3), respectively."( Intestinal metabolism and portal venous transport of 1,25(OH)2D3, 25(OH)D3, and vitamin D3 in the rat.
Baylink, DJ; Lau, KH; McDonald, GB; Schy, AL; Wergedal, JE, 1985
)
0.27
" This last value is similar to the magnesium absorption rate in untreated normal subjects."( Effect of 1,25-(OH)2D3 on jejunal absorption of magnesium in patients with chronic renal disease.
Fordtran, JS; Lerman, M; Morawski, S; Pak, CY; Schmulen, AC; Vergne-Marini, P; Zerwekh, J, 1980
)
0.26
" Because vitamin D3 absorption rate is partly regulated by the dimensions of the unstirred water layer, we assessed the dimensions of the UWL of our aging animals."( Influence of aging on vitamin D absorption and unstirred water layer dimensions in the rat.
Hollander, D; Tarnawski, H, 1984
)
0.27
" When rats were cannulated in the intestinal lymph duct and given an intraduodenal bolus of [3H]retinol and 14C-labelled vitamin D-3, 14C-labeled vitamin D-3 appeared later in the intestinal lymph than [3H]retinol and the rate of absorption of vitamin D-3 was still maximal at a time when that of retinol had declined."( Lymphatic absorption and transport of retinol and vitamin D-3 from rat intestine. Evidence for different pathways.
Berg, T; Blomhoff, R; Drevon, CA; Dueland, S; Helgerud, P; Norum, KR; Pedersen, JI, 1984
)
0.27
" Nonesterified vitamin D2 is well absorbed both in very young and older infants, although absorption efficiency increases with age, perhaps due to increased bile acid secretion."( Effect of age on the intestinal absorption of vitamin D3-palmitate and nonesterified vitamin D2 in the term human infant.
Guy, DG; Hansen, JW; Hollis, BW; Lowery, JW; Pittard, WB, 1996
)
0.29
"Obesity-associated vitamin D insufficiency is likely due to the decreased bioavailability of vitamin D(3) from cutaneous and dietary sources because of its deposition in body fat compartments."( Decreased bioavailability of vitamin D in obesity.
Chen, TC; Holick, MF; Lu, Z; Matsuoka, LY; Wortsman, J, 2000
)
0.31
" This effect could not be explained by an higher P bioavailability in the 25OHD3-fed chickens."( Performance and bone development in broiler chickens given 25-hydroxycholecalciferol.
Bar, A; Plavnik, I; Razaphkovsky, V; Vax, E, 2003
)
0.55
"The goals of the experiments reported in this paper were to explore skin bioavailability and cell growth inhibitory activity of new vitamin D3-based conjugates studied as a potential drug complex for psoriasis."( Vitamin D3-based conjugates for topical treatment of psoriasis: synthesis, antiproliferative activity, and cutaneous penetration studies.
Ben-Shabat, S; Benisty, R; Sintov, AC; Wormser, U, 2005
)
0.33
"We conducted 2 studies to determine the effect of vitamin D-fortified cheese on vitamin D status and the bioavailability of vitamin D in cheese."( Bioavailability of vitamin D from fortified process cheese and effects on vitamin D status in the elderly.
Hogie-Lorenzen, T; Hollis, BW; Johnson, JL; Mistry, VV; Specker, BL; Vukovich, MD, 2005
)
0.33
", cheese, yogurt, and ice cream) with vitamin D3; however, the inherent complexity of these foods may influence the stability and bioavailability of this nutrient."( Interactions of vitamin D3 with bovine beta-lactoglobulin A and beta-casein.
Forrest, SA; Rousseau, D; Yada, RY, 2005
)
0.33
" The mean oral bioavailability of alendronate or colecalciferol is similar when administered alone or as one once-weekly tablet containing alendronate/colecalciferol 70 mg/2800 IU."( Alendronate/colecalciferol.
Curran, MP; Reynolds, NA, 2005
)
0.33
"The aim of the present study was to compare the bioavailability of calcium from calcium carbonate and milk and to investigate if 1,200 IU of cholecalciferol a day increased intestinal absorption of calcium."( Bioavailability of calcium: comparison of calcium carbonate and milk and the effect of vitamin D, age, and sex using 24-hour urine calcium as a method.
Eskildsen, PC; Hitz, MF; Jensen, JB, 2005
)
0.53
" The bioavailability of cholecalciferol from bread is not known."( Bread fortified with cholecalciferol increases the serum 25-hydroxyvitamin D concentration in women as effectively as a cholecalciferol supplement.
Huttunen, M; Jakobsen, J; Kärkkäinen, MU; Lamberg-Allardt, CJ; Natri, AM; Palssa, A; Piironen, V; Salo, P; Salovaara, H; Vikstedt, T, 2006
)
0.96
"To examine the correlation between the in vitro solubilization process of lipophilic compounds from different lipid solutions and the corresponding in vivo oral bioavailability data."( Use of a dynamic in vitro lipolysis model to rationalize oral formulation development for poor water soluble drugs: correlation with in vivo data and the relationship to intra-enterocyte processes in rats.
Dahan, A; Hoffman, A, 2006
)
0.33
" The absolute oral bioavailability of the drugs from the tested formulations was investigated in rats."( Use of a dynamic in vitro lipolysis model to rationalize oral formulation development for poor water soluble drugs: correlation with in vivo data and the relationship to intra-enterocyte processes in rats.
Dahan, A; Hoffman, A, 2006
)
0.33
" The bioavailability of progesterone correlated with the in vitro data, despite its significant pre-systemic metabolism."( Use of a dynamic in vitro lipolysis model to rationalize oral formulation development for poor water soluble drugs: correlation with in vivo data and the relationship to intra-enterocyte processes in rats.
Dahan, A; Hoffman, A, 2006
)
0.33
"Many types of vitamin supplements are available on the market, but little is known about whether cholecalciferol obtained from fat-containing capsules differs in bioavailability from that of solid tablets."( A randomised comparison of increase in serum 25-hydroxyvitamin D concentration after 4 weeks of daily oral intake of 10 microg cholecalciferol from multivitamin tablets or fish oil capsules in healthy young adults.
Holvik, K; Lofthus, CM; Madar, AA; Meyer, HE; Stene, LC, 2007
)
0.76
" Our aim was to characterize the bioavailability of vitamin D from fortified cheeses."( The bioavailability of vitamin D from fortified cheeses and supplements is equivalent in adults.
Rousseau, D; Sidhom, G; Vieth, R; Wagner, D; Whiting, SJ, 2008
)
0.35
"There is a strong interest in developing an in vitro arsenic (As) model that satisfactorily estimates the variability in in vivo relative oral bioavailability (RBA) measurements."( In vitro model improves the prediction of soil arsenic bioavailability: worst-case scenario.
Datta, R; Makris, KC; Nagar, R; Quazi, S; Sarkar, D; Sylvia, VL, 2008
)
0.35
" In addition, MART-10 has a lower affinity for DBP and less substrate degradation by CYP24A1 compared to 1alpha,25(OH)2D3, indicating that MART-10 has more bioavailability and a longer half-life."( Evaluation of 19-nor-2alpha-(3-hydroxypropyl)-1alpha,25-dihydroxyvitamin D3 as a therapeutic agent for androgen-dependent prostate cancer.
Chen, TC; Chiang, KC; Flanagan, JN; Holick, MF; Kittaka, A; Mathieu, JS; Nakabayashi, S; Persons, KS; Sakaki, T; Spanjaard, RA; Zhao, X; Zheng, S, 2009
)
0.35
"The objective was to compare the bioavailability of vitamin D(2) and vitamin D(3) from orange juice with that from vitamin D(2) and vitamin D(3) supplements."( Fortification of orange juice with vitamin D(2) or vitamin D(3) is as effective as an oral supplement in maintaining vitamin D status in adults.
Ameri, A; Biancuzzo, RM; Bibuld, D; Cai, MH; Chen, TC; Holick, MF; Klein, EK; Reitz, R; Salameh, W; Winter, MR; Young, A, 2010
)
0.36
"To evaluate the bioavailability of vitamin D in capsules as compared with oily drops in nuns living in a closed community with very low sun exposure."( Bioavailability of vitamin D3 in non-oily capsules: the role of formulated compounds and implications for intermittent replacement.
Andrade, LD; Bandeira, F; Coelho, IM; Diniz, ET; Griz, L; Saldanha, L, 2010
)
0.36
" The bioavailability of vitamin D(3) is similar in the combination tablets and when administered alone."( Bioavailability of alendronate and vitamin D(3) in an alendronate/vitamin D(3) combination tablet.
Chavez-Eng, C; Constanzer, M; Denker, AE; Gottesdiener, K; Larson, P; Lazarus, N; Maganti, L; Porras, A; Ramakrishnan, R; Scott, BB; Wagner, JA; Woolf, E, 2011
)
0.37
"Insulin-like growth factor binding protein-6 (IGFBP-6) is a secreted glycoprotein that reduces the bioavailability of IGFs."( A novel interaction between insulin-like growth factor binding protein-6 and the vitamin D receptor inhibits the role of vitamin D3 in osteoblast differentiation.
Chen, H; Cui, J; Huang, B; Ma, C; Ma, X; Qiu, J; Wang, X, 2011
)
0.37
" The bioavailability of vitamin D during malnutrition is unknown."( Bioavailability of vitamin D in malnourished adolescents with anorexia nervosa.
Brown, JN; Divasta, AD; Feldman, HA; Giancaterino, C; Gordon, CM; Holick, MF, 2011
)
0.37
"Despite severe malnutrition, young women with AN had a similar bioavailability of oral ergocalciferol as the healthy-weighted controls."( Bioavailability of vitamin D in malnourished adolescents with anorexia nervosa.
Brown, JN; Divasta, AD; Feldman, HA; Giancaterino, C; Gordon, CM; Holick, MF, 2011
)
0.37
" In mice, cholecalciferol bioavailability was 15-fold lower in the presence of β-sitosterol (p<0."( Phytosterols can impair vitamin D intestinal absorption in vitro and in mice.
Amiot, MJ; Borel, P; Bott, R; Gleize, B; Goncalves, A; Lairon, D; Nowicki, M; Reboul, E, 2011
)
0.77
"We evaluated the long-term bioavailability and metabolism of a single po or intramuscular (im) high dose of ergocalciferol (D₂) or D₃."( Long-term bioavailability after a single oral or intramuscular administration of 600,000 IU of ergocalciferol or cholecalciferol: implications for treatment and prophylaxis.
Carlucci, L; Cipriani, C; McMahon, DJ; Minisola, S; Nieddu, L; Pepe, J; Piemonte, S; Romagnoli, E; Russo, S; Singh, R, 2013
)
0.6
" Therefore, the current study suggests that the βlg/D3 complex can effectively be used for the fortification of milk products and low-fat content foods to improve the intake and bioavailability of D3."( Increased stability and protease resistance of the β-lactoglobulin/vitamin D3 complex.
Alvarez, P; Beyssac, E; Diarrassouba, F; Garrait, G; Remondetto, G; Subirade, M, 2014
)
0.4
" Simultaneous administration of these two vitamins and their improved and prolonged bioavailability has scope for their use in treatment and control of tuberculosis."( Development of a validated UPLC method for simultaneous estimation of both free and entrapped (in solid lipid nanoparticles) all-trans retinoic acid and cholecalciferol (vitamin D3) and its pharmacokinetic applicability in rats.
Chauhan, AS; Kaur, IP; Kumar, M; Sahwney, S; Sharma, G; Singh, G; Singh, S; Singla, D, 2014
)
0.6
" The present study was undertaken to investigate the effect of VD supplementation on the bioavailability and lipid lowering effect of simvastatin (ST)."( Effect of vitamin D on bioavailability and lipid lowering efficacy of simvastatin.
Al-Asmari, AK; Al-Eid, A; Al-Omani, SF; Al-Sabaan, F; Tariq, M; Ullah, Z, 2015
)
0.42
" The main conclusions are: (i) ergocalciferol (vitamin D2), the form mostly used in supplements and fortified foods, is apparently absorbed with similar efficiency to cholecalciferol (vitamin D3, the main dietary form), (ii) 25-hydroxyvitamin D (25OHD), the metabolite produced in the liver, and which can be found in foods, is better absorbed than the nonhydroxy vitamin D forms cholecalciferol and ergocalciferol, (iii) the amount of fat with which vitamin D is ingested does not seem to significantly modify the bioavailability of vitamin D3, (iv) the food matrix has apparently little effect on vitamin D bioavailability, (v) sucrose polyesters (Olestra) and tetrahydrolipstatin (orlistat) probably diminish vitamin D absorption, and (vi) there is apparently no effect of aging on vitamin D absorption efficiency."( Vitamin D bioavailability: state of the art.
Borel, P; Caillaud, D; Cano, NJ, 2015
)
0.61
"Vitamin D3 could be well absorbed through nasal mucosa."( [Effect of nasal instillation of vitamin D3 on patient with allergic rhinitis symptoms].
Feng, Y; Gong, W; Jiang, Y; Li, S; Ren, X; Xu, F; Yan, P; Yu, C; Zhang, D; Zhou, J; Zhou, X, 2014
)
0.4
" Additionally, the impact of the sequestration of D3 within the matrix of βlg-based coagulum on its bioavailability was determined in vivo with force-fed rats."( Improved bioavailability of vitamin D3 using a β-lactoglobulin-based coagulum.
Alvarez, P; Beyssac, E; Diarrassouba, F; Garrait, G; Remondetto, G; Subirade, M, 2015
)
0.42
" The impact of the D3-loaded βlg/Lyso microspheres on the bioavailability of D3 was evaluated in vivo by force-feeding rats."( Food protein-based microspheres for increased uptake of vitamin D3.
Alvarez, P; Beyssac, E; Diarrassouba, F; Garrait, G; Remondetto, G; Subirade, M, 2015
)
0.42
"The aim of this study was to evaluate the effects of fortification and nano-size reduction on calcium absorption and bioavailability of milk powder formula in sham, ovariectomized, and ovariectomized-osteoporosis rats as a menopause and menopause-osteoporosis model."( Absorption and Bioavailability of Nano-Size Reduced Calcium Citrate Fortified Milk Powder in Ovariectomized and Ovariectomized-Osteoporosis Rats.
Abd Manap, MY; Bin Mustafa, S; Erfanian, A; Hair-Bejo, M; Mirhosseini, H; Rasti, B, 2015
)
0.42
"To assess the bioavailability and safety of vitamin D3 from fortified mozzarella cheese baked on pizza."( Bioavailability and Safety of Vitamin D3 from Pizza Baked with Fortified Mozzarella Cheese: A Randomized Controlled Trial.
Al-Khalidi, B; Chiu, W; Rousseau, D; Vieth, R, 2015
)
0.42
"There is an abnormal increase in TGF-β1 bioavailability in women with polycystic ovary syndrome (PCOS), which might play a role in the pathophysiology of this syndrome."( Vitamin D Supplementation Decreases TGF-β1 Bioavailability in PCOS: A Randomized Placebo-Controlled Trial.
Bhatt, D; Grazi, RV; Irani, M; Irani, S; Julka, N; Kalgi, B; Lambert-Messerlian, G; Seifer, DB; Tal, O; Tal, R, 2015
)
0.42
"The objective of the study was to determine the effect of VD supplementation on TGF-β1 bioavailability in VD-deficient women with PCOS and assess whether changes in TGF-β1/soluble endoglin (sENG) levels correlate with an improvement in PCOS clinical manifestations."( Vitamin D Supplementation Decreases TGF-β1 Bioavailability in PCOS: A Randomized Placebo-Controlled Trial.
Bhatt, D; Grazi, RV; Irani, M; Irani, S; Julka, N; Kalgi, B; Lambert-Messerlian, G; Seifer, DB; Tal, O; Tal, R, 2015
)
0.42
"VD supplementation in VD-deficient women with PCOS significantly decreases the bioavailability of TGF-β1, which correlates with an improvement in some abnormal clinical parameters associated with PCOS."( Vitamin D Supplementation Decreases TGF-β1 Bioavailability in PCOS: A Randomized Placebo-Controlled Trial.
Bhatt, D; Grazi, RV; Irani, M; Irani, S; Julka, N; Kalgi, B; Lambert-Messerlian, G; Seifer, DB; Tal, O; Tal, R, 2015
)
0.42
" We investigated the bioavailability of D2 from UV-irradiated yeast present in bread in an 8-week randomised-controlled trial in healthy 20-37-year-old women (n 33) in Helsinki (60°N) during winter (February-April) 2014."( Effects of vitamin D2-fortified bread v. supplementation with vitamin D2 or D3 on serum 25-hydroxyvitamin D metabolites: an 8-week randomised-controlled trial in young adult Finnish women.
Cashman, KD; Erkkola, M; Itkonen, ST; Jakobsen, J; Lamberg-Allardt, C; Saaristo, P; Saarnio, EM; Skaffari, E, 2016
)
0.43
" Our objectives were to assess the bioavailability of VD3, from fat-free yogurt, in re-assembled casein micelles (rCMs) compared to that in polysorbate-80 (PS80/Tween-80) a commonly used synthetic emulsifier, and to assess and compare their rheology and palatability."( Bioavailability, rheology and sensory evaluation of fat-free yogurt enriched with VD3 encapsulated in re-assembled casein micelles.
Ish-Shalom, S; Levinson, Y; Livney, YD; Segal, E, 2016
)
0.43
"This study was undertaken to evaluate the following: 1) the bioavailability of vitamin D from the fortified Iranian bread and 2) the possible effects of daily consumption of the fortified bread on certain health aspects."( Vitamin D-Fortified Bread Is as Effective as Supplement in Improving Vitamin D Status: A Randomized Clinical Trial.
Abdollahi, Z; Hosseini, SH; Kalayi, A; Lotfollahi, N; Maleki, MR; Mirzay Razaz, J; Mohammadi, M; Neyestani, TR; Nikooyeh, B; Salehi, F; Shariatzadeh, N; Zahedirad, M, 2016
)
0.43
" However, as bioavailability is related not only to the active molecules but also to the formulations and excipients used, the optimization of the pharmaceutical form of vitamin D₃ is also important."( A Randomised, Cross-Over Study to Estimate the Influence of Food on the 25-Hydroxyvitamin D₃ Serum Level after Vitamin D₃ Supplementation.
Cavalier, E; Coffiner, M; Da Silva, S; De Niet, S; Jandrain, B; Souberbielle, JC; Vanderbist, F, 2016
)
0.43
" Our results indicate that vitD may be encapsulated and stabilized for enrichment of clear beverages at neutral pH to improve the intake and bioavailability of vitD."( Using protein-fatty acid complexes to improve vitamin D stability.
Frislev, HS; Otzen, DE; Pedersen, JN; Pedersen, JS, 2016
)
0.43
"We assessed whether the variability in cholecalciferol bioavailability was associated with single-nucleotide polymorphisms (SNPs) in candidate genes."( A Combination of Single-Nucleotide Polymorphisms Is Associated with Interindividual Variability in Cholecalciferol Bioavailability in Healthy Men.
Borel, P; Desmarchelier, C; Goncalves, A; Kopec, R; Lesavre, N; Morange, S; Nowicki, M; Portugal, H; Reboul, E, 2016
)
0.92
"In healthy men, there is a high interindividual variability in cholecalciferol bioavailability that is associated with a combination of SNPs located in or near genes involved in both vitamin D and lipid metabolism."( A Combination of Single-Nucleotide Polymorphisms Is Associated with Interindividual Variability in Cholecalciferol Bioavailability in Healthy Men.
Borel, P; Desmarchelier, C; Goncalves, A; Kopec, R; Lesavre, N; Morange, S; Nowicki, M; Portugal, H; Reboul, E, 2016
)
0.89
" The developed systems not only enhanced the oral bioavailability of the drug, but also offered substantially elevated brain drug levels to that of plain drug."( Vitamin-Derived Nanolipoidal Carriers for Brain Delivery of Dimethyl Fumarate: A Novel Approach with Preclinical Evidence.
Katare, OP; Kumar, P; Kumar, R; Malik, R; Raza, K; Sharma, G; Singh, B, 2017
)
0.46
" Therefore, the developed NLCs are promising carriers for increasing the oral bioavailability of VD3."( Development of nanostructured lipid carriers for the encapsulation and controlled release of vitamin D3.
Garcia, CV; Kim, JT; Park, SJ; Shin, GH, 2017
)
0.46
"In the context of the global prevalence of vitamin D insufficiency, we compared two key determinants of the bioavailability of 3 vitamin D forms with significant biopotencies: cholecalciferol, 25-hydroxycholecalciferol and 1-α-hydroxycholecalciferol."( Comparison of the Micellar Incorporation and the Intestinal Cell Uptake of Cholecalciferol, 25-Hydroxycholecalciferol and 1-α-Hydroxycholecalciferol.
Borel, P; Desmarchelier, C; Margier, M; Nowicki, M; Prévéraud, DP; Reboul, E; Rosilio, V, 2017
)
0.88
"This study assessed bioavailability and utilisation of vitamin D3 in two feeding trials using young, growing Sprague-Dawley male rats."( Effect of the dietary delivery matrix on vitamin D3 bioavailability and bone mineralisation in vitamin-D3-deficient growing male rats.
Hodgkinson, AJ; Kruger, MC; Prosser, CG; Wallace, OAM, 2018
)
0.48
" Furthermore, metabolic changes are associated with transient increase in the bioavailability of antioxidants, including lactic acid and cholic acid and anti-inflammatory metabolites 3 deoxyvitamin D3, and docosahexaenoic acid."( A Metabolomic and Lipidomic Serum Signature from Nonhuman Primates Administered with a Promising Radiation Countermeasure, Gamma-Tocotrienol.
Cheema, AK; Fatanmi, OO; Hinzman, CP; Mehta, KY; Singh, VK; Wise, SY; Wolff, J, 2017
)
0.46
"Nanoemulsion formulation of vitamin D3 have been shown to have better bioavailability than the coarse emulsion preparation in vitro and in vivo animal studies."( A randomised controlled trial comparing the efficacy of micellised and fat-soluble vitamin D3 supplementation in healthy adults.
Arora, P; Chadha, A; Dang, N; Dev, T; Goel, M; Mani, K; Marwaha, RK; Mittal, A; Narang, A; Sethuraman, G; Sharma, VK; Singh, A, 2019
)
0.51
" Animal experiments exhibited that the bioavailability was significantly increased after vitamin D3 was encapsulated by the composite gel."( Stability and bioavailability of vitamin D3 encapsulated in composite gels of whey protein isolate and lotus root amylopectin.
Kong, XL; Li, QM; Liu, K; Luo, JP; Zha, XQ; Zhang, HL, 2020
)
0.56
" The study evaluated the effect of selected biocomponents on calcium bioavailability by using an in vitro digestion model."( Effect of fortification with calcium from eggshells on bioavailability, quality, and rheological characteristics of traditional Polish bread spread.
Jarzębski, M; Jędrusek-Golińska, A; Kobus-Cisowska, J; Kobus-Moryson, M; Marciniak, G; Rezler, R; Szczepaniak, O; Szymandera-Buszka, K; Szymanowska-Powałowska, D, 2020
)
0.56
" Postulated mechanisms include reduced bioavailability of intestinal cholesterol and alterations in endogenous cholesterol synthesis."( Exploring the effect of vitamin D3 supplementation on surrogate biomarkers of cholesterol absorption and endogenous synthesis in patients with type 2 diabetes-randomized controlled trial.
Angellotti, E; Lichtenstein, AH; Matthan, NR; Meng, H; Pittas, AG, 2020
)
0.56
" Oral Nanococh-D3 significantly increased the bioavailability of Vit-D3, enhanced bone mechanical strength, and improved osteogenic biomarkers including B-ALP, osteocalcin, Ca, and OPG in GIO rats."( Novel osteoprotective nanocochleate formulation: A dual combination therapy-codelivery system against glucocorticoid induced osteoporosis.
Alaeddini, M; Dehpour, AR; Doustimotlagh, AH; Eskandarynasab, M; Etemad-Moghadam, S; Goudarzi, R; Nazeri, A; Partoazar, A, 2020
)
0.56
"Equivocal association the contribution of 25-hydroxyvitamin D (25(OH)D) and the well-accepted role of vitamin D-binding protein (VDBP) on bioavailability of 25(OH)D or its independent roles, has led to possible association of the VDBP in glucose metabolism."( Association of vitamin D-binding protein and vitamin D
Amini, A; Casazza, K; Mehranfar, S; Mirzaei, K; Moradi, N; Setayesh, L; Yarizadeh, H; Yekaninejad, MS, 2021
)
0.62
" Mixed micelles (MM) have potential to enhance bioavailability of vitamin-D."( Improving vitamin D
Brougham, DF; Lyng, JG; Mulrooney, SL; O'Neill, GJ; O'Riordan, D, 2021
)
0.62
"Novel protein-based nanovehicles offer alternatives to fat for delivery of lipophilic bioactives (nutraceuticals and drugs), yet they raise important questions regarding the bioavailability and absorption mechanism of the bioactive without fat."( Mechanisms of absorption of vitamin D
Cohen, Y; Lesmes, U; Livney, YD; Margier, M; Reboul, E, 2021
)
0.62
" Three important points were identified: i) theoretical models of fortification; ii) stability, bioaccessibility, and bioavailability studies of vitamin d-fortified breads; and iii) clinical effects of vitamin d-fortified breads."( Vitamin d-fortified bread: Systematic review of fortification approaches and clinical studies.
Borges, N; Souza, SVS; Vieira, EF, 2022
)
0.72
" While many foods can be vitamin D fortified, vitamin D bioavailability differs depending on fortification methods, food structure and composition."( Using food fortification to improve vitamin D bioaccessibility and intakes.
McCourt, AF; O'Sullivan, AM, 2022
)
0.72
" Subsequently, in vitro experiments were performed to evaluate the biological activity of Vitamin D3 complexed in the nanosponges on intestinal cells and assess its bioavailability without cytotoxic effect."( Developing New Cyclodextrin-Based Nanosponges Complexes to Improve Vitamin D Absorption in an In Vitro Study.
Bisericaru, DM; Cavalli, R; Ferrari, S; Matencio, A; Pagliaro, P; Penna, C; Trotta, F; Uberti, F, 2023
)
0.91
"Cytochrome P450 3A4 (CYP3A4) is involved in first-pass metabolism in the small intestine and is heavily implicated in oral drug bioavailability and pharmacokinetics."( The Effect of Vitamin D3 and Valproic Acid on the Maturation of Human-Induced Pluripotent Stem Cell-Derived Enterocyte-Like Cells.
Kato, Y; Koike, M; Kume, S; Leo, S; Shiraki, N; Tsuchiya, K; Wu, Y; Yokota, M; Yui, S, 2023
)
0.91

Dosage Studied

The best repletion and maintenance dosing regimens with cholecalciferol in vitamin D-deficient HIV-1 patients remain unknown. The National Institute of Standards and Technology has developed SRM 3532 Calcium-Containing Solid Oral Dosage Form.

ExcerptRelevanceReference
" Plasma-25-OHD was a power function of dosage with both compounds."( Comparison of oral 25-hydroxycholecalciferol, vitamin D, and ultraviolet light as determinants of circulating 25-hydroxyvitamin D.
Haddad, JG; Stamp, TC; Twigg, CA, 1977
)
0.55
" Thus, the dosage ratio of 25-hydroxyvitamin D3 to 1 alpha,25-dihydroxyvitamin D3 approximated 100:1."( Treatment of hypoparathyroidism and pseudohypoparathyroidism with metabolites of vitamin D: evidence for impaired conversion of 25-hydroxyvitamin D to 1 alpha,25-dihydroxyvitamin D.
Belsey, RE; Clark, MB; DeLuca, HF; Fraser, D; Holick, MF; Kooh, SW; Murray, TM, 1975
)
0.25
" Treatment with 25 OH CC in high dosage brought about clinical, radiological and laboratory cure of osteomalacia in both cases, reducing the frequency of fits in the epileptic patient."( [4 cases of osteomalacia during anticonvulsant or sedative treatment].
Alcalay, M; Amor, B; Bontoux, D; Cayla, J; Charbonnier, A; Mery, C; Miravet, L; Rondier, J, 1975
)
0.25
" All of the compounds promoted bone mineralization in a linear log dose-response relationship."( Relative activities of some metabolites and analogs of cholecalciferol in stimulation of tibia ash weight in chicks otherwise deprived of vitamin D.
Boris, A; Hurley, JF; Trmal, T, 1977
)
0.5
" after dosing with D3 and 6 hr."( Effect of dietary aflatoxin on vitamin D3 metabolism in chicks.
Britton, WM; Wyatt, RD, 1978
)
0.26
" Calcium-binding-protein mRNA could only just be detected in the intestinal nuclei 2h after dosing with these steroids which is the same time that it was first observed in the polyribosomes."( Stimulation of intestinal calcium-binding-protein mRNA synthesis in the nucleus of vitamin D-deficient chicks by 1,25-dihydroxycholecalciferol.
Charman, M; Lawson, DE; Spencer, R, 1978
)
0.46
" A close correlation between the dosage of D3-vitamin and the amount of Ca2+ consumed by the intestine from the solution and bound with the mucosa was established."( [Rapid biological method for assessing D-vitamin supply of chicks].
Andrushaĭte, RE; Bauman, VK; Berzin', NI,
)
0.13
" In addition considering that a lower dosage is required of 25OHD3 compared to vit."( [Behavior of serum 25-hydroxycholecalciferol in humans after administration of vitamin D and 25-OHD3].
Bianchi, AR; Bianchini, G; Casciani, CU; Coen, G; Gallucci, G; Lucentini, G; Matteucci, MC; Picca, S; Taccone Gallucci, M, 1979
)
0.55
" The results indicate that the maximal stimulation of transcaltachia occurs at 50 pM PTHrP(1-40), and that the dose-response curve is biphasic in nature."( A parathyroid-related peptide induces transcaltachia (the rapid, hormonal stimulation of intestinal Ca2+ transport).
Nemere, I; Norman, AW; Zhou, LX, 1992
)
0.28
" Adverse effects can be minimized by bedtime dosing and possibly the use of new noncalciotropic analogs."( Vitamin D therapy in psoriasis.
Araugo, OE; Brown, K; Flowers, FP,
)
0.13
" They responded to a reduction in dosage of vitamin D3."( Calcium imbalance in hypoparathyroidism.
Gupta, MM, 1991
)
0.28
" Dose-response curves following noradrenergic stimulation were shifted to the right after 13 (but not after 180) days recovery."( Vascular calcium overload produced by administration of vitamin D3 and nicotine in rats. Changes in tissue calcium levels, blood pressure, and pressor responses to electrical stimulation or norepinephrine in vivo.
Atkinson, J; Capdeville, C; Chillon, JM; Henrion, D; Hicks, PE; Martin, JA; Oster, L; Thorin, E; Thorin-Trescases, N, 1990
)
0.28
" However, thyroid hormone potentiates, by one order of magnitude, the dose-response effect of retinoic acid in HL-60 cells."( Stimulatory effect of thyroid hormone on RA-induced granulocytic differentiation in leukemic cells.
Balitrand, N; Ballerini, P; Chomienne, C; Lenoble, M; Najean, Y; Schaison, G, 1991
)
0.28
" The author suggests that combined therapy with hydrochlorothiazide, vitamin D3 and calcium prevents hypercalciuria but may require changes in vitamin D3 dosage and withdrawal of hydrochlorothiazide in some patients."( [Effect of hydrochlorothiazide on calcium metabolism in postoperative hypoparathyroidism].
Sawicki, A,
)
0.13
" Three-monthly administration of the moderate dosage of 100,000 IU of vitamin D3 all year round would offer a simple, effective and risk-free system to counteract vitamin D deficiency in the elderly and of preventing the risk of osteomalacia, thus reducing the incidence of fractures."( [Vitamin D supplementation in institutionalized elderly. Effects of vitamin D3 (100,000 IU) orally administered every 3 months on serum levels of 25-hydroxyvitamin D].
Garabedian, M; Jardel, A; Moulias, R; Salvatore, R; Zeghoud, F, 1990
)
0.28
" Serial measurements of the serum concentration of vitamin D3 after dosage were made."( Absorption of a pharmacological dose of vitamin D3 from two different lipid vehicles in man: comparison of peanut oil and a medium chain triglyceride.
Aksnes, L; Berlin, T; Holmberg, I; Lindbäck, B; Lindeke, B; Zemgals, J, 1990
)
0.28
" Six male and five female gastrostomy fed, nonambulant, epileptic, profoundly mentally retarded individuals ranging in age from 7 to 17 years were given vitamin D therapy at a dosage of 4,000 IU/m2 body surface area/day for 6 months."( Bone status in nonambulant, epileptic, institutionalized youth. Improvement with vitamin D therapy.
Adkins, WN; Fischer, MH; Liebl, BH; Marlett, JA; VanCalcar, SC, 1988
)
0.27
" This dosage appears therefore to be sufficient to reduce the risk of vitamin D deficiency of the newborn and the occurrence of neonatal hypocalcemia."( [Administration of a single dose of 100,000 U.I. of vitamin D3 in the pregnant woman in winter. The effect on blood calcium level of the newborn infant].
Bernard, N; Garabedian, M; Jardel, A; Melchior, J; Zeghoud, F, 1988
)
0.27
" to vitamin D-deficient rats, 25-hydroxyvitamin D3 and 1alpha,-25-dihydroxyvitamin D3 were detected in the serum at levels less than or equal to those noted in animals dosed with the respective free sterols."( Biologic activity of 3beta-D-glucopyranosides of vitamin D compounds.
Gross, M; Kost, SB; Kumar, R; Labler, L; Londowski, JM; Meier, W, 1985
)
0.27
" Repeated dosing provided for more efficient use of the injected vitamin D3."( Effect of parenteral vitamin D3 on plasma 25-hydroxyvitamin D3 concentration in sheep.
Smith, BS; Wright, H, 1985
)
0.27
" Only the daily dosage of 250,000 IU caused significant increases of concentrations of vitamin D or 25-hydroxyvitamin D in plasma."( Effects of dietary vitamin D3 on concentrations of vitamin D and its metabolites in blood plasma and milk of dairy cows.
Beitz, DC; Horst, RL; Littledike, ET; McDermott, CM, 1985
)
0.27
" Rapidly growing male rats were dosed with 24,25-dihydroxyvitamin D3 orally until plasma concentrations of 24,25-dihydroxyvitamin D3 were at steady state."( Metabolism and pharmacokinetics of 24,25-dihydroxyvitamin D3 in the vitamin D3-replete rat.
DeLuca, HF; Jarnagin, K; Phelps, M; Zeng, SY, 1985
)
0.27
" These variables may explain the inability of different laboratories to duplicate dose-response curves."( In vitro use of vitamin D3 metabolites: culture conditions determine cell uptake.
Brand, JS; Puzas, JE, 1985
)
0.27
" The effect of vitamin D metabolites was estimated on 3 experimental animals applying a daily dosage of 600."( [Effect of bile on intestinal calcium and vitamin D absorption. Animal experiment studies in swine].
Braun, F, 1986
)
0.27
" The dose-response curve was biphasic for all compounds studied; for 1,25(OH)2D3 initial stimulation of transport was detected at only 30 pM [the plasma concentration of 1,25(OH)2D3 is normally 125 pM] while maximal stimulation was 154% above control at a concentration of 650 pM."( Biological activity of vitamin D metabolites and analogs: dose-response study of 45Ca transport in an isolated chick duodenum perfusion system.
Norman, AW; Yoshimoto, Y, 1986
)
0.27
" The dose-response profiles for two additional bioresponses in these cells, namely induction of 24-hydroxylase and inhibition of 1 alpha-hydroxylase activity, were comparable to those for CaBP induction."( 1,25-Dihydroxyvitamin D3 induces the synthesis of vitamin D-dependent calcium-binding protein in cultured chick kidney cells.
Clemens, TL; Craviso, GL; Garrett, KP, 1987
)
0.27
" Dosing pregnant ewes with 300,000 iu of vitamin D3 in a rapidly available form, approximately two months before lambing, provided a safe means of increasing the vitamin D status of the ewe and the newborn lamb by preventing the seasonally low concentrations of 25-hydroxyvitamin D3."( Effect of vitamin D supplementation during pregnancy on the vitamin D status of ewes and their lambs.
Brown, KG; Smith, BS; Wright, H, 1987
)
0.27
" Comparison of stimulation of bone resorption by 25-hydroxycholecalciferol and parathyroid hormone reveals similarities with respect to time course, dose-response slope, and inhibition by calcitonin."( 25-Hydroxycholecalciferol: stimulation of bone resorption in tissue culture.
Blunt, JW; Deluca, HF; Raisz, LG; Trummel, CL, 1969
)
0.89
" The (3)H/(14)C ratios in these four radioactive components were the same as that of the dosed material (4."( Metabolism of vitamin D. A new cholecalciferol metabolite, involving loss of hydrogen at C-1, in chick intestinal nuclei.
Kodicek, E; Lawson, DE; Wilson, PW, 1969
)
0.53
" The assessment of radioactivity in plasma and tissues of outdoor sheep dosed with either tritiated 25-hydroxycholecalciferol or with equivalent amounts of tritiated cholecalciferol revealed that plasma and tissue radioactivity were substantially higher in sheep dosed with tritiated 25-hydroxycholecalciferol than in sheep dosed with tritiated cholecaliferol."( Fate of isotopically labeled cholecalciferol and 25-hydroxycholecalciferol in sheep.
Hidiroglou, M; Williams, CJ, 1980
)
0.76
"The dose-response relationship of estradiol benzoate (E2B)-induced increase of in vitro 1,25-dihydroxyvitamin D3 - 1,25-(OH)2D3 - production in Japanese quail raised on a vitamin D-deficient diet was investigated."( Estradiol-induced stimulation of 25-hydroxyvitamin D3-1-hydroxylase in vitamin D-deficient Japanese quail.
Baksi, SN; Kenny, AD, 1980
)
0.26
" Using labeled material it was shown that the dosing levels of 1,25(OH)2D3 employed ensured a higher than normal plasma concentration of that metabolite over the period between doses."( Histological observations on the failure of rachitic rat bones to respond to 1,25/OH)2D3.
Gallagher, JA; Lawson, DE, 1980
)
0.26
" High doses of vitamin D 3 and dosage of phosphate mitigated the complains although with respect to the radiological, scintigraphic, humoral and histological findings there was only slow improvement or no improvement at all."( [Chronic hypophosphatemic osteopathy (author's transl)].
Hofmann, E; Koppers, B; Sauer, E; Schmid, L, 1980
)
0.26
" Radioactivity concentrations were higher in the tissues of ewes dosed with vitamin D3 than in those dosed with 25-hydroxycholecalciferol."( Transfer of tritium-labeled vitamin D3 and 25-hydroxyvitamin D3 in ovine placenta.
Hidiroglou, M; Williams, CJ, 1981
)
0.47
" In contrast to currently available preparations, this extemporaneous formulation of injectable cholecalciferol potentially offers a versatile dosage form for therapeutic or prophylactic therapy of vitamin D deficiency."( Stability of an extemporaneous formulation of injectable cholecalciferol.
Bertino, JS; Halpin, TC; Lambert, PW; Reed, MD, 1981
)
0.73
" Blood samples were obtained after 10 and 20 d of dosing and serum 25-OHD levels were repeated."( Studies on vitamin D metabolism in malnourished children.
Raghuramulu, N; Reddy, V, 1982
)
0.26
" Animals were dosed by stomach tube with radioactive forms of vitamins A and D and killed 18 hours later."( The influence of aging on intestinal absorption of vitamins A and D by the rat.
Barrows, CH; Fleming, BB, 1982
)
0.26
" irradiation or during oral dosage of 62."( Vitamin D from skin: contribution to vitamin D status compared with oral vitamin D in normal and anticonvulsant-treated subjects.
Barnes, JL; Barnes, ND; Davie, MW; Emberson, C; Lawson, DE; Roberts, GE, 1982
)
0.26
" 3 and 4) given the respective vitamins at a daily dosage of 33,000 IU/kg of initial (day 0) body weight for 30 days."( Acute vitamin D3 toxicosis in horses: case reports and experimental studies of the comparative toxicity of vitamins D2 and D3.
Harrington, DD; Page, EH, 1983
)
0.27
" Pups were killed at either 1, 2, 3, 4, or 5 days after dosing of the does, and does were killed after 5 days."( Fate of tritium-labeled vitamin D3 and 25-hydroxyvitamin D3 in rabbit does and their pups.
Hidiroglou, M, 1984
)
0.27
" The results indicated that in these sheep dosed with this large dose of vitamin D3, their depletion in this liposoluble vitamin was a long process."( Vitamin D3 levels in certain sheep tissues at various times after the intramuscular administration of vitamin D3.
Hidiroglou, M; Williams, CJ, 1984
)
0.27
" The effects of various dietary levels of cholecalciferol (vitamin D3) or 25-hydroxycholecalciferol (25-OH-D3) were compared using a "basal" dosage level of 69 micrograms/kg feed, as well as levels ranging from ."( Comparison of dietary 25-hydroxycholecalciferol and cholecalciferol in broiler chickens.
Gray, RW; Hollis, BW; McNaughton, JL; Quarles, CL; Saunders, CA; Yarger, JG, 1995
)
0.84
" Indomethacin shifted the G-CSF dose-response curve of cells treated with 10 nM RA to lower G-CSF concentrations."( Indomethacin potentiates the induction of HL60 differentiation to neutrophils, by retinoic acid and granulocyte colony-stimulating factor, and to monocytes, by vitamin D3.
Brown, G; Bunce, CM; Durham, J; French, PJ; Michell, RH; Stockley, RA, 1994
)
0.29
" We studied vitamin D transport from the skin in seven healthy volunteers who received whole body irradiation with 27 mJ/cm2 dosage of ultraviolet B light (290-320 nm)."( Human plasma transport of vitamin D after its endogenous synthesis.
Haddad, JG; Hollis, BW; Hu, YZ; Matsuoka, LY; Wortsman, J, 1993
)
0.29
"The separation and characterization of vitamin D(3)- and 25-hydroxyvitamin D(3)-monoglucuronides, biliary metabolites obtained from rats dosed with D(3) and 25-hydroxyvitamin D(3) per os, respectively, were carried out by HPLC."( Separation and characterization of monoglucuronides of vitamin D(3) and25-hydroxyvitamin D(3) in rat bile by high-performance liquid chromatography.
Mitamura, K; Nakatani, I; Saito, K; Shimada, K, 1996
)
0.29
" Dose-response studies showed that each of the analogues had antiproliferative activities, and LH [1,25-(OH)2-16-ene-23-yne-26,27-F6-19-nor D3] was the most potent analogue, suppressing at 10(-11) M greater than 50% clonal proliferation (ED50) of the MCF-7 and SK-BR-3 breast cancer cells, increasing the proportion of MCF-7 cells in the G0-G1 phase, and decreasing those in the S phase of the cell cycle."( 19-nor-hexafluoride analogue of vitamin D3: a novel class of potent inhibitors of proliferation of human breast cell lines.
Asou, H; Campbell, MJ; Elstner, E; Koeffler, HP; Koike, M; Tsuruoka, N; Uskokovic, M, 1997
)
0.3
" These results were achieved by a lower drug dosage of vitamin D3 and at lower trough blood levels of 1,25(OH)2D3 as compared to those of oral One-Alpha."( Comparison of the efficacy of two injectable forms of vitamin D3 and oral one-alpha in treatment of secondary hyperparathyroidism in patients on maintenance hemodialysis.
al-Mohannadi, S; el-Reshaid, K; el-Reshaid, W; Sivanandan, R; Sugathan, T, 1997
)
0.3
" Additional studies with TPA after the determination of optimum dosing regimens are needed to determine whether long-lasting or permanent remissions of myelocytic leukemia can be achieved."( Effect of intravenous infusions of 12-O-tetradecanoylphorbol-13-acetate (TPA) in patients with myelocytic leukemia: preliminary studies on therapeutic efficacy and toxicity.
Cao, GS; Chang, RL; Conney, AH; Han, ZT; Liu, XJ; Newmark, HL; Sun, JZ; Tian, GF; Yang, RY; Zhu, XX, 1998
)
0.3
" Dose-response curves were non-monotonic passing a maximum at low dosages."( Low-molecular-weight hormonal factors that affect head formation in Hydra.
Bartsch, C; Bartsch, H; Bayer, E; Maidonis, I; Müller, WA, 1998
)
0.3
"Using ethylene glycol (EG) and vitamin D3 as crystal-inducing diet (CID) in rats, we investigated the effect of the dosage of EG on the generation of chronic calcium oxalate (CaOx) nephrolithiasis."( Experimental nephrolithiasis in rats: the effect of ethylene glycol and vitamin D3 on the induction of renal calcium oxalate crystals.
Boevé, ER; Cao, LC; de Bruijn, WC; de Water, R; Deng, G; Schröder, FH; Stijnen, T; van Miert, PP, 1996
)
0.29
" Dose-response studies showed that 1,25(OH)2-16-ene-5,6-trans-D3 had 10-100-fold greater antiproliferative activities than 1,25(OH)2D3 when measuring clonal growth of breast (MCF-7) and prostate (LNCaP) cancer cell lines as well as a myeloid leukemia cell line (HL-60)."( 5,6-trans-16-ene-vitamin D3: a new class of potent inhibitors of proliferation of prostate, breast, and myeloid leukemic cells.
Hisatake, J; Hisatake, Y; Koeffler, HP; Kubota, T; Tomoyasu, S; Uskokovic, M, 1999
)
0.3
" Dose-response studies of Cmpd E showed that in serumless culture conditions, transactivation of the VDRE-CAT was stronger than cmpd J [1,25(OH)2D3]."( 20-Cyclopropyl-cholecalciferol vitamin D3 analogs: a unique class of potent inhibitors of proliferation of human prostate, breast and myeloid leukemia cell lines.
Kawabata, H; Koeffler, HP; Koike, M; Koshizuka, K; Said, J; Taub, HE; Tsuruoka, N; Uskokovic, M; Yang, R,
)
0.48
" In Experiment 1, vitamin D3 was supplemented at a dosage of either 2,064 IU/kg (low level) or 4,128 IU/kg (high level) in drinking water provided ad libitum only from Days 1 through 5 after hatch."( The effect of vitamin D3 on resistance to stress-related infection in an experimental model of turkey osteomyelitis complex.
Balog, JM; Huff, GR; Huff, WE; Rath, NC, 2000
)
0.31
" Serum calcium and urinary calcium excretion did not change significantly at either dosage during the study."( Efficacy and safety of vitamin D3 intake exceeding the lowest observed adverse effect level.
Chan, PC; MacFarlane, GD; Vieth, R, 2001
)
0.31
"The 100-microg/d dosage of vitamin D3 effectively increased 25(OH)D to high-normal concentrations in practically all adults and serum 25(OH)D remained within the physiologic range; therefore, we consider 100 microg vitamin D3/d to be a safe intake."( Efficacy and safety of vitamin D3 intake exceeding the lowest observed adverse effect level.
Chan, PC; MacFarlane, GD; Vieth, R, 2001
)
0.31
"The chronotherapeutic effects of 1-alpha-(OH) vitamin D3, a pro-drug of 1,25(OH)2 vitamin D3 (1,25(OH)2D3), were evaluated by repeated dosing of the drug in aged stroke-prone spontaneously hypertensive male rats, a model of osteoporosis."( Chronotherapy with active vitamin D3 in aged stroke-prone spontaneously hypertensive rats, a model of osteoporosis.
Fujimura, A; Nishiki, K; Sugimoto, K; Tsuruoka, S, 2001
)
0.31
" Animals with a dosing of the drug at 2 hours after light on (HALO) had more grade of hypercalcemia and hyperphosphatemia than those at 14 HALO."( Time of day improves efficacy and reduces adverse reactions of vitamin D3 in 5/6 nephrectomized rat.
Fujimura, A; Nishiki, K; Sugimoto, K; Tsuruoka, S, 2002
)
0.31
" This study was undertaken to determine whether the effectiveness and safety of D3 also depend on its dosing time during a repeated treatment."( Chronotherapy of high-dose active vitamin D3 in haemodialysis patients with secondary hyperparathyroidsm: a repeated dosing study.
Fujimura, A; Saito, T; Sugimoto, K; Tsuruoka, S; Wakaumi, M, 2003
)
0.32
"00 h dosing in the remaining ten patients."( Chronotherapy of high-dose active vitamin D3 in haemodialysis patients with secondary hyperparathyroidsm: a repeated dosing study.
Fujimura, A; Saito, T; Sugimoto, K; Tsuruoka, S; Wakaumi, M, 2003
)
0.32
"These results indicate that a higher dose of oral D3 is more effective and safe after dosing at evening in patients with renal osteodystrophy."( Chronotherapy of high-dose active vitamin D3 in haemodialysis patients with secondary hyperparathyroidsm: a repeated dosing study.
Fujimura, A; Saito, T; Sugimoto, K; Tsuruoka, S; Wakaumi, M, 2003
)
0.32
" Serum Ca, P, Mg, 25-OH D3, 1,25-dihydroxyvitamin D [1,25-(OH)2 D3], albumin, and protein were measured 24 h before dosing (-24 h), at dosing (0 h), and 6 and 24 h after dosing, after which the cattle were slaughtered at a commercial facility."( Short communication: serum and tissue concentrations of vitamin D metabolites in beef heifers after buccal dosing of 25-hydroxyvitamin D3.
Bachman, SE; Branine, ME; Galyean, ML; Horst, RL; Hubbert, ME; Rivera, JD; Williams, SN, 2005
)
0.33
" The aortic calcification was significantly attenuated by subcutaneous administration of ghrelin 30 and 300 nmol kg(-1) day(-1) for 4 weeks, and the latter dosage was more potent than the former."( Ghrelin blunted vascular calcification in vivo and in vitro in rats.
Cao, J; Chang, L; Jiang, W; Li, GZ; Pan, CS; Tang, CS; Zhao, J, 2005
)
0.33
" 1,25-(OH)2D3 rapidly stimulated PHF release with enhanced sensitivity in SHR versus WKY cultures indicated by a leftward shift in the dose-response curve, whereas 24,25-dihydroxyvitamin D3 (24,25-(OH)2D3) had the converse effect."( Regulation of parathyroid hypertensive factor secretion by vitamin D3 analogs in parathyroid cells derived from spontaneously hypertensive rats.
Benishin, CG; Nemere, I; Sutherland, SK, 2005
)
0.33
" Further clinical trials should be conducted to prove the preventive effect of vitamin D3 as well as dosing and timing of the agent on radiation-induced alopecia."( The preventive effect of vitamin D3 on radiation-induced hair toxicity in a rat model.
Abban, G; Baltalarli, B; Bir, F; Demirkan, N, 2006
)
0.33
" Estimates of the population distribution of serum 25(OH)D values, coupled with available dose-response data, indicate that it would require input of an additional 2600 iu/d (65 microg/d) of oral vitamin D3 to ensure that 97."( Barriers to optimizing vitamin D3 intake for the elderly.
Heaney, RP, 2006
)
0.33
" The potential for general correlations between this type of oxidizability data and actual oxidative performance in LFC and solid oral dosage forms is discussed."( A novel peroxy radical based oxidative stressing system for ranking the oxidizability of drug substances.
Harmon, PA; Kosuda, K; Mowery, M; Nelson, E; Reed, RA, 2006
)
0.33
" In addition to screening potential antipsoriatic substances, the PPT can help answer other questions (frequency of use, dose-response relationship)."( [Is the psoriasis plaque test still relevant in the age of biologicals?].
Wozel, G, 2006
)
0.33
" The dose-response to supplementation decreased with increasing vitamin D status at baseline, r = -0."( How much vitamin D3 do the elderly need?
Jakobsen, J; Kärkkäinen, M; Lamberg-Allardt, C; Palssa, A; Viljakainen, HT, 2006
)
0.33
" Newer topical therapies that have a convenient once-daily dosing schedule are needed and will have important implications for patient compliance."( The roles of safety and compliance in determining effectiveness of topical therapy for psoriasis.
Corvari, L; Stein Gold, L, 2007
)
0.34
" Other practical issues, including who should receive vitamin D replacement, what form of vitamin D should be used, and what dosage is required to prevent falls, are discussed."( Vitamin D supplementation to prevent falls in the elderly: evidence and practical considerations.
Fosnight, SM; Hazelett, SE; Zafirau, WJ, 2008
)
0.35
" Dosing for NT-020 and vehicle consisted of daily oral administration (using a gavage) over a 2-week period."( Dietary supplementation exerts neuroprotective effects in ischemic stroke model.
Bickford, PC; Borlongan, CV; Hara, K; Maki, M; Masuda, T; Sanberg, CD; Sanberg, PR; Yasuhara, T, 2008
)
0.35
"There is much interest in dosing vitamin D intermittently for patient convenience and long-term adherence."( Pharmacokinetics of a single, large dose of cholecalciferol.
Armas, LA; Heaney, RP; Ilahi, M, 2008
)
0.61
"Serum calcidiol rose promptly after cholecalciferol dosing from a mean (+/-SD) baseline of 27."( Pharmacokinetics of a single, large dose of cholecalciferol.
Armas, LA; Heaney, RP; Ilahi, M, 2008
)
0.88
" The dosing interval should be < or =2 mo to ensure continuous serum calcidiol concentrations above baseline."( Pharmacokinetics of a single, large dose of cholecalciferol.
Armas, LA; Heaney, RP; Ilahi, M, 2008
)
0.61
" Serum 25-hydroxyvitamin D(3) was greater for cows dosed with 25-OH (119."( Blood mineral, hormone, and osteocalcin responses of multiparous Jersey cows to an oral dose of 25-hydroxyvitamin D3 or vitamin D3 before parturition.
Herbein, JH; Knowlton, KF; McGilliard, ML; Seymour, WM; Taylor, MS, 2008
)
0.35
" The dosing regimen comprised a loading dose of 1000 IU of cholecalciferol per day for one month (two tablets) and thereafter a maintenance dose of 500 IU of cholecalciferol per day for 2 months (one tablet)."( The effect of a combined oral calcium and vitamin D supplement for treating mild to moderate vitamin D deficiency in postmenopausal women.
Diamond, T; Golombick, T, 2008
)
0.59
"Different dosing protocols have been used for vitamin D supplementation, but there has been a lack of comparative data among them."( Comparison of daily, weekly, and monthly vitamin D3 in ethanol dosing protocols for two months in elderly hip fracture patients.
Bromberg, IL; Ish-Shalom, S; Raz, B; Salganik, T; Segal, E; Vieth, R, 2008
)
0.35
" After 2 months, serum 25(OH)D with daily, weekly, and monthly dosing were, respectively, 33."( Comparison of daily, weekly, and monthly vitamin D3 in ethanol dosing protocols for two months in elderly hip fracture patients.
Bromberg, IL; Ish-Shalom, S; Raz, B; Salganik, T; Segal, E; Vieth, R, 2008
)
0.35
"Supplementation with vitamin D can be achieved equally well with daily, weekly, or monthly dosing frequencies."( Comparison of daily, weekly, and monthly vitamin D3 in ethanol dosing protocols for two months in elderly hip fracture patients.
Bromberg, IL; Ish-Shalom, S; Raz, B; Salganik, T; Segal, E; Vieth, R, 2008
)
0.35
"Twenty vitamin D-deficient HIV-1-infected patients were prospectively treated with 2000 IU cholecalciferol/day for 14 weeks, whereafter treatment was continued with half this dosage until 48 weeks."( The effect of cholecalciferol supplementation on vitamin D levels and insulin sensitivity is dose related in vitamin D-deficient HIV-1-infected patients.
Bosch, ME; Burger, DM; Hermus, AR; Koopmans, PP; Oyen, WJ; Sweep, FC; Tack, CJ; van den Bos, M; van den Bout-van den Beukel, CJ; van der Ven, AJ, 2008
)
0.93
" After 48 weeks, however, only 25(OH)D3 levels remained significantly different from baseline, while the other parameter levels returned to baseline, suggesting a dose-response effect."( The effect of cholecalciferol supplementation on vitamin D levels and insulin sensitivity is dose related in vitamin D-deficient HIV-1-infected patients.
Bosch, ME; Burger, DM; Hermus, AR; Koopmans, PP; Oyen, WJ; Sweep, FC; Tack, CJ; van den Bos, M; van den Bout-van den Beukel, CJ; van der Ven, AJ, 2008
)
0.71
" Dose-response clonogenic studies showed that all six analogs had greater antiproliferative activities against cancer cells than 1,25(OH)(2)D(3)."( Novel Gemini vitamin D(3) analogs have potent antitumor activity.
Badr, R; Haritunians, T; Jankowski, P; Koeffler, HP; Maehr, H; Marczak, S; O'Kelly, J; Okamoto, R; Saito, T; Uskokovic, M, 2008
)
0.35
" We tested the potential of intermittently dosed calcitriol and calcitonin (CT) to restore bone properties in ovariectomized (Ovx) rats."( Bone parameters are improved with intermittent dosing of vitamin D3 and calcitonin.
Andresen, CJ; Bagi, CM; Berryman, E; Moalli, M; Pero, R; Turner, CH, 2008
)
0.35
"Daily dosing with vitamin D often fails to achieve optimal outcomes, and it is uncertain what the target level of 25-hydroxyvitamin D should be."( High-dose oral vitamin D3 supplementation in the elderly.
Bacon, CJ; Gamble, GD; Horne, AM; Reid, IR; Scott, MA, 2009
)
0.35
" Monthly dosing is similarly effective and safe, but takes 3-5 months for plateau 25OHD levels to be reached."( High-dose oral vitamin D3 supplementation in the elderly.
Bacon, CJ; Gamble, GD; Horne, AM; Reid, IR; Scott, MA, 2009
)
0.35
"Administration of oral cholecalciferol to HIV-infected children and adolescents at a dosage of 100,000 IU every 2 months, together with 1 g/day calcium, is safe and results in significant increases in serum 25-hydroxyvitamin D concentrations."( Effect of bimonthly supplementation with oral cholecalciferol on serum 25-hydroxyvitamin D concentrations in HIV-infected children and adolescents.
Abrams, EJ; Arpadi, SM; Bamji, M; Engelson, ES; Horlick, M; McMahon, D; Purswani, M; Shane, E, 2009
)
0.92
"Oral dosing with adenine induced CKD in rats in only 10 days."( Vascular calcification and secondary hyperparathyroidism of severe chronic kidney disease and its relation to serum phosphate and calcium levels.
Fujimori, A; Fukushima, S; Itoh, H; Mizukami, K; Nara, H; Okada, M; Sanagi, M; Takakura, K; Terai, K, 2009
)
0.35
"These data suggest that rats dosed orally with adenine provide a more useful model for analysing calcium/phosphate homeostasis in severe CKD."( Vascular calcification and secondary hyperparathyroidism of severe chronic kidney disease and its relation to serum phosphate and calcium levels.
Fujimori, A; Fukushima, S; Itoh, H; Mizukami, K; Nara, H; Okada, M; Sanagi, M; Takakura, K; Terai, K, 2009
)
0.35
" Prospective studies are required to determine appropriate dosing regimen to achieve optimal levels in the majority of MS patients and to ascertain the safety, immunological response, and ultimately the clinical efficacy of vitamin D replacement therapy."( Vitamin D status and effect of low-dose cholecalciferol and high-dose ergocalciferol supplementation in multiple sclerosis.
Baynes, M; Calabresi, PA; Cettomai, D; Greenberg, BM; Harrison, D; Hiremath, GS; Kerr, D; Newsome, S; Ratchford, JN, 2009
)
0.62
"Daily dosing of vitamin D supplements may be difficult among older people."( The same annual dose of 292000 IU of vitamin D (cholecalciferol) on either daily or four monthly basis for elderly women: 1-year comparative study of the effects on serum 25(OH)D concentrations and renal function.
Aarum, S; Hämäläinen, E; Löyttyniemi, E; Pekkarinen, T; Turpeinen, U; Välimäki, MJ; Välimäki, VV, 2010
)
0.62
" However, there are no data to indicate which dosage would be most efficient."( Monthly cholecalciferol administration in haemodialysis patients: a simple and efficient strategy for vitamin D supplementation.
Chazot, C; Jean, G; Souberbielle, JC, 2009
)
0.79
"A 56-year-old patient with postsurgical hypothyroidism and hypoparathyroidism associated with gastrointestinal malabsorption syndrome was prescribed with L: -thyroxine and 1alpha(OH)D(3) at a massive daily dosage of 600 and 39 mug, respectively."( Successful treatment of postsurgical hypoparathyroidism by intramuscular injection of vitamin D3 in a patient associated with malabsorption syndrome due to multiple abdominal surgeries.
Katsura, Y; Kure, M; Ohwada, R; Sato, K; Seki, T; Sekine, H; Takano, K; Yamamoto, M, 2010
)
0.36
" The current study was undertaken to obtain information on the dose-response pattern of 2 vitamin D sources, the commonly used cholecalciferol, called vitamin D(3), and a newly developed Hy."( Reproductive performance and bone status markers of gilts and lactating sows supplemented with two different forms of vitamin D.
Halekoh, U; Jensen, SK; Larsen, T; Lauridsen, C, 2010
)
0.57
"According to current classifications, the metabolite of greatest clinical interest to evaluate vitamin D(3) dosage is 25-hydroxyvitamin D(3) with a reference interval of approximately 10-70ng/ml, although many authors consider values of approximately 40ng/ml or 100nmol/l to be desirable."( [Has vitamin D(3) dosage improved in Spain? Current levels in a population sample].
Benedicto Lorenzo, I; Bernal Pérez, M; Cortés Flores, G; Giner Soria, A; Horno Pérez, M; Orden Gonzalo, I,
)
0.13
" VDRM2 suppressed eroded surface on trabecular bone surfaces at normal serum calcium dosage levels, suggesting dual anabolic and antiresorptive activity."( A nonsecosteroidal vitamin D receptor ligand with improved therapeutic window of bone efficacy over hypercalcemia.
Barr, RJ; Bryant, HU; Burris, LL; Iturria, S; Lu, J; Ma, YL; Montrose-Rafizadeh, C; Sato, M; Schmidt, A; Stayrook, KR; Zeng, QQ, 2010
)
0.36
" There was a reduction in the dosage and in the number of patients who were treated with paricalcitol and sevelamer."( Cholecalciferol supplementation in hemodialysis patients: effects on mineral metabolism, inflammation, and cardiac dimension parameters.
Aires, I; Amaral, T; Borges, M; Cortez, J; Ferreira, A; Ferreira, C; Gil, C; Jorge, C; Matias, PJ, 2010
)
1.8
" It allows reduction of vitamin D deficiency, better control of mineral metabolism with less use of active vitamin D, attenuation of inflammation, reduced dosing of erythropoiesis-stimulating agents, and possibly improvement of cardiac dysfunction."( Cholecalciferol supplementation in hemodialysis patients: effects on mineral metabolism, inflammation, and cardiac dimension parameters.
Aires, I; Amaral, T; Borges, M; Cortez, J; Ferreira, A; Ferreira, C; Gil, C; Jorge, C; Matias, PJ, 2010
)
1.8
" As data on repletion with vitamin D(2) have recently been published, we restricted our discussion to the use of vitamin D(3) from dietary supplements, prescriptions for large oral doses, and bolus dosing or injections."( Correcting poor vitamin D status: do older adults need higher repletion doses of vitamin D3 than younger adults?
Calvo, MS; Whiting, SJ, 2010
)
0.36
"To compare the effects on parathyroid hormone (PTH) and 25-hydroxy-vitamin D (25(OH)D) of two dosing regimens of cholecalciferol in women with secondary hyperparathyroidism (sHPTH) and hypovitaminosis D and to investigate variables affecting 25(OH)D response to cholecalciferol."( Heterogeneity in serum 25-hydroxy-vitamin D response to cholecalciferol in elderly women with secondary hyperparathyroidism and vitamin D deficiency.
Barone, A; Bianchi, G; Girasole, G; Giusti, A; Palummeri, E; Pedrazzoni, M; Pioli, G; Pizzonia, M; Razzano, M, 2010
)
0.82
" Calciferols were dosed at 50,000 IU/wk for 12 wk."( Vitamin D(3) is more potent than vitamin D(2) in humans.
Armas, LA; Grote, J; Heaney, RP; Horst, RL; Recker, RR, 2011
)
0.37
"The aim of the study was to evaluate the effect of daily and once monthly dosing of D(2) or D(3) on circulating 25(OH)D and serum and urinary calcium."( Evaluation of ergocalciferol or cholecalciferol dosing, 1,600 IU daily or 50,000 IU monthly in older adults.
Binkley, N; Drezner, MK; Engelke, J; Gangnon, R; Gemar, D; Krueger, D; Ramamurthy, R, 2011
)
0.65
" One year of D(2) or D(3) dosing (1,600 IU daily or 50,000 IU monthly) does not produce toxicity, and 25(OH)D levels of less than 30 ng/ml persist in approximately 20% of individuals."( Evaluation of ergocalciferol or cholecalciferol dosing, 1,600 IU daily or 50,000 IU monthly in older adults.
Binkley, N; Drezner, MK; Engelke, J; Gangnon, R; Gemar, D; Krueger, D; Ramamurthy, R, 2011
)
0.65
" While a routine dosage is often proposed in osteoporotic patients, it is not so evident in rheumatology outpatients where it has been shown that the prevalence of hypovitaminosis D is high."( High prevalence of hypovitaminosis D in a Swiss rheumatology outpatient population.
Aubry-Rozier, B; Dudler, J; Hans, D; Krieg, MA; Lamy, O; So, A; Stoll, D, 2011
)
0.37
" Vitamin D dosing for patients suffering from malnutrition may not differ from that for normal-weighted adolescents."( Bioavailability of vitamin D in malnourished adolescents with anorexia nervosa.
Brown, JN; Divasta, AD; Feldman, HA; Giancaterino, C; Gordon, CM; Holick, MF, 2011
)
0.37
" When allowing for a conversion period of vitamin D(3) to its active metabolites, supplementing the zilpaterol treated steers with a high dosage of vitamin D(3) (6D7M7N) resulted in improved colour stability, higher stability towards protein oxidation and lower stability towards lipid oxidation."( The effect of vitamin D(3) supplementation on texture and oxidative stability of beef loins from steers treated with zilpaterol hydrochloride.
Frylinck, L; Hansen, S; Strydom, PE, 2012
)
0.38
" As more and more people use vitamin D supplements, it is important to recognize that, while rare, hypervitaminosis D is a possibility and dosage conversion of vitamin D units can result in errors."( Hypervitaminosis D associated with a vitamin D dispensing error.
Hronek, BW; Jacobsen, RB; Schilling, ML; Schmidt, GA, 2011
)
0.37
" In addition, health care providers should understand dosage conversion regarding vitamin D and electronic prescribing and dispensing software should be designed to detect such errors."( Hypervitaminosis D associated with a vitamin D dispensing error.
Hronek, BW; Jacobsen, RB; Schilling, ML; Schmidt, GA, 2011
)
0.37
" Cumulative dosing may be more important than frequency of dosing (strength of recommendation [SOR]: C, inconsistent results from randomized controlled trials [RCTs] of disease-oriented outcomes)."( Clinical inquiries. Which regimen treats vitamin D deficiency most effectively?
Germann, A; Osborn, J; St Anna, L, 2011
)
0.37
"One gram of calcium per day and oral cholecalciferol at a dosage of 100,000 IU every 2 mo administered to HIV-infected children and adolescents did not affect bone mass accrual despite significant increases in serum 25(OH)D concentrations."( Effect of supplementation with cholecalciferol and calcium on 2-y bone mass accrual in HIV-infected children and adolescents: a randomized clinical trial.
Abrams, EJ; Arpadi, SM; Bamji, M; Engelson, ES; Horlick, M; McMahon, DJ; Purswani, M; Shane, E, 2012
)
0.94
" Current data support vitamin D(3) supplementation as risk-modifying intervention in tuberculosis and viral respiratory tract infection, but the optimal dosage regimen remains to be determined."( Translating the role of vitamin D3 in infectious diseases.
Chai, L; Joosten, I; Khoo, AL; Koenen, H; Netea, M; van der Ven, A, 2012
)
0.38
" Alternative vitamin D(3) dosing schedules need further investigation in colorectal cancer patients undergoing chemotherapy."( A prospective clinical trial of cholecalciferol 2000 IU/day in colorectal cancer patients: evidence of a chemotherapy-response interaction.
Andrews, C; Fakih, MG; McMahon, J; Muindi, JR, 2012
)
0.66
" Because a lower dose tends to be selected for patients with a better outcome, simple summarizations may wrongly show a better outcome for the lower dose, producing an incorrect dose-response relationship."( Dose-response relationship from longitudinal data with response-dependent dose modification using likelihood methods.
Funatogawa, I; Funatogawa, T, 2012
)
0.38
" For both dosing regimens, there were no significant differences in the expression of gut-homing markers, CCR9, and integrin α(4)β(7)."( High-dose vitamin D3 supplementation is a requisite for modulation of skin-homing markers on regulatory T cells in HIV-infected patients.
Bosch, M; Joosten, I; Khoo, AL; Koenen, HJ; Michels, M; Netea, MG; Ooms, S; van der Ven, AJ, 2013
)
0.39
" Optimal vitamin D dosing for treatment is unclear."( Serum 25-hydroxyvitamin D response to vitamin D3 supplementation 50,000 IU monthly in youth with HIV-1 infection.
Flynn, P; Havens, PL; Hazra, R; Kapogiannis, BG; Lujan-Zilbermann, J; Mulligan, K; Rutledge, B; Stephensen, CB; Van Loan, MD; Wilson, CM, 2012
)
0.38
"No information on optimal cholecalciferol dosing in kidney transplant patients is currently available because the time-course of serum 25-hydroxy vitamin D [25(OH)D] concentration has never been investigated."( Determination of optimal cholecalciferol treatment in renal transplant recipients using a population pharmacokinetic approach.
Benaboud, S; Courbebaisse, M; Friedlander, G; Hirt, D; Legendre, C; Prié, D; Souberbielle, JC; Thervet, E; Treluyer, JM; Urien, S, 2013
)
0.99
" Based on these values, in order to maintain 25(OH)D concentrations between 30 and 80 ng/mL, cholecalciferol dosing should be six successive administrations of 100,000 IU at 2-week intervals, followed by 100,000 IU once a month until the end of the first year."( Determination of optimal cholecalciferol treatment in renal transplant recipients using a population pharmacokinetic approach.
Benaboud, S; Courbebaisse, M; Friedlander, G; Hirt, D; Legendre, C; Prié, D; Souberbielle, JC; Thervet, E; Treluyer, JM; Urien, S, 2013
)
0.91
"Participants were randomly assigned to receive an initial dose of 200,000 IU oral vitamin D3, then 200,000 IU 1 month later, then 100,000 IU monthly (n = 161), or placebo administered in an identical dosing regimen (n = 161), for a total of 18 months."( Effect of vitamin D3 supplementation on upper respiratory tract infections in healthy adults: the VIDARIS randomized controlled trial.
Camargo, CA; Chambers, ST; Florkowski, CM; Jennings, LC; Livesey, JH; Murdoch, DR; Priest, PC; Scragg, R; Slow, S; Stewart, AW, 2012
)
0.38
" Alphacalciferol dosing was kept constant during treatment with cholecalciferol."( Vitamin D deficiency, insulin resistance, serum adipokine, and leptin levels in peritoneal dialysis patients.
Taskapan, H; Taskapan, MC; Temel, I; Ulutas, O, 2013
)
0.63
" Our aims were to investigate the pharmacokinetics of 25-hydroxycholecalciferol [25(OH)D], the effect of antiretroviral treatment (ARV) and others factors that may influence the pharmacokinetics, and to determine a vitamin D3 dosing scheme to reach the 30 ng ml(-1) threshold (defined as 25(OH)D sufficiency)."( Vitamin D3 supplementation scheme in HIV-infected patients based upon pharmacokinetic modelling of 25-hydroxycholecalciferol.
Foissac, F; Rostane, H; Souberbielle, JC; Tréluyer, JM; Urien, S; Viard, JP, 2013
)
0.84
" To obtain concentrations between 30 and 80 ng ml(-1), the dosing recommendation was 100,000 IU every month."( Vitamin D3 supplementation scheme in HIV-infected patients based upon pharmacokinetic modelling of 25-hydroxycholecalciferol.
Foissac, F; Rostane, H; Souberbielle, JC; Tréluyer, JM; Urien, S; Viard, JP, 2013
)
0.6
" A dosing scheme to reach sufficient 25(OH)D concentrations is proposed."( Vitamin D3 supplementation scheme in HIV-infected patients based upon pharmacokinetic modelling of 25-hydroxycholecalciferol.
Foissac, F; Rostane, H; Souberbielle, JC; Tréluyer, JM; Urien, S; Viard, JP, 2013
)
0.6
" No modification of the prednisone dosage or initiation of new immunosuppressant agents was needed in all patients."( Restoration of regulatory and effector T cell balance and B cell homeostasis in systemic lupus erythematosus patients through vitamin D supplementation.
Carpentier, W; Chaara, W; Costedoat-Chalumeau, N; Derian, N; Geri, G; Klatzmann, D; Mariampillai, K; Musset, L; Patrice, C; Piette, JC; Rosenzwajg, M; Saadoun, D; Schoindre, Y; Six, A; Terrier, B; Zahr, N, 2012
)
0.38
" Nevertheless, the current evidence suggests that regular dosing with oral cholecalciferol (e."( Prevention and treatment of vitamin D deficiency.
Cheetham, TD; Pearce, SH; Sinha, A, 2013
)
0.62
"A linear dose-response relationship between dietary vitamin D(3) level and egg yolk vitamin D(3) content was established at relatively low enrichment levels."( Effects of vitamin D(3) -enriched diet on egg yolk vitamin D(3) content and yolk quality.
Higgins, M; Horst, RL; Persia, M; Wang, T; Yao, L, 2013
)
0.39
" Of 66 subjects who were enrolled, 63 completed the dosing protocol."( Randomized clinical trial of vitamin D3 doses on prostatic vitamin D metabolite levels and ki67 labeling in prostate cancer patients.
Cardoza, M; Dias, A; Finelli, A; Fleshner, N; Giangreco, AA; Hersey, K; Klotz, L; Laszlo, S; Li, D; Nonn, L; Trudel, D; Van der Kwast, T; Vieth, R; Wagner, D, 2013
)
0.39
"A pharmacokinetic study was conducted to assess the biochemical dose-response and tolerability of high-dose prenatal vitamin D3 supplementation in Dhaka, Bangladesh (23°N)."( Pharmacokinetics of high-dose weekly oral vitamin D3 supplementation during the third trimester of pregnancy in Dhaka, Bangladesh.
Akhtar, E; Al Mahmud, A; Baqui, AH; Black, RE; Raqib, R; Roth, DE, 2013
)
0.39
" We extrapolated individual study dose-response curves to zero concentration values for serum 25(OH)D by using both linear and curvilinear approaches and measured seasonal oscillation in the serum 25(OH)D concentration."( All-source basal vitamin D inputs are greater than previously thought and cutaneous inputs are smaller.
Armas, LA; French, C; Heaney, RP, 2013
)
0.39
" The 1600-IU/d dosage was discontinued prematurely because of elevated plasma 25(OH)D concentrations."( Effect of different dosages of oral vitamin D supplementation on vitamin D status in healthy, breastfed infants: a randomized trial.
Agellon, S; Comeau, K; Gallo, S; Jones, G; Khamessan, A; L'Abbé, M; Rodd, C; Sharma, A; Vanstone, C; Weiler, H, 2013
)
0.39
"Among healthy, term, breastfed infants, only a vitamin D supplement dosage of 1600 IU/d (but not dosages of 400, 800, or 1200 IU/d) increased plasma 25(OH)D concentration to 75 nmol/L or greater in 97."( Effect of different dosages of oral vitamin D supplementation on vitamin D status in healthy, breastfed infants: a randomized trial.
Agellon, S; Comeau, K; Gallo, S; Jones, G; Khamessan, A; L'Abbé, M; Rodd, C; Sharma, A; Vanstone, C; Weiler, H, 2013
)
0.39
" Expression of CAMP mRNA and protein increased in a dose-response fashion after exposure of acute myeloid leukemia (AML) cells to the Gemini analog, BXL-01-126, in vitro."( Novel Gemini vitamin D3 analogs: large structure/function analysis and ability to induce antimicrobial peptide.
Akagi, T; Alvarez, R; Borregaard, N; Gery, S; Ho, Q; Koeffler, HP; Kuwayama, Y; Liu, GY; Okamoto, R; Uskokovic, MR, 2014
)
0.4
" Participants were given an oral dose of either 200 000 IU vitamin D3 for each of 2 months, followed by 100 000 IU monthly or placebo in an identical dosing regimen, for a total of 18 months."( Effect of vitamin D3 supplementation on Staphylococcus aureus nasal carriage: a randomized, double-blind, placebo-controlled trial in healthy adults.
Camargo, CA; Chambers, ST; Florkowski, CM; Jennings, LC; Livesey, JH; Murdoch, DR; Priest, PC; Scragg, R; Slow, S; Stewart, AW, 2014
)
0.4
" Dose-response studies linking vitamin D status to musculoskeletal and survival outcomes in cancer patients are lacking."( Clinical outcomes of vitamin D deficiency and supplementation in cancer patients.
Baker, J; Isenring, EA; Kimlin, MG; Koczwara, B; Teleni, L; Tsai, K; Walpole, E, 2013
)
0.39
"The purpose of this study was to characterize the pharmacokinetics of 25-hydroxyvitamin D [25(OH)D] response to 3 different doses of vitamin D₃ (cholecalciferol) in a group of obese subjects and to quantify the 25(OH)D dose-response relationship."( 25-Hydroxyvitamin D response to graded vitamin D₃ supplementation among obese adults.
Armas, LA; Drincic, A; Fuller, E; Heaney, RP, 2013
)
0.59
" Fasting blood samples are collected at baseline and three-month intervals for the measurement of plasma 25OHD, parathyroid hormone (PTH), biochemical markers of bone turnover and biochemistry to assess the dose-response and safety of supplementation."( Vitamin D supplementation in older people (VDOP): Study protocol for a randomised controlled intervention trial with monthly oral dosing with 12,000 IU, 24,000 IU or 48,000 IU of vitamin D₃.
Aspray, T; Chadwick, T; Francis, RM; Goldberg, GR; Harle, C; McColl, E; Parker, J; Prentice, A; Schoenmakers, I; Wilkinson, J; Yarnall, A, 2013
)
0.39
" Dose-response studies are needed to determine in a definitive manner the daily allowance of vitamin D for Middle Eastern adolescents with a similar profile."( Vitamin D3 dose requirement to raise 25-hydroxyvitamin D to desirable levels in adolescents: results from a randomized controlled trial.
Al-Shaar, L; Fuleihan, Gel-H; Maalouf, J; Mneimneh, R, 2014
)
0.4
" We therefore aimed to investigate the importance of body weight for the dose-response relation in circulating 25OHD."( Vitamin D supplementation, body weight and human serum 25-hydroxyvitamin D response: a systematic review.
Börgermann, J; Ernst, JB; Gummert, JF; Zittermann, A, 2014
)
0.4
" Dose-response curves were completed, and results indicate that exposure to 1,000 µg/ml vitamin D3 significantly increased the lifespan of wild-type worms by up to 39% (p<0."( Effect of vitamin D3 on lifespan in Caenorhabditis elegans.
Heuberger, R; Messing, JA; Schisa, JA, 2013
)
0.39
" No evidence of nonlinearity was observed in the dose-response curve."( Vitamin D supplementation increases calcium absorption without a threshold effect.
Abrams, SA; Aloia, JF; Dhaliwal, R; Fazzari, M; Mikhail, M; Ragolia, L; Shieh, A, 2014
)
0.4
"Our primary objective was to determine the dose-response relation between vitamin D and plasma 25(OH)D."( Dose response to vitamin D supplementation in African Americans: results of a 4-arm, randomized, placebo-controlled trial.
Bennett, GG; Chan, AT; Chandler, PD; Drake, BF; Emmons, KM; Fuchs, CS; Giovannucci, EL; Gonzalez-Suarez, E; Hollis, BW; Meyerhardt, JA; Ng, K; Scott, JB, 2014
)
0.4
" Of 66 subjects who were enrolled, 63 completed the dosing protocol."( Commentary on "randomized clinical trial of vitamin D3 doses on prostatic vitamin D metabolite levels and Ki67 labeling in prostate cancer patients." Wagner D, Trudel D, Van der Kwast T, Nonn L, Giangreco AA, Li D, Dias A, Cardoza M, Laszlo S, Hersey K, K
Olumi, AF, 2014
)
0.4
" Evidence-based guidelines regarding the dosing and the frequency of dosing for prophylactic intermittent supplementation (stoss doses) in severely-deficient subjects are few."( Serum 25 hydroxyvitamin D profile after single large oral doses of cholecalciferol (vitamin D3) in medical staff in North India: a pilot study.
Bhatia, E; Bhatia, V; Priyambada, L; Singh, N,
)
0.37
" After the dosing period of 8 days the animals were sacrificed and the blood was collected for the analysis of ST, its active metabolite simvastatin acid (STA), total cholesterol, triglyceride and liver enzymes including aspartate transaminase and alanine transaminase."( Effect of vitamin D on bioavailability and lipid lowering efficacy of simvastatin.
Al-Asmari, AK; Al-Eid, A; Al-Omani, SF; Al-Sabaan, F; Tariq, M; Ullah, Z, 2015
)
0.42
" According to 25(OH)D baseline concentrations, dosing schemes to reach sufficient concentrations are proposed."( Determination of optimal vitamin D3 dosing regimens in HIV-infected paediatric patients using a population pharmacokinetic approach.
Benaboud, S; Blanche, S; Bouazza, N; Chappuy, H; Foissac, F; Frange, P; Friedlander, G; Meyzer, C; Souberbielle, JC; Tréluyer, JM; Urien, S, 2014
)
0.4
" In this study, of 22 patients on maintenance dialysis who had been administered calcium (Ca) carbonate in our hospital, we investigated the dosage amount of vitamin D3 preparations after the phosphorus (P) binder was switched from Ca carbonate to the newly developed lanthanum carbonate (LC)."( Increase in the dosage amount of vitamin D3 preparations by switching from calcium carbonate to lanthanum carbonate.
Hida, M; Hyodo, T; Ishii, D; Iwamura, M; Kawakami, J; Kurata, Y; Mikami, N; Wakai, H; Yoshida, K, 2014
)
0.4
" This study is an extension of our previous study of vitamin D dosing in healthy adults."( The vitamin d dose response in obesity.
Aloia, JF; Dhaliwal, R; Feuerman, M; Mikhail, M, 2014
)
0.4
" It is necessary to determine the dosage range, as well as the optimal level of vitamin D3 metabolite-25OHD3, where the immunosuppressant effect is the best, with no toxic effects."( The role of vitamin D3 in inflammatory bowel diseases.
Kosmowska-Miśków, A,
)
0.13
" A larger or more frequent dosing regimen may be needed for long-term vitamin D sufficiency."( The effect of a single, large bolus of vitamin D in healthy adults over the winter and following year: a randomized, double-blind, placebo-controlled trial.
Alvarez, JA; Binongo, JN; Kearns, MD; Lodin, D; Tangpricha, V; Watson, D; Ziegler, TR, 2015
)
0.42
" A positive dose-response was observed for mean ± SEM pup plasma concentrations of 25(OH)D (10."( Dietary vitamin D during pregnancy has dose-dependent effects on long bone density and architecture in guinea pig offspring but not the sows.
Khavandgar, Z; Kremer, R; Murshed, M; Rodd, CJ; Tabatabaei, N; Weiler, HA, 2014
)
0.4
"Using data derived from the National Health and Nutrition Examination Survey (NHANES) and a recently published dosing formula, we calculated the required supplemental dose of vitamin D to meet the IOM target in children and adolescents."( Importance of body weight and skin color in determining appropriate vitamin D3 supplement doses for children and adolescents.
Rajan, S; Weishaar, T, 2015
)
0.42
"Health professionals should work with their patients to encourage lifelong vitamin D supplement use at a dosage sufficient to obtain adequate 25(OH)D levels."( Importance of body weight and skin color in determining appropriate vitamin D3 supplement doses for children and adolescents.
Rajan, S; Weishaar, T, 2015
)
0.42
"001) and differed between groups (time × dosage interaction, P<0."( The effect of monthly 50,000 IU or 100,000 IU vitamin D supplements on vitamin D status in premenopausal Middle Eastern women living in Auckland.
Mazahery, H; Stonehouse, W; von Hurst, PR, 2015
)
0.42
"An in vivo dosing study of vitamin D in a rat posterolateral spinal fusion model with autogenous bone grafting."( The relationship between serum vitamin D levels and spinal fusion success: a quantitative analysis.
Delamarter, RB; Kanim, LE; Metzger, MF; Robinson, ST; Zhao, L, 2015
)
0.42
"To determine the dose-response of vitamin D3 supplementation on serum 25-hydroxyvitamin D [25(OH)D] among Chinese adults."( A dose-response study of vitamin D3 supplementation in healthy Chinese: a 5-arm randomized, placebo-controlled trial.
Chen, X; Chen, Y; Hu, FB; Hu, Y; Li, H; Lin, X; Liu, G; Lu, L; Sun, L; Yao, P; Ye, X; Zheng, H, 2016
)
0.43
"7) nmol/L, and the dose-response relationship was curvilinear with a plateau around 6 weeks for all doses."( A dose-response study of vitamin D3 supplementation in healthy Chinese: a 5-arm randomized, placebo-controlled trial.
Chen, X; Chen, Y; Hu, FB; Hu, Y; Li, H; Lin, X; Liu, G; Lu, L; Sun, L; Yao, P; Ye, X; Zheng, H, 2016
)
0.43
" Subsequently, one group (n=2) was fed a vitamin D-free diet and another group (n=2) was dosed daily with 13C-labeled vitamin D3."( Tissue content of vitamin D3 and 25-hydroxy vitamin D3 in minipigs after cutaneous synthesis, supplementation and deprivation of vitamin D3.
Burild, A; Frandsen, HL; Jakobsen, J; Poulsen, M, 2015
)
0.42
"In this observational study, we included 38 dialysis patients treated by stable dosage of cholecalciferol."( Efficiency of delivery observed treatment in hemodialysis patients: the example of the native vitamin D therapy.
Cavalier, E; Delanaye, P; Dubois, BE; Fafin, C; Krzesinski, JM; Moranne, O, 2016
)
0.66
" The dosage of the vitamin D was normal for 28% of patients (n=46)."( [Study of vitamin D supplementation in people over 65 years in primary care].
Berrut, G; Breysse, C; Guillot, P, 2015
)
0.42
"There are wide variations in recommended dosing for vitamin D repletion."( Evaluating Vitamin D Repletion Regimens and Effects in Veteran Patients.
Aterrado, S; Kanehira-Mar, S; Meier, J; Ono, G; Swislocki, A, 2015
)
0.42
" Ergocalciferol and cholecalciferol groups were separately organized into quartiles to identify dosing ranges that had the most impact on changes in 25(OH)D laboratory values."( Evaluating Vitamin D Repletion Regimens and Effects in Veteran Patients.
Aterrado, S; Kanehira-Mar, S; Meier, J; Ono, G; Swislocki, A, 2015
)
0.74
" Most regimens in current use are based on daily dosing, which may raise concerns of dosage inadequacy and suboptimal patient compliance."( Effects of a 10-day course of a high dose calciferol versus a single mega dose of ergocalciferol in correcting vitamin D deficiency.
Aiedeh, KM; Hadidi, KA; Melhem, SJ,
)
0.13
" The shortened dosing interval over 10 consecutive days might result in higher compliance."( Effects of a 10-day course of a high dose calciferol versus a single mega dose of ergocalciferol in correcting vitamin D deficiency.
Aiedeh, KM; Hadidi, KA; Melhem, SJ,
)
0.13
" This study demonstrated a linear dose-response relationship with an increase in 25(OH)D levels proportional to the dose administered."( A Randomized, Double-Blind, Parallel Study to Evaluate the Dose-Response of Three Different Vitamin D Treatment Schemes on the 25-Hydroxyvitamin D Serum Concentration in Patients with Vitamin D Deficiency.
Cavalier, E; Da Silva, S; De Niet, S; Jandrain, B; Scheen, A; Schleck, ML; Souberbielle, JC; Vanderbist, F, 2015
)
0.42
"There is uncertainty whether long-term daily dosing with vitamin D3 (cholecalciferol) supplementation (vitD3) above the 4000-IU/d dietary reference intake upper tolerable limit in children and adults is safe."( Comprehensive Safety Monitoring of 12-Month Daily 7000-IU Vitamin D3 Supplementation in Human Immunodeficiency Virus-Infected Children and Young Adults.
Hediger, ML; Rutstein, RM; Schall, JI; Stallings, VA; Zemel, BS, 2016
)
0.67
" We aimed to conduct a pilot trial comparing the efficacy of 2 vitamin D regimens of weekly dosing for the repletion of hypovitaminosis D in pediatric IBD."( Pilot Study Evaluating Efficacy of 2 Regimens for Hypovitaminosis D Repletion in Pediatric Inflammatory Bowel Disease.
Freeman, AJ; Hofmekler, T; Kugathasan, S; Kumar, A; Martineau, B; McCracken, C; McElhanon, BO; Prince, J; Sauer, CG; Schoen, BT; Simek, RZ; Syed, S; Tangpricha, V; Tenjarla, G; Ziegler, TR, 2016
)
0.43
"In the higher dosing group, serum 25(OH)D increased from 23."( Pilot Study Evaluating Efficacy of 2 Regimens for Hypovitaminosis D Repletion in Pediatric Inflammatory Bowel Disease.
Freeman, AJ; Hofmekler, T; Kugathasan, S; Kumar, A; Martineau, B; McCracken, C; McElhanon, BO; Prince, J; Sauer, CG; Schoen, BT; Simek, RZ; Syed, S; Tangpricha, V; Tenjarla, G; Ziegler, TR, 2016
)
0.43
" Although significant repletion of 25(OH)D concentration was achieved in both dosing groups at 8 weeks, this effect was lost by the 12-week follow-up."( Pilot Study Evaluating Efficacy of 2 Regimens for Hypovitaminosis D Repletion in Pediatric Inflammatory Bowel Disease.
Freeman, AJ; Hofmekler, T; Kugathasan, S; Kumar, A; Martineau, B; McCracken, C; McElhanon, BO; Prince, J; Sauer, CG; Schoen, BT; Simek, RZ; Syed, S; Tangpricha, V; Tenjarla, G; Ziegler, TR, 2016
)
0.43
" Whether substitution of native vitamin D in these patients is beneficial is a matter of ongoing discussion, as is the optimal dosing schedule."( Efficacy and safety of body weight-adapted oral cholecalciferol substitution in dialysis patients with vitamin D deficiency.
Lhotta, K; Mündle, M; Sprenger-Mähr, H; Zitt, E, 2015
)
0.67
"The dosing regimen of oral cholecalciferol supplementation with 100 IU per kg body weight per week for 26 weeks in dialysis patients with vitamin D deficiency causes a significant increase in 25OHD3 close to the supposed target level of 30 ng/mL and a significant reduction in iPTH, without affecting serum calcium or phosphorous levels."( Efficacy and safety of body weight-adapted oral cholecalciferol substitution in dialysis patients with vitamin D deficiency.
Lhotta, K; Mündle, M; Sprenger-Mähr, H; Zitt, E, 2015
)
0.97
" Therefore, the aim of this study is to examine effects and safety of a forced dosing regimen of vitamin D versus conventional dose supplementation on vitamin D levels and other parameters in bariatric patients."( The link between obesity and vitamin D in bariatric patients with omega-loop gastric bypass surgery - a vitamin D supplementation trial to compare the efficacy of postoperative cholecalciferol loading (LOAD): study protocol for a randomized controlled tri
Haslacher, H; Hoppichler, F; Kallay, E; Kienbacher, C; Klammer, C; Kral, M; Kruschitz, R; Langer, F; Ludvik, B; Luger, E; Luger, M; Marculescu, R; Prager, G; Schindler, K; Trauner, M; Traussnigg, S; Würger, T, 2015
)
0.61
"The study includes loading plus repeat dosing compared with repeated administration of vitamin D without a loading dose, according to guidelines, in a prospective, double-blind, randomized controlled trial."( The link between obesity and vitamin D in bariatric patients with omega-loop gastric bypass surgery - a vitamin D supplementation trial to compare the efficacy of postoperative cholecalciferol loading (LOAD): study protocol for a randomized controlled tri
Haslacher, H; Hoppichler, F; Kallay, E; Kienbacher, C; Klammer, C; Kral, M; Kruschitz, R; Langer, F; Ludvik, B; Luger, E; Luger, M; Marculescu, R; Prager, G; Schindler, K; Trauner, M; Traussnigg, S; Würger, T, 2015
)
0.61
" This alternative vitamin D dosing regimen has the potential to be a safe, fast, evidence-based treatment of vitamin D deficiency in bariatric patients."( The link between obesity and vitamin D in bariatric patients with omega-loop gastric bypass surgery - a vitamin D supplementation trial to compare the efficacy of postoperative cholecalciferol loading (LOAD): study protocol for a randomized controlled tri
Haslacher, H; Hoppichler, F; Kallay, E; Kienbacher, C; Klammer, C; Kral, M; Kruschitz, R; Langer, F; Ludvik, B; Luger, E; Luger, M; Marculescu, R; Prager, G; Schindler, K; Trauner, M; Traussnigg, S; Würger, T, 2015
)
0.61
"The best repletion and maintenance dosing regimens with cholecalciferol in vitamin D-deficient HIV-1 patients remain unknown."( An oral high dose of cholecalciferol restores vitamin D status in deficient postmenopausal HIV-1-infected women independently of protease inhibitors therapy: a pilot study.
Biondi, P; Cilli, M; Cipriani, C; Di Traglia, M; Diacinti, D; Falciano, M; Fantauzzi, A; Mezzaroma, I; Minisola, S; Pepe, J; Salotti, A, 2016
)
1
" The secondary outcome evaluated the safety of vitamin D dosing protocol as measured by serum and urine calcium, phosphate, creatinine, and serum parathyroid hormone (PTH)."( Bioavailability and Safety of Vitamin D3 from Pizza Baked with Fortified Mozzarella Cheese: A Randomized Controlled Trial.
Al-Khalidi, B; Chiu, W; Rousseau, D; Vieth, R, 2015
)
0.42
"To determine if vitamin D dosage positively correlated with gross motor development at 3 and 6 months of age."( Impact of Vitamin D Supplementation on Gross Motor Development of Healthy Term Infants: A Randomized Dose-Response Trial.
Comeau, K; Gallo, S; Jones, G; Khamessan, A; L'Abbe, M; Majnemer, A; Rodd, C; Sharma, A; Vanstone, C; Weiler, H; Wicklow, B, 2016
)
0.43
" Also, in contrast to earlier studies that used infrequent dosing regimens, our trial will study effects of a weekly dose of vitamin D supplementation."( Prevention of exacerbations in patients with COPD and vitamin D deficiency through vitamin D supplementation (PRECOVID): a study protocol.
Aleva, FE; Bet, PM; Daniels, JM; de Jongh, RT; den Heijer, M; Heijdra, YF; Hiemstra, PS; Lips, P; Rafiq, R; Schrumpf, JA; Taube, C; van der Ven, AJ, 2015
)
0.42
" Pregnant women were enrolled at 27 wk of gestation and randomly assigned to the following 3 groups: a placebo group, a group who received one dosage of daily oral vitamin D3 (1000 IU), or a group who received 2 dosages of daily oral vitamin D3 (2000 IU)."( Vitamin D activity of breast milk in women randomly assigned to vitamin D3 supplementation during pregnancy.
Camargo, CA; Crane, J; Ekeroma, A; Grant, CC; Horst, R; Milne, T; Mitchell, EA; Rowden, J; Scragg, R; Stewart, AW; Wall, CR, 2016
)
0.43
"Intermittent dosing may improve adherence to vitamin D therapy."( How well are the optimal serum 25OHD concentrations reached in high-dose intermittent vitamin D therapy? a placebo-controlled study on comparison between 100 000 IU and 200 000 IU of oral D3 every 3 months in elderly women.
Löyttyniemi, E; Pekkarinen, T; Välimäki, MJ; Välimäki, VV, 2016
)
0.43
"To determine the dose-response relationship between 25-hydroxyvitamin D (25(OH)D) and supplemental vitamin D3 in elderly nursing home residents."( Response of Vitamin D Concentration to Vitamin D3 Administration in Older Adults without Sun Exposure: A Randomized Double-Blind Trial.
Bikle, D; Kane, L; Schwartz, JB, 2016
)
0.43
" Daily average of the group mean D3 during the week following dosing was 66."( Effect of weekly high-dose vitamin D3 supplementation on serum cholecalciferol concentrations in pregnant women.
Baqui, AH; Craig-Barnes, HA; Dimitris, MC; Leadley, M; Mahmud, AA; Perumal, N; Roth, DE, 2016
)
0.67
" The fat-soluble vitamins are very sensitive to over- or under-supply because they interact with each other with respect to dose-response and chemical form."( Interactions between retinol, α-tocopherol and cholecalciferol need consideration in diets for farmed mink (Mustela vison).
Clausen, TN; Hymøller, L; Jensen, SK, 2016
)
0.69
"Timing and frequency of the dosing (daily vs weekly) have no effect on the rise in serum 25(OH)D levels as long as the accumulative dose of cholecalciferol is similar."( Vitamin D Dosing Strategies Among Jordanians With Hypovitaminosis D.
Ajlouni, K; Alkhateeb, H; Bajawi, D; El-Khateeb, M; Elmohtaseb, M; Hyassat, D; Khawaja, N; Liswi, M, 2017
)
0.66
"Clinical studies investigating relationships between D3 and 25OHD3 vary in dosing regimen, assays, demographics, and control of exogenous D3."( Model-based meta-analysis for development of a population-pharmacokinetic (PPK) model for Vitamin D3 and its 25OHD3 metabolite using both individual and arm-level data.
French, JF; Gastonguay, MR; Ocampo-Pelland, AS; Riggs, MM, 2016
)
0.43
"The objective of this study was to determine the dose-response of vitamin D supplementation on fasting glucose, insulin, and a surrogate measure of insulin resistance in white and black children aged 9–13 years, who participated in the Georgia, Purdue, and Indiana University (or GAPI) trial: a 12-week multisite, randomized, triple-masked, dose-response, placebo-controlled vitamin D trial."( Vitamin D Supplementation Does Not Impact Insulin Resistance in Black and White Children.
Ferira, AJ; Hall, DB; Hausman, DB; Hill Gallant, KM; Laing, EM; Lewis, RD; Martin, BR; McCabe, GP; Peacock, M; Warden, SJ; Weaver, CM, 2016
)
0.43
" The objective of this study was to determine if a dose-response relationship exists between infant vitamin D supplementation, vitamin D status, and bone outcomes at 3 years of age."( Vitamin D supplementation in breastfed infants from Montréal, Canada: 25-hydroxyvitamin D and bone health effects from a follow-up study at 3 years of age.
Agellon, S; Gallo, S; Hazell, T; Jones, G; L'Abbé, M; Rodd, C; Vanstone, CA; Weiler, HA, 2016
)
0.43
"This is the first longitudinal follow-up of an infant vitamin D dose-response study which examines bone mineralization at 3 years of age."( Vitamin D supplementation in breastfed infants from Montréal, Canada: 25-hydroxyvitamin D and bone health effects from a follow-up study at 3 years of age.
Agellon, S; Gallo, S; Hazell, T; Jones, G; L'Abbé, M; Rodd, C; Vanstone, CA; Weiler, HA, 2016
)
0.43
"VD replenishment is safe and can be effectively achieved by means of the employed cholecalciferol dosage in the majority of patients."( Efficacy and safety of vitamin D supplementation in patients with chronic lymphocytic leukemia.
Bednarek, A; Chudek, J; Karwasiecka, D; Kubeczko, M; Nowara, E; Spychałowicz, W; Wdowiak, K; Wojnar, J, 2016
)
0.66
"To assess the prevalence of vitamin D deficiency in Dutch athletes and to define the required dosage of vitamin D3 supplementation to prevent vitamin D deficiency over the course of a year."( The impact of 1-year vitamin D supplementation on vitamin D status in athletes: a dose-response study.
Backx, EM; de Groot, LC; Kies, AK; Maase, K; Mensink, M; Tieland, M; van Loon, LJ, 2016
)
0.43
" Of these 128 athletes, 54 male and 48 female athletes (18-32 years) were included in a randomized, double blind, dose-response study."( The impact of 1-year vitamin D supplementation on vitamin D status in athletes: a dose-response study.
Backx, EM; de Groot, LC; Kies, AK; Maase, K; Mensink, M; Tieland, M; van Loon, LJ, 2016
)
0.43
" Until further safety data is available, bolus dosing or daily doses should not exceed 3,000 IU and serum levels of 25-hydroxyvitamin D should not exceed 40-45 ng/ml (equivalent to 100-112 nmol/l) in elderly individuals."( Vitamin D and falls - the dosage conundrum.
Gallagher, JC, 2016
)
0.43
" Further studies are required to determine optimum dose and dosing frequency."( High-Dose Monthly Maternal Cholecalciferol Supplementation during Breastfeeding Affects Maternal and Infant Vitamin D Status at 5 Months Postpartum: A Randomized Controlled Trial.
Harper, MJ; Haszard, JJ; Herbison, P; Houghton, LA; Jones, S; Mikhail, A; Taylor, BJ; Wheeler, BJ, 2016
)
0.73
" Therefore, we examined the efficacy and safety of a forced vitamin D dosing regimen and intervention effects in liver fibrotic patients."( Vitamin D
Hoppichler, F; Kallay, E; Kienbacher, C; Krebs, M; Kruschitz, R; Langer, FB; Ludvik, B; Luger, M; Marculescu, R; Prager, G; Schindler, K; Trauner, M; Traussnigg, S, 2017
)
0.46
" The aim of this study was to examine the cardiovascular-vitamin D dose-response curve in a normal rat model."( Both high and low plasma levels of 25-hydroxy vitamin D increase blood pressure in a normal rat model.
Bohaychuk, K; Knaus, SJ; Mirhosseini, NZ; Singh, J; Vatanparast, HA; Weber, LP, 2016
)
0.43
" Toxicity from hypercalcemia occurred after prolonged oral dosing with these supraphysiologic doses."( Results of daily oral dosing with up to 60,000 international units (iu) of vitamin D3 for 2 to 6 years in 3 adult males.
Amend, J; McCullough, P, 2017
)
0.46
" As vitamin D deficiency has been linked to numerous diseases, understanding how genetic variation contributes to vitamin D dose-response is important for personalized vitamin D treatment and cost-effective disease prevention."( SNP rs11185644 of RXRA gene is identified for dose-response variability to vitamin D3 supplementation: a randomized clinical trial.
Badr, R; Deng, HW; Lappe, JM; Recker, RR; Watson, P; Ye, A; Zhang, J; Zhang, M; Zhao, LJ; Zhou, B; Zhou, Y, 2017
)
0.46
"0% dosing range."( Optimization and validation of a fast supercritical fluid chromatography method for the quantitative determination of vitamin D3 and its related impurities.
Andri, B; Dispas, A; Hubert, P; Klinkenberg, R; Lebrun, P; Marini, RD; Streel, B; Ziemons, E, 2017
)
0.46
" The often required dosage of 25(OH)VitD is reasonably not necessary to initiate VitD supplementation protocol in this vulnerable population."( Vitamin D Supplementation in Nursing Home Residents: Randomized Single Cholecalciferol Loading Protocol vs. Individualized Loading Dose Regimen.
Delomas, C; Hertzog, M; Lang, PO; Vogel, T, 2017
)
0.69
" The effects of daily or weekly dosing require further study."( Effect of Monthly High-Dose Vitamin D Supplementation on Cardiovascular Disease in the Vitamin D Assessment Study : A Randomized Clinical Trial.
Camargo, CA; Khaw, KT; Lawes, CMM; Murphy, J; Scragg, R; Sluyter, J; Stewart, AW; Toop, L; Waayer, D, 2017
)
0.46
" Model simulations compared 25OHD exposures, following repeated D2 and D3 oral administration across typical dosing and baseline ranges."( Model-based meta-analysis for comparing Vitamin D2 and D3 parent-metabolite pharmacokinetics.
Gastonguay, MR; Ocampo-Pelland, AS; Riggs, MM, 2017
)
0.46
" The National Institute of Standards and Technology, in collaboration with the National Institutes of Health Office of Dietary Supplements, has developed SRM 3532 Calcium-Containing Solid Oral Dosage Form to help address the analytical challenges seen by the dietary supplement communities for the determination of vitamin D3 (cholecalciferol) and elements."( Technical Note: Determination of Cholecalciferol (Vitamin D₃) in Standard Reference Material 3532 Calcium-Containing Solid Oral Dosage Form.
Burdette, CQ, 2017
)
0.91
"Existing trials of adjunctive vitamin D in the treatment of pulmonary tuberculosis (PTB) are variously limited by small sample sizes, inadequate dosing regimens, and high baseline vitamin D status among participants."( High-Dose Vitamin D
Baasansuren, E; Bayasgalan, P; Bloom, BR; Bromage, S; Buyankhishig, B; Fawzi, W; Ganmaa, D; Jolliffe, DA; Martineau, AR; Munkhzul, B; Oyun-Erdene, S; Spiegelman, D; Willett, WC; Xenakis, T, 2017
)
0.46
"0% of the API content) for a dosing range corresponding to at least 70."( Is supercritical fluid chromatography hyphenated to mass spectrometry suitable for the quality control of vitamin D3 oily formulations?
Andri, B; Dispas, A; Hubert, P; Klinkenberg, R; Marini, RD; Streel, B; Ziémons, E, 2017
)
0.46
" This study determined the dose-response effects of vitamin D3 supplementation on arterial stiffness in overweight African Americans with vitamin D deficiency."( Dose responses of vitamin D3 supplementation on arterial stiffness in overweight African Americans with vitamin D deficiency: A placebo controlled randomized trial.
Bhagatwala, J; Dong, Y; Guo, DH; Havens, R; Huang, Y; Kotak, I; Parikh, SJ; Pollock, NK; Raed, A; Zhu, H, 2017
)
0.46
"Vitamin D3 supplementation demonstrated a dose-response increase in serum 25(OH)D concentrations between groups (P<0."( Dose responses of vitamin D3 supplementation on arterial stiffness in overweight African Americans with vitamin D deficiency: A placebo controlled randomized trial.
Bhagatwala, J; Dong, Y; Guo, DH; Havens, R; Huang, Y; Kotak, I; Parikh, SJ; Pollock, NK; Raed, A; Zhu, H, 2017
)
0.46
"Arterial stiffness was improved by vitamin D3 supplementation in a dose-response manner in overweight African Americans with vitamin D deficiency."( Dose responses of vitamin D3 supplementation on arterial stiffness in overweight African Americans with vitamin D deficiency: A placebo controlled randomized trial.
Bhagatwala, J; Dong, Y; Guo, DH; Havens, R; Huang, Y; Kotak, I; Parikh, SJ; Pollock, NK; Raed, A; Zhu, H, 2017
)
0.46
" Chronic copper poisoning model created by intragastric administration of copper sulfate solution at a dosage of 20 mg/kg (in terms of metal) for 30 days, daily one time a day."( Influence hypervitaminosis D3 on hemodynamic presentation of experimental copper intoxication.
Brin, VB; Kabisov, OT; Mittsiev, AK; Mittsiev, KG,
)
0.13
" There is need to study the fact that how much vitamin D levels are raised after administration of these different formulations as this can be a pivotal factor in determining dosage and route of vitamin D3."( Comparison Of Different Formulations Of Vitamin D.
Ahmad, Z; Chauhdary, KK; Fahan Rashid, HM; Kumar, S; Musharraf, U; Syed, U,
)
0.13
"We performed a double-blind, placebo-controlled, dose-response winter trial at 55ºN."( Winter vitamin D
Damsgaard, CT; Hauger, H; Kristensen, M; Mortensen, C; Mølgaard, C, 2019
)
0.51
" However larger clinical trials are essential to investigate optimum dosage of vitamin D3 in this group."( Effect of vitamin D3 supplementation in pregnancy on risk of pre-eclampsia - Randomized controlled trial.
Ali, AM; Alobaid, A; Khattab, AF; Malhis, TN, 2019
)
0.51
" Further studies are needed to standardize guidelines for optimal vitamin D dosing and prevention of toxicity."( Response to Long-term Vitamin D Therapy for Bone Disease in Children With Sickle Cell Disease.
Brittenham, GM; Fennoy, I; Lee, MT; Licursi, M; Williams, KM, 2018
)
0.48
"To assess the effectiveness of 2 vitamin D dosing strategies in preventing recurrent wheezing."( Effect of Vitamin D Supplementation on Recurrent Wheezing in Black Infants Who Were Born Preterm: The D-Wheeze Randomized Clinical Trial.
Fuloria, M; Groh-Wargo, S; Hibbs, AM; Kerns, LA; Minich, N; Ross, K; Tatsuoka, C; Wagner, C; Zimmerman, T, 2018
)
0.48
"To determine whether daily supplementation with 1200 IU of vitamin D3 increases bone strength or decreases incidence of infections in the first 2 years of life compared with a dosage of 400 IU/d."( Effect of Higher vs Standard Dosage of Vitamin D3 Supplementation on Bone Strength and Infection in Healthy Infants: A Randomized Clinical Trial.
Andersson, S; Enlund-Cerullo, M; Hauta-Alus, H; Helve, O; Holmlund-Suila, E; Hytinantti, T; Kajantie, E; Levälahti, E; Mäkitie, O; Rosendahl, J; Valkama, S; Viljakainen, H, 2018
)
0.48
"In a dose-response trial, 110 adolescents (mean ± SD age: 15."( Winter Cholecalciferol Supplementation at 51°N Has No Effect on Markers of Cardiometabolic Risk in Healthy Adolescents Aged 14-18 Years.
Damsgaard, CT; Hart, KH; Hauger, H; Lanham-New, SA; Mølgaard, C; Smith, TJ; Tripkovic, L, 2018
)
0.94
" The increase in the single-dose group was significantly higher than in the daily low dosage group at the 12th week (23."( The effects of single high-dose or daily low-dosage oral colecalciferol treatment on vitamin D levels and muscle strength in postmenopausal women.
Apaydin, M; Beysel, S; Cakal, E; Caliskan, M; Can, AG; Demirci, T; Kan, S; Kizilgul, M; Ozbek, M; Ozcelik, O, 2018
)
0.48
"The aim of this cross-sectional observational study in somatic and psychogeriatric nursing home residents was to determine the efficacy of a standardized oral vitamin D dosing regimen (VDDR) consisting of a loading dose (LD) of cholecalciferol 200,000 IU followed by a maintenance dose (MD) of 100,000 IU every 13 weeks in obtaining and maintaining an adequate and safe vitamin D trough level (VDTL), defined as 75-220 nmol/L (reference range)."( Efficacy of a Standardized Oral Vitamin D Dosing Regimen in Nursing Home Residents.
Kappelle, JW; Toren-Wielema, M; van Roon, E; Veeger, N; Veenhuizen, R, 2018
)
0.66
" The primary outcome for the efficacy of the VDDR was the percentage of nursing home residents with a VDTL 75-220 nmol/L, with a target percentage of 85% for the dosing regimen to be considered efficacious."( Efficacy of a Standardized Oral Vitamin D Dosing Regimen in Nursing Home Residents.
Kappelle, JW; Toren-Wielema, M; van Roon, E; Veeger, N; Veenhuizen, R, 2018
)
0.48
" Improvement in PCS was greater in patients whose calcitriol dosage was reduced and duration of disease was shorter."( Quality of Life in Hypoparathyroidism Improves With rhPTH(1-84) Throughout 8 Years of Therapy.
Almonte, MG; Bilezikian, JP; Cusano, NE; Majeed, R; Omeragic, B; Rubin, MR; Tabacco, G; Tay, YD; Williams, J, 2019
)
0.51
" Larger studies with longer duration and cholecalciferol dosage stratification are suggested."( [Sustained serum 25-hydroxyvitamin D concentrations for one year with cholecalciferol supplementation improves glycaemic control and slows the decline of residual β cell function in children with type 1 diabetes].
Attri, SV; Bhalla, AK; Dayal, D; Panjiyar, RP; Sachdeva, N; Sharma, R, 2018
)
0.98
" A protocol was created for an adequate dose-response trial to test the NS combination in men with ED and prostatism."( Toward a Scientific Nutritional Supplement Combination for Prostatism and Erectile Dysfunction I: From Known Pharmacology to Clinical Testing.
Pyke, RE, 2019
)
0.51
" The 2 dosing regimens did not differ in clinical or biochemical changes."( Mediators in Preterm Infants With Late-onset Sepsis: A Randomized Controlled Trial.
Abdel-Hady, H; Aly, H; Bhattacharjee, I; Megahed, A; Mosbah, A; Nageh, E; Seif, B; Yahia, S, 2019
)
0.51
"The presence of obesity may confound cholecalciferol dosing in vitamin D-deficient patients owing to potentially decreased bioavailability."( Obesity attenuates serum 25-hydroxyvitamin D response to cholecalciferol therapy in critically ill patients.
Croce, MA; Dickerson, RN; Holmes, WL; Maish, GO; Minard, G,
)
0.65
" The gummy bear food supplements are more acceptable to consumers and have fewer limitations compared to other dosage forms."( Natural Ingredients-Based Gummy Bear Composition Designed According to Texture Analysis and Sensory Evaluation In Vivo.
Čižauskaitė, U; Jakubaitytė, G; Kasparavičienė, G; Žitkevičius, V, 2019
)
0.51
"With intermittent vitamin D supplementation, serum 25-hydroxyvitamin D (25OHD) levels may remain stable only if the dosing interval is shorter than 3 months, the ideal perhaps being about 1 month."( Vitamin D Supplementation in France in patients with or at risk for osteoporosis: Recent data and new practices.
Breuil, V; Cavalier, E; Cormier, C; Cortet, B; Debiais, F; Fardellone, P; Guggenbuhl, P; Javier, RM; Legrand, E; Lespessailles, E; Paccou, J; Souberbielle, JC; Thomas, T, 2020
)
0.56
"Despite the availability of consensus guidelines for the treatment of vitamin D deficiency, prospective trials are lacking to examine alternative dosing strategies for adult patients with cystic fibrosis (CF) who do not meet therapeutic goals with standard regimens."( High-dose Cholecalciferol Supplementation in Adults with Cystic Fibrosis.
Brown, C; Janzen, KM; Lehman, A; Sakon, C; Sommer, B, 2019
)
0.92
" Whether effects of daily or weekly dosing differ requires further study."( Effect of Monthly High-Dose Vitamin D Supplementation on Acute Respiratory Infections in Older Adults: A Randomized Controlled Trial.
Camargo, CA; Khaw, KT; Lawes, CMM; Scragg, R; Sluyter, J; Stewart, AW; Toop, L; Waayer, D, 2020
)
0.56
" 25(OH)D3 (10, 15, and 20 µg) and D3 (20 µg) were dosed daily for 6 mo followed by 6 mo of washout."( Supplemental 25-Hydroxycholecalciferol Is More Effective than Cholecalciferol in Raising Serum 25-Hydroxyvitamin D Concentrations in Older Adults.
Beck, M; Bendik, I; Graeff-Armas, LA; Hull, S; Kunz, I; Schoop, R, 2020
)
0.87
" Among athletes with baseline serum 25(OH)D values suggesting insufficiency, vitamin D3 daily dosage at 5000 IU for over 4 weeks led to a serum 25(OH)D concentration of 31."( Effects of vitamin D3 supplementation on serum 25(OH)D concentration and strength in athletes: a systematic review and meta-analysis of randomized controlled trials.
Han, Q; Li, X; Shao, J; Tan, Q; Yi, M, 2019
)
0.51
"The association of antiseizure medication (ASM) and bone density abnormalities has long been recognized; however, there remains a lack of consensus on efficacy and optimal vitamin D dosing in patients receiving enzyme inducing and non-inducing ASMs."( Effects of enzyme-inducing antiseizure medication on vitamin D dosing in adult veterans with epilepsy.
Breslow, R; Gidal, B; Koukounas, Y; Margolis, A; Menninga, N, 2020
)
0.56
" Various factors can affect the absorption of VitD, including dosage and formulation."( Efficiency of Vitamin D Supplementation in Healthy Adults is Associated with Body Mass Index and Baseline Serum 25-Hydroxyvitamin D Level.
Hribar, M; Hristov, H; Pravst, I; Žmitek, K, 2020
)
0.56
" Cholecalciferol, unlike calcifediol, guarantees an exact dosage in IU (International Units) of vitamin D and has pharmacokinetic properties that allow either daily or even weekly, fortnightly, or monthly administration in its equivalent doses, which can facilitate adherence to treatment."( Cholecalciferol or Calcifediol in the Management of Vitamin D Deficiency.
Gómez de Tejada Romero, MJ; Sosa Henríquez, M, 2020
)
2.91
" They underwent 24-hour ABPM, along with glycated hemoglobin, creatine, lipids profile and PCRus dosage before and after VD supplementation."( High-dose Cholecalciferol Supplementation Reducing Morning Blood Pressure in Normotensive DM1 Patients.
Abrahão Neto, JF; da Mota Queiroz, A; de Alcântara, AL; de Figueiredo, PBB; de Lemos, MN; de Melo, FTC; de Moraes, LV; de Oliveira, MCNI; de Queiroz, NNM; de Sá Oliveira Dos Reis, M; de Souza D'Albuquerque Silva, L; de Souza Neto, NJK; de Souza Resende, F; de Souza, ACCB; de Souza, ÍJA; Dos Santos, MC; Felício, JS; Felício, KM; Freire Piani, PP; Janaú, LC; Lobato, IJC; Motta, ARB; Said, NM, 2021
)
1.02
"This study assessed the effects of weekly vitamin D (VD) supplementation on clinical and biological parameters after scaling and root planning (SRP) in the treatment of periodontitis and served to validate the VD dosage regimen."( The Effects of 6-Month Vitamin D Supplementation during the Non-Surgical Treatment of Periodontitis in Vitamin-D-Deficient Patients: A Randomized Double-Blind Placebo-Controlled Study.
Cavalier, E; Lasserre, JF; Maiter, D; Perić, M; Toma, S, 2020
)
0.56
" Orally disintegrating tablets (ODT) were first developed to overcome the difficulty experienced by pediatric and geriatric patients of swallowing traditional oral dosage forms and, recently, orodispersible films (ODF) are gaining popularity as novel dosage form for assuming active pharmaceutical ingredients, vitamins, and ingredients for food supplements."( Development and Characterization of an Orodispersible Film for Vitamin D3 Supplementation.
Cupone, IE; Dellera, E; Giori, AM; Marra, F, 2020
)
0.56
" We compared cholecalciferol dosing regimens for achieving and maintaining 25OHD concentrations ≥30 ng/mL in children with CKD stages 2-4."( Determining the optimal cholecalciferol dosing regimen in children with CKD: a randomized controlled trial.
Ekambaram, S; Fischer, DC; Iyengar, A; Kamath, N; Rahn, A; Reddy, HV; Selvam, S; Sharma, J; Shroff, R; Singhal, J; Uthup, S; Wan, M, 2022
)
1.4
" Irrespective of dosing regimen, children with glomerular disease had 25OHD concentrations lower than non-glomerular disease (25."( Determining the optimal cholecalciferol dosing regimen in children with CKD: a randomized controlled trial.
Ekambaram, S; Fischer, DC; Iyengar, A; Kamath, N; Rahn, A; Reddy, HV; Selvam, S; Sharma, J; Shroff, R; Singhal, J; Uthup, S; Wan, M, 2022
)
1.03
"Calcifediol is able to rapidly normalize the vitamin D deficiency, and the 30 µg daily dosage could be suggested in those patients who need to rapidly reach optimal 25OHD levels."( Pharmacokinetic profile and effect on bone markers and muscle strength of two daily dosage regimens of calcifediol in osteopenic/osteoporotic postmenopausal women.
Caffarelli, C; Camarri, S; Franci, B; Gonnelli, S; Lucani, B; Nuti, R; Tomai Pitinca, MD, 2021
)
0.62
"Guidelines for the dosage of vitamin D supplementation vary widely globally."( Vitamin D3 Dose Requirement That Raises 25-Hydroxyvitamin D to Desirable Level in Overweight and Obese Elderly.
Al-Shaar, L; Arabi, A; Bacha, DS; Baddoura, R; El-Hajj Fuleihan, G; Habib, R; Halaby, G; Mahfoud, ZR; Rahme, M; Singh, RJ, 2021
)
0.62
" Vitamin D dosing regimens to prevent maternal and infant vitamin D deficiency should take into consideration the mean 25(OH)D concentration of the target population."( Basal Vitamin D Status and Supplement Dose Are Primary Contributors to Maternal 25-Hydroxyvitamin D Response to Prenatal and Postpartum Cholecalciferol Supplementation.
Gernand, AD; Islam, MM; Levy, B; Mahmud, AA; O'Callaghan, KM; Qamar, H; Roth, DE, 2021
)
0.82
"Comparative pharmacodynamic (PD) analyses on different dosing schedules for cholecalciferol supplementation are limited."( Pharmacodynamics of Oral Cholecalciferol in Healthy Individuals with Vitamin D Deficiency: A Randomized Open-Label Study.
Adami, G; Benini, C; Bertoldo, E; Fassio, A; Fracassi, E; Gatti, D; Gatti, M; Milleri, S; Rossini, M; Viapiana, O, 2021
)
1.15
"Vitamin D supplementation demonstrated generally positive effects on HDL cholesterol, LDL cholesterol, and total cholesterol, especially at the lower dosage of 600 IU/d, with several significant changes persisting during the post-supplementation period."( Vitamin D supplementation and cardiometabolic risk factors among diverse schoolchildren: a randomized clinical trial.
Chomitz, VR; Economos, CD; Eliasziw, M; Goodman, E; Gordon, CM; Huang, Q; Sacheck, JM; Van Rompay, MI, 2022
)
0.72
" Two studies compared the exact dosage of vitamin D by different routes of administration, and three studies compared different doses by the same route."( Safety and effectiveness of vitamin D mega-dose: A systematic review.
Ataide, FL; Carvalho Bastos, LM; Freire de Carvalho, J; Skare, TL; Vicente Matias, MF, 2021
)
0.62
" However, there is a lack of evidence regarding the optimal dosage and duration of vitamin D supplementation for individualised and long-term management of the vitamin D status in the context of SCI."( Vitamin D supplementation in chronic spinal cord injury (VitD-SCI): study protocol for a randomised controlled trial.
Brinkhof, MWG; Flueck, JL; Hertig-Godeschalk, A; Jenny, A; Landmann, G; Perret, C; Scheel-Sailer, A; Wyss, PO, 2021
)
0.62
" Participants receive either a monthly dosage of 24 000 IU or 48 000 IU vitamin D or a placebo for 12 months."( Vitamin D supplementation in chronic spinal cord injury (VitD-SCI): study protocol for a randomised controlled trial.
Brinkhof, MWG; Flueck, JL; Hertig-Godeschalk, A; Jenny, A; Landmann, G; Perret, C; Scheel-Sailer, A; Wyss, PO, 2021
)
0.62
" Rickets and vitamin D deficiency should be treated with oral cholecalciferol, preferably in a daily dosing schedule (2000 IU below 1 year of age and 3000 IU in older children) for 12 weeks."( Indian Academy of Pediatrics Revised (2021) Guidelines on Prevention and Treatment of Vitamin D Deficiency and Rickets.
Ahmad, A; Angadi, K; Balasubramanian, S; Basavaraj, GV; Bhakhri, BK; Bhatia, VL; Dabas, A; Godbole, T; Goyal, JP; Gupta, P; Khadgawat, R; Khadilkar, V; Krishnamurthy, S; Kumar, P; Kurpad, A; Mallikarjuna, HB; Marwaha, RK; Munns, C; Parekh, BJ; Sachdev, HPS; Seth, A; Shah, D, 2022
)
0.96
" Patients with low vitamin D levels (25 (OH)D <20 ng / ml) were divided into two subgroups: 30 people were prescribed cholecalciferol at a dosage of 8 000 IU/day for three months and 30 people who were not treated with cholecalciferol."( [Prevention of cognitive disorders in elderly and senile patients.]
Goldobin, VV; Golovkin, VI; Klocheva, EG; Lobzin, SV; Lobzin, VY; Mirzaeva, LM; Pervova, EM; Shvartsman, GI; Sokolova, MG, 2021
)
0.83
" Overall, relative changes in 25(OH)D inversely affected maximum muscle strength in a dose-response manner."( Effect of Daily Vitamin D3 Supplementation on Muscle Health: An Individual Participant Meta-analysis.
Bislev, LS; Grove-Laugesen, D; Rejnmark, L; Rolighed, L; Wamberg, L, 2022
)
0.72
" Dosing was directly observed and administered in conjunction with infliximab infusions."( Efficacy and Safety of High-dose Cholecalciferol in Patients With Inflammatory Bowel Disease Receiving Infliximab.
Dahlberg, SE; Gordon, RJ; Johansen, C; Liu, S; Rufo, PA; Snapper, SB; Wells, R, 2022
)
1
"To evaluate the dose-response effect of consuming 2, 7, or 12 commercially available eggs per week on serum 25(OH)D concentrations during the autumn-winter months in young adults."( Dose-Response Effect of Consuming Commercially Available Eggs on Wintertime Serum 25-Hydroxyvitamin D Concentrations in Young Australian Adults: a 12-Week Randomized Controlled Trial.
Daly, RM; De Ross, B; Gianoudis, J; Tan, SY, 2022
)
0.72
" Thirteen of the 24 (54%) had vitamin D deficiency or insufficiency despite advice to supplement; 9 of these 13 (69%) subsequently started or increased the dosage of vitamin D supplements and levels became sufficient (> 50 nmol/L), while the remaining 4 patients (31%) continued to have persistent insufficient levels due to noncompliance with supplements."( Establishing an appropriate level of vitamin D supplementation in paediatric patients with recessive dystrophic epidermolysis bullosa.
Bageta, M; Loizou, A; Martinez, AE; Petrof, G; Yerlett, N, 2022
)
0.72
" We found a very weak relationship between the dosage of oral vitamin D3 and the subsequent calcium levels, both in serum and in urinary excretion over 24 h, respectively."( Safety Data in Patients with Autoimmune Diseases during Treatment with High Doses of Vitamin D3 According to the "Coimbra Protocol".
Amon, J; Amon, U; Ennis, M; Holick, MF; Yaguboglu, R, 2022
)
0.72
" An interaction between dosage group and season-at-birth (p = 0."( Vitamin D supplementation and gross motor development: A 3-year follow-up of a randomized trial.
Gallo, S; Hazell, TJ; Majnemer, A; Rodd, CJ; Vanstone, CA; Weiler, HA, 2022
)
0.72
"VitD supplementation does not improve antidepressant outcomes with flexibly dosed escitalopram."( A randomized, double-blind, placebo-controlled, 12-week trial of vitamin D augmentation in major depressive disorder associated with vitamin D deficiency.
Andrade, C; Kumar, PNS; Menon, V, 2022
)
0.72
" Ideal dosing to fully replete 25OHD concentrations in this population remains unknown."( Vitamin D supplementation in children and young adults with persistent proteinuria secondary to glomerular disease.
Atkinson, MA; Ballester, LS; Denburg, MR; Hoofnagle, AN; Kogon, AJ; Leonard, MB; Sethna, CB; Walker, N; Zaritsky, JJ; Zee, J, 2023
)
0.91
" This dosage did not improve endothelial function but did improve the 6-min walk distance, symptoms, and left atrial diameter at 6 months."( Effect of vitamin D on endothelial and ventricular function in chronic heart failure patients: A prospective, randomized, placebo-controlled trial.
Ha, SJ; Jang, JY; Woo, JS; Woo, Y, 2022
)
0.72
"The effects of vitamin D3 supplementation on bone mineral density (BMD) and markers of bone turnover, as well as the dose-response relationship between vitamin D3 and bone health in adults, were evaluated."( Effect of supplemental vitamin D3 on bone mineral density: a systematic review and meta-analysis.
Basirat, V; Davoodi, SH; Holick, MF; Karimi, M; Kazemian, E; Pourali, A; Sajadi Hezaveh, Z; Sedaghat, F, 2023
)
0.91
" A one-stage random-effects dose-response model was used to estimate the dose-response relationship between vitamin D3 supplementation and BMD."( Effect of supplemental vitamin D3 on bone mineral density: a systematic review and meta-analysis.
Basirat, V; Davoodi, SH; Holick, MF; Karimi, M; Kazemian, E; Pourali, A; Sajadi Hezaveh, Z; Sedaghat, F, 2023
)
0.91
" Dose-response analysis revealed a linear relationship between vitamin D3 supplementation doses and BMD at the femoral neck, lumbar spine, and total hip sites."( Effect of supplemental vitamin D3 on bone mineral density: a systematic review and meta-analysis.
Basirat, V; Davoodi, SH; Holick, MF; Karimi, M; Kazemian, E; Pourali, A; Sajadi Hezaveh, Z; Sedaghat, F, 2023
)
0.91
"The effect of different dosing regimens of cholecalciferol supplementation on bone biomarkers has not been studied in children with chronic kidney disease (CKD)."( Changes in bone biomarkers in response to different dosing regimens of cholecalciferol supplementation in children with chronic kidney disease.
Christiane-Fischer, D; Ekambaram, S; Iyengar, A; Kamath, N; Rahn, A; Reddy, HV; Selvam, S; Sharma, J; Shroff, R; Singhal, J; Uthup, S; Wan, M, 2023
)
1.41
"Although cholecalciferol supplementation was associated with a significant increase in bone formation, the three dosing regimens of cholecalciferol supplementation have a comparable effect on the bone biomarker profile, suggesting that they can be used interchangeably to suit the patient's needs and optimize adherence to therapy."( Changes in bone biomarkers in response to different dosing regimens of cholecalciferol supplementation in children with chronic kidney disease.
Christiane-Fischer, D; Ekambaram, S; Iyengar, A; Kamath, N; Rahn, A; Reddy, HV; Selvam, S; Sharma, J; Shroff, R; Singhal, J; Uthup, S; Wan, M, 2023
)
1.56
" This is a single-center, open-label, randomized, parallel group study involving healthy subjects deficient in vitamin D (baseline 25OHD < 20 ng/mL) receiving oral cholecalciferol with three different dosing regimens: Group A: 10,000 IU/day for 8 weeks followed by 1000 IU/day for 4 weeks; Group B: 50,000 IU/week for 12 weeks and Group C: 100,000 IU every other week for 12 weeks."( Effects on Serum Inflammatory Cytokines of Cholecalciferol Supplementation in Healthy Subjects with Vitamin D Deficiency.
Adami, G; Benini, C; Bertelle, D; Bixio, R; Fassio, A; Gatti, D; Milleri, S; Pistillo, F; Rossini, M; Viapiana, O; Zanetti, G, 2022
)
1.18
"D 3 every week, an n-3FA group that received 300 mg of omega-3 fatty acid every day, and a D+ group that received a combination of both supplements, with the same dosage administered by the previous groups but with a 4-6-hour time interval between Vit."( Combined Effect of Omega-3 Fatty Acid and Vitamin D 3 on Oxidized LDL-C and Non-HDL-C Levels in People With Vitamin D Deficiency: A Randomized Controlled Trial.
Abu-Samak, MS; Awwad, S; Habash, M; Hasoun, L; Khader, HA; Mehdawi, A; Mohammad, BA; Mosleh, I; Nassar, RI, 2023
)
0.91
" We performed subgroup analyses to determine whether the effect of vitamin D on risk of asthma exacerbation was modified by baseline vitamin D status, vitamin D dose, frequency of dosing regimen, form of vitamin D given, and age of participants."( Vitamin D for the management of asthma.
Griffiths, CJ; Jolliffe, D; Martineau, AR; Sheikh, A; Williamson, A, 2023
)
0.91
" However, little information is available on the quantity of the most prescribed patient-specific items, their dosage form, and why they were required to be dispensed."( The use of Special-Order products in England between 2012 and 2020: An insight into the need for Point-of-Care manufacturing.
Alhnan, MA; Del-Nevo, L; Duncan, JC; Gill, A; Li, KY; O'Donovan, A; Peak, M, 2023
)
0.91
" Furthermore, optimizing dosing regimens is an important clinical consideration."( A Scoping Review of Vitamin D for Nonskeletal Health: A Framework for Evidence-based Clinical Practice.
Delpino, FM; Forbes, SC; Martins, CEC; Santos, HO, 2023
)
0.91
" Dosing was based on patient body weight and titrated per individual pharmacokinetics."( Optimized vitamin D repletion with oral thin film cholecalciferol in patients undergoing stem cell transplant.
Bartlett, AL; Davidson, R; Davies, SM; Jodele, S; McLean, S; Myers, KC; Patel, B; Taggart, C; Teusink-Cross, A; Wallace, G; Zhang, G, 2023
)
1.16
" Our results show a decrease in miR-155-5p expression after cholecalciferol supplementation in both dosage groups, consistent with previous observations."( Cholecalciferol Supplementation Induced Up-Regulation of
Bizjak, A; Fabjan, TH; Gorenjak, M; Gselman, S; Potočnik, U, 2023
)
2.6
" Since vitamin D insufficiency is highly prevalent in diabetics, we aimed to evaluate the effect of three dosage forms of vitamin D supplementation on lipid profile, NF-κB, platelet aggregation, and platelet calcium content in type 2 diabetic patients."( Effect of oral versus parenteral vitamin D3 supplementation on nuclear factor-κB and platelet aggregation in type 2 diabetic patients.
Ali, S; Ghanem, Y; Habiba, E; Hewedy, W; Sharaki, O, 2023
)
0.91
" After three days in the hospital, the patient's initial symptoms subsided, resulting in discharge with a prescription of ongoing oral medications including Calcium Carbonate and Vitamin D3 Tablets, Calcitriol Soft Capsules, and Potassium Aspartate and Magnesium Aspartate Tablets, with the same usage and dosage as the above three drugs."( Hypomagnesemia with Secondary Hypocalcemia (HSH): a Case Report.
Jiang, Z; Lin, Y; Zhao, C, 2023
)
0.91
" As expected, there was a dose-response association between the amount of vitamin D consumed (600, 2000, or 4000 IU daily) and maternal 25(OH)D levels at the end of the intervention."( Maternal vitamin D intakes during pregnancy and child health outcome.
Altantuya, S; Amgalan, B; Enkhmaa, D; Ganmaa, D; Nasantogtokh, E, 2023
)
0.91
" The patient then admitted that in October 2020, she received a course of "megadose" parenteral vitamin D, but she could not recall the exact dosage nor wanted to mention the department administering the treatment."( [A rare cause of kidney injury: vitamin D3 intoxication].
Bodor, M; Hutkai, D, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Occurs in Manufacturing (125 Items)

ItemProcessFrequency
Plant-based foods and beveragescore-ingredient28
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Productos sin glutencore-ingredient1
prenatalcore-ingredient1
Iced teascore-ingredient1
Tea-based beveragescore-ingredient1
Flavored waterscore-ingredient1
Fish oilscore-ingredient1
Animal fatscore-ingredient1
Nutritional Supplementcore-ingredient1
Multi-Vitamincore-ingredient1
Open Products Factscore-ingredient1
Non alimentairecore-ingredient1
Teufelskrallecore-ingredient1
Kräuterteescore-ingredient1
Pflanzliche Getränkecore-ingredient1
Heißgetränkecore-ingredient1
Getränkecore-ingredient1
Gélatinecore-ingredient1
Gélifiantscore-ingredient1
Additifs alimentairescore-ingredient1
Mélange d'huile d'olive et de grainescore-ingredient1
Mélanges d'huilescore-ingredient1
Huilescore-ingredient1
Matières grasses végétalescore-ingredient1
Margarinencore-ingredient1
Pflanzenfettecore-ingredient1
Streichfettecore-ingredient1
Pflanzliche Brotaufstrichecore-ingredient1
Brotaufstrichecore-ingredient1
Fettecore-ingredient1
Pflanzliche Lebensmittelcore-ingredient1
fr:multivitamincore-ingredient1
Huiles de poissonscore-ingredient1
Matières grasses animalescore-ingredient1
Produits de la mercore-ingredient1
Kosttilskudcore-ingredient1
Banana flavoured powdercore-ingredient1
Banana flavour mix and added vitamins and minerals for milkcore-ingredient1
Cow milkscore-ingredient1
Whole milkscore-ingredient1
UHT Milkscore-ingredient1
Homogenized milkscore-ingredient1
Milkscore-ingredient1
en:produits sous licencecore-ingredient1
Licensed productscore-ingredient1
Candiescore-ingredient1
Specific productscore-ingredient1
Confectioneriescore-ingredient1
Sweet snackscore-ingredient1
Artificially sweetened beveragescore-ingredient1

Roles (2)

RoleDescription
human metaboliteAny mammalian metabolite produced during a metabolic reaction in humans (Homo sapiens).
geroprotectorAny compound that supports healthy aging, slows the biological aging process, or extends lifespan.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (5)

ClassDescription
seco-cholestane
hydroxy seco-steroid
D3 vitaminsA vitamin D that is calciol or its hydroxylated metabolites calcidiol and calcitriol. Calciol (also known as vitamin D3) acts as a hormone precursor, being hydroxylated in the liver to calcidiol (25-hydroxyvitamin D3), which is then further hydroxylated in the kidney to give calcitriol (1,25-dihydroxyvitamin D3), the active hormone.
secondary alcoholA secondary alcohol is a compound in which a hydroxy group, -OH, is attached to a saturated carbon atom which has two other carbon atoms attached to it.
steroid hormoneAny steroid that acts as hormone.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (44)

PathwayProteinsCompounds
Metabolism14961108
Metabolism of lipids500463
Metabolism of steroids111135
Vitamin D (calciferol) metabolism1210
Biological oxidations150276
Phase I - Functionalization of compounds69175
Cytochrome P450 - arranged by substrate type30110
Vitamins415
Steroid Biosynthesis2142
Smith-Lemli-Opitz Syndrome (SLOS)2142
CHILD Syndrome2142
Desmosterolosis2142
Chondrodysplasia Punctata II, X-Linked Dominant (CDPX2)2142
Lysosomal Acid Lipase Deficiency (Wolman Disease)2142
Ibandronate Action Pathway2143
Simvastatin Action Pathway2143
Pravastatin Action Pathway2143
Rosuvastatin Action Pathway2143
Alendronate Action Pathway2143
Hypercholesterolemia2142
Lovastatin Action Pathway2143
Zoledronate Action Pathway2143
Cerivastatin Action Pathway2143
Risedronate Action Pathway2143
Pamidronate Action Pathway2143
Fluvastatin Action Pathway2143
Atorvastatin Action Pathway2143
Cholesteryl Ester Storage Disease2142
Hyper-IgD Syndrome2142
Mevalonic Aciduria2142
Wolman Disease2142
Disease1278231
Diseases of metabolism69121
Metabolic disorders of biological oxidation enzymes647
Defective CYP27B1 causes VDDR1B14
Vitamin D-sensitive calcium signaling in depression213
STING pathway in Kawasaki-like disease and COVID-1904
RAS and bradykinin pathways in COVID-19113
Non-classical role of vitamin D86
Vitamin D metabolism19
Osteoblast signaling03
Biochemical pathways: part I0466
Vitamins A and D - action mechanisms09
Vitamin A and carotenoid metabolism020

Protein Targets (56)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, HADH2 proteinHomo sapiens (human)Potency31.62280.025120.237639.8107AID886
Chain B, HADH2 proteinHomo sapiens (human)Potency31.62280.025120.237639.8107AID886
Chain A, Ferritin light chainEquus caballus (horse)Potency22.38725.623417.292931.6228AID485281
Chain A, CruzipainTrypanosoma cruziPotency26.65140.002014.677939.8107AID1476
LuciferasePhotinus pyralis (common eastern firefly)Potency28.69540.007215.758889.3584AID624030
interleukin 8Homo sapiens (human)Potency66.82420.047349.480674.9780AID651758
15-lipoxygenase, partialHomo sapiens (human)Potency15.84890.012610.691788.5700AID887
USP1 protein, partialHomo sapiens (human)Potency44.66840.031637.5844354.8130AID504865
Microtubule-associated protein tauHomo sapiens (human)Potency17.48820.180013.557439.8107AID1460; AID1468
AR proteinHomo sapiens (human)Potency35.48130.000221.22318,912.5098AID588516
aldehyde dehydrogenase 1 family, member A1Homo sapiens (human)Potency33.55210.011212.4002100.0000AID1030
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency50.11870.000214.376460.0339AID588533
retinoid X nuclear receptor alphaHomo sapiens (human)Potency19.95260.000817.505159.3239AID588544
farnesoid X nuclear receptorHomo sapiens (human)Potency44.66840.375827.485161.6524AID588526; AID588527
pregnane X nuclear receptorHomo sapiens (human)Potency15.84890.005428.02631,258.9301AID720659
estrogen nuclear receptor alphaHomo sapiens (human)Potency19.11800.000229.305416,493.5996AID588513; AID588514
peroxisome proliferator-activated receptor deltaHomo sapiens (human)Potency39.81070.001024.504861.6448AID588534; AID588535
peroxisome proliferator activated receptor gammaHomo sapiens (human)Potency44.66840.001019.414170.9645AID588537
vitamin D (1,25- dihydroxyvitamin D3) receptorHomo sapiens (human)Potency32.46480.023723.228263.5986AID588541; AID588543
euchromatic histone-lysine N-methyltransferase 2Homo sapiens (human)Potency9.50560.035520.977089.1251AID504332
15-hydroxyprostaglandin dehydrogenase [NAD(+)] isoform 1Homo sapiens (human)Potency22.38720.001815.663839.8107AID894
vitamin D3 receptor isoform VDRAHomo sapiens (human)Potency37.61880.354828.065989.1251AID504847
thyroid hormone receptor beta isoform aHomo sapiens (human)Potency44.66840.010039.53711,122.0200AID588547
nuclear factor erythroid 2-related factor 2 isoform 1Homo sapiens (human)Potency32.93670.000627.21521,122.0200AID651741; AID720636
nuclear receptor ROR-gamma isoform 1Mus musculus (house mouse)Potency16.03430.00798.23321,122.0200AID2546; AID2551
gemininHomo sapiens (human)Potency23.71500.004611.374133.4983AID624296
DNA polymerase kappa isoform 1Homo sapiens (human)Potency44.66840.031622.3146100.0000AID588579
survival motor neuron protein isoform dHomo sapiens (human)Potency25.11890.125912.234435.4813AID1458
cytochrome P450 3A4 isoform 1Homo sapiens (human)Potency31.62280.031610.279239.8107AID884; AID885
Gamma-aminobutyric acid receptor subunit piRattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Cellular tumor antigen p53Homo sapiens (human)Potency70.79460.002319.595674.0614AID651743
Gamma-aminobutyric acid receptor subunit beta-1Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit deltaRattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-2Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-5Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-3Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-1Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-2Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-4Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-3Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-6Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Nuclear receptor ROR-gammaHomo sapiens (human)Potency37.57800.026622.448266.8242AID651802
Gamma-aminobutyric acid receptor subunit alpha-1Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit beta-3Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit beta-2Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
GABA theta subunitRattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit epsilonRattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
60 kDa heat shock protein, mitochondrialHomo sapiens (human)IC50 (µMol)11.00000.17004.559010.0000AID1594139
Vitamin D3 receptorHomo sapiens (human)IC50 (µMol)0.08700.00000.43746.4300AID1915533
10 kDa heat shock protein, mitochondrialHomo sapiens (human)IC50 (µMol)11.00000.17004.559010.0000AID1594139
Thiosulfate sulfurtransferaseHomo sapiens (human)IC50 (µMol)100.00000.06003.96319.7000AID1594135
60 kDa chaperonin Escherichia coliIC50 (µMol)26.50000.03903.55529.8000AID1594140; AID1594141
10 kDa chaperonin Escherichia coliIC50 (µMol)26.50000.03903.55529.8000AID1594140; AID1594141
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Vitamin D3 receptorHomo sapiens (human)EC50 (µMol)0.00020.00000.14232.1400AID1168708
Glycine receptor subunit alpha-1Homo sapiens (human)EC50 (µMol)0.40000.32001.45774.2000AID1203550
Vitamin D3 receptorMus musculus (house mouse)EC50 (µMol)0.90000.00770.40190.9000AID1585872
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Other Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (219)

Processvia Protein(s)Taxonomy
negative regulation of cell population proliferationCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycleCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycle G2/M phase transitionCellular tumor antigen p53Homo sapiens (human)
DNA damage responseCellular tumor antigen p53Homo sapiens (human)
ER overload responseCellular tumor antigen p53Homo sapiens (human)
cellular response to glucose starvationCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
positive regulation of miRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
negative regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
mitophagyCellular tumor antigen p53Homo sapiens (human)
in utero embryonic developmentCellular tumor antigen p53Homo sapiens (human)
somitogenesisCellular tumor antigen p53Homo sapiens (human)
release of cytochrome c from mitochondriaCellular tumor antigen p53Homo sapiens (human)
hematopoietic progenitor cell differentiationCellular tumor antigen p53Homo sapiens (human)
T cell proliferation involved in immune responseCellular tumor antigen p53Homo sapiens (human)
B cell lineage commitmentCellular tumor antigen p53Homo sapiens (human)
T cell lineage commitmentCellular tumor antigen p53Homo sapiens (human)
response to ischemiaCellular tumor antigen p53Homo sapiens (human)
nucleotide-excision repairCellular tumor antigen p53Homo sapiens (human)
double-strand break repairCellular tumor antigen p53Homo sapiens (human)
regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
protein import into nucleusCellular tumor antigen p53Homo sapiens (human)
autophagyCellular tumor antigen p53Homo sapiens (human)
DNA damage responseCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediator resulting in cell cycle arrestCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediator resulting in transcription of p21 class mediatorCellular tumor antigen p53Homo sapiens (human)
transforming growth factor beta receptor signaling pathwayCellular tumor antigen p53Homo sapiens (human)
Ras protein signal transductionCellular tumor antigen p53Homo sapiens (human)
gastrulationCellular tumor antigen p53Homo sapiens (human)
neuroblast proliferationCellular tumor antigen p53Homo sapiens (human)
negative regulation of neuroblast proliferationCellular tumor antigen p53Homo sapiens (human)
protein localizationCellular tumor antigen p53Homo sapiens (human)
negative regulation of DNA replicationCellular tumor antigen p53Homo sapiens (human)
negative regulation of cell population proliferationCellular tumor antigen p53Homo sapiens (human)
determination of adult lifespanCellular tumor antigen p53Homo sapiens (human)
mRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
rRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
response to salt stressCellular tumor antigen p53Homo sapiens (human)
response to inorganic substanceCellular tumor antigen p53Homo sapiens (human)
response to X-rayCellular tumor antigen p53Homo sapiens (human)
response to gamma radiationCellular tumor antigen p53Homo sapiens (human)
positive regulation of gene expressionCellular tumor antigen p53Homo sapiens (human)
cardiac muscle cell apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of cardiac muscle cell apoptotic processCellular tumor antigen p53Homo sapiens (human)
glial cell proliferationCellular tumor antigen p53Homo sapiens (human)
viral processCellular tumor antigen p53Homo sapiens (human)
glucose catabolic process to lactate via pyruvateCellular tumor antigen p53Homo sapiens (human)
cerebellum developmentCellular tumor antigen p53Homo sapiens (human)
negative regulation of cell growthCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
negative regulation of transforming growth factor beta receptor signaling pathwayCellular tumor antigen p53Homo sapiens (human)
mitotic G1 DNA damage checkpoint signalingCellular tumor antigen p53Homo sapiens (human)
negative regulation of telomere maintenance via telomeraseCellular tumor antigen p53Homo sapiens (human)
T cell differentiation in thymusCellular tumor antigen p53Homo sapiens (human)
tumor necrosis factor-mediated signaling pathwayCellular tumor antigen p53Homo sapiens (human)
regulation of tissue remodelingCellular tumor antigen p53Homo sapiens (human)
cellular response to UVCellular tumor antigen p53Homo sapiens (human)
multicellular organism growthCellular tumor antigen p53Homo sapiens (human)
positive regulation of mitochondrial membrane permeabilityCellular tumor antigen p53Homo sapiens (human)
cellular response to glucose starvationCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
entrainment of circadian clock by photoperiodCellular tumor antigen p53Homo sapiens (human)
mitochondrial DNA repairCellular tumor antigen p53Homo sapiens (human)
regulation of DNA damage response, signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of neuron apoptotic processCellular tumor antigen p53Homo sapiens (human)
transcription initiation-coupled chromatin remodelingCellular tumor antigen p53Homo sapiens (human)
negative regulation of proteolysisCellular tumor antigen p53Homo sapiens (human)
negative regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
positive regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
positive regulation of RNA polymerase II transcription preinitiation complex assemblyCellular tumor antigen p53Homo sapiens (human)
positive regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
response to antibioticCellular tumor antigen p53Homo sapiens (human)
fibroblast proliferationCellular tumor antigen p53Homo sapiens (human)
negative regulation of fibroblast proliferationCellular tumor antigen p53Homo sapiens (human)
circadian behaviorCellular tumor antigen p53Homo sapiens (human)
bone marrow developmentCellular tumor antigen p53Homo sapiens (human)
embryonic organ developmentCellular tumor antigen p53Homo sapiens (human)
positive regulation of peptidyl-tyrosine phosphorylationCellular tumor antigen p53Homo sapiens (human)
protein stabilizationCellular tumor antigen p53Homo sapiens (human)
negative regulation of helicase activityCellular tumor antigen p53Homo sapiens (human)
protein tetramerizationCellular tumor antigen p53Homo sapiens (human)
chromosome organizationCellular tumor antigen p53Homo sapiens (human)
neuron apoptotic processCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycleCellular tumor antigen p53Homo sapiens (human)
hematopoietic stem cell differentiationCellular tumor antigen p53Homo sapiens (human)
negative regulation of glial cell proliferationCellular tumor antigen p53Homo sapiens (human)
type II interferon-mediated signaling pathwayCellular tumor antigen p53Homo sapiens (human)
cardiac septum morphogenesisCellular tumor antigen p53Homo sapiens (human)
positive regulation of programmed necrotic cell deathCellular tumor antigen p53Homo sapiens (human)
protein-containing complex assemblyCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to endoplasmic reticulum stressCellular tumor antigen p53Homo sapiens (human)
thymocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of thymocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
necroptotic processCellular tumor antigen p53Homo sapiens (human)
cellular response to hypoxiaCellular tumor antigen p53Homo sapiens (human)
cellular response to xenobiotic stimulusCellular tumor antigen p53Homo sapiens (human)
cellular response to ionizing radiationCellular tumor antigen p53Homo sapiens (human)
cellular response to gamma radiationCellular tumor antigen p53Homo sapiens (human)
cellular response to UV-CCellular tumor antigen p53Homo sapiens (human)
stem cell proliferationCellular tumor antigen p53Homo sapiens (human)
signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
cellular response to actinomycin DCellular tumor antigen p53Homo sapiens (human)
positive regulation of release of cytochrome c from mitochondriaCellular tumor antigen p53Homo sapiens (human)
cellular senescenceCellular tumor antigen p53Homo sapiens (human)
replicative senescenceCellular tumor antigen p53Homo sapiens (human)
oxidative stress-induced premature senescenceCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathwayCellular tumor antigen p53Homo sapiens (human)
oligodendrocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of execution phase of apoptosisCellular tumor antigen p53Homo sapiens (human)
negative regulation of mitophagyCellular tumor antigen p53Homo sapiens (human)
regulation of mitochondrial membrane permeability involved in apoptotic processCellular tumor antigen p53Homo sapiens (human)
regulation of intrinsic apoptotic signaling pathway by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of miRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
negative regulation of G1 to G0 transitionCellular tumor antigen p53Homo sapiens (human)
negative regulation of miRNA processingCellular tumor antigen p53Homo sapiens (human)
negative regulation of glucose catabolic process to lactate via pyruvateCellular tumor antigen p53Homo sapiens (human)
negative regulation of pentose-phosphate shuntCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to hypoxiaCellular tumor antigen p53Homo sapiens (human)
regulation of fibroblast apoptotic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of stem cell proliferationCellular tumor antigen p53Homo sapiens (human)
positive regulation of cellular senescenceCellular tumor antigen p53Homo sapiens (human)
positive regulation of intrinsic apoptotic signaling pathwayCellular tumor antigen p53Homo sapiens (human)
protein folding60 kDa chaperoninEscherichia coli K-12
response to radiation60 kDa chaperoninEscherichia coli K-12
response to heat60 kDa chaperoninEscherichia coli K-12
virion assembly60 kDa chaperoninEscherichia coli K-12
chaperone cofactor-dependent protein refolding60 kDa chaperoninEscherichia coli K-12
protein refolding60 kDa chaperoninEscherichia coli K-12
chaperone cofactor-dependent protein refolding60 kDa chaperoninEscherichia coli K-12
response to heat60 kDa chaperoninEscherichia coli K-12
adhesion of symbiont to host60 kDa heat shock protein, mitochondrialHomo sapiens (human)
positive regulation of type II interferon production60 kDa heat shock protein, mitochondrialHomo sapiens (human)
T cell activation60 kDa heat shock protein, mitochondrialHomo sapiens (human)
MyD88-dependent toll-like receptor signaling pathway60 kDa heat shock protein, mitochondrialHomo sapiens (human)
positive regulation of T cell mediated immune response to tumor cell60 kDa heat shock protein, mitochondrialHomo sapiens (human)
'de novo' protein folding60 kDa heat shock protein, mitochondrialHomo sapiens (human)
activation of cysteine-type endopeptidase activity involved in apoptotic process60 kDa heat shock protein, mitochondrialHomo sapiens (human)
response to unfolded protein60 kDa heat shock protein, mitochondrialHomo sapiens (human)
response to cold60 kDa heat shock protein, mitochondrialHomo sapiens (human)
positive regulation of interferon-alpha production60 kDa heat shock protein, mitochondrialHomo sapiens (human)
positive regulation of type II interferon production60 kDa heat shock protein, mitochondrialHomo sapiens (human)
positive regulation of interleukin-10 production60 kDa heat shock protein, mitochondrialHomo sapiens (human)
positive regulation of interleukin-12 production60 kDa heat shock protein, mitochondrialHomo sapiens (human)
positive regulation of interleukin-6 production60 kDa heat shock protein, mitochondrialHomo sapiens (human)
protein refolding60 kDa heat shock protein, mitochondrialHomo sapiens (human)
B cell proliferation60 kDa heat shock protein, mitochondrialHomo sapiens (human)
B cell activation60 kDa heat shock protein, mitochondrialHomo sapiens (human)
positive regulation of macrophage activation60 kDa heat shock protein, mitochondrialHomo sapiens (human)
positive regulation of apoptotic process60 kDa heat shock protein, mitochondrialHomo sapiens (human)
negative regulation of apoptotic process60 kDa heat shock protein, mitochondrialHomo sapiens (human)
isotype switching to IgG isotypes60 kDa heat shock protein, mitochondrialHomo sapiens (human)
protein stabilization60 kDa heat shock protein, mitochondrialHomo sapiens (human)
positive regulation of T cell activation60 kDa heat shock protein, mitochondrialHomo sapiens (human)
chaperone-mediated protein complex assembly60 kDa heat shock protein, mitochondrialHomo sapiens (human)
protein maturation60 kDa heat shock protein, mitochondrialHomo sapiens (human)
biological process involved in interaction with symbiont60 kDa heat shock protein, mitochondrialHomo sapiens (human)
cellular response to interleukin-760 kDa heat shock protein, mitochondrialHomo sapiens (human)
T cell activation60 kDa heat shock protein, mitochondrialHomo sapiens (human)
protein import into mitochondrial intermembrane space60 kDa heat shock protein, mitochondrialHomo sapiens (human)
protein folding60 kDa heat shock protein, mitochondrialHomo sapiens (human)
mitochondrial unfolded protein response60 kDa heat shock protein, mitochondrialHomo sapiens (human)
apoptotic mitochondrial changes60 kDa heat shock protein, mitochondrialHomo sapiens (human)
negative regulation of DNA-templated transcriptionVitamin D3 receptorHomo sapiens (human)
negative regulation of transcription by RNA polymerase IIVitamin D3 receptorHomo sapiens (human)
cell morphogenesisVitamin D3 receptorHomo sapiens (human)
skeletal system developmentVitamin D3 receptorHomo sapiens (human)
calcium ion transportVitamin D3 receptorHomo sapiens (human)
intracellular calcium ion homeostasisVitamin D3 receptorHomo sapiens (human)
lactationVitamin D3 receptorHomo sapiens (human)
negative regulation of cell population proliferationVitamin D3 receptorHomo sapiens (human)
positive regulation of gene expressionVitamin D3 receptorHomo sapiens (human)
negative regulation of keratinocyte proliferationVitamin D3 receptorHomo sapiens (human)
positive regulation of vitamin D 24-hydroxylase activityVitamin D3 receptorHomo sapiens (human)
positive regulation of bone mineralizationVitamin D3 receptorHomo sapiens (human)
phosphate ion transmembrane transportVitamin D3 receptorHomo sapiens (human)
bile acid signaling pathwayVitamin D3 receptorHomo sapiens (human)
mRNA transcription by RNA polymerase IIVitamin D3 receptorHomo sapiens (human)
positive regulation of keratinocyte differentiationVitamin D3 receptorHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIVitamin D3 receptorHomo sapiens (human)
decidualizationVitamin D3 receptorHomo sapiens (human)
intestinal absorptionVitamin D3 receptorHomo sapiens (human)
apoptotic process involved in mammary gland involutionVitamin D3 receptorHomo sapiens (human)
positive regulation of apoptotic process involved in mammary gland involutionVitamin D3 receptorHomo sapiens (human)
regulation of calcidiol 1-monooxygenase activityVitamin D3 receptorHomo sapiens (human)
mammary gland branching involved in pregnancyVitamin D3 receptorHomo sapiens (human)
vitamin D receptor signaling pathwayVitamin D3 receptorHomo sapiens (human)
positive regulation of vitamin D receptor signaling pathwayVitamin D3 receptorHomo sapiens (human)
response to bile acidVitamin D3 receptorHomo sapiens (human)
multicellular organism developmentVitamin D3 receptorHomo sapiens (human)
cell differentiationVitamin D3 receptorHomo sapiens (human)
startle responseGlycine receptor subunit alpha-1Homo sapiens (human)
regulation of membrane potentialGlycine receptor subunit alpha-1Homo sapiens (human)
startle responseGlycine receptor subunit alpha-1Homo sapiens (human)
regulation of respiratory gaseous exchange by nervous system processGlycine receptor subunit alpha-1Homo sapiens (human)
monoatomic ion transportGlycine receptor subunit alpha-1Homo sapiens (human)
chloride transportGlycine receptor subunit alpha-1Homo sapiens (human)
muscle contractionGlycine receptor subunit alpha-1Homo sapiens (human)
neuropeptide signaling pathwayGlycine receptor subunit alpha-1Homo sapiens (human)
acrosome reactionGlycine receptor subunit alpha-1Homo sapiens (human)
visual perceptionGlycine receptor subunit alpha-1Homo sapiens (human)
adult walking behaviorGlycine receptor subunit alpha-1Homo sapiens (human)
neuronal action potentialGlycine receptor subunit alpha-1Homo sapiens (human)
neuromuscular process controlling postureGlycine receptor subunit alpha-1Homo sapiens (human)
negative regulation of transmission of nerve impulseGlycine receptor subunit alpha-1Homo sapiens (human)
synaptic transmission, glycinergicGlycine receptor subunit alpha-1Homo sapiens (human)
righting reflexGlycine receptor subunit alpha-1Homo sapiens (human)
excitatory postsynaptic potentialGlycine receptor subunit alpha-1Homo sapiens (human)
inhibitory postsynaptic potentialGlycine receptor subunit alpha-1Homo sapiens (human)
cellular response to amino acid stimulusGlycine receptor subunit alpha-1Homo sapiens (human)
cellular response to zinc ionGlycine receptor subunit alpha-1Homo sapiens (human)
cellular response to ethanolGlycine receptor subunit alpha-1Homo sapiens (human)
response to alcoholGlycine receptor subunit alpha-1Homo sapiens (human)
regulation of presynaptic membrane potentialGlycine receptor subunit alpha-1Homo sapiens (human)
chloride transmembrane transportGlycine receptor subunit alpha-1Homo sapiens (human)
positive regulation of acrosome reactionGlycine receptor subunit alpha-1Homo sapiens (human)
chemical synaptic transmissionGlycine receptor subunit alpha-1Homo sapiens (human)
regulation of membrane potentialGlycine receptor subunit alpha-1Homo sapiens (human)
negative regulation of transcription by RNA polymerase IINuclear receptor ROR-gammaHomo sapiens (human)
xenobiotic metabolic processNuclear receptor ROR-gammaHomo sapiens (human)
regulation of glucose metabolic processNuclear receptor ROR-gammaHomo sapiens (human)
regulation of steroid metabolic processNuclear receptor ROR-gammaHomo sapiens (human)
intracellular receptor signaling pathwayNuclear receptor ROR-gammaHomo sapiens (human)
circadian regulation of gene expressionNuclear receptor ROR-gammaHomo sapiens (human)
cellular response to sterolNuclear receptor ROR-gammaHomo sapiens (human)
positive regulation of circadian rhythmNuclear receptor ROR-gammaHomo sapiens (human)
regulation of fat cell differentiationNuclear receptor ROR-gammaHomo sapiens (human)
positive regulation of DNA-templated transcriptionNuclear receptor ROR-gammaHomo sapiens (human)
adipose tissue developmentNuclear receptor ROR-gammaHomo sapiens (human)
T-helper 17 cell differentiationNuclear receptor ROR-gammaHomo sapiens (human)
regulation of transcription by RNA polymerase IINuclear receptor ROR-gammaHomo sapiens (human)
osteoblast differentiation10 kDa heat shock protein, mitochondrialHomo sapiens (human)
protein folding10 kDa heat shock protein, mitochondrialHomo sapiens (human)
activation of cysteine-type endopeptidase activity involved in apoptotic process10 kDa heat shock protein, mitochondrialHomo sapiens (human)
response to unfolded protein10 kDa heat shock protein, mitochondrialHomo sapiens (human)
chaperone cofactor-dependent protein refolding10 kDa heat shock protein, mitochondrialHomo sapiens (human)
sulfur amino acid catabolic processThiosulfate sulfurtransferaseHomo sapiens (human)
cyanate catabolic processThiosulfate sulfurtransferaseHomo sapiens (human)
epithelial cell differentiationThiosulfate sulfurtransferaseHomo sapiens (human)
rRNA import into mitochondrionThiosulfate sulfurtransferaseHomo sapiens (human)
rRNA transportThiosulfate sulfurtransferaseHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (71)

Processvia Protein(s)Taxonomy
transcription cis-regulatory region bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
cis-regulatory region sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
core promoter sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
TFIID-class transcription factor complex bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription repressor activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
protease bindingCellular tumor antigen p53Homo sapiens (human)
p53 bindingCellular tumor antigen p53Homo sapiens (human)
DNA bindingCellular tumor antigen p53Homo sapiens (human)
chromatin bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription factor activityCellular tumor antigen p53Homo sapiens (human)
mRNA 3'-UTR bindingCellular tumor antigen p53Homo sapiens (human)
copper ion bindingCellular tumor antigen p53Homo sapiens (human)
protein bindingCellular tumor antigen p53Homo sapiens (human)
zinc ion bindingCellular tumor antigen p53Homo sapiens (human)
enzyme bindingCellular tumor antigen p53Homo sapiens (human)
receptor tyrosine kinase bindingCellular tumor antigen p53Homo sapiens (human)
ubiquitin protein ligase bindingCellular tumor antigen p53Homo sapiens (human)
histone deacetylase regulator activityCellular tumor antigen p53Homo sapiens (human)
ATP-dependent DNA/DNA annealing activityCellular tumor antigen p53Homo sapiens (human)
identical protein bindingCellular tumor antigen p53Homo sapiens (human)
histone deacetylase bindingCellular tumor antigen p53Homo sapiens (human)
protein heterodimerization activityCellular tumor antigen p53Homo sapiens (human)
protein-folding chaperone bindingCellular tumor antigen p53Homo sapiens (human)
protein phosphatase 2A bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II-specific DNA-binding transcription factor bindingCellular tumor antigen p53Homo sapiens (human)
14-3-3 protein bindingCellular tumor antigen p53Homo sapiens (human)
MDM2/MDM4 family protein bindingCellular tumor antigen p53Homo sapiens (human)
disordered domain specific bindingCellular tumor antigen p53Homo sapiens (human)
general transcription initiation factor bindingCellular tumor antigen p53Homo sapiens (human)
molecular function activator activityCellular tumor antigen p53Homo sapiens (human)
promoter-specific chromatin bindingCellular tumor antigen p53Homo sapiens (human)
magnesium ion binding60 kDa chaperoninEscherichia coli K-12
protein binding60 kDa chaperoninEscherichia coli K-12
ATP binding60 kDa chaperoninEscherichia coli K-12
isomerase activity60 kDa chaperoninEscherichia coli K-12
ATP hydrolysis activity60 kDa chaperoninEscherichia coli K-12
identical protein binding60 kDa chaperoninEscherichia coli K-12
unfolded protein binding60 kDa chaperoninEscherichia coli K-12
ATP-dependent protein folding chaperone60 kDa chaperoninEscherichia coli K-12
lipopolysaccharide binding60 kDa heat shock protein, mitochondrialHomo sapiens (human)
p53 binding60 kDa heat shock protein, mitochondrialHomo sapiens (human)
DNA replication origin binding60 kDa heat shock protein, mitochondrialHomo sapiens (human)
single-stranded DNA binding60 kDa heat shock protein, mitochondrialHomo sapiens (human)
RNA binding60 kDa heat shock protein, mitochondrialHomo sapiens (human)
double-stranded RNA binding60 kDa heat shock protein, mitochondrialHomo sapiens (human)
protein binding60 kDa heat shock protein, mitochondrialHomo sapiens (human)
ATP binding60 kDa heat shock protein, mitochondrialHomo sapiens (human)
high-density lipoprotein particle binding60 kDa heat shock protein, mitochondrialHomo sapiens (human)
isomerase activity60 kDa heat shock protein, mitochondrialHomo sapiens (human)
ATP hydrolysis activity60 kDa heat shock protein, mitochondrialHomo sapiens (human)
enzyme binding60 kDa heat shock protein, mitochondrialHomo sapiens (human)
ubiquitin protein ligase binding60 kDa heat shock protein, mitochondrialHomo sapiens (human)
apolipoprotein binding60 kDa heat shock protein, mitochondrialHomo sapiens (human)
apolipoprotein A-I binding60 kDa heat shock protein, mitochondrialHomo sapiens (human)
unfolded protein binding60 kDa heat shock protein, mitochondrialHomo sapiens (human)
protein-folding chaperone binding60 kDa heat shock protein, mitochondrialHomo sapiens (human)
ATP-dependent protein folding chaperone60 kDa heat shock protein, mitochondrialHomo sapiens (human)
DNA-binding transcription factor activityVitamin D3 receptorHomo sapiens (human)
vitamin D response element bindingVitamin D3 receptorHomo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificVitamin D3 receptorHomo sapiens (human)
DNA bindingVitamin D3 receptorHomo sapiens (human)
nuclear receptor activityVitamin D3 receptorHomo sapiens (human)
protein bindingVitamin D3 receptorHomo sapiens (human)
zinc ion bindingVitamin D3 receptorHomo sapiens (human)
bile acid nuclear receptor activityVitamin D3 receptorHomo sapiens (human)
nuclear retinoid X receptor bindingVitamin D3 receptorHomo sapiens (human)
calcitriol bindingVitamin D3 receptorHomo sapiens (human)
lithocholic acid bindingVitamin D3 receptorHomo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingVitamin D3 receptorHomo sapiens (human)
transmembrane signaling receptor activityGlycine receptor subunit alpha-1Homo sapiens (human)
protein bindingGlycine receptor subunit alpha-1Homo sapiens (human)
zinc ion bindingGlycine receptor subunit alpha-1Homo sapiens (human)
glycine bindingGlycine receptor subunit alpha-1Homo sapiens (human)
extracellularly glycine-gated chloride channel activityGlycine receptor subunit alpha-1Homo sapiens (human)
taurine bindingGlycine receptor subunit alpha-1Homo sapiens (human)
ligand-gated monoatomic ion channel activity involved in regulation of presynaptic membrane potentialGlycine receptor subunit alpha-1Homo sapiens (human)
transmitter-gated monoatomic ion channel activity involved in regulation of postsynaptic membrane potentialGlycine receptor subunit alpha-1Homo sapiens (human)
neurotransmitter receptor activityGlycine receptor subunit alpha-1Homo sapiens (human)
chloride channel activityGlycine receptor subunit alpha-1Homo sapiens (human)
excitatory extracellular ligand-gated monoatomic ion channel activityGlycine receptor subunit alpha-1Homo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingNuclear receptor ROR-gammaHomo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificNuclear receptor ROR-gammaHomo sapiens (human)
DNA-binding transcription repressor activity, RNA polymerase II-specificNuclear receptor ROR-gammaHomo sapiens (human)
DNA-binding transcription factor activityNuclear receptor ROR-gammaHomo sapiens (human)
protein bindingNuclear receptor ROR-gammaHomo sapiens (human)
oxysterol bindingNuclear receptor ROR-gammaHomo sapiens (human)
zinc ion bindingNuclear receptor ROR-gammaHomo sapiens (human)
ligand-activated transcription factor activityNuclear receptor ROR-gammaHomo sapiens (human)
sequence-specific double-stranded DNA bindingNuclear receptor ROR-gammaHomo sapiens (human)
nuclear receptor activityNuclear receptor ROR-gammaHomo sapiens (human)
RNA binding10 kDa heat shock protein, mitochondrialHomo sapiens (human)
protein binding10 kDa heat shock protein, mitochondrialHomo sapiens (human)
ATP binding10 kDa heat shock protein, mitochondrialHomo sapiens (human)
protein folding chaperone10 kDa heat shock protein, mitochondrialHomo sapiens (human)
unfolded protein binding10 kDa heat shock protein, mitochondrialHomo sapiens (human)
protein-folding chaperone binding10 kDa heat shock protein, mitochondrialHomo sapiens (human)
metal ion binding10 kDa heat shock protein, mitochondrialHomo sapiens (human)
thiosulfate sulfurtransferase activityThiosulfate sulfurtransferaseHomo sapiens (human)
5S rRNA bindingThiosulfate sulfurtransferaseHomo sapiens (human)
3-mercaptopyruvate sulfurtransferase activityThiosulfate sulfurtransferaseHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (48)

Processvia Protein(s)Taxonomy
nuclear bodyCellular tumor antigen p53Homo sapiens (human)
nucleusCellular tumor antigen p53Homo sapiens (human)
nucleoplasmCellular tumor antigen p53Homo sapiens (human)
replication forkCellular tumor antigen p53Homo sapiens (human)
nucleolusCellular tumor antigen p53Homo sapiens (human)
cytoplasmCellular tumor antigen p53Homo sapiens (human)
mitochondrionCellular tumor antigen p53Homo sapiens (human)
mitochondrial matrixCellular tumor antigen p53Homo sapiens (human)
endoplasmic reticulumCellular tumor antigen p53Homo sapiens (human)
centrosomeCellular tumor antigen p53Homo sapiens (human)
cytosolCellular tumor antigen p53Homo sapiens (human)
nuclear matrixCellular tumor antigen p53Homo sapiens (human)
PML bodyCellular tumor antigen p53Homo sapiens (human)
transcription repressor complexCellular tumor antigen p53Homo sapiens (human)
site of double-strand breakCellular tumor antigen p53Homo sapiens (human)
germ cell nucleusCellular tumor antigen p53Homo sapiens (human)
chromatinCellular tumor antigen p53Homo sapiens (human)
transcription regulator complexCellular tumor antigen p53Homo sapiens (human)
protein-containing complexCellular tumor antigen p53Homo sapiens (human)
cytoplasm60 kDa chaperoninEscherichia coli K-12
cytosol60 kDa chaperoninEscherichia coli K-12
membrane60 kDa chaperoninEscherichia coli K-12
GroEL-GroES complex60 kDa chaperoninEscherichia coli K-12
mitochondrial matrix60 kDa heat shock protein, mitochondrialHomo sapiens (human)
extracellular space60 kDa heat shock protein, mitochondrialHomo sapiens (human)
cytoplasm60 kDa heat shock protein, mitochondrialHomo sapiens (human)
mitochondrion60 kDa heat shock protein, mitochondrialHomo sapiens (human)
mitochondrial inner membrane60 kDa heat shock protein, mitochondrialHomo sapiens (human)
mitochondrial matrix60 kDa heat shock protein, mitochondrialHomo sapiens (human)
early endosome60 kDa heat shock protein, mitochondrialHomo sapiens (human)
cytosol60 kDa heat shock protein, mitochondrialHomo sapiens (human)
plasma membrane60 kDa heat shock protein, mitochondrialHomo sapiens (human)
clathrin-coated pit60 kDa heat shock protein, mitochondrialHomo sapiens (human)
cell surface60 kDa heat shock protein, mitochondrialHomo sapiens (human)
membrane60 kDa heat shock protein, mitochondrialHomo sapiens (human)
coated vesicle60 kDa heat shock protein, mitochondrialHomo sapiens (human)
secretory granule60 kDa heat shock protein, mitochondrialHomo sapiens (human)
extracellular exosome60 kDa heat shock protein, mitochondrialHomo sapiens (human)
sperm midpiece60 kDa heat shock protein, mitochondrialHomo sapiens (human)
sperm plasma membrane60 kDa heat shock protein, mitochondrialHomo sapiens (human)
migrasome60 kDa heat shock protein, mitochondrialHomo sapiens (human)
protein-containing complex60 kDa heat shock protein, mitochondrialHomo sapiens (human)
lipopolysaccharide receptor complex60 kDa heat shock protein, mitochondrialHomo sapiens (human)
mitochondrial inner membrane60 kDa heat shock protein, mitochondrialHomo sapiens (human)
nucleusVitamin D3 receptorHomo sapiens (human)
nucleusVitamin D3 receptorHomo sapiens (human)
nucleoplasmVitamin D3 receptorHomo sapiens (human)
cytosolVitamin D3 receptorHomo sapiens (human)
RNA polymerase II transcription regulator complexVitamin D3 receptorHomo sapiens (human)
chromatinVitamin D3 receptorHomo sapiens (human)
receptor complexVitamin D3 receptorHomo sapiens (human)
plasma membraneGamma-aminobutyric acid receptor subunit gamma-2Rattus norvegicus (Norway rat)
plasma membraneGlycine receptor subunit alpha-1Homo sapiens (human)
external side of plasma membraneGlycine receptor subunit alpha-1Homo sapiens (human)
membraneGlycine receptor subunit alpha-1Homo sapiens (human)
dendriteGlycine receptor subunit alpha-1Homo sapiens (human)
neuron projectionGlycine receptor subunit alpha-1Homo sapiens (human)
neuronal cell bodyGlycine receptor subunit alpha-1Homo sapiens (human)
perikaryonGlycine receptor subunit alpha-1Homo sapiens (human)
intracellular membrane-bounded organelleGlycine receptor subunit alpha-1Homo sapiens (human)
synapseGlycine receptor subunit alpha-1Homo sapiens (human)
postsynaptic membraneGlycine receptor subunit alpha-1Homo sapiens (human)
inhibitory synapseGlycine receptor subunit alpha-1Homo sapiens (human)
glycinergic synapseGlycine receptor subunit alpha-1Homo sapiens (human)
chloride channel complexGlycine receptor subunit alpha-1Homo sapiens (human)
transmembrane transporter complexGlycine receptor subunit alpha-1Homo sapiens (human)
synapseGlycine receptor subunit alpha-1Homo sapiens (human)
neuron projectionGlycine receptor subunit alpha-1Homo sapiens (human)
plasma membraneGlycine receptor subunit alpha-1Homo sapiens (human)
nucleusNuclear receptor ROR-gammaHomo sapiens (human)
nucleoplasmNuclear receptor ROR-gammaHomo sapiens (human)
nuclear bodyNuclear receptor ROR-gammaHomo sapiens (human)
chromatinNuclear receptor ROR-gammaHomo sapiens (human)
nucleusNuclear receptor ROR-gammaHomo sapiens (human)
mitochondrion10 kDa heat shock protein, mitochondrialHomo sapiens (human)
membrane10 kDa heat shock protein, mitochondrialHomo sapiens (human)
extracellular exosome10 kDa heat shock protein, mitochondrialHomo sapiens (human)
mitochondrial matrix10 kDa heat shock protein, mitochondrialHomo sapiens (human)
plasma membraneGamma-aminobutyric acid receptor subunit alpha-1Rattus norvegicus (Norway rat)
plasma membraneGamma-aminobutyric acid receptor subunit beta-2Rattus norvegicus (Norway rat)
extracellular spaceThiosulfate sulfurtransferaseHomo sapiens (human)
mitochondrionThiosulfate sulfurtransferaseHomo sapiens (human)
mitochondrial matrixThiosulfate sulfurtransferaseHomo sapiens (human)
mitochondrionThiosulfate sulfurtransferaseHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (137)

Assay IDTitleYearJournalArticle
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID647355Antiproliferative activity against human U87MG cells after 72 hrs by MTS assay2012Bioorganic & medicinal chemistry letters, Feb-01, Volume: 22, Issue:3
Evaluation of vitamin D3 A-ring analogues as Hedgehog pathway inhibitors.
AID647359Inhibition of Hedgehog signaling pathway in human U87MG cells assessed as down regulation of Gli1 at 10 uM after 4 to 24 hrs by RT-PCR analysis2012Bioorganic & medicinal chemistry letters, Feb-01, Volume: 22, Issue:3
Evaluation of vitamin D3 A-ring analogues as Hedgehog pathway inhibitors.
AID760021Inhibition of Hedgehog signaling in mouse M210B4 cells assessed as downregulation of Gli1 mRNA expression at 10 uM after 24 hrs by RT-PCR analysis relative to 20(S)-hydroxycholesterol and 22(S)-hydroxycholesterol2013ACS medicinal chemistry letters, Jul-11, Volume: 4, Issue:7
Identification of vitamin d3-based hedgehog pathway inhibitors that incorporate an aromatic a-ring isostere.
AID760016Activation of VDR in mouse ASZ001 cells assessed as upregulation of Cyp24A1 mRNA expression at 2.5 uM after 48 hrs by RT-PCR analysis relative to DMSO-treated control2013ACS medicinal chemistry letters, Jul-11, Volume: 4, Issue:7
Identification of vitamin d3-based hedgehog pathway inhibitors that incorporate an aromatic a-ring isostere.
AID647364Activation of VDR in human HT-29 cells assessed as up-regulation of CYP24A1 at 10 uM by RT-PCR analysis relative to control2012Bioorganic & medicinal chemistry letters, Feb-01, Volume: 22, Issue:3
Evaluation of vitamin D3 A-ring analogues as Hedgehog pathway inhibitors.
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1149344Induction of bone calcium mobilization in rachitic white leghorn cockerel assessed as Ca2+ level in serum up to 78 nmol, ip treated 24 hrs prior to testing measured at 24 hrs post treatment by atomic absorption spectrometric analysis1977Journal of medicinal chemistry, Jan, Volume: 20, Issue:1
Studies on vitamin D (calciferol) and its analogues. 10. Side-chain analogues of 25-hydroxyvitamin D3.
AID1824241Inhibition of hedgehog signalling in mouse Ptch-KO MEF cells assessed as reduction in Gli1 mRNA expression measured after 48 hrs by RT-PCR analysis2022European journal of medicinal chemistry, Jan-15, Volume: 228Affinity-based protein profiling identifies vitamin D3 as a heat shock protein 70 antagonist that regulates hedgehog transduction in murine basal cell carcinoma.
AID1140483Activation of VDR in mouse C3H10T1/2 cells assessed as upregulation of CYP24A1 mRNA expression at 5 uM after 24 hrs by RT-PCR analysis relative to DMSO-treated control2014Journal of medicinal chemistry, May-08, Volume: 57, Issue:9
Structure-activity relationships for vitamin D3-based aromatic a-ring analogues as hedgehog pathway inhibitors.
AID1585881Inhibition of Hedgehog signaling pathway in Sufu-deficient mouse C3H10T1/2 cells assessed as reduction in oxysterol-induced Gli1 mRNA expression at 5 uM after 24 hrs by q-PCR analysis2019European journal of medicinal chemistry, Jan-15, Volume: 162Synthesis and evaluation of third generation vitamin D3 analogues as inhibitors of Hedgehog signaling.
AID1140500Inhibition of hedgehog signaling pathway in non-targeting siRNA treated mouse C3H10T1/2 cells assessed as effect on VDR expression at 5 uM after 24 hrs by qPCR analysis2014Journal of medicinal chemistry, May-08, Volume: 57, Issue:9
Structure-activity relationships for vitamin D3-based aromatic a-ring analogues as hedgehog pathway inhibitors.
AID1585887Inhibition of Hedgehog signaling pathway in Sufu-deficient mouse C3H10T1/2 cells assessed as reduction in oxysterol-induced Gli1 mRNA expression after 24 hrs by q-PCR analysis2019European journal of medicinal chemistry, Jan-15, Volume: 162Synthesis and evaluation of third generation vitamin D3 analogues as inhibitors of Hedgehog signaling.
AID1140499Activation of hedgehog signaling pathway in non-targeting siRNA treated mouse C3H10T1/2 cells assessed as effect on VDR expression at 5 uM after 24 hrs by qPCR analysis2014Journal of medicinal chemistry, May-08, Volume: 57, Issue:9
Structure-activity relationships for vitamin D3-based aromatic a-ring analogues as hedgehog pathway inhibitors.
AID1824251Inhibition of hedgehog signalling in mouse ASZ001 cells assessed as upregulation of Cyp27A1 expression by immunoblot analysis2022European journal of medicinal chemistry, Jan-15, Volume: 228Affinity-based protein profiling identifies vitamin D3 as a heat shock protein 70 antagonist that regulates hedgehog transduction in murine basal cell carcinoma.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1203551Potentiation of human GlyR-alpha1 expressed in Xenopus laevis oocytes assessed as induction of glycine-activated currents at 10 uM after 1 to 4 days by two-electrode voltage clamp assay relative to control2015Journal of medicinal chemistry, Apr-09, Volume: 58, Issue:7
Ensemble-based virtual screening for cannabinoid-like potentiators of the human glycine receptor α1 for the treatment of pain.
AID1594139Inhibition of human N-terminal octa-His-tagged HSP60 expressed in Escherichia coli Rosetta(DE3) pLysS/human HSP10 expressed in Escherichia coli Rosetta(DE3) assessed as reduction in HSP60/HSP10-mediated denatured MDH refolding by measuring MDH enzyme acti2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
HSP60/10 chaperonin systems are inhibited by a variety of approved drugs, natural products, and known bioactive molecules.
AID1585885Inhibition of Hedgehog signaling pathway in Sufu-deficient mouse C3H10T1/2 cells assessed as change in CYP24A1 mRNA expression at 5 uM after 24 hrs by q-PCR analysis2019European journal of medicinal chemistry, Jan-15, Volume: 162Synthesis and evaluation of third generation vitamin D3 analogues as inhibitors of Hedgehog signaling.
AID1585879Inhibition of Hedgehog signaling pathway in VDR-deficient mouse C3H10T1/2 cells assessed as reduction in oxysterol-induced Gli1 mRNA expression at 5 uM after 24 hrs by q-PCR analysis2019European journal of medicinal chemistry, Jan-15, Volume: 162Synthesis and evaluation of third generation vitamin D3 analogues as inhibitors of Hedgehog signaling.
AID1140502Inhibition of hedgehog signaling pathway in VDR-knockdown mouse C3H10T1/2 cells assessed as effect on VDR expression at 5 uM after 24 hrs by qPCR analysis2014Journal of medicinal chemistry, May-08, Volume: 57, Issue:9
Structure-activity relationships for vitamin D3-based aromatic a-ring analogues as hedgehog pathway inhibitors.
AID1594144Inhibition of Escherichia coli GroEL expressed in Escherichia coliDH5alpha/Escherichia coli GroES expressed in Escherichia coli BL21 (DE3) assessed as reduction in GroEL/GroES-mediated denatured soluble pig heart MDH refolding by measuring MDH enzyme acti2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
HSP60/10 chaperonin systems are inhibited by a variety of approved drugs, natural products, and known bioactive molecules.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1203549Potentiation of human GlyR-alpha1 expressed in Xenopus laevis oocytes assessed as induction of glycine-activated currents at 1 uM after 1 to 4 days by two-electrode voltage clamp assay relative to control2015Journal of medicinal chemistry, Apr-09, Volume: 58, Issue:7
Ensemble-based virtual screening for cannabinoid-like potentiators of the human glycine receptor α1 for the treatment of pain.
AID624606Specific activity of expressed human recombinant UGT1A12000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID674343Inhibition of SMO expressed in mouse C3H10T1/2 cells assessed as down-regulation of Gli1 mRNA expression at 5 uM after 24 hrs by RT-PCR analysis relative to oxysterol2012Bioorganic & medicinal chemistry letters, Jul-15, Volume: 22, Issue:14
Probing the structural requirements for vitamin D3 inhibition of the hedgehog signaling pathway.
AID760014Inhibition of Hedgehog signaling in human DaOY cells assessed as downregulation of Gli1 mRNA expression after 48 hrs by RT-PCR analysis2013ACS medicinal chemistry letters, Jul-11, Volume: 4, Issue:7
Identification of vitamin d3-based hedgehog pathway inhibitors that incorporate an aromatic a-ring isostere.
AID674346Growth inhibition of human U87MG cells after 72 hrs by MTS assay2012Bioorganic & medicinal chemistry letters, Jul-15, Volume: 22, Issue:14
Probing the structural requirements for vitamin D3 inhibition of the hedgehog signaling pathway.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID24178Compound was tested for rate constant for the transformation of vitamin to previtamin1994Journal of medicinal chemistry, Jul-22, Volume: 37, Issue:15
14-epi stereoisomers of 25-hydroxy- and 1 alpha,25-dihydroxyvitamin D3: synthesis, isomerization to previtamins, and biological studies.
AID674352Ratio of CYP24A1 mRNA upregulation in human HT-19 cells to upregulation of CYP24A1 mRNA in human U87MG cells2012Bioorganic & medicinal chemistry letters, Jul-15, Volume: 22, Issue:14
Probing the structural requirements for vitamin D3 inhibition of the hedgehog signaling pathway.
AID674344Binding affinity to full length human VDR by fluorescence polarization-based competitive assay2012Bioorganic & medicinal chemistry letters, Jul-15, Volume: 22, Issue:14
Probing the structural requirements for vitamin D3 inhibition of the hedgehog signaling pathway.
AID1140509Effect on CYP24A1 RNA level in non-targeting siRNA treated mouse C3H10T1/2 cells at 5 uM after 24 hrs by qPCR analysis2014Journal of medicinal chemistry, May-08, Volume: 57, Issue:9
Structure-activity relationships for vitamin D3-based aromatic a-ring analogues as hedgehog pathway inhibitors.
AID647354Inhibition of Hedgehog signaling pathway in oxysterols-induced mouse C3H10T1/2 cells assessed as down-regulation of endogenous Gli1 mRNA level at 5 uM by RT-PCR analysis relative to oxysterol2012Bioorganic & medicinal chemistry letters, Feb-01, Volume: 22, Issue:3
Evaluation of vitamin D3 A-ring analogues as Hedgehog pathway inhibitors.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1140494Displacement of BODIPY-cyclopamine from full length human SMO receptor overexpressed in HEK293T cells up to 10 uM after 4 hrs by flow cytometric analysis2014Journal of medicinal chemistry, May-08, Volume: 57, Issue:9
Structure-activity relationships for vitamin D3-based aromatic a-ring analogues as hedgehog pathway inhibitors.
AID770732Activation of hedgehog signaling in mouse C3H10T1/2 cells assessed as downregulation of GLI1 mRNA expression at 5 uM after 24 hrs by RT-PCR analysis in presence of oxysterol2013Bioorganic & medicinal chemistry letters, Oct-01, Volume: 23, Issue:19
Analogues of the Inhoffen-Lythgoe diol with anti-proliferative activity.
AID1140493Inhibition of hedgehog signaling pathway-mediated PTCH mRNA expression in mouse ASZ001 cells up to 10 uM after 24 hrs by RT-PCR analysis2014Journal of medicinal chemistry, May-08, Volume: 57, Issue:9
Structure-activity relationships for vitamin D3-based aromatic a-ring analogues as hedgehog pathway inhibitors.
AID647369Activation of VDR in mouse C3H10T1/2 cells up-regulation of CYP24A1 at 0.5 uM after 24 hrs by RT-PCR analysis relative to control2012Bioorganic & medicinal chemistry letters, Feb-01, Volume: 22, Issue:3
Evaluation of vitamin D3 A-ring analogues as Hedgehog pathway inhibitors.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1198288Inhibition of hedgehog signaling in mouse ASZ cells assessed as reduction in Gli1 mRNA level after 24 hrs by quantitative PCR analysis2015European journal of medicinal chemistry, Mar-26, Volume: 93Vitamin D3 analogues that contain modified A- and seco-B-rings as hedgehog pathway inhibitors.
AID1198286Activation of VDR in mouse C3H10T1/2 cells assessed as up-regulation of Cyp24A1 mRNA at 5 uM after 24 hrs by quantitative PCR analysis relative to control2015European journal of medicinal chemistry, Mar-26, Volume: 93Vitamin D3 analogues that contain modified A- and seco-B-rings as hedgehog pathway inhibitors.
AID1594135Inhibition of native rhodanese (unknown origin) assessed as reduction in rhodanese enzyme activity after 45 mins by Fe(SCN)3 dye based spectrometric analysis2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
HSP60/10 chaperonin systems are inhibited by a variety of approved drugs, natural products, and known bioactive molecules.
AID1140487Inhibition of hedgehog signaling pathway-mediated GLI1 mRNA expression in mouse ASZ001 cells after 24 hrs by RT-PCR analysis2014Journal of medicinal chemistry, May-08, Volume: 57, Issue:9
Structure-activity relationships for vitamin D3-based aromatic a-ring analogues as hedgehog pathway inhibitors.
AID1824249Inhibition of hedgehog signalling in mouse Sufu-KO MEF cells assessed as upregulation of Cyp27A1 expression by immunoblot analysis2022European journal of medicinal chemistry, Jan-15, Volume: 228Affinity-based protein profiling identifies vitamin D3 as a heat shock protein 70 antagonist that regulates hedgehog transduction in murine basal cell carcinoma.
AID760028Inhibition of Hedgehog signaling in mouse C3H10T1/2 cells assessed as downregulation of Gli1 mRNA expression at 5 uM after 24 hrs by RT-PCR analysis relative to 20(S)-hydroxycholesterol and 22(S)-hydroxycholesterol2013ACS medicinal chemistry letters, Jul-11, Volume: 4, Issue:7
Identification of vitamin d3-based hedgehog pathway inhibitors that incorporate an aromatic a-ring isostere.
AID674348Down-regulation of Gli1 mRNA expression in human U87MG cells at 10 uM after 24 hrs by RT-PCR analysis relative to DMSO-treated control2012Bioorganic & medicinal chemistry letters, Jul-15, Volume: 22, Issue:14
Probing the structural requirements for vitamin D3 inhibition of the hedgehog signaling pathway.
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1140492Inhibition of hedgehog signaling pathway-mediated PTCH mRNA expression in human DaOY cells after 24 hrs by RT-PCR analysis2014Journal of medicinal chemistry, May-08, Volume: 57, Issue:9
Structure-activity relationships for vitamin D3-based aromatic a-ring analogues as hedgehog pathway inhibitors.
AID1594140Inhibition of Escherichia coli GroEL expressed in Escherichia coli DH5alpha/Escherichia coli GroES expressed in Escherichia coli BL21 (DE3) assessed as reduction in GroEL/GroES-mediated denatured rhodanese refolding by measuring rhodanese enzyme activity 2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
HSP60/10 chaperonin systems are inhibited by a variety of approved drugs, natural products, and known bioactive molecules.
AID760020Activation of VDR in mouse M210B4 cells assessed as upregulation of Cyp24A1 mRNA expression at 5 uM after 24 hrs by RT-PCR analysis relative to DMSO-treated control2013ACS medicinal chemistry letters, Jul-11, Volume: 4, Issue:7
Identification of vitamin d3-based hedgehog pathway inhibitors that incorporate an aromatic a-ring isostere.
AID1140490Activation of VDR in human DaOY cells assessed as upregulation of CYP24A1 mRNA expression at 5 uM after 24 hrs by RT-PCR analysis relative to DMSO-treated control2014Journal of medicinal chemistry, May-08, Volume: 57, Issue:9
Structure-activity relationships for vitamin D3-based aromatic a-ring analogues as hedgehog pathway inhibitors.
AID1135767Induction of bone calcium mobilization in vitamin-D-deficient chicken assessed per 100 ml of serum at 3.3 nmol, ip using 45Ca2+ and 40Ca2+ after 24 hrs1978Journal of medicinal chemistry, Oct, Volume: 21, Issue:10
Studies on vitamin D (calciferol) and its analogues. 15. 24-Nor-1alpha,25-dihydroxyvitamin D3 and 24-nor-25-hydroxy-5,6-trans-vitamin D3.
AID1546671Induction of ROS scavenging activity in HUVEC assessed as reduction in high glucose-induced intracellular ROS level at 5 uM incubated for 6 hrs by DCFH-DA/Hoechst 33342 staining based assay relative to control2020Journal of natural products, 01-24, Volume: 83, Issue:1
Antcamphorols A-K, Cytotoxic and ROS Scavenging Triterpenoids from
AID1149343Induction of intestinal [45Ca2+] absorption in rachitic white leghorn cockerel assessed as radioactivity in serum up to 78 nmol, ip treated 24 hrs prior to testing measured at 24 hrs post treatment1977Journal of medicinal chemistry, Jan, Volume: 20, Issue:1
Studies on vitamin D (calciferol) and its analogues. 10. Side-chain analogues of 25-hydroxyvitamin D3.
AID1140495Displacement of BODIPY-cyclopamine from full length human SMO receptor overexpressed in HEK293T cell membranes up to 10 uM after 5 hrs by fluorescence polarization assay2014Journal of medicinal chemistry, May-08, Volume: 57, Issue:9
Structure-activity relationships for vitamin D3-based aromatic a-ring analogues as hedgehog pathway inhibitors.
AID647368Activation of VDR in mouse C3H10T1/2 cells assessed as up-regulation of CYP24A1 after 24 hrs by RT-PCR analysis relative to control2012Bioorganic & medicinal chemistry letters, Feb-01, Volume: 22, Issue:3
Evaluation of vitamin D3 A-ring analogues as Hedgehog pathway inhibitors.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1585873Antiproliferative activity against medulloblastoma cells derived from conditional patched knockout mouse after 48 hrs by [3H]-thymidine incorporation assay2019European journal of medicinal chemistry, Jan-15, Volume: 162Synthesis and evaluation of third generation vitamin D3 analogues as inhibitors of Hedgehog signaling.
AID1198285Inhibition of hedgehog signaling in mouse C3H10T1/2 cells assessed as reduction in Gli1 mRNA level at 5 uM after 24 hrs by quantitative PCR analysis relative to control2015European journal of medicinal chemistry, Mar-26, Volume: 93Vitamin D3 analogues that contain modified A- and seco-B-rings as hedgehog pathway inhibitors.
AID647365Activation of VDR in mouse C3H10T1/2 cells assessed as up-regulation of CYP24A1 at 5 uM by RT-PCR analysis relative to control2012Bioorganic & medicinal chemistry letters, Feb-01, Volume: 22, Issue:3
Evaluation of vitamin D3 A-ring analogues as Hedgehog pathway inhibitors.
AID760029Activation of VDR in mouse ASZ001 cells assessed as upregulation of Cyp24A1 mRNA expression at =< 2.5 uM after 48 hrs by RT-PCR analysis2013ACS medicinal chemistry letters, Jul-11, Volume: 4, Issue:7
Identification of vitamin d3-based hedgehog pathway inhibitors that incorporate an aromatic a-ring isostere.
AID402361Activity at human estrogen receptor expressed in transgenic Arabidopsis plant at 400 uM by pER8-GFP reporter assay2005Journal of natural products, Jul, Volume: 68, Issue:7
The transgenic Arabidopsis plant system, pER8-GFP, as a powerful tool in searching for natural product estrogen-agonists/antagonists.
AID1594142Selectivity index, ratio of IC50 for inhibition of native rhodanese (unknown origin) to IC50 for inhibition of Escherichia coli GroEL expressed in Escherichia coli DH5alpha/Escherichia coli GroES expressed in Escherichia coli BL21 (DE3) assessed as reduct2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
HSP60/10 chaperonin systems are inhibited by a variety of approved drugs, natural products, and known bioactive molecules.
AID1594143Selectivity index, ratio of IC50 for inhibition of native rhodanese (unknown origin) to IC50 for inhibition of Escherichia coli GroEL expressed in Escherichia coliDH5alpha/Escherichia coli GroES expressed in Escherichia coli BL21 (DE3) assessed as reducti2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
HSP60/10 chaperonin systems are inhibited by a variety of approved drugs, natural products, and known bioactive molecules.
AID674351Upregulation of CYP24A1 mRNA expression in human HT-29 cells at 10 uM after 24 hrs by RT-PCR analysis relative to DMSO-treated control2012Bioorganic & medicinal chemistry letters, Jul-15, Volume: 22, Issue:14
Probing the structural requirements for vitamin D3 inhibition of the hedgehog signaling pathway.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1824244Selectivity index, ratio of IC50 for Inhibition of hedgehog signalling in mouse VDR-KO MEF cells to IC50 for inhibition of hedgehog signalling in mouse ASZ001 cells2022European journal of medicinal chemistry, Jan-15, Volume: 228Affinity-based protein profiling identifies vitamin D3 as a heat shock protein 70 antagonist that regulates hedgehog transduction in murine basal cell carcinoma.
AID1168708Agonist activity at human VDR expressed in HEK293 cells by luciferase reporter gene assay2014Bioorganic & medicinal chemistry letters, Nov-15, Volume: 24, Issue:22
Identification of the first inverse agonist of retinoid-related orphan receptor (ROR) with dual selectivity for RORβ and RORγt.
AID1140485Inhibition of hedgehog signaling pathway-mediated GLI1 mRNA expression in mouse C3H10T1/2 cells after 24 hrs by RT-PCR analysis2014Journal of medicinal chemistry, May-08, Volume: 57, Issue:9
Structure-activity relationships for vitamin D3-based aromatic a-ring analogues as hedgehog pathway inhibitors.
AID1198287Inhibition of hedgehog signaling in mouse C3H10T1/2 cells assessed as reduction in Gli1 mRNA level after 24 hrs by quantitative PCR analysis2015European journal of medicinal chemistry, Mar-26, Volume: 93Vitamin D3 analogues that contain modified A- and seco-B-rings as hedgehog pathway inhibitors.
AID760017Inhibition of Hedgehog signaling in mouse ASZ001 cells assessed as downregulation of Gli1 mRNA expression after 48 hrs by RT-PCR analysis2013ACS medicinal chemistry letters, Jul-11, Volume: 4, Issue:7
Identification of vitamin d3-based hedgehog pathway inhibitors that incorporate an aromatic a-ring isostere.
AID1824247Inhibition of hedgehog signalling in mouse Sufu-KO MEF cells assessed as upregulation of VDR expression at >15 uM in by immunoblot analysis2022European journal of medicinal chemistry, Jan-15, Volume: 228Affinity-based protein profiling identifies vitamin D3 as a heat shock protein 70 antagonist that regulates hedgehog transduction in murine basal cell carcinoma.
AID647357Inhibition of Hedgehog signaling pathway in human U87MG cells assessed as down regulation of Gli1 at 5 uM after 24 hrs by RT-PCR analysis2012Bioorganic & medicinal chemistry letters, Feb-01, Volume: 22, Issue:3
Evaluation of vitamin D3 A-ring analogues as Hedgehog pathway inhibitors.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID216847Displacement of [3H]25-(OH)-D3 from rat plasma Vitamin D binding protein1990Journal of medicinal chemistry, Feb, Volume: 33, Issue:2
Synthesis and biological activity of novel vitamin D analogues: 24,24-difluoro-25-hydroxy-26,27-dimethylvitamin D3 and 24,24-difluoro-1 alpha,25-dihydroxy-26,27-dimethylvitamin D3.
AID760013Activation of VDR in human DaOY cells assessed as upregulation of Cyp24A1 mRNA expression at 5 uM after 48 hrs by RT-PCR analysis relative to DMSO-treated control2013ACS medicinal chemistry letters, Jul-11, Volume: 4, Issue:7
Identification of vitamin d3-based hedgehog pathway inhibitors that incorporate an aromatic a-ring isostere.
AID1585872Activation of VDR in mouse ASZ001 cells assessed as change in Cyp24A1 mRNA expression after 48 hrs by q-PCR analysis2019European journal of medicinal chemistry, Jan-15, Volume: 162Synthesis and evaluation of third generation vitamin D3 analogues as inhibitors of Hedgehog signaling.
AID760025Inhibition of Hedgehog signaling in mouse C3H10T1/2 cells assessed as downregulation of Gli1 mRNA expression after 24 hrs by RT-PCR analysis2013ACS medicinal chemistry letters, Jul-11, Volume: 4, Issue:7
Identification of vitamin d3-based hedgehog pathway inhibitors that incorporate an aromatic a-ring isostere.
AID1915533Agonist activity at Vitamin D receptor (unknown origin) by fluorescence polarization assay2021European journal of medicinal chemistry, Jan-01, Volume: 209Comprehensive review for anticancer hybridized multitargeting HDAC inhibitors.
AID770733Growth inhibition of human HT-29 cells after 72 hrs by MTS-PMS assay2013Bioorganic & medicinal chemistry letters, Oct-01, Volume: 23, Issue:19
Analogues of the Inhoffen-Lythgoe diol with anti-proliferative activity.
AID1198289Activation of VDR in mouse ASZ cells assessed as up-regulation of Cyp24A1 mRNA at 2.5 uM after 24 hrs by quantitative PCR analysis relative to control2015European journal of medicinal chemistry, Mar-26, Volume: 93Vitamin D3 analogues that contain modified A- and seco-B-rings as hedgehog pathway inhibitors.
AID1140488Activation of VDR in mouse ASZ001 cells assessed as upregulation of CYP24A1 mRNA expression at 5 uM after 24 hrs by RT-PCR analysis relative to DMSO-treated control2014Journal of medicinal chemistry, May-08, Volume: 57, Issue:9
Structure-activity relationships for vitamin D3-based aromatic a-ring analogues as hedgehog pathway inhibitors.
AID1140486Inhibition of hedgehog signaling pathway-mediated PTCH mRNA expression in mouse C3H10T1/2 cells after 24 hrs by RT-PCR analysis2014Journal of medicinal chemistry, May-08, Volume: 57, Issue:9
Structure-activity relationships for vitamin D3-based aromatic a-ring analogues as hedgehog pathway inhibitors.
AID1824240Binding affinity to recombinant human HSP70 assessed as dissociation constant incubated for 1 hrs by MTS assay2022European journal of medicinal chemistry, Jan-15, Volume: 228Affinity-based protein profiling identifies vitamin D3 as a heat shock protein 70 antagonist that regulates hedgehog transduction in murine basal cell carcinoma.
AID770730Activation of VDR in mouse C3H10T1/2 cells assessed as upregulation of CYP24A1 mRNA expression at 5 uM after 24 hrs by RT-PCR analysis relative to DMSO-treated control2013Bioorganic & medicinal chemistry letters, Oct-01, Volume: 23, Issue:19
Analogues of the Inhoffen-Lythgoe diol with anti-proliferative activity.
AID1140501Activation of hedgehog signaling pathway in VDR-knockdown mouse C3H10T1/2 cells assessed as effect on VDR expression at 5 uM after 24 hrs by qPCR analysis2014Journal of medicinal chemistry, May-08, Volume: 57, Issue:9
Structure-activity relationships for vitamin D3-based aromatic a-ring analogues as hedgehog pathway inhibitors.
AID760026Binding affinity to human VDR by fluorescence polarization assay2013ACS medicinal chemistry letters, Jul-11, Volume: 4, Issue:7
Identification of vitamin d3-based hedgehog pathway inhibitors that incorporate an aromatic a-ring isostere.
AID1824250Inhibition of hedgehog signalling in mouse Sufu-KO MEF cells assessed as upregulation of Cyp27B1 expression by immunoblot analysis2022European journal of medicinal chemistry, Jan-15, Volume: 228Affinity-based protein profiling identifies vitamin D3 as a heat shock protein 70 antagonist that regulates hedgehog transduction in murine basal cell carcinoma.
AID1824245Inhibition of hedgehog signalling in mouse ASZ001 cells assessed as downregulation of VDR expression in by immunoblot analysis2022European journal of medicinal chemistry, Jan-15, Volume: 228Affinity-based protein profiling identifies vitamin D3 as a heat shock protein 70 antagonist that regulates hedgehog transduction in murine basal cell carcinoma.
AID1594138Selectivity index, ratio of IC50 for inhibition of native soluble pig heart MDH to IC50 for inhibition of Escherichia coli GroEL expressed in Escherichia coli DH5alpha/Escherichia coli GroES expressed in Escherichia coli BL21 (DE3) assessed as reduction i2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
HSP60/10 chaperonin systems are inhibited by a variety of approved drugs, natural products, and known bioactive molecules.
AID1824236Inhibition of hedgehog signalling in mouse C3H 10T1/2 cells assessed as reduction in Gli1 mRNA expression measured after 48 hrs by RT-PCR analysis2022European journal of medicinal chemistry, Jan-15, Volume: 228Affinity-based protein profiling identifies vitamin D3 as a heat shock protein 70 antagonist that regulates hedgehog transduction in murine basal cell carcinoma.
AID674347Growth inhibition of human HT-29 cells overexpressing VDR gene after 72 hrs by MTS assay2012Bioorganic & medicinal chemistry letters, Jul-15, Volume: 22, Issue:14
Probing the structural requirements for vitamin D3 inhibition of the hedgehog signaling pathway.
AID1135786Induction of intestinal calcium absorption in vitamin-D-deficient chicken assessed per 0.2 ml of plasma at 3.3 nmol, ip using 45Ca2+ and 40Ca2+ after 24 hrs relative to control1978Journal of medicinal chemistry, Oct, Volume: 21, Issue:10
Studies on vitamin D (calciferol) and its analogues. 15. 24-Nor-1alpha,25-dihydroxyvitamin D3 and 24-nor-25-hydroxy-5,6-trans-vitamin D3.
AID1135775Induction of intestinal calcium absorption in vitamin-D-deficient chicken assessed per 0.2 ml of plasma at 3.3 nmol, ip using 45Ca2+ and 40Ca2+ after 24 hrs1978Journal of medicinal chemistry, Oct, Volume: 21, Issue:10
Studies on vitamin D (calciferol) and its analogues. 15. 24-Nor-1alpha,25-dihydroxyvitamin D3 and 24-nor-25-hydroxy-5,6-trans-vitamin D3.
AID760023Inhibition of Hedgehog signaling in mouse M210B4 cells assessed as downregulation of Gli1 mRNA expression after 24 hrs by RT-PCR analysis2013ACS medicinal chemistry letters, Jul-11, Volume: 4, Issue:7
Identification of vitamin d3-based hedgehog pathway inhibitors that incorporate an aromatic a-ring isostere.
AID1594136Selectivity index, ratio of IC50 for inhibition of native soluble pig heart MDH to IC50 for inhibition of Escherichia coli GroEL expressed in Escherichia coliDH5alpha/Escherichia coli GroES expressed in Escherichia coli BL21 (DE3) assessed as reduction in2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
HSP60/10 chaperonin systems are inhibited by a variety of approved drugs, natural products, and known bioactive molecules.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID674345Binding affinity to full length human VDR expressed in mouse C3H10T1/2 cells assessed as upregulation of CYP24A1 mRNA expression at 5 uM after 24 hrs by RT-PCR analysis relative to control2012Bioorganic & medicinal chemistry letters, Jul-15, Volume: 22, Issue:14
Probing the structural requirements for vitamin D3 inhibition of the hedgehog signaling pathway.
AID1140481Inhibition of hedgehog signaling pathway-mediated GLI1 mRNA expression in mouse C3H10T1/2 cells assessed as residual activity at 5 uM after 24 hrs by RT-PCR analysis relative to 20alpha-hydroxycholesterol/22(S)-hydroxycholesterol2014Journal of medicinal chemistry, May-08, Volume: 57, Issue:9
Structure-activity relationships for vitamin D3-based aromatic a-ring analogues as hedgehog pathway inhibitors.
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1824233Activation of VDR in mouse ASZ001 cells assessed as upregulation of Cyp24A1 mRNA expression at 5 uM measured after 48 hrs by RT-PCR analysis relative to control2022European journal of medicinal chemistry, Jan-15, Volume: 228Affinity-based protein profiling identifies vitamin D3 as a heat shock protein 70 antagonist that regulates hedgehog transduction in murine basal cell carcinoma.
AID1585883Inhibition of Hedgehog signaling pathway in VDR-deficient mouse C3H10T1/2 cells assessed as change in CYP24A1 mRNA expression at 5 uM after 24 hrs by q-PCR analysis2019European journal of medicinal chemistry, Jan-15, Volume: 162Synthesis and evaluation of third generation vitamin D3 analogues as inhibitors of Hedgehog signaling.
AID1824232Inhibition of hedgehog signalling in mouse ASZ001 cells assessed as reduction in Gli1 mRNA expression measured after 48 hrs by RT-PCR analysis2022European journal of medicinal chemistry, Jan-15, Volume: 228Affinity-based protein profiling identifies vitamin D3 as a heat shock protein 70 antagonist that regulates hedgehog transduction in murine basal cell carcinoma.
AID647363Activation of VDR in human U87MG cells assessed as up-regulation of CYP24A1 at 10 uM by RT-PCR analysis relative to control2012Bioorganic & medicinal chemistry letters, Feb-01, Volume: 22, Issue:3
Evaluation of vitamin D3 A-ring analogues as Hedgehog pathway inhibitors.
AID760022Inhibition of Hedgehog signaling in mouse M210B4 cells assessed as downregulation of Ptch mRNA expression after 24 hrs by RT-PCR analysis2013ACS medicinal chemistry letters, Jul-11, Volume: 4, Issue:7
Identification of vitamin d3-based hedgehog pathway inhibitors that incorporate an aromatic a-ring isostere.
AID1824252Inhibition of hedgehog signalling in mouse ASZ001 cells assessed as upregulation of Cyp27B1 expression by immunoblot analysis2022European journal of medicinal chemistry, Jan-15, Volume: 228Affinity-based protein profiling identifies vitamin D3 as a heat shock protein 70 antagonist that regulates hedgehog transduction in murine basal cell carcinoma.
AID1140508Inhibition of hedgehog signaling pathway in non-targeting siRNA treated mouse C3H10T1/2 cells assessed as downregulation of GLI1 expression at 5 uM after 24 hrs by qPCR analysis2014Journal of medicinal chemistry, May-08, Volume: 57, Issue:9
Structure-activity relationships for vitamin D3-based aromatic a-ring analogues as hedgehog pathway inhibitors.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1198291Binding affinity to full length human VDR by fluorescent displacement assay2015European journal of medicinal chemistry, Mar-26, Volume: 93Vitamin D3 analogues that contain modified A- and seco-B-rings as hedgehog pathway inhibitors.
AID1824242Inhibition of hedgehog signalling in mouse Sufu-KO MEF cells assessed as reduction in Gli1 mRNA expression measured after 48 hrs by RT-PCR analysis2022European journal of medicinal chemistry, Jan-15, Volume: 228Affinity-based protein profiling identifies vitamin D3 as a heat shock protein 70 antagonist that regulates hedgehog transduction in murine basal cell carcinoma.
AID1140498Inhibition of hedgehog signaling pathway-mediated GLI1 mRNA expression in mouse C3H10T1/2 cells after 24 hrs by RT-PCR analysis in presence of GDC-04492014Journal of medicinal chemistry, May-08, Volume: 57, Issue:9
Structure-activity relationships for vitamin D3-based aromatic a-ring analogues as hedgehog pathway inhibitors.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID760027Activation of VDR in mouse C3H10T1/2 cells assessed as upregulation of Cyp24A1 mRNA expression at 5 uM after 24 hrs by RT-PCR analysis relative to DMSO-treated control2013ACS medicinal chemistry letters, Jul-11, Volume: 4, Issue:7
Identification of vitamin d3-based hedgehog pathway inhibitors that incorporate an aromatic a-ring isostere.
AID1824231Activation of VDR in mouse C3H 10T1/2 cells assessed as upregulation of Cyp24A1 mRNA expression at 5 uM measured after 48 hrs by RT-PCR analysis relative to control2022European journal of medicinal chemistry, Jan-15, Volume: 228Affinity-based protein profiling identifies vitamin D3 as a heat shock protein 70 antagonist that regulates hedgehog transduction in murine basal cell carcinoma.
AID647356Binding affinity to human VDR at > 100 uM by fluorescence polarization-based competition assay2012Bioorganic & medicinal chemistry letters, Feb-01, Volume: 22, Issue:3
Evaluation of vitamin D3 A-ring analogues as Hedgehog pathway inhibitors.
AID760009Activation of VDR in mouse ASZ001 cells assessed as upregulation of Cyp24A1 mRNA expression at 5 to 10 uM after 48 hrs by RT-PCR analysis2013ACS medicinal chemistry letters, Jul-11, Volume: 4, Issue:7
Identification of vitamin d3-based hedgehog pathway inhibitors that incorporate an aromatic a-ring isostere.
AID674350Down-regulation of Gli1 mRNA expression in human HT-29 cells at 10 uM after 24 hrs by RT-PCR analysis relative to DMSO-treated control2012Bioorganic & medicinal chemistry letters, Jul-15, Volume: 22, Issue:14
Probing the structural requirements for vitamin D3 inhibition of the hedgehog signaling pathway.
AID603957Octanol-water partition coefficient, log P of the compound2008European journal of medicinal chemistry, Apr, Volume: 43, Issue:4
QSPR modeling of octanol/water partition coefficient for vitamins by optimal descriptors calculated with SMILES.
AID1585888Inhibition of Hedgehog signaling pathway in VDR-deficient mouse C3H10T1/2 cells assessed as reduction in oxysterol-induced Gli1 mRNA expression after 24 hrs by q-PCR analysis2019European journal of medicinal chemistry, Jan-15, Volume: 162Synthesis and evaluation of third generation vitamin D3 analogues as inhibitors of Hedgehog signaling.
AID1594145Inhibition of Escherichia coli GroEL expressed in Escherichia coli DH5alpha/Escherichia coli GroES expressed in Escherichia coli BL21 (DE3) assessed as reduction in GroEL/GroES-mediated denatured rhodanese refolding by measuring rhodanese enzyme activity 2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
HSP60/10 chaperonin systems are inhibited by a variety of approved drugs, natural products, and known bioactive molecules.
AID1140489Inhibition of hedgehog signaling pathway-mediated GLI1 mRNA expression in human DaOY cells after 24 hrs by RT-PCR analysis2014Journal of medicinal chemistry, May-08, Volume: 57, Issue:9
Structure-activity relationships for vitamin D3-based aromatic a-ring analogues as hedgehog pathway inhibitors.
AID1594141Inhibition of Escherichia coli GroEL expressed in Escherichia coliDH5alpha/Escherichia coli GroES expressed in Escherichia coli BL21 (DE3) assessed as reduction in GroEL/GroES-mediated denatured soluble pig heart MDH refolding by measuring MDH enzyme acti2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
HSP60/10 chaperonin systems are inhibited by a variety of approved drugs, natural products, and known bioactive molecules.
AID1140507Inhibition of hedgehog signaling pathway in VDR-knockdown mouse C3H10T1/2 cells assessed as downregulation of GLI1 expression at 5 uM after 24 hrs by qPCR analysis2014Journal of medicinal chemistry, May-08, Volume: 57, Issue:9
Structure-activity relationships for vitamin D3-based aromatic a-ring analogues as hedgehog pathway inhibitors.
AID674349Upregulation of CYP24A1 mRNA expression in human U87MG cells at 10 uM after 24 hrs by RT-PCR analysis relative to DMSO-treated control2012Bioorganic & medicinal chemistry letters, Jul-15, Volume: 22, Issue:14
Probing the structural requirements for vitamin D3 inhibition of the hedgehog signaling pathway.
AID1203552Modulation of human alpha7 nAChR expressed in Xenopus laevis oocytes assessed as effect on acetylcholine-induced currents at 10 uM after 1 to 4 days by two-electrode voltage clamp assay relative to control2015Journal of medicinal chemistry, Apr-09, Volume: 58, Issue:7
Ensemble-based virtual screening for cannabinoid-like potentiators of the human glycine receptor α1 for the treatment of pain.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1594137Inhibition of ATPase activity of Escherichia coli GroEL expressed in Escherichia coliDH5alpha incubated for 60 mins using ATP by spectrometric analysis2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
HSP60/10 chaperonin systems are inhibited by a variety of approved drugs, natural products, and known bioactive molecules.
AID624608Specific activity of expressed human recombinant UGT1A42000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID1594134Inhibition of native soluble pig heart MDH assessed as reduction in MDH enzyme activity using sodium mesoxalate as substrate and NADH by malachite green dye based spectrometric analysis2019Bioorganic & medicinal chemistry letters, 05-01, Volume: 29, Issue:9
HSP60/10 chaperonin systems are inhibited by a variety of approved drugs, natural products, and known bioactive molecules.
AID1203550Potentiation of human GlyR-alpha1 expressed in Xenopus laevis oocytes assessed as induction of glycine-activated currents after 1 to 4 days by two-electrode voltage clamp assay2015Journal of medicinal chemistry, Apr-09, Volume: 58, Issue:7
Ensemble-based virtual screening for cannabinoid-like potentiators of the human glycine receptor α1 for the treatment of pain.
AID760024Inhibition of Hedgehog signaling in mouse C3H10T1/2 cells assessed as downregulation of Ptch mRNA expression after 24 hrs by RT-PCR analysis2013ACS medicinal chemistry letters, Jul-11, Volume: 4, Issue:7
Identification of vitamin d3-based hedgehog pathway inhibitors that incorporate an aromatic a-ring isostere.
AID1140491Competitive binding affinity to full length human VDR by fluorescence polarization assay2014Journal of medicinal chemistry, May-08, Volume: 57, Issue:9
Structure-activity relationships for vitamin D3-based aromatic a-ring analogues as hedgehog pathway inhibitors.
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID1347054Inhibition of BCRP-mediated mitoxantrone efflux in human myeloid leukemia PLB985 cells measured by flow cytometry2017SLAS discovery : advancing life sciences R & D, 01, Volume: 22, Issue:1
Virtual Screening of DrugBank Reveals Two Drugs as New BCRP Inhibitors.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (7,843)

TimeframeStudies, This Drug (%)All Drugs %
pre-19902089 (26.64)18.7374
1990's879 (11.21)18.2507
2000's1189 (15.16)29.6817
2010's2641 (33.67)24.3611
2020's1045 (13.32)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 89.66

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index89.66 (24.57)
Research Supply Index9.18 (2.92)
Research Growth Index4.80 (4.65)
Search Engine Demand Index290.46 (26.88)
Search Engine Supply Index3.48 (0.95)

This Compound (89.66)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials1,425 (17.31%)5.53%
Reviews855 (10.38%)6.00%
Case Studies293 (3.56%)4.05%
Observational51 (0.62%)0.25%
Other5,610 (68.13%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (1113)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Clinical Trial of Vitamin D3 to Reduce Cancer Risk in Postmenopausal Women [NCT01052051]Phase 2/Phase 32,303 participants (Actual)Interventional2009-06-30Completed
Vitamin D 24'000 IU for Oral Intermittent Supplementation [NCT03920150]Phase 358 participants (Actual)Interventional2019-09-30Completed
Vitamin D Status: Relative Efficacy of Vitamins D2 and D3 [NCT01139840]32 participants (Actual)Interventional2010-01-31Completed
The Influence of Vitamin D on the Physical Performance and General Health of Conscripts of the Estonian Defence Forces [NCT04939636]112 participants (Actual)Interventional2021-07-19Completed
A Randomized, Placebo-Controlled, Double Blind Study Evaluating the Effect of Cholecalciferol on Vasoactive Hormones, Heart Function, Arterial Stiffness, and Blood Pressure in Dialysis Patients. [NCT01312714]Phase 264 participants (Actual)Interventional2011-02-28Completed
Vitamin D and Osteoporosis Prevention in Elderly African American Women: A 4-year Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Vitamin D Status in Elderly African American Women [NCT01153568]Phase 3260 participants (Actual)Interventional2010-08-31Completed
Phase III, Randomized, Double Blind Trial on Vitamin D Supplementation for Resected Stage II Melanoma Patients [NCT01264874]Phase 3150 participants (Actual)Interventional2010-05-31Terminated(stopped due to poor accrual rate)
McFlu2 COLD3 Prevention: A Randomized, Placebo-controlled, Double Blind Trial of Vitamin D and Health Advice for the Prevention of Upper Respiratory Tract Infections in McMaster University Students [NCT01158560]Phase 3600 participants (Actual)Interventional2010-09-30Completed
Rationale and Design of the Vitamin K2 and Vitamin D3 Intervention Trial in Children and Adolescents With the Low-energy Bone Fractures [NCT03871322]90 participants (Anticipated)Interventional2019-07-01Recruiting
Vitamin D Supplementation in Elderly Nursing Home Residents: Daily Supplementation Compared to a Loading Dose an Monthly Supplementation, a Randomised Trial [NCT01168544]Phase 3160 participants (Anticipated)Interventional2011-05-31Completed
Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels: A Randomized Controlled Trial [NCT01170494]279 participants (Actual)Interventional2013-02-28Completed
Effects of Vitamin D Supplementation in Coronary Artery Disease Patients With Postchallenge Hyperglycemia and Vitamin D Deficiency on Endothelial Function and Insulin Sensitivity [NCT01183442]Phase 322 participants (Actual)Interventional2010-06-30Terminated(stopped due to unable to recruit)
Vitamin D Supplementation in Chronic Stable Heart Failure: a Randomized, Double-blind, Placebo-controlled Trial [NCT01292720]Phase 329 participants (Actual)Interventional2011-04-30Completed
The Effect of Vitamin D Substitution on Pancreatic Parenchyma and Development of Fibrosis After First Acute Alcoholic Pancreatitis: A Randomized Prospective Trial [NCT02965898]260 participants (Anticipated)Interventional2016-09-30Active, not recruiting
Does Oral Vitamin D Supplementation in Egyptian Infants With Acute Bronchiolitis Improve the Outcome? A Double Blind Randomized Controlled Trial [NCT03799406]Phase 260 participants (Actual)Interventional2016-10-01Completed
Effect of Vitamin D Replacement in Vitamin D Deficient Patients With History of Urolithiasis: A Randomized Controlled Trial [NCT01349764]10 participants (Actual)Observational2011-04-30Terminated(stopped due to Unable to recruit required sample size)
Vitamin D on Glycemic Control in African American Children With Type 2 Diabetes [NCT01325987]31 participants (Actual)Interventional2011-03-31Completed
Effect of Vitamin D Administration Along With Selective Serotonin Reuptake Inhibitors (SSRIs) in Patients With Major Depressive Disorder (MDD) [NCT03754712]90 participants (Anticipated)Interventional2018-03-10Recruiting
[NCT01121796]90 participants (Anticipated)Interventional2010-06-30Not yet recruiting
Oral Cholecalciferol (Vitamin D3) Therapy in Prevalent Hemodialysis Patients: A Randomized Placebo Controlled Pilot Study [NCT01214928]20 participants (Actual)Interventional2011-01-31Completed
Immunomodulatory Effect of Vitamin D Supplementation on Monocyte in Major Beta-thalassemia [NCT03919812]60 participants (Actual)Interventional2018-04-01Completed
Multicentric, Randomized, Double-blind Versus Placebo Study Evaluating the Efficacy of Treatment With Cholecalciferol (Vitamin D3) for Delaying the Diagnosis of Multiple Sclerosis (MS) After a Clinically Isolated Syndrome (CIS). Comparison of Conversion R [NCT01817166]Phase 3316 participants (Actual)Interventional2013-07-16Completed
Early Effect of Vitamin D in Primary Hyperparathyroidism [NCT01329666]Phase 2/Phase 30 participants (Actual)Interventional2010-05-31Withdrawn(stopped due to Poor enrollment)
Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption [NCT01141998]27 participants (Actual)Interventional2009-12-31Completed
The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis, a Multicenter Randomized Controlled Trial [NCT05860270]Phase 4176 participants (Anticipated)Interventional2023-06-15Recruiting
To Test the Effect of Calcifediol Hy.D Supplementation on Muscle Function and Bone Quality in Younger Postmenopausal Women With Osteopenia: a Double-blind Randomized Placebo-controlled Trial [NCT02527668]Phase 2150 participants (Anticipated)Interventional2015-09-30Completed
Effect of Vitamin D Supplementation on Muscular Strength, Musculoskeletal Pain and Headache in Immigrants Living in Norway. Randomized, Double Blinded, Placebo Controlled Study [NCT01263288]Phase 4251 participants (Actual)Interventional2011-01-31Completed
Effects of Vitamin D3 Supplementation on Lung Functions and Exercise Tolerance in D3 Deficient Asthma COPD Overlap (ACO) Patients [NCT03880734]Phase 270 participants (Actual)Interventional2018-03-01Completed
Does Vitamin D Reduce Risk of Developing Type II DM in Prediabetics? A Double Blind Randomized Controlled Trial [NCT01170468]Phase 325 participants (Actual)Interventional2011-12-31Terminated(stopped due to inadequate enrollement)
A Pilot Study of Vitamin D Supplementation in Bronx Psychiatric Patients [NCT01169142]Phase 440 participants (Actual)Interventional2010-01-31Completed
Vitamin D Supplementation Enhances Immune Response to BCG Vaccination in Infants [NCT01288950]49 participants (Actual)Interventional2011-02-28Completed
The Effect of Calcium and Vitamin D Supplements as an Adjuvant Therapy to Metformin on Metabolic and Hormonal Disturbances in Polycystic Ovary Syndrome Patients [NCT03792984]Phase 340 participants (Actual)Interventional2016-12-01Completed
A 6-Month, Randomized, Open-Label, Active-Comparator Controlled, Parallel-Group Study With a 6-Month Extension to Evaluate the Safety and Efficacy of Alendronate Sodium 70 mg/Vitamin D3 5600 I.U. Combination Tablets Versus Calcitriol in the Treatment of O [NCT01350934]Phase 4219 participants (Actual)Interventional2011-06-19Completed
The Effects of Vitamin D2 Supplement During Pregnancy on Postpartum Maternal and Fetal Vitamin D Levels: the Randomized Controlled Trial [NCT03743922]60 participants (Actual)Interventional2018-11-01Completed
Vitamin D Deficiency Augments Renin-Angiotensin System Activity in Obesity [NCT01068418]26 participants (Actual)Interventional2010-02-28Completed
"Correction of Vitamin D Deficiency in Critically Ill Patients: a Randomized, Double-blind, Placebo-controlled Trial (VITDAL@ICU)" [NCT01130181]Phase 3480 participants (Actual)Interventional2010-05-31Completed
Allogenic Adipose Derived Mesenchymal Stem Cells and Vitamin D Supplementation in Patients With Recent-onset Type 1 Diabetes Mellitus [NCT03920397]30 participants (Actual)Interventional2015-03-01Completed
Correlation of Vitamin D Supplementation in Emergency Medicine Residents and Seasonal Mood Symptoms [NCT03739671]27 participants (Actual)Interventional2018-10-01Completed
Vitamin D Supplementation in Children and Adolescents Seen in the Paediatric Nephrology Service: Study of the Efficacy of Service Usual Care (Cholecalciferol) and Its Impact on Calciuria. [NCT02238418]Phase 443 participants (Actual)Interventional2014-09-30Completed
Effects of Vitamin D Supplementation With and With Out Exercise on Metabolic and Physical Consequences of Vitamin D Deficiency in the Elderly [NCT01145703]39 participants (Actual)Interventional2010-05-31Terminated(stopped due to Investigator terminated study due to low enrollment of eligible subjects)
Magnitude of Changes in 25 OH Vitamin D3 Levels After Vitamin D3 Supplementation: A Randomized Controlled Study [NCT01170507]Phase 1/Phase 20 participants (Actual)Interventional2011-12-31Withdrawn(stopped due to No funding)
High-Dose Vitamin D in Combination With Chemoradiotherapy in the Treatment of Glioblastoma Multiforme [NCT01181193]Phase 1/Phase 220 participants (Anticipated)Interventional2011-03-31Recruiting
The Effect of Vitamin D3 Alone and in Combination With Calcium Phosphate on Bone Metabolism in Healthy Adults [NCT01297023]60 participants (Actual)Interventional2011-01-31Completed
Clinical Trial of Oral Phenylbutyrate and Vitamin D Adjunctive Therapy in Pulmonary Tuberculosis in Bangladesh: a Pilot Study [NCT01580007]Phase 2288 participants (Actual)Interventional2010-12-31Completed
Pilot, Double-blind, Randomized Controlled, Multi-center Study of the Effects of Fish Oil and Vitamin D in the Prevention of Chronic Pain Following Major Thermal Burn Injury [NCT03313076]Phase 224 participants (Actual)Interventional2018-07-19Terminated(stopped due to COVID-19 global pandemic, and study funding period ended 7/31/2020.)
The Role of Vitamin D and Calcium Supplementation in the Pathogenesis of Type 2 Diabetes Mellitus [NCT02464462]Phase 111 participants (Actual)Interventional2010-05-31Completed
A 15-Week, Double-Blind, Randomized, Active-Controlled, Multi-Center Study With 24-Week Extension to Evaluate the Safety, Tolerability, Efficacy of Alendronate 70 mg Plus Vitamin D3 2800 IU Combination Tablet in Men and Postmenopausal Women With Osteoporo [NCT00092066]Phase 3717 participants (Actual)Interventional2003-09-24Completed
Effect of Alfacalcidol Supplementation to Respiratory Infection, Inflammatory Markers and CD4/CD8 Ratio of Indonesian Elderly [NCT03292744]Phase 4110 participants (Anticipated)Interventional2017-01-10Recruiting
Adjunct Vitamin D Therapy as a Means to Reduce the Disparity in Subclinical Target Organ Cardiac Damage Among Vulnerable Hypertensive Patients [NCT01360476]354 participants (Actual)Interventional2011-08-31Completed
Randomised Placebo-controlled Supplementation Study With Vitamin D and Calcium in Breastfeeding Mothers [NCT01349127]136 participants (Actual)Interventional2008-08-31Completed
A Randomized, Open-label, Single-dose Study to Evaluate the Safety and the Pharmacokinetics After Oral Concurrent Administration of HDDO-16141 and HDDO-16142 in Healthy Adult Subjects [NCT03234244]Phase 137 participants (Actual)Interventional2017-04-12Completed
Vitamin D Supplementation in Patients With Operated Tibia Fracture and Low Vitamin D. Does it Improve Healing Rate?. Randomized Controlled Trial [NCT03232216]682 participants (Anticipated)Interventional2017-11-21Recruiting
Personalized Treatment Algorithms for Difficult-to-treat Asthma: Bench to Community [NCT04179461]Phase 221 participants (Actual)Interventional2018-03-16Completed
A Prospective, Multi-centre, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency [NCT02443246]Phase 384 participants (Actual)Interventional2014-11-30Completed
Identifying Vit D Deficiency in VLBW Infants Part 2 [NCT01363167]68 participants (Actual)Interventional2011-10-31Completed
Psychological Impact of Amenorrhea in Women With Endometriosis: Perspective Randomized Study [NCT02393482]Phase 450 participants (Anticipated)Interventional2021-06-30Not yet recruiting
Effects of Vitamin D Supplementation During a Non-surgical Treatment of Generalized Chronic Periodontitis: A Randomized Double-blinded Placebo Controlled Clinical Trial [NCT03162406]30 participants (Anticipated)Interventional2017-05-18Recruiting
A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Diamyd® to Preserve Endogenous Beta Cell Function in Adolescents and Adults With Recently Diagnosed Type 1 Diabetes, Carrying the Genetic H [NCT05018585]Phase 3330 participants (Anticipated)Interventional2022-05-19Recruiting
Drug Metabolizing Enzyme and Transporter Function in Chronic Kidney Disease [NCT02360644]23 participants (Actual)Interventional2014-10-31Completed
Exploratory Study on the Effects of Probiotic Supplementation on SARS-CoV-2 Antibody Response in Healthy Adults [NCT04734886]161 participants (Actual)Interventional2020-11-27Completed
Efficacy and Security of the Magnesium and Vitamin D Combination as Adjuvant Treatment of Post-COVID Syndrome. A Randomised Double-blind Clinical Trial [NCT05630339]150 participants (Actual)Interventional2022-01-30Completed
A 2-Part, Open-Label, Randomized, Crossover Study to Evaluate the Bioequivalence of the 70-mg Alendronate/5600 IU Vitamin D3 Final Market Combination Tablet to a 70-mg Alendronate Marketed Tablet, and the Relative Bioavailability of Vitamin D3 [NCT00803790]Phase 1318 participants (Actual)Interventional2006-05-31Completed
The Impact of the Dose of Vitamin D (vitD) on the Metabolism of ca, p and Concentrations of 25OHD, Bone Status and Development of Premature Infants up to 2 Years of Age. Prospective, Randomized, Clinical Study [NCT03691896]Phase 3200 participants (Anticipated)Interventional2016-01-31Recruiting
A Randomized, Double-blinded, Parallel, Placebo-controlled Pilot Study to Investigate the Effect of Nutrition Ingredients on Microbiota Composition in Healthy Adults [NCT03668964]96 participants (Actual)Interventional2018-08-20Completed
Randomized Clinical Trial for The Evaluation of The Effects Of Cholecalciferol Supplementation On The Parathyroid Hormone In Hemodialysis Patients [NCT03648528]Phase 4120 participants (Actual)Interventional2015-10-15Completed
The Efficacy of Vitamin D3 for the Treatment of Chronic Plaque Type Psoriatic Patients With Vitamin D Deficiency and Insufficiency: a Randomized Controlled Trial [NCT01339741]30 participants (Anticipated)Interventional2011-03-31Recruiting
Vitamin D Supplementation, Parathyroid Hormone (PTH) and Plasma Vitamin D Response Among Malaysian Female Adults: Double Blinded, Randomised Clinical Trial of Efficacy [NCT05281107]Early Phase 1106 participants (Actual)Interventional2015-07-10Completed
Effect of Vitamin d Supplementation on the Control of Persistent Asthma in Children at Dr George Mukhari Academic Hospital, Pretoria, South Africa [NCT02053402]Phase 4100 participants (Anticipated)Interventional2014-03-31Not yet recruiting
Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 2 [NCT03810261]105 participants (Actual)Interventional2019-01-08Completed
Effect of Vitamin D Supplementation in Young Children With Acute Lower Respiratory Tract Infection at Dr George Mukhari Academic Hospital, Pretoria, South Africa [NCT02054182]Phase 4320 participants (Anticipated)Interventional2014-02-28Not yet recruiting
The Influence of Food Matrix Delivery System on the Bioavailability of Vitamin D3 [NCT03783273]30 participants (Actual)Interventional2019-01-08Completed
Effect of Vitamin D Treatment on Some Inflammatory Markers in Non-obese Lebanese Patients With Type 2 Diabetes [NCT03782805]88 participants (Actual)Interventional2018-05-09Completed
Effect of Vitamin D Repletion on Insulin Resistance and Systemic Inflammation [NCT01354964]Phase 219 participants (Actual)Interventional2009-03-13Completed
Vitamin D Supplementation and Clinical Outcomes in Severe COVID-19 Patients - Randomized Controlled Trial [NCT05384574]200 participants (Anticipated)Interventional2021-11-22Active, not recruiting
[NCT02069990]Phase 389 participants (Actual)Interventional2013-03-31Completed
The Link Between Obesity And Vitamin D in Bariatric Patients With Omega-loop Bypass Surgery: a Randomized Controlled, Double-blinded Clinical Supplementation Trial [NCT02092376]Phase 450 participants (Actual)Interventional2014-03-31Completed
Effect of Cholecalciferol on Hemodialysis Patients [NCT03602430]Phase 2/Phase 360 participants (Actual)Interventional2018-07-01Completed
Vitamin D and Immunomodulation: Effects in Crohn's Disease [NCT01369667]Phase 4117 participants (Actual)Interventional2012-04-30Completed
[NCT02158598]Phase 438 participants (Actual)Interventional2014-06-30Completed
Vitamin D Supplementation to Persistent Carriers of MRSA - A Double Blind, Randomised Controlled Trial [NCT02178488]Phase 260 participants (Actual)Interventional2014-12-31Completed
Effect of Maternal Vitamin D Supplementation During Pregnancy on Offspring Bone Mass, Body Composition and Muscle Strength in Early Childhood: Follow-up of a Randomized Controlled Trial Cohort. [NCT03537443]642 participants (Actual)Interventional2018-10-21Completed
Secondary Prevention of Osteoporosis: A Window of Opportunity in the Acute Rehabilitation Setting [NCT00421343]Phase 329 participants (Actual)Interventional2007-02-28Completed
Meal Effects on the 25OHD3 Response to Supplemental Vitamin D3 [NCT01268176]Phase 162 participants (Actual)Interventional2010-12-31Completed
Vitamin D Supplementation: Impact on Severe Pneumonia Among Under-five Children [NCT02185196]Phase 1197 participants (Actual)Interventional2014-06-30Completed
Does Vitamin D Improve Glycemic Control in Type II DM? A Double Blind Randomized Controlled Trial [NCT01170442]Phase 325 participants (Actual)Interventional2011-12-31Terminated(stopped due to In adequate enrollment)
Vitamin D/Calcium Polyp Prevention Study [NCT00153816]Phase 2/Phase 32,813 participants (Actual)Interventional2004-07-31Completed
Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps [NCT01185808]0 participants (Actual)Interventional2013-10-31Withdrawn
Vitamin D Supplementation and CD4 Count in HIV-Infected Children [NCT00911664]Phase 254 participants (Actual)Interventional2009-02-28Completed
Pilot Study of Transplant-related Events in Patients Receiving Ultra-high-dose Vitamin D Supplementation [NCT03759262]33 participants (Actual)Interventional2018-12-10Completed
Vitamin D Supplementation as a Neoadjuvant for Photodynamic Therapy of Actinic Keratoses [NCT04140292]Phase 275 participants (Actual)Interventional2020-01-13Completed
Effectiveness of Vitamin D Supplementation to Reduce Injury and Illness in the UK Armed Forces With Specific Reference to Stress Fracture Risk Reduction [NCT03963128]4,450 participants (Anticipated)Interventional2017-11-06Recruiting
Effect of Vitamin D on All-cause Mortality in Heart Failure Patients [NCT01326650]Phase 4400 participants (Actual)Interventional2010-11-30Completed
Vitamin D and Prostate Cancer [NCT01045109]Phase 252 participants (Actual)Interventional2007-10-31Completed
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin K Inhibitor) in the Treatment of Postmenopausal Women With Osteoporosis [NCT00112437]Phase 2399 participants (Actual)Interventional2005-06-24Completed
Rapid Normalization of Vitamin D Deficiency in PICU: A Multi-Centre Phase III Double-Blind Randomized Controlled Trial [NCT03742505]Phase 3766 participants (Anticipated)Interventional2019-06-17Recruiting
Evaluation of a Food Supplement Containing Lactobacillus Reuteri DSM 17938 + Vitamin D3 in the Prevention of Recurrent Respiratory Infections in Paediatric Patients [NCT04408443]200 participants (Actual)Interventional2019-11-25Terminated(stopped due to No enrollment due COVID PANDEMIA)
Multicentre, Cross-over, PRAgmatic Trial in Atopic Dermatitis Testing Long-term Control Effectiveness of New Phototherapy Regimen During Winter as an add-on Therapy, Coupled With Oral Vitamin D Supplementation vs. Placebo in a Randomised, Parallel-group T [NCT02537509]Phase 2111 participants (Actual)Interventional2015-10-27Completed
Influence of Vitamin K2 Administration on Vessel Calcification Markers in Patients With Chronic Kidney Disease [NCT01101698]Phase 460 participants (Anticipated)Interventional2009-06-30Recruiting
Pharmacokinetics Evaluation of Different Vitamin D3 Formulations [NCT05209425]37 participants (Actual)Interventional2022-01-01Completed
Comparing the Efficiency of Vitamin D3 and 25-hydroxyvitamin D3 Treatment on Changes of the Transcriptome of Low Vitamin D Responders [NCT03537027]Phase 140 participants (Actual)Interventional2018-05-03Completed
Efficacy Study of Vitamin D to Treat Contrast-induced Nephropathy [NCT02489240]306 participants (Anticipated)Interventional2015-07-31Recruiting
Effect of Oral Vitamin D on Oxidative Stress and Inflammation in Hemodialysis [NCT05460338]Phase 2/Phase 325 participants (Actual)Interventional2022-05-15Completed
Safety and Efficacy Evaluation of the Dose Regimen of Vitamin D 50,000 IU(Biodal) Tablet Supplementation in the Treatment of Population With Vitamin D Deficiency. [NCT02192229]Phase 280 participants (Anticipated)Interventional2014-08-31Not yet recruiting
EVALUATION OF THE HIGH DOSE VITAMIN D3 SUPPLEMENTATION EFFECT AND INFLUENCE OF POLYMORPHISM VDR GENE ON OXIDATIVE STRESS AND INFLAMMATORY PROCESS IN ELDERLY [NCT02222649]Phase 240 participants (Anticipated)Interventional2014-07-31Recruiting
High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients [NCT05838716]Phase 3366 participants (Anticipated)Interventional2023-12-29Not yet recruiting
Effect of Vitamin D Supplement for Cognitive Function in Patients With Bipolar Disorder- Randomized Double-Blind Controlled Trial [NCT05357859]21 participants (Actual)Interventional2022-05-03Completed
A Pilot Dose Response Study to Vitamin D in Obesity and Weight Loss: Effect on Bone [NCT01631292]81 participants (Actual)Interventional2010-01-31Completed
The Influence of Vitamin D Supplementation on Serum Brain Derived Neurotrophic Factor Level and Cognitive Function in Schizophrenia Treated With Atypical Antipsychotic [NCT03284294]Phase 340 participants (Anticipated)Interventional2020-04-15Not yet recruiting
A Multicenter Randomized Controlled Study of Vitamin D Supplementation in Pregnant Women for the Prevention of Gestational Diabetes [NCT05208827]Early Phase 11,600 participants (Anticipated)Interventional2022-01-01Recruiting
The Effect of Vitamin D Repletion on Postmenopausal Women With HIV [NCT01375010]Phase 1/Phase 285 participants (Actual)Interventional2011-01-31Completed
Randomized, Double-blind, Placebo Controlled Trial of Vitamin D3 Supplementation on Clinical, and Subjective Symptoms of Paediatric Asthma [NCT02428322]53 participants (Actual)Interventional2013-10-31Completed
Effect of Calcium and High-dose Vitamin D Supplementation on Bone Mineral Density Among Perinatally HIV-infected Children and Adolescents [NCT02426840]Phase 3200 participants (Actual)Interventional2015-04-30Completed
Vitamin D In the Prevention of Viral-induced Asthma in Preschoolers: a Randomized Controlled Multicenter Trial (DIVA) [NCT03365687]Phase 3865 participants (Anticipated)Interventional2018-10-01Recruiting
A Double-Blind, Randomized, Control Study to Examine the Effects of Vitamin D Fortification on Vitamin D Metabolite Profiles and Status in Vitamin D Insufficient Individuals. [NCT02422784]Phase 10 participants (Actual)Interventional2016-07-31Withdrawn
A Double-Blind, Randomized, Placebo-Controlled, Multicenter 4-Week Study to Assess the Effect of Alendronate 70 mg and Vitamin D3 2800 IU Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women [NCT00641771]Phase 156 participants (Actual)Interventional2004-05-31Completed
Trial of High-Dose Vitamin D in the Treatment of Complicated Severe Acute Malnutrition [NCT04270643]Phase 2259 participants (Actual)Interventional2021-12-27Active, not recruiting
Correlation Between Serum Vitamin D3 Level and Incidence of Uterine Leiomyoma in Egyptian Women [NCT05151393]80 participants (Anticipated)Observational2021-12-01Not yet recruiting
Menier's Disease - Bone Density Study [NCT05322538]60 participants (Anticipated)Interventional2022-10-01Not yet recruiting
Efficacy of Vitamin D Supplementation for Children With Bronchiolitis at Sohag University Hospital [NCT05795933]Phase 2/Phase 3146 participants (Anticipated)Interventional2023-04-01Recruiting
Determining the Effect of Vitamin D, Dyslipidemia and Microvascular in Patients With Type 2 Diabetes [NCT04439474]187 participants (Actual)Interventional2018-10-10Completed
Improving Body Composition, Strength, Function and Health Related Quality of Life in Older Individuals With Sarcopenic Obesity Through Lifestyle Modifications [NCT02379026]18 participants (Actual)Interventional2014-10-31Active, not recruiting
Effect of Suplementation of 5,000 UI Vitamin D3 on the Glycemic Profile in Patients With Gestational Diabetes Mellitus of the Hospital Civil de Guadalajara Dr. Juan I. Menchaca [NCT03645109]50 participants (Actual)Interventional2020-02-28Completed
Evaluating the Safety of Acute Baclofen in Methadone-maintained Individuals With Opiate Dependence. An Adaptive, Single-blind, Placebo-controlled Ascending Dose Study of Acute Baclofen on Safety Parameters in Opioid Dependence During Methadone-maintenance [NCT05161351]Phase 464 participants (Anticipated)Interventional2022-01-11Recruiting
Effect of Vitamin D on Metabolic Profile in Overweight or Obese Women [NCT01344161]Phase 385 participants (Actual)Interventional2009-10-31Completed
Effect of Vitamin D3 Supplementation on Cardiometabolic Risk Factors in a Cohort of Overweight and Obese Adults in the United Kingdom (UK) [NCT02359214]49 participants (Actual)Interventional2014-04-30Completed
Evaluation of a Strategy for Systematic Screening for Vitamin D Deficiency and Treatment in Case of Deficiency, on the Improvement of the Maximum Walking Distance in Patients With Stage 2 Lower Limb Arterial Disease. [NCT03615833]Phase 427 participants (Actual)Interventional2019-03-11Completed
Longitudinal Effect of Vitamin D3 Replacement on Cognitive Performance and MRI Markers in Multiple Sclerosis Patients: A Single-Blind Randomized Clinical Trial [NCT03610139]162 participants (Anticipated)Interventional2018-05-21Recruiting
Free Vitamin D Correlate Better With BMD and Fracture Than Total Serum Vitamin D? [NCT03605173]125 participants (Anticipated)Interventional2018-03-01Recruiting
Vitamin D to Improve Outcomes by Leveraging Early Treatment: Long-term Brain Outcomes in Vitamin D Deficient Patients (VIOLET-BUD) [NCT03733418]95 participants (Actual)Observational2018-11-01Completed
Effect of Raloxifene Plus Cholecalciferol and Cholecalciferol Alone on the Bone Mineral Density in Postmenopausal Women With Osteopenia: an 1-year Randomized Controlled Trial [NCT05386784]Phase 4112 participants (Anticipated)Interventional2020-12-16Recruiting
A Cluster-Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Vitamin D3 Supplementation to Reduce Disease Severity in Persons With Newly Diagnosed COVID-19 Infection and to Prevent Infection in Household Members [NCT04536298]Phase 32,024 participants (Actual)Interventional2020-12-28Active, not recruiting
Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight [NCT05459298]180 participants (Anticipated)Interventional2022-09-06Recruiting
Vitamin-D Treatment Targeted to Hyperprolinemia-Associated Schizophrenia. [NCT02197286]Phase 20 participants (Actual)Interventional2015-02-28Withdrawn(stopped due to Personnel changes at study site.)
Validating a Vitamin D3 Supplementation Regimen Among Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation [NCT03534674]84 participants (Anticipated)Interventional2018-06-15Not yet recruiting
The Effect of a High-dose Oral Vitamin D3 Bolus on Serum 25-hydroxyvitamin D3 and Vitamin D Receptor Target Gene Expression (VitDbol) [NCT02063334]Phase 135 participants (Actual)Interventional2014-02-28Completed
Weekly Vitamin D3 for Treatment of Hypovitaminosis D in Children and Adolescents With Inflammatory Bowel Disease [NCT02076750]Phase 1/Phase 234 participants (Actual)Interventional2013-03-31Completed
Randomized Clinical Trial of Hypovitaminosis D Treatment in the Neurocritical Care Unit [NCT02881957]Phase 2/Phase 3274 participants (Actual)Interventional2016-10-10Completed
Blood Pressure in Blacks and Calcium (BBC) and Vitamin D Study [NCT03070483]Phase 25 participants (Actual)Interventional2018-03-25Completed
Adjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED): A Randomized, Double-blind, Placebo-controlled Trial [NCT04225819]100 participants (Anticipated)Interventional2020-10-01Suspended(stopped due to Protocol is being modified.)
Vitamin D for Sickle-cell Respiratory Complications [NCT01443728]Phase 2130 participants (Anticipated)Interventional2011-12-13Completed
High-dose Vitamin D Supplement for the Prevention of Acute Asthma-like Symptoms in Preschool Children - a Double-blind, Randomized, Controlled Trial [NCT05043116]Phase 2320 participants (Anticipated)Interventional2022-10-01Recruiting
Effects of Vitamin D Supplementation on Reproductive, Hormonal and Metabolic Profiles, and on IVF Outcomes, in PCOS Infertile Saudi Women : a Randomized-controlled Clinical Trial [NCT05106712]700 participants (Anticipated)Interventional2021-11-01Not yet recruiting
Vitamin D Supplementation and Changes of Hematology Parameter, Coagulation Profile, and Clinical Improvement Among COVID-19 Patients [NCT05126602]60 participants (Actual)Interventional2021-04-01Completed
A Randomized, Examiner-blind Comparator-controlled Crossover Bioequivalence Study on Vitamin D in Healthy Adults [NCT03552666]9 participants (Actual)Interventional2016-12-26Completed
The Effect of High Oral Loading Dose of Cholecalciferol in Non-Alcoholic Fatty Liver Disease Patients [NCT05578404]Phase 2100 participants (Actual)Interventional2022-10-20Completed
Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury - a Placebo-controlled Randomized Double-blinded Study [NCT04652544]Phase 350 participants (Actual)Interventional2021-05-19Active, not recruiting
The Effect of Single High Dose of Vitamin D3 on Short-term Postoperative Pain in Patients Under Craniotomy for Brain Tumor Resection [NCT03614403]60 participants (Actual)Interventional2017-07-30Completed
Improving Cognition and Brain Imagery Through Optimal Vitamin D Supplementation in the Elderly [NCT03611049]Phase 214 participants (Actual)Interventional2018-08-01Terminated(stopped due to Principal Investigator (Dr. Peiris) is retiring)
Effect of Supplementary Vitamin D in Patients With Diabetes Mellitus and Pulmonary Tuberculosis (EVIDENT Study): a Randomized, Double Blind, Controlled Trial [NCT02169570]Phase 4435 participants (Anticipated)Interventional2014-12-31Not yet recruiting
Evaluation of a Transdermal Vitamin D3 Delivery System, D3forME [NCT02174718]0 participants (Actual)Interventional2015-11-30Withdrawn(stopped due to Due to manufacturing problems the transdermal patch was not produced.)
The Effect of Oral Loading Doses of Cholecalciferol on the Serum Concentration of 25-OH-vitamin-D [NCT02186106]Phase 431 participants (Actual)Interventional2012-01-31Completed
Estudo clínico Randomizado, Controlado e Duplo-cego do Impacto da inibição de um Transportador de Membrana do Colesterol na absorção da Vitamina D [NCT02234544]Phase 452 participants (Actual)Interventional2014-10-31Completed
A Randomized, Open-label Study of High-Dose Vitamin D Versus Standard of Care Vitamin D Supplementation to Evaluate the Impact on Bone Health in Young Women With Early Stage Breast Cancer [NCT05016310]7 participants (Actual)Interventional2021-09-16Active, not recruiting
Effect of Vitamin D Supplementation on Myocardial Regional Function by Dobutamine Stress Echocardiography in Diabetic Patients. [NCT03437421]100 participants (Actual)Interventional2018-02-04Completed
A Phase II Trial on the Effect of Low-Dose Versus High-Dose Vitamin D Supplementation on Bone Mass in Adults With Neurofibromatosis Type 1 (NF1) [NCT01968590]Phase 226 participants (Actual)Interventional2017-08-16Terminated(stopped due to unable to enroll)
The Effects of Vitamin D3 Versus 25OHD3 (HyD) on Serum Vitamin D Metabolites and Markers of Mineral Metabolism and Immune Function [NCT02091219]Early Phase 135 participants (Actual)Interventional2014-06-30Completed
Effects of a One Year Cholecalciferol Supplementation on Bone Health and Muscle Strength in Adults During Post-burn Period [NCT02092701]0 participants Interventional2012-10-31Completed
Regulation of the Stress-axis by Vitamin D3 in Subjects With Multiple Sclerosis; a Double-blinded, Randomized, Placebo-controlled Study [NCT02096133]Phase 254 participants (Actual)Interventional2014-10-13Terminated(stopped due to difficulties with inclusion)
Effects of Vitamin D Deficiency and Its Replacement on Pulmonary and Endocrine Function in Persons With SCI [NCT02099955]Phase 1/Phase 288 participants (Actual)Interventional2012-01-31Completed
A Phase II Study of Curcumin and Vitamin D in Previously Untreated Patients With Early Stage Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) [NCT02100423]Phase 235 participants (Actual)Interventional2014-09-26Completed
Styrian Vitamin D Hypertension Trial: A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Effects of Vitamin D Supplementation on Systolic Ambulatory Blood Pressure in Vitamin D Deficient Hypertensive Patients [NCT02136771]Phase 4200 participants (Actual)Interventional2011-06-30Completed
Vitamin D Replacement After Kidney Transplant [NCT00748618]165 participants (Actual)Interventional2008-10-31Active, not recruiting
Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN) Junior [NCT02145195]130 participants (Actual)Interventional2014-06-30Completed
[NCT02158143]28 participants (Actual)Interventional2013-10-31Completed
The Effect of Co-administered β-Carotene, Vitamin D3, Zinc and Antenatal Steroid Therapy on Hyaline Membrane Disease and Feeding Intolerance in Premature Neonates [NCT03366584]Phase 4120 participants (Anticipated)Interventional2017-01-31Recruiting
Effect of a Single Colecalciferol Dose on Insulin Resistance: A Prospective Randomized Trial [NCT01075022]136 participants (Anticipated)Interventional2009-05-31Enrolling by invitation
The Effect of Antenatal Vitamin D Supplementation on Maternal-fetal Vitamin D Status and Neonatal Immune Function: a Randomized Controlled Trial in Bangladesh [NCT01126528]Phase 2160 participants (Actual)Interventional2010-08-31Completed
Evaluation of Gingival Crevicular Fluid Levels of LL-37 and Serum Vitamin D3 Levels in Smoker and Non-Smoker Patients With Chronic Periodontitis [NCT03923218]60 participants (Actual)Observational2011-12-31Completed
The Effect of Vitamin D Supplementation on Glucose Metabolism in Non-Diabetic African American Adults [NCT01141192]48 participants (Actual)Interventional2010-01-31Completed
The Beneficial Effect of Vitamin D Supplement to Peg Interferon Alpha 2a or to Telbivudine Monotherapy in Patients With Chronic HBV Viral Infection [NCT01083251]120 participants (Anticipated)Interventional2010-03-31Recruiting
Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint [NCT02185222]Phase 368 participants (Actual)Interventional2014-10-23Completed
Vitamin D In the Prevention of Viral-induced Asthma of Preschoolers: a Randomised Controlled Trial (RCT)- (DIVA) [NCT02197702]Phase 2/Phase 347 participants (Actual)Interventional2014-09-30Completed
Vitamin D Supplementation in Overweight/Obese African American Adults and Youth (D-SUNNY) [NCT01583621]74 participants (Actual)Interventional2011-11-30Completed
EVALUATION OF CHOLECALCIFEROL (VitD3) MAINTENANCE SUPPLEMENTATION IN PATIENTS WITH MULTIPLE MYELOMA (MM) UNDERGOING TRANSPLANTATION AND IN COMBINATION WITH LENALIDOMIDE MAINTENANCE [NCT05846880]Early Phase 1100 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Age-related Macular Degeneration (AMD) in the Vitamin D and Omega-3 Trial (VITAL) [NCT01782352]25,871 participants (Actual)Interventional2010-07-31Active, not recruiting
Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS [NCT01339676]Phase 470 participants (Actual)Interventional2008-03-31Active, not recruiting
Effect of Vitamin D Replacement on Tumor Response and Survival Parameters for Vitamin D Insufficient Patients With Cancer [NCT01787409]500 participants (Anticipated)Interventional2013-03-06Recruiting
Effect of Preoperative High-dose Cholecalciferol in Prevention of Post-thyroidectomy Hypocalcaemia : A Randomized Controlled Trial [NCT05586529]170 participants (Anticipated)Interventional2022-11-01Recruiting
PROVENT: A Randomised, Double Blind, Placebo Controlled Feasibility Study to Examine the Clinical Effectiveness of Aspirin and/or Vitamin D3 to Prevent Disease Progression in Men on Active Surveillance for Prostate Cancer [NCT03103152]Phase 2/Phase 3104 participants (Actual)Interventional2016-12-31Completed
Does Vitamin D Supplement Alter Serum Level of Glycosylated Hemoglobin in Adult Patients Between 34-74 Years With Type 2 Diabetes Mellitus and Vitamin D Deficiency? [NCT01354262]Phase 2150 participants (Actual)Interventional2011-03-31Completed
A Randomized, Placebo-Controlled, Double-Blinded, 250-Subject Clinical Trial of Vitamin D Replacement in Patients With Pulmonary Tuberculosis [NCT01130311]259 participants (Actual)Interventional2009-10-31Completed
A Randomised Comparative Study of the Effect of LYL Love Your Life ® sunD3 LYL Micro™ Vitamin D Sublingual Spray on Vitamin D3 Levels in the Blood Compared to Other Forms of Vitamin D3 - Oral Oil Droplets and Capsules [NCT06142136]99 participants (Actual)Interventional2021-03-28Completed
Can Vitamin D Supplementation Prevent Food Allergy in Infants? The VITALITY Trial [NCT02112734]Phase 42,739 participants (Actual)Interventional2014-12-31Active, not recruiting
Changes in Serum Vitamin D Level and Clinical Parameters After Different Loading Doses of Cholecalciferol (D3) in Young Adults With Vitamin D Deficiency [NCT03504280]105 participants (Actual)Interventional2015-04-30Completed
Effect of Antenatal Vitamin D3 Supplementation on Risk of Pre-eclampsia [NCT03101150]Phase 1/Phase 2179 participants (Actual)Interventional2012-10-01Completed
Can Vitamin D Supplementation in People With Crohn's Disease Improve Symptoms as an Adjunct Therapy? D-CODE Feasibility Randomised Controlled Trial [NCT03718182]Phase 450 participants (Anticipated)Interventional2019-09-17Recruiting
Vit D to Treat Asthma in Children: a Randomized, Double-blind, Placebo-controlled Trial [NCT01284907]0 participants (Actual)Interventional2013-03-31Withdrawn(stopped due to No Participants)
Bio-equivalency Study of the Effects of Vitamin D2 and Vitamin D3 Supplements on 25-hydroxyvitamin D Levels in Exclusively Breast Fed Canadian Infants [NCT01190137]Phase 352 participants (Actual)Interventional2010-03-31Completed
Skeletal Muscle Strength,Bone Mineral Homeostasis and Th1 and Th2 Cytokines Expression in Asian Indians With Chronic Hypovitaminosis D Before and After Oral Cholecalciferol Supplementation [NCT01190683]Phase 3170 participants (Actual)Interventional2010-08-31Completed
Vitamin D Dose-response Study Throughout Pregnancy and Lactation [NCT01112891]Phase 4225 participants (Actual)Interventional2010-03-31Completed
Topical Calcipotriol Versus Narrowband Ultraviolet B in Treatment of Alopecia Areata: A Randomized Controlled Trial [NCT03847441]60 participants (Actual)Interventional2017-10-01Completed
Pilot Study for Zoledronic Acid to Prevent High-Turnover Bone Loss After Bariatric Surgery [NCT03424239]Phase 46 participants (Actual)Interventional2018-08-01Completed
Differences in Immunological Effects of Vitamin D Replacement Among Black/African American (AA) Prostate Cancer Patients With Localized Versus Metastatic Disease [NCT05045066]Early Phase 1400 participants (Anticipated)Interventional2021-12-29Recruiting
Effects of Vitamin D3 Supplementation on Antioxidant Enzymes Status in Vitamin D3 Deficient Asthma COPD Overlap (ACO) Patients [NCT03931889]40 participants (Actual)Interventional2018-03-01Active, not recruiting
Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial: The MINDD Trial [NCT03380091]Phase 45 participants (Actual)Interventional2017-12-12Terminated(stopped due to Recruitment challenges)
Vitamin D to Improve Outcomes by Leveraging Early Treatment [NCT03096314]Phase 31,358 participants (Actual)Interventional2017-04-27Completed
A Randomized Controlled Trial on the Effect of 400 vs. 800 IU of Vitamin D on T Regulatory Cells in Preterm Infants [NCT03793309]Phase 140 participants (Actual)Interventional2017-01-09Completed
Impact of Vitamin D3 Administration on Cardiac Autonomic Tone in Asthma COPD Overlap(ACO) Patients: A Blinded Randomized Control Trial [NCT03773809]50 participants (Actual)Interventional2017-08-01Completed
Topical Delivery of Vitamin D3: A Randomized Controlled Trial (RCT) [NCT02735200]Phase 2550 participants (Actual)Interventional2016-04-30Completed
The Efficacy of Different Vitamin D Supplementation Delivery Methods on Serum 25(OH)D in Humans a Randomised Double-blind Placebo Trial [NCT03463642]62 participants (Actual)Interventional2017-02-02Completed
Follow-up Study With Randomized Clinical Vitamin D Supplementation Trial on Patients With Depression (DepFuD) [NCT02521012]3,028 participants (Anticipated)Interventional2015-11-30Recruiting
Effect of High Dose Vitamin D Supplementation on HIV Latency: A Pilot Randomized Controlled Trial [NCT03426592]Phase 230 participants (Actual)Interventional2018-01-29Completed
Maternal Oral Vitamin D Supplementation Via Daily or Monthly Regimens and the Effect on Levels of Vitamin D in Human Milk and Infant Serum [NCT01240265]Phase 2/Phase 380 participants (Actual)Interventional2010-12-31Completed
Effect of Vitamin D on Metabolic Parameters in Patients With the Metabolic Syndrome [NCT01237769]Phase 450 participants (Anticipated)Interventional2010-10-31Recruiting
Vitamin D Testing and Treatment for Adults With COVID 19 [NCT04407286]Phase 141 participants (Actual)Interventional2020-05-19Completed
Effect of Cholecalciferol on 24-hr ABPM and Vasoactive Hormones in Patients With Hypertension. [NCT01166165]Phase 2136 participants (Actual)Interventional2010-07-31Completed
[NCT01287455]83 participants (Actual)Interventional2011-02-28Completed
Work Package 5: The Potential Advantages and Limitations of Use of Novel Food-based Solutions for Prevention of Vitamin D Deficiency. Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN) [NCT02525003]41 participants (Actual)Interventional2014-01-31Completed
Vitamin D in Pediatric Crohn's Disease [NCT01187459]Phase 487 participants (Actual)Interventional2010-09-30Completed
Acute Effect of Vitamin D3 Supplementation on Serum 25(OH)D [NCT03849833]19 participants (Anticipated)Interventional2019-01-31Recruiting
A Phase IIb, 2-Arm, Randomized, Double-blind, Placebo-Controlled, Multicentre Study to Optimize Diamyd Therapy Administered Into Lymph Nodes Combined With Oral Vitamin D to Investigate the Impact on the Progression of Type 1 Diabetes [NCT03345004]Phase 2109 participants (Actual)Interventional2017-12-20Completed
Vitamin D3 for Autism Spectrum Disorder: a Randomized, Double-blind, Placebo-controlled Trial. [NCT02508922]42 participants (Actual)Interventional2015-09-30Completed
D-Light Intervention: A Randomised Controlled Human Intervention Study to Assess the Impact of Vitamin D From Milk and Supplements on Functional Health Outcomes and Future Vitamin D Synthesis From UV Exposure [NCT02495584]52 participants (Actual)Interventional2014-09-30Completed
Vitamin D Supplementation and Male Infertility: The Copenhagen Bone-Gonadal Study a Double Blinded Randomized Clinical Trial [NCT01304927]Phase 2/Phase 3307 participants (Actual)Interventional2011-02-28Completed
Effect of Vitamin D3 on Lung Function and Exercise Tolerance in D3 Deficient COPD Patients [NCT03781895]Phase 148 participants (Actual)Interventional2017-03-01Completed
Impact of Monthly High Dose Oral Cholecalciferol on Serum 25 Hydroxy Vitamin D Levels in Bariatric Surgery Subjects [NCT02477956]Phase 131 participants (Actual)Interventional2012-11-30Completed
Role of Vitamin D in Secondary Prevention of Knee Osteoarthritis: A Double-blind Randomized Controlled Trial [NCT00599807]Phase 4273 participants (Actual)Interventional2008-01-31Completed
Randomized Controlled Trial of Vitamin D Repletion Regimens in Primary Hyperparathyroidism [NCT01306656]Phase 49 participants (Actual)Interventional2011-10-31Completed
Vitamin D Supplements for HIV-positive Patients on cART [NCT01295034]62 participants (Actual)Interventional2011-03-31Completed
The Effect of Vitamin D3 Therapy on 25(OH)D, 1,25(OH)2D, VDBP, and 24,25(OH)2D Maternal Serum Levels in Pregnant Women With Vitamin D Deficient and Insufficient [NCT06054919]Phase 2/Phase 352 participants (Actual)Interventional2021-04-01Active, not recruiting
Vitamin D Replacement: The Effect on Statin-Related Myalgias [NCT01022398]4 participants (Actual)Interventional2010-02-28Terminated(stopped due to Recruitment slow, funding ended.)
Effect of Aerobic Interval Training Combined With Vitamin D Supplement on Functional Capacity and Perceived Myalgia in Middle Aged Obese Women [NCT04319289]45 participants (Actual)Interventional2020-01-12Completed
Investigation of the Impact of Maternal Body Weight on Vitamin D Status During Pregnancy: a Randomised Supplementation Study [NCT02713009]240 participants (Actual)Interventional2015-11-30Completed
Vitamin D Dynamics in Pregnant Women and Non-Pregnant Women of Reproductive Age [NCT02705287]160 participants (Anticipated)Observational2015-07-31Active, not recruiting
Vitamin D Status in Patients With Severe Sepsis: A Randomized Clinical Trial [NCT02684487]Phase 30 participants (Actual)Interventional2017-12-31Withdrawn(stopped due to PI left institution. Protocol not submitted to IRB, contract not executed, and study was not done.)
Effects of Vitamin D on Lipids [NCT00723385]130 participants (Actual)Interventional2008-07-31Completed
Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics [NCT04183257]Phase 4106 participants (Actual)Interventional2016-09-30Completed
Effects of Vitamin D and Calcium Supplementation on Health of UAE Citizens [NCT02662491]545 participants (Actual)Interventional2017-01-31Completed
An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in Patients With Secondary Hy [NCT03588884]Phase 469 participants (Actual)Interventional2018-06-08Completed
RCT Double Blinded Evaluation of Changes in Gene Expression, Metabolomic, Microbiome, and Calcium Metabolism in Response to Varied Vitamin D Dosages in Adults Who Are Vitamin D Insufficient [NCT02856776]39 participants (Actual)Interventional2017-12-01Completed
VITA-D: Cholecalciferol Substitution in Vitamin D Deficient Kidney Transplant Recipients: A Randomized, Placebo-controlled Study to Evaluate the Posttransplant Outcome [NCT00752401]Phase 3200 participants (Anticipated)Interventional2009-05-31Active, not recruiting
Growth Hormone Therapy and Bone Quality in Pediatric Osteoporosis [NCT00757393]Phase 321 participants (Actual)Interventional2008-09-30Completed
Effect of Vitamin D3 Supplementation on Clinical Signs, Oxidative Stress and Inflammatory Biomarkers in Patients With Irritable Bowel Syndrome [NCT02579902]Phase 190 participants (Actual)Interventional2015-02-28Completed
A Double Blind Randomized Control Trial to Study the Effect of Long Term Vitamin D Supplementation on Peripheral Insulin Sensitivity in Apparently Healthy Middle Aged Centrally Obese Adults [NCT01052181]Phase 4300 participants (Actual)Interventional2010-01-31Completed
Can Vitamin D Supplementation Prevent Bone Loss in Persons With MS? A Randomised, Placebo-controlled, Single-centre Study [NCT00785473]Phase 480 participants (Anticipated)Interventional2008-01-31Completed
Prevention of Secondary Hyperparathyroidism With Vitamin D in Stage II/III Chronic Kidney Disease [NCT00781417]48 participants (Actual)Interventional2008-10-31Completed
Effect of POSTbiotics Supplementation on Microbiome in OBese Children: the POST-OB Study [NCT04151823]Phase 430 participants (Anticipated)Interventional2019-01-07Recruiting
Cholecalciferol Supplementation in Critically Ill Patients With Severe Vitamin D Deficiency in Intensive Care Unit- A Randomized Controlled Trial. [NCT02868827]Phase 2/Phase 3127 participants (Actual)Interventional2017-08-27Terminated(stopped due to The initial plan was 2 years but due to slow recruitment. We were able to screen 635 patients in 4 years and recruited only 127 patients.)
Randomized Placebo-Controlled Trial of Cholecalciferol for Vitamin D Deficiency in Adults With Cystic Fibrosis [NCT00685971]200 participants (Anticipated)Interventional2008-12-31Completed
Vitamin D Deficiency in Pregnancy - Identifying Associations and Mechanisms Linking Maternal Vitamin D Deficiency to Placental Dysfunction and Adverse Pregnancy Outcomes [NCT04291313]2,000 participants (Anticipated)Interventional2020-06-08Recruiting
Effect of Supplemental Vitamin D on Skeletal Muscle Function in COPD Patients. [NCT00914810]Phase 339 participants (Actual)Interventional2009-06-30Completed
Impact of Vitamin D on Arteriovenous Fistulae Maturation Among ESRD Patients [NCT00912782]52 participants (Actual)Interventional2009-01-31Completed
Impact of Vitamin D Supplementation on Lactation Associated Bone Loss [NCT00903344]22 participants (Actual)Interventional2009-12-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Dose-Finding Study of MK-0822 in the Treatment of Involutional Osteoporosis [NCT00620113]Phase 2287 participants (Actual)Interventional2007-12-03Completed
EFFECT OF THREE DIFFERENT DOSES OF ORAL CHOLECALCIFEROL (1000 IU, 3000 IU AND 6000 IU DAILY) ON SERUM 25-HYDROXYVITAMIN D CHANGES AMONG EPILEPSY PATIENTS WITH HYPOVITAMINOSIS D: A RANDOMIZED PROSPECTIVE STUDY [NCT02890823]Phase 4210 participants (Actual)Interventional2015-07-31Completed
Vitamin D Intervention For Colon Cancer Prevention In African-Americans-A Pilot Study [NCT00870961]22 participants (Actual)Interventional2009-02-28Terminated(stopped due to PI changed institutions and accrual was not completed.)
Use of Vitamin D in Treatment of Non-Alcoholic Fatty Liver Disease Detected by Transient Elastography [NCT04038853]Phase 4360 participants (Actual)Interventional2015-12-01Completed
"Effect of Vitamin D Supplementation on the Allostatic Load and Chronic Stress Along Line of Control in Azad Jammu and Kashmir. Double Blind Randomized Placebo-controlled Trial" [NCT06101589]120 participants (Anticipated)Interventional2023-12-15Not yet recruiting
A Pilot Study of Low and High Dose Vitamin Cholecalciferol (D3) With Pharmacokinetic and Pharmacodynamic Correlates in Patients With Resected Colon Cancer [NCT00470353]8 participants (Actual)Interventional2006-09-30Terminated(stopped due to Withdrawn due to poor accrual/lack of funding)
Supplementation of Vitamin D in Patients With Type 2 Diabetes and Hypertension: Randomized Clinical Trial [NCT02204527]40 participants (Actual)Interventional2015-10-31Terminated
Assessment of Dose Effectiveness of Vitamin D Supplementation During Pregnancy [NCT02215213]350 participants (Actual)Interventional2013-06-30Completed
Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain [NCT01351805]25,871 participants (Actual)Interventional2010-07-31Active, not recruiting
A Phase I Study of Photodynamic Therapy (PDT) Plus Vitamin D3 for High-grade Anal Dysplasia and Microinvasive Anal Cancer [NCT02698293]Phase 10 participants (Actual)Interventional2019-12-01Withdrawn(stopped due to Covid-19)
Effects of Vitamin D on Skeletal Muscle Strength in Resistance Trained Adult Females [NCT05489666]40 participants (Anticipated)Interventional2022-09-01Not yet recruiting
Vitamin D Supplementation in Veterans With Early-Stage Prostate Cancer [NCT00953225]Phase 283 participants (Actual)Interventional2010-01-07Completed
Investigation of Vitamin D3 Enriched, Reduced-fat Yellow Cheese Efficacy to Prevent Vitamin D Deficiency [NCT02543671]80 participants (Actual)Interventional2014-10-31Completed
High-Dose Vitamin D and Antimicrobial Peptide Expression in Lung Failure [NCT01372995]Phase 231 participants (Actual)Interventional2011-07-31Completed
SAGE: Supplementation in Adolescent Girls With Endometriosis [NCT02387931]Phase 469 participants (Actual)Interventional2014-09-30Completed
Vitamin D Supplementation for Reduction of Dyslipidemia in Premenopausal Women [NCT03133975]Phase 330 participants (Anticipated)Interventional2017-04-01Recruiting
[NCT02256605]40 participants (Anticipated)Observational2013-11-30Completed
Maintenance of Vitamin D Sufficiency With Oral Vitamin D Supplementation in Malaysian Women of Malay and Indian Ethnicity With Post Menopausal Osteoporosis [NCT02389179]Phase 4150 participants (Anticipated)Interventional2014-08-31Recruiting
Acute Effects of Fruit Juice Enriched With Vitamin D3 or n-3 Fatty Acids or Probiotics and the Combination of the Three Ingredients on Glucose Metabolism in Healthy Adults [NCT05702359]11 participants (Actual)Interventional2022-11-02Completed
Cholecalciferol Comedication in Patients With Chronic Inflammatory Bowel Diseases (Crohn's Disease or Ulcerative Colitis) - the 5C-study [NCT04991324]Phase 3150 participants (Anticipated)Interventional2022-09-21Recruiting
Pioneering Pre- and Post-Operative Integrative Care to Improve Thoracic Cancer Quality of Care - The Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) Trial - Stage II [NCT04871412]Phase 320 participants (Anticipated)Interventional2022-04-04Recruiting
Pearlium®/Effecti-Cal®, a Novel Formulation of Calcium, Vitamin D and Minerals for Prevention of Postmenopausal Bone Loss [NCT04609189]Phase 497 participants (Actual)Interventional2012-07-12Completed
A Phase I Double-Blind Randomized Placebo-Controlled Trial of Combination Therapy to Treat COVID-19 Infection [NCT04482686]Phase 131 participants (Actual)Interventional2020-12-09Active, not recruiting
Vitamin D Status and Intakes and Their Association With Cognitive Trajectory in a Longitudinal Study of Urban Adults [NCT03320109]3,720 participants (Actual)Observational2004-08-18Completed
A Pilot Study Evaluating Single, High-dose Pharmacokinetics/Pharmacodynamics of Vitamin D3 in CF [NCT03734744]6 participants (Actual)Interventional2019-06-17Terminated(stopped due to Clinical research currently on hold)
Adjuvant Therapeutic Effect of Vitamin D on Hashimoto's Thyroiditis [NCT05871957]30 participants (Anticipated)Observational2023-06-01Not yet recruiting
Can Vitamin D Supplementation Improve Hepatitis C Cure Rates : A Pilot Multicentre Randomised Controlled Clinical Trial [NCT02053519]Phase 372 participants (Actual)Interventional2014-02-28Completed
Evaluation and Comparison of the Efficacy of 1000 and 2000 IU/d Vitamin D Supplementation During Pregnancy on Maternal and Newborn Vitamin D Status and Pregnancy Outcomes [NCT03308487]84 participants (Actual)Interventional2017-01-31Completed
A Blinded Exploratory Randomized Controlled Trial (RCT) to Determine Optimal Vitamin D3 Supplementation Strategies for Acute Fracture Healing [NCT02786498]Phase 2102 participants (Actual)Interventional2016-11-21Completed
Vitamin D3 Supplementation vs Placebo for Vitamin D Deficient/Insufficient Patients Undergoing Arthroscopic Rotator Cuff Repair: a Quadruple-blinded Randomized Controlled Trial [NCT05009498]240 participants (Anticipated)Interventional2021-09-01Not yet recruiting
Prevention of Exacerbations in Patients With COPD Through Vitamin D Supplementation: a Randomized Controlled Trial [NCT02122627]158 participants (Actual)Interventional2015-04-10Completed
Tolerance-Induction With Dendritic Cells Treated With Vitamin-D3 and Loaded With Myelin Peptides, in Multiple Sclerosis Patients (TOLERVIT-MS) [NCT02903537]Phase 116 participants (Anticipated)Interventional2017-07-06Recruiting
Rapid Normalization of Vitamin D in Critically Ill Children: A Phase II Dose Evaluation Randomized Controlled Trial [NCT02452762]Phase 267 participants (Actual)Interventional2016-01-31Completed
Double-blind, Investigator-initiated Study to Determine the Effect of Alum-GAD (Diamyd) in Combination With Vitamin D3 on the Progression to Type 1 Diabetes in Children With Multiple Islet Autoantibodies [NCT02387164]Phase 226 participants (Actual)Interventional2015-03-09Terminated(stopped due to The study was interrupted early and terminated when only 26 out of 80 patients were enrolled due to new clinical study results indicating that the current study would not be informative.)
Prospective Open Pilot of Low vs. Higher Dose Vitamin D in D-deficient Asthmatic Children: Does Diet Predict Immune Function and Asthma Symptom Response to Vitamin D Supplementation? [NCT02054975]18 participants (Actual)Interventional2014-01-31Active, not recruiting
A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency [NCT03233295]Phase 4108 participants (Actual)Interventional2014-10-23Completed
Effects of Cholecalciferol on Depressive Symptoms in Type 2 Diabetes Mellitus Patients: Study of Neurotrophin-3, Serotonin, and C-Peptide [NCT04917458]Phase 290 participants (Anticipated)Interventional2021-01-18Recruiting
A Vitamin D Dosing Strategy for Adequate Repletion and Maintenance in IBD Patients With Minimal Disease Activity [NCT03053414]0 participants (Actual)Interventional2017-02-20Withdrawn(stopped due to change in study design before recruitment began)
Dairy Product, Calcium & Vitamin D Supplementation and Cognitive-motor Function [NCT02086409]Phase 2/Phase 340 participants (Actual)Interventional2014-09-30Completed
Effect of Vitamin D Supplementation on the Metabolic Control and Body Composition of Type 2 Diabetes Subjects in Ajman (UAE) [NCT02101151]87 participants (Actual)Interventional2012-06-30Completed
Short-term Effects of Fruit Juice Enriched With Vitamin D3, n-3 Fatty Acids, and Probiotics on Subjective Appetite, Energy Intake, and Glycemic Responses, in Healthy Adults [NCT05928741]50 participants (Actual)Interventional2023-02-02Completed
PROTECT RCT (PRevention of COVID-19 With Oral Vitamin D Supplemental Therapy in Essential healthCare Teams [NCT04483635]Phase 334 participants (Actual)Interventional2021-02-08Terminated(stopped due to A premature discontinuation was recommended by the Data Safety Monitoring Board and agreed upon by the principal investigator, because the significantly lower recruitment than planned, in the context of mass vaccination of the target population.)
'Palliative-D' Vitamin D Supplementation to Palliative Cancer Patients - A Double Blind, Randomised Controlled Trial [NCT03038516]Phase 2244 participants (Actual)Interventional2017-11-01Completed
A Randomized, Examiner-blind Comparator-controlled Crossover Bioequivalence Study on Vitamin D in Healthy Adults [NCT03552653]31 participants (Actual)Interventional2017-08-26Completed
Efficacy of Vitamin D Therapy on Glucose Homeostasis in Obese Adolescents [NCT02414529]20 participants (Actual)Interventional2013-11-30Completed
A Randomized Controlled, Open-label, Multi-center Study With 104-week Saxagliptin or (and) Vitamin D3 Assessing Protective Effects on Beta Cell Function in Latent Autoimmune Diabetes in Adults (LADA) Treated With Metformin (and Insulin) [NCT02407899]Phase 4300 participants (Actual)Interventional2015-03-31Completed
Effect of Vitamin D Supplementation on Testosterone Level in Women With Polycystic Ovary Syndrome: A Randomized, Double-blind, Placebo-controlled Trial [NCT06101147]Phase 266 participants (Anticipated)Interventional2023-09-21Recruiting
Vitamin D Supplementation to Prevent Vitamin D Deficiency for Children With Epilepsy: a Randomized Controlled Clinical Trial [NCT03536845]Phase 3116 participants (Actual)Interventional2018-01-01Completed
Randomized Controlled Trial of High Dose Vitamin D in Children With Newly Diagnosed Crohn's Disease for the Prevention of Relapses [NCT02186275]Phase 325 participants (Actual)Interventional2016-02-29Completed
"Multicenter, Prospective, Double-blind, Placebo-controlled, Randomized Study of the Feasibility of Using the Dietary Supplement ARTNEO®, Capsules for Oral Administration in Patients With Stage II-III Primary Knee Osteoarthritis" [NCT05975879]212 participants (Actual)Interventional2022-05-31Completed
Vitamin D Supplementation for the Prevention of Acute Respiratory Tract Infection: a Randomized, Double-blinded and Plasebo Controlled Trial Among Young Finnish Men [NCT05014048]231 participants (Actual)Interventional2018-01-04Completed
GORG - 002 Randomized Phase III Trial to Determine the Effectiveness of High Dose Versus Standard Dose of Vitamin D2 (Ergocalciferol) Given With Docetaxel in Patients With Metastatic Breast Cancer [NCT00944424]Phase 3260 participants (Anticipated)Interventional2009-07-31Recruiting
Pilot Pharmacokinetic Study of Daily Versus Monthly High-Dose Cholecalciferol Supplementation [NCT01079923]40 participants (Actual)Interventional2010-02-28Completed
Effects of Vitamin D3 Supplementation on Antioxidant Enzymes Level in Vitamin D3 Deficient COPD Patients [NCT04011930]Phase 240 participants (Anticipated)Interventional2019-03-01Recruiting
Effect of Vitamin D3 on the IFN Alpha Signature in Patients With Systemic Lupus Erythematosus (ALE02) [NCT00710021]Phase 257 participants (Actual)Interventional2008-11-30Completed
Impact of Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy [NCT05259527]Phase 2120 participants (Anticipated)Interventional2022-12-19Recruiting
Temporal Profile of Serum Vitamin D Levels and Outcomes After Total Ankle Arthroplasty, Ankle Arthrodesis and First Metatarsophalangeal Joint Arthrodesis [NCT04772196]Early Phase 190 participants (Anticipated)Interventional2020-12-21Enrolling by invitation
A Pilot, Safety and Feasibility Trial of High-Dose Omega-3 Fatty Acids and High-Dose Cholecalciferol (Vitamin D) Supplementation in Type 1 Diabetes [NCT03406897]Phase 1/Phase 256 participants (Anticipated)Interventional2018-07-23Recruiting
Supplemental Vitamin D and Functional Outcomes in Early Adolescence [NCT00931580]323 participants (Actual)Interventional2009-10-31Completed
Antenatal Vitamin D Supplementation to Improve Neonatal Health Outcomes in Dhaka, Bangladesh: Preliminary Dose-finding and Safety Study [NCT00938600]Phase 175 participants (Actual)Interventional2009-07-31Completed
The Influence of Vitamin D on Mineral Metabolism, Blood Pressure and Pulse Wave Analysis in Healthy Individuals. A Randomised Double Blinded Placebo Controlled Trial. [NCT00952562]40 participants (Anticipated)Interventional2009-08-31Completed
Vitamin D and Genetics in Nutritional Rickets [NCT00949832]Phase 4109 participants (Actual)Interventional2004-01-31Completed
Impact of Vitamin D Supplementation on Cardiac Hypertrophy and Function in Chronic Kidney Disease Patients - a Randomised Controlled Trial [NCT01323712]Phase 2/Phase 350 participants (Anticipated)Interventional2011-03-31Active, not recruiting
Vitamin D Supplementation After Successful Parathyroid Surgery for Primary Hyperparathyroidism [NCT00982722]150 participants (Actual)Interventional2008-04-30Completed
Effects of Vitamin D and Exercise in Preventing Falls of Elderly Women [NCT00986466]409 participants (Actual)Interventional2009-09-30Completed
Assessing the Combined Effect of Omega-3 Fatty Acid and Vitamin D3 on Plasma Osteocalcin Levels : a Randomized Controlled Trial in Males and Females With Vitamin D Deficiency [NCT04005612]120 participants (Actual)Interventional2019-11-01Completed
Effects of Vitamin D Supplementation in Vitamin D Deficient Obese Subject. [NCT01037140]Phase 455 participants (Actual)Interventional2010-01-31Completed
Vitamin D, Glucose Control and Insulin Sensitivity in African-Americans [NCT00784511]Phase 2100 participants (Actual)Interventional2008-07-31Completed
Long-Term Effects of Giving Nursing-Home Residents Bread Fortified With 125 Micrograms (5000 IU) Vitamin D3 Per Daily Serving [NCT00789503]Phase 1/Phase 245 participants (Actual)Interventional2004-11-30Completed
hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease [NCT01026363]0 participants (Actual)Interventional2009-12-31Withdrawn(stopped due to Inadequate enrollment)
Phase IIB Randomized Controlled Biomarker Modulation Study of Vitamin D in Premenopausal Women at High Risk for Breast Cancer [NCT01097278]208 participants (Actual)Interventional2011-11-01Completed
12 Month Open-Label Extension Study of the Effect of Alendronate on Bone in People With Chronic SCI Previously Treated With Teriparatide [NCT02195895]Phase 217 participants (Actual)Interventional2014-04-30Completed
Phase I/II Study Evaluating Safety and Effects of Preoperative High-Dose Vitamin D on the Receptors, Biomarkers and Pathological Characteristics of High Grade DCIS or Invasive Breast Cancer. [NCT02856503]Phase 1/Phase 20 participants (Actual)Interventional2019-01-31Withdrawn(stopped due to Lack of Funding)
The Effect of Alendronate Sodium Vitamin D3 Tablets on Knee Joint Structure and Knee Osteoarthritis Pain: A Multi-center, Randomized, Double-blind, Controlled Study. [NCT04739592]Phase 460 participants (Anticipated)Interventional2021-07-07Recruiting
Long-term Effects of Vitamin D Supplementation in Vitamin D Deficient Obese Children During Integrated Weight-loss Program - a Double Blind Placebo Controlled Study [NCT02828228]200 participants (Anticipated)Interventional2016-02-29Recruiting
Randomized Placebo-Controlled, Double-Blind Study of Cholecalciferol Replacement in Patients on Expectant Management for Localized Prostate Cancer [NCT00887432]132 participants (Actual)Interventional2009-04-08Completed
Prospective Pilot Study to Assess the Effectiveness of Vitamin D Supplementation for Patients Requiring Chemotherapy for Stage III Colorectal Cancer [NCT02603757]70 participants (Anticipated)Interventional2016-03-31Completed
Efficacy Comparison of Two Doses of Vitamin D3 in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy [NCT05657678]Phase 4138 participants (Anticipated)Interventional2022-12-20Recruiting
A Prospective Randomised Placebo-controlled Study of the Influence of Vitamin D Supplementation on Resolution of Inflammation Following Community-acquired Pneumonia [NCT02802722]50 participants (Anticipated)Interventional2017-02-24Recruiting
The GLOBAL Vitamin D Study. A Genomic, Transcriptomic, Proteomic and Metabolomic Approach to the Effects of Vitamin D in Adipose Tissue and Peripheral Blood [NCT02783924]Phase 250 participants (Actual)Interventional2014-10-31Completed
Effects of Vitamin D and Fish Oil on the Kidney in Hypertensives [NCT02757872]Phase 32,612 participants (Actual)Interventional2016-04-30Completed
A Dietary Intervention Study Examining the Effect of Consumption of Vitamin D-enhanced Eggs on Winter-time Vitamin D Status in Adults [NCT02678364]55 participants (Actual)Interventional2015-01-31Completed
A Phase I/II Dose-Escalation Trial of Vitamin D3 With Calcium Supplementation in Patients With Multiple Sclerosis [NCT00644904]Phase 1/Phase 249 participants (Actual)Interventional2006-07-31Completed
A Study of Improvement in Psoriasis Symptoms Associated With Combinations of Biologically Active Natural Substances (SFA-002) With Known Safety Profile [NCT05642182]Phase 130 participants (Anticipated)Interventional2022-03-31Recruiting
Blue Sky Study: Impact of Milk and Vitamin D for Child Growth and Health [NCT00886379]Phase 2597 participants (Actual)Interventional2009-01-31Completed
Vitamin D Levels in Subjects With Vitamin D Deficiency Following Topical Application of Three Doses of Vitamin D Ointment - A Proof of Concept Study [NCT02676674]Phase 110 participants (Actual)Interventional2016-03-31Completed
Vitamin D Inadequacy: Documentation in Rural Populations and Evaluation of Correction by Food Supplementation (Phase III; Manitowoc Prevalence Study) [NCT00690417]108 participants (Actual)Interventional2007-08-31Completed
The Vitamin D Dose Response Curve in Obesity [NCT00960037]57 participants (Actual)Interventional2009-01-31Completed
A Randomized, Double-blind Study of the Efficacy of Intensive Cholecalciferol Monitoring and Supplementation on Serum Vitamin D Levels in Pediatric Patients With Cystic Fibrosis [NCT05276960]Phase 440 participants (Anticipated)Interventional2022-02-22Recruiting
Optimum Vitamin D Nutrition in Young Women [NCT00662844]198 participants (Actual)Interventional2008-04-30Completed
Physiologic Interactions Between the Adrenal- and the Parathyroid Glands [NCT02572960]Phase 481 participants (Actual)Interventional2015-10-31Completed
Pharmacokinetic Study in Healthy Postmenopausal Women to Compare Supplementation of Vitamin D3 to 25(OH)D [NCT00718276]Phase 135 participants (Actual)Interventional2008-03-31Completed
The Effect of Vitamin D Repletion on Small LDL Particle Number in Subjects at Elevated Cardiovascular Risk [NCT01008384]150 participants (Actual)Interventional2009-10-31Completed
Optimization of Vitamin D Stores and Its Impact on the Bone Health and Disease Outcomes of Children and Adolescents With IBD. [NCT00621257]134 participants (Actual)Interventional2008-01-31Terminated(stopped due to Maintenance phase outcome unattenable)
The Effect of Supplementation of Vitamin D3 on Inflammation Induced by 100 km Running, Iron Metabolism and Erythropoiesis [NCT05880030]40 participants (Actual)Interventional2016-10-19Completed
Role of Vitamin D Supplementation as an Adjuvant Therapy inTreatment of Helicobacter Pylori in Children [NCT05879237]200 participants (Anticipated)Interventional2023-06-01Not yet recruiting
A Comparative Vitamin D Bioavailability Study Following Supplementation of an Orodispersible, Chewable Tablet and Soft Gelatin Capsule Vitamin D3 Supplementation in Vitamin D Deficient Healthy Adults [NCT05706259]40 participants (Actual)Interventional2023-01-11Completed
Diabetes Prevention in the Vitamin D and Omega-3 Trial [NCT01633177]25,875 participants (Actual)Interventional2010-09-30Active, not recruiting
Effect of 8-week Supplementation With Vitamin D3 on Functional and Cognitive Performance in Patients With Chronic Low Back Pain Eligible for Neurosurgery Intervention [NCT06082375]40 participants (Actual)Interventional2019-08-01Completed
A Pilot Study of Vitamin D Deficiency and Myalgias, Arthralgias and/or Joint Stiffness Associated With Letrozole (Femara® ) [NCT00416715]Phase 2100 participants (Actual)Interventional2006-10-31Completed
Vitamin D Deficiency Treatment Outcomes on Inflammation, Endothelial Function and Ventricular Retrieval After Non ST-Segment Elevation Myocardial Infarction: A Randomized Placebo Controlled Clinical Trial (NAVID Study) [NCT03405207]Phase 270 participants (Anticipated)Interventional2018-05-01Recruiting
Effects of Vitamin D Supplement Before and During Pregnancy on Complications, Birth Weight and Bone Mineral Density During Lactation [NCT01038453]400 participants (Anticipated)Interventional2009-12-31Recruiting
Immunointervention With 1,25-dihydroxy-vitamin D3 in New-onset Type 1 Diabetes [NCT00960635]Phase 20 participants Interventional2001-06-30Completed
Randomised, Multi-Centre, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation in Patients With Chronic Obstructive Pulmonary Disease [NCT00977873]Phase 2/Phase 3240 participants (Actual)Interventional2009-09-30Completed
Effect of Vitamin D Supplementation on Hemoglobin A1c in Patients With Uncontrolled Type 2 Diabetes Mellitus [NCT00985361]37 participants (Actual)Interventional2009-10-31Completed
Effect of Vitamin D Supplementation on C-reactive Protein and Insulin Resistance in Postmenopausal Women With Type 2 Diabetes Mellitus [NCT01019642]Phase 3104 participants (Actual)Interventional2008-03-31Completed
A Dose-response, Double-blind Randomised Placebo-controlled Trial to Estimate the Dietary Requirement for Vitamin D in Caucasian Male and Female Adolescents Aged 14-18 Years (The ODIN Study) [NCT02150122]120 participants (Actual)Interventional2014-10-31Completed
Vitamin D Status in Relation to Insulin Sensitivity, Resistance and Inflammatory Response Among Saudi Women With Polycystic Ovary Syndrome [NCT02164552]340 participants (Anticipated)Observational2009-01-31Recruiting
Vitamin D Intervention in Young Adults With Severe Childhood-onset Obesity [NCT02549326]42 participants (Actual)Interventional2012-11-30Completed
Vitamin D3 in Sensory Recovery After Digital NERVe Suture: a Randomized Controlled Trial. [NCT04115982]Phase 372 participants (Anticipated)Interventional2020-01-20Recruiting
Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy [NCT00692120]64 participants (Actual)Interventional2007-02-28Completed
Skeletal Muscle Strength Including Its Energy Metabolism, Bone Mineral Homeostasis and Th1/Th2 Cytokines Expression in Asian Indians With Chronic Hypovitaminosis D Before and After Oral Cholecalciferol Supplementation [NCT00682214]Phase 140 participants (Actual)Interventional2008-05-31Completed
Impact of High Dose Vitamin D3 Supplementation in Treatment of Crohn's Disease in Remission: A Randomized Double-blind Controlled Study [NCT02615288]40 participants (Anticipated)Interventional2014-01-31Completed
Role of Vitamin D in Secondary Prevention of Cardiovascular Events [NCT01018849]24 participants (Actual)Interventional2009-07-31Completed
Effect of Vitamin D Supplementation on Postoperative Pain and Sedation-agitation [NCT02664857]Phase 450 participants (Actual)Interventional2016-07-31Completed
Immunomodulatory Effect of Vitamin D in Allogenic Post-transplant [NCT02600988]Phase 1/Phase 2150 participants (Actual)Interventional2011-07-31Completed
Vitamin D Deficiency in Interstitial Lung Diseases [NCT04100226]104 participants (Actual)Interventional2019-03-01Active, not recruiting
A Randomized, Open-label, Single-dose, 3-period, 6-sequence Crossover Study to Evaluate the Safety and the Pharmacokinetics After Oral Concurrent Administration of Raloxifene, Cholecalciferol in Healthy Korean Male Subjects [NCT02654093]Phase 124 participants (Actual)Interventional2016-01-31Completed
Effect of Vitamin D Repletion on Asthma Exacerbation [NCT02661191]119 participants (Actual)Interventional2012-10-31Completed
The Efficacy and Safety of Topical Vitamin D and Supplementation In Acne Vulgaris The Study of VDR, IL-1β, IL-6, IL-10 and IL-17 Expression [NCT05758259]Phase 4105 participants (Anticipated)Interventional2023-02-16Enrolling by invitation
Randomized Controlled Trial of Vitamin D to Reduce Racial Disparity in Chronic Pain Following Motor Vehicle Collision [NCT05458024]Phase 290 participants (Anticipated)Interventional2022-12-08Recruiting
A Prospective, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Fosamax Plus D in Postmenopausal Osteoporotic Women [NCT00729651]Phase 4343 participants (Actual)Interventional2008-03-20Completed
A Phase III Randomized, Placebo-Controlled Study to Evaluate the Effect of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Overall Safety, and to Estimate the Effect of Odanacatib (MK-0822) on Bone Micro-architecture in Postmenopausal Women Treated [NCT00729183]Phase 3214 participants (Actual)Interventional2008-10-02Completed
Phase 3 Trial of Oral L-arginine and / or Vitamin D as Adjunctive Therapies in Pulmonary Tuberculosis in Papua Province, Indonesia. [NCT00677339]Phase 3200 participants (Actual)Interventional2008-06-30Completed
A Pilot Study to Assess the Relative Safety and Immunology Effects of Low Dose Versus High Dose Cholecalciferol Supplementation in Patients With Multiple Sclerosis [NCT01024777]Phase 140 participants (Actual)Interventional2010-03-31Completed
Efficacy of Intralesional Vitamin D Injection for Treatment of Common Warts: A Randomized Controlled Trial [NCT04278573]Phase 260 participants (Actual)Interventional2020-10-20Completed
Does Treatment of Hypovitaminosis D Increase Calcium Absorption? [NCT00581828]Phase 419 participants (Actual)Interventional2005-01-31Completed
Antimicrobial Peptide LL-37 (Cathelicidin) Production in Active Tuberculosis Disease: Role of Vitamin D Supplementation [NCT00788320]0 participants (Actual)Interventional2008-10-31Withdrawn(stopped due to Inadequate enrollment)
The Granheim COPD Study: Effects of Vitamin D3-supplementation on the Efficacy of Strength Training in COPD Patients and Healthy Controls - a Double-blinded RCT [NCT02598830]97 participants (Actual)Interventional2015-11-30Completed
Pilot Study Evaluating the Role of Vitamin D Repletion on Gut and Lung Microbiota in Cystic Fibrosis [NCT02589444]41 participants (Actual)Interventional2015-12-31Completed
Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination With Low Dose Vitamin D for the Treatment of Subjects With Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis [NCT00803712]Phase 4313 participants (Actual)Interventional2009-02-01Completed
A Comparison of Capsules and Oral Spray Solution as Methods of Delivering Vitamin D3 and Raising Status: a Randomised Crossover Study [NCT02608164]22 participants (Actual)Interventional2015-08-31Completed
Defining Vitamin D Insufficiency in School Age Children: A Randomized Placebo Controlled Trial of Vitamin D3 [NCT00732758]Phase 1157 participants (Actual)Interventional2008-10-31Completed
Innovative Food Structures to Enhance the Sensory Experience, the Nutrient Profile and Nutrient Bioavailability for Older People [NCT04156074]80 participants (Actual)Interventional2019-11-04Completed
Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes - a Randomized Controlled Trial [NCT00812578]Phase 216 participants (Actual)Interventional2008-12-31Completed
A Phase III (Phase V Program), Open-Label, Randomized, Referred-Care-Controlled, Clinical Trial to Evaluate the Efficacy and Safety of MK -0217A/Alendronate Sodium-70 mg/Vitamin D3 5600 I.U. Combination Tablet on Vitamin D Inadequacy in the Treatment of O [NCT00692913]Phase 3515 participants (Actual)Interventional2008-06-30Completed
Effect of Anti-inflammatory and Anti-microbial Co-supplementations in Traumatic ICU Patients at High Risk of Sepsis [NCT04216459]112 participants (Actual)Interventional2020-02-18Completed
Treatment of Vitamin D Insufficiency [NCT00933244]Phase 4230 participants (Actual)Interventional2010-04-30Completed
A Randomized Controlled Clinical Trial of Oral Vitamin D2 for the Prevention of COVID-19 [NCT05673980]218 participants (Anticipated)Interventional2022-12-18Recruiting
Cardiometabolic Health Effects and Mechanisms of Action of Fish Nutrients [NCT02668159]23 participants (Actual)Interventional2015-08-31Completed
A Randomized, Double-Blind Study of Combination Vitamin E, Selenium and Lycopene vs. Placebo in Men Undergoing Radical Prostatectomy for Prostate Cancer [NCT00844792]Phase 248 participants (Actual)Interventional2008-10-31Completed
Study for Effectiveness in Prevention of Postoperative Hypocalcemia of Preoperative Oral Supplementation of Vitamin D (D-mac 30,000 IU) in Patients Undergoing Total Thyroidectomy [NCT05216419]Phase 4108 participants (Anticipated)Interventional2021-06-07Recruiting
A Comparative Trial of Calcitriol Versus Placebo for the Preservation of Bone Mass and Strength After Kidney Transplantation [NCT02224144]Phase 267 participants (Actual)Interventional2014-08-18Completed
A Pilot Study of Vitamin D Replacement in Patients With Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia With Low Vitamin D Levels [NCT02553447]197 participants (Actual)Interventional2015-10-19Active, not recruiting
Pilot Study of Vitamin D Therapy to Prevent Respiratory Complications in Children With Sickle Cell Disease [NCT01276587]Phase 1/Phase 24 participants (Actual)Interventional2011-01-31Completed
The Effect of Vitamin D and Calcium on Bone in Pediatric HIV [NCT00724178]Phase 2/Phase 359 participants (Actual)Interventional2003-07-31Completed
The Effect of 25-hydroxyvitamin D Supplementation and a Structured Exercise Program on Exercise Capacity and Quality of Life in Dialysis Patients [NCT00798993]Phase 419 participants (Actual)Interventional2009-01-31Completed
Physiological and Dietary Characteristics of Boys and Girls High School Basketball Players [NCT05658159]120 participants (Anticipated)Observational2022-11-01Recruiting
Randomized Trial of Vitamin D Supplementation in Winter-related, Childhood Atopic Dermatitis [NCT00879424]107 participants (Actual)Interventional2009-02-28Completed
A Randomized Controlled Trial of Vitamin D3 Supplementation for the Prevention of Viral Upper Respiratory Tract Infections [NCT00656929]167 participants (Actual)Interventional2006-12-31Completed
Randomized Controlled Trial of Neo-adjuvant Progesterone and Vitamin D3 in Women With Large Operable Breast Cancer and Locally Advanced Breast Cancer. [NCT01608451]Phase 3800 participants (Actual)Interventional2007-09-30Terminated(stopped due to Slow accrual implies that clinical questions being questioned have lost its significance.)
Cyclic Versus Daily Teriparatide on Bone Mass [NCT00668941]Phase 2140 participants (Anticipated)Interventional2005-09-30Active, not recruiting
The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (The IBDVit Study): Double-Blind, Placebo-Controlled Trial of Adjuvant Vitamin D (Colecalciferol) With Corticosteroids in Active Crohn's Disease [NCT00672763]Phase 40 participants (Actual)Interventional2008-05-31Withdrawn(stopped due to Unable to recruit adequate trial participants)
SYNchronizing Exercises, Remedies in GaIt and Cognition (SYNERGIC): A Randomized Controlled Double Blind Trial [NCT02808676]176 participants (Actual)Interventional2016-07-14Terminated(stopped due to Due to the COVID-19 pandemic, in-person interventions/assessments no longer possible.)
V.I.P. Feasibility Study (Vitamin D Intake Project) [NCT00909454]45 participants (Actual)Interventional2009-02-28Completed
Isfahan University of Medical Sciences [NCT02696590]200 participants (Actual)Interventional2015-07-31Completed
Effect of Vitamin D Supplementation on Leptin Resistance, Hunger, Body Weight and Resting Energy Expenditure in Obese Women. [NCT00907270]50 participants (Anticipated)Interventional2009-09-30Not yet recruiting
Effect of Vitamin D3 Supplementation in Parkinson's Disease Patients - A Pilot Study [NCT00907972]Phase 223 participants (Actual)Interventional2009-09-30Completed
Significance of Vitamin D Status in Obese Adolescents- A Pilot Study to Examine the Effect of Vitamin D3 Supplementation on Insulin Resistance and Cardiovascular Risk Factors [NCT00858247]Phase 251 participants (Actual)Interventional2009-04-30Completed
Interventional Testing of Gene-environment Interactions Via the Verifomics Mobile Application [NCT02758990]16 participants (Actual)Interventional2016-03-31Terminated(stopped due to Recruiting and financial constraints)
Vitamin D Levels in Stage IV Colorectal Cancer Patients: A Phase II Study [NCT01074216]Phase 245 participants (Actual)Interventional2010-02-28Completed
The Effect of Vitamin D Repletion on Insulin Resistance [NCT00606957]10 participants (Anticipated)Interventional2008-01-31Completed
The Effects of Vitamin D on Balance in Persons With PD [NCT01119131]Phase 2101 participants (Actual)Interventional2011-05-31Completed
High Dose Vitamin D Supplementation in Treatment of Chronic Spontaneous Urticaria [NCT02873364]Phase 380 participants (Anticipated)Interventional2016-08-31Recruiting
The Role of Vitamin D in Immune Function in Patients With CKD Stages 3 and 4. [NCT00749736]Phase 4100 participants (Actual)Interventional2008-07-31Completed
Vitamin D Supplementation as Non-toxic Immunomodulation in Children With Crohn's Disease [NCT01046773]Phase 13 participants (Actual)Interventional2010-01-31Terminated(stopped due to Low enrollment)
The Use of the 25 (OH) D Saliva Test as a Substitute for the 25 (OH) D Serum Test in Healthy People [NCT04655664]56 participants (Actual)Interventional2020-04-11Completed
A Comparative Study of Calcium Metabolism in Caucasian and Asian Postmenopausal Women of Chinese Descent and the Use of Strontium as a Qualitative Marker of Calcium Metabolism in Humans [NCT02565602]10 participants (Actual)Interventional2014-02-28Completed
VITAL-DEP: Depression Endpoint Prevention in the VITamin D and OmegA-3 TriaL [NCT01696435]18,353 participants (Actual)Interventional2010-07-31Active, not recruiting
A Randomized, Double-Blind, Placebo-Controlled Trial of Vitamin D in Heart Failure: A Pilot Study [NCT01388855]13 participants (Actual)Interventional2011-09-30Completed
Placebo Controlled Pilot Study on Effects of Vitamin D Supplementation in Subjects With New Onset of Type 1 Diabetes on Immunological, Endocrine and Metabolic Parameters: Step 2 in the Austrian Diabetes Prevention Programme [NCT01390480]Phase 431 participants (Actual)Interventional2010-11-30Completed
Phase 4 Study of Vitamin D3 Supplementation for Outcomes in Patients With Unipolar Depression [NCT01390662]Phase 4150 participants (Anticipated)Interventional2011-03-31Recruiting
A Double Blind Study on the Efficacy of a Combination of Beta-hydroxy-beta-methylbutyrate and Vitamin D on Muscular Strength and Functionality in Older Adults. [NCT00874575]Phase 176 participants (Actual)Interventional2008-11-30Completed
The Efficacy of Vitamin D Supplementation in Patients With Severe and Extremely Severe COVID-19 [NCT05092698]110 participants (Actual)Interventional2020-05-01Completed
Investigating the Mechanisms of Epigenetic Memory at the Example of the Responsiveness of Human Immune Cells to Vitamin D [NCT06104111]Phase 150 participants (Anticipated)Interventional2023-10-01Recruiting
The Effect of Early High-dose Vitamin D Intervention on the Residual β-cell Function in Adolescents and Children With Type 1 Diabetes [NCT05270343]Phase 3198 participants (Anticipated)Interventional2022-06-01Not yet recruiting
The Effect of Weekly 50,000 IU Vitamin D3 Supplements on the Serum Levels of Selected Cytokines Involved in Cytokine Storm of Covid-19; A Randomized Clinical Trial in the Covid-19 Uninfected Jordanian People With Vitamin D Deficiency [NCT04476745]100 participants (Actual)Interventional2020-10-05Completed
Comparison of the Bioefficacy of Oral 25-hydroxyvitamin D3 and Vitamin D3 Supplements on Vitamin D Status in Older Adults [NCT01398202]56 participants (Actual)Interventional2011-01-31Completed
Evaluation of the Effect of 25-OH-Vitamin D3 Therapy on 15-Prostaglandin Dehydrogenase Expression in Primary Tumor and Normal Colorectal Mucosa in Patients With Colorectal Cancer [NCT01403103]Early Phase 10 participants (Actual)Interventional2012-04-30Withdrawn(stopped due to Slow Accrual)
Vitamin D, Blood Pressure, Lipids, Infection and Depression [NCT00960232]Phase 3250 participants (Actual)Interventional2009-09-30Completed
Vitamin D and Its Non-Classic Roles in Cystic Fibrosis [NCT00762918]Phase 30 participants (Actual)Interventional2008-03-31Withdrawn(stopped due to Recruitment)
Evaluation d'Une stratégie thérapeutique d'Association médicamenteuse Pour la Prise en Charge de la Maladie d'Alzheimer et Des Maladies apparentées au Stade modéré [NCT01409694]Phase 390 participants (Actual)Interventional2011-09-30Completed
Pilot Study: Effects of Hectorol (Doxercalciferol) Vitamin D Replacement on Proteinuria, PTH Level and Bone Turnover in Stable Kidney Transplant Recipients: a Single-Blind, Placebo-Controlled Study in Patients Receiving 25-OH Vitamin D3 [NCT00889629]Phase 439 participants (Actual)Interventional2008-11-30Completed
Prediabetes, Prehypertension and Vitamin D Supplementation - A Practice Based Clinical Intervention Pilot Study [NCT01425424]18 participants (Actual)Interventional2012-04-30Terminated(stopped due to The PI was leaving Pennington)
Breast Cancer Prevention Using Synergistic Prostaglandin Inhibitors (The Vitamin D/Celecoxib Study) [NCT01425476]Phase 1/Phase 245 participants (Actual)Interventional2008-07-31Completed
Effect of Vitamin D Treatment in Primary Hyperparathyroidism [NCT00674154]Phase 2/Phase 346 participants (Actual)Interventional2008-05-31Completed
The Effect of Weight on Vitamin D Dose Response [NCT01013584]67 participants (Actual)Interventional2009-11-30Completed
Does Vitamin D3 (Cholecalciferol) Supplementation Change Insulin Resistance in Patients With Chronic Kidney Disease? [NCT00893451]24 participants (Actual)Interventional2009-09-30Completed
Vitamin D Status After Single Oral Dose of Cholecalciferol in Low Fat Meal Compared to High-fat Meal [NCT00968734]30 participants (Actual)Interventional2009-08-31Completed
Tele-health Enabled Clinical Trial for COVID-19: Vitamin D as an Immunomodulator to Prevent Complications and Reduce Resource Utilization in Outpatients [NCT04489628]Phase 1/Phase 20 participants (Actual)Interventional2020-08-01Withdrawn(stopped due to Unable to overcome hurdles to study recruitment)
A Pilot Study of the Impact of Vitamin D3 on Muscle Performance in Elderly Women [NCT00986596]24 participants (Actual)Interventional2006-10-31Completed
A Randomized, Clinical Trial of a Novel Immunotherapy for Chronic Sinusitis: Vitamin D [NCT01007799]30 participants (Actual)Interventional2009-11-30Completed
Prevention of Type 2 Diabetes With Vitamin D Supplementation in Subjects With Reduced Glucose Tolerance Detected in the Tromso Study 2007/2008 [NCT00685594]Phase 2/Phase 3511 participants (Actual)Interventional2008-03-31Completed
Impact of Vitamin D Supplementation on the Cardiometabolic Status and Androgen Profile in Women With Polycystic Ovary Syndrome: Placebo-Controlled Clinical Trial [NCT04117750]145 participants (Actual)Interventional2017-11-01Completed
Role of Lactobacillus Rhamnosus (FloraActive™) 19070 and Lactobacillus Reuteri (FloraActive™) DSM 12246 in Infant Colic: a Controlled Dietary Study [NCT02839239]168 participants (Actual)Interventional2016-12-09Completed
Vitamin D Supplementation and Covid-19: a Randomised, Double- Blind, Controlled Study [NCT04636086]Phase 450 participants (Actual)Interventional2020-11-12Completed
Safety and Efficacy of Single, High Dose Vitamin D Replacement in Patients Undergoing Hematopoietic Stem Cell Transplantation [NCT02876822]10 participants (Actual)Interventional2016-08-26Terminated(stopped due to Step 1 enrollment complete.)
Improved Insulin Sensitivity With Therapeutic Vitamin D Replacement in Pre-Diabetic Vitamin D Deficient Individuals [NCT00749918]12 participants (Actual)Interventional2007-01-31Completed
D-activating Decline- Exploring the Effects of Vitamin D3 Supplementation on Cognitive Function in Community Dwelling Healthy Older Adults- A Pilot Study [NCT02804841]60 participants (Actual)Interventional2015-11-30Completed
Safety of Vitamin D Supplementation in the Elderly [NCT00681590]Phase 3105 participants (Actual)Interventional2008-04-30Completed
ILyAD (Indolent Lymphoma And Vitamin D) A Phase III Double Blind, Randomized Trial to Evaluate the Supplemental Effect of Vitamin D on Progression-free Survival in Patients With Low Tumor-burden Indolent Non-Hodgkin Lymphoma Treated With Rituximab [NCT03078855]Phase 3211 participants (Actual)Interventional2017-09-07Active, not recruiting
Exploring the Role of Extrarenal 1-Alpha-Hydroxylase in Patients With End Stage Renal Disease [NCT00677534]7 participants (Actual)Interventional2008-05-31Completed
Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect on Insulin Requirements After Supplementation With Vitamin D-A Pilot Study [NCT01029392]Phase 375 participants (Actual)Interventional2009-11-30Completed
Role of Vitamin D3 Supplementation With Conventional Synthetic Disease Modifying Antirheumatic Drugs (csDMARD) in Rheumatoid Arthritis Patients: Randomized Double-blind Placebo Controlled Trial [NCT05078502]58 participants (Actual)Interventional2021-06-01Completed
A PHASE 2, MULTICENTER, RANDOMIZED, ACTIVE-CONTROLLED, PARALLEL-GROUP, DOSE-FINDING AND SAFETY STUDY OF RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 (RHBMP-2)/CALCIUM PHOSPHATE MATRIX(CPM) IN SUBJECTS WITH DECREASED BONE MINERAL DENSITY [NCT00752557]Phase 250 participants (Actual)Interventional2008-12-03Completed
Effects of 12 Weeks of Vitamin D Supplementation on Muscle Characteristics in Trained Subjects [NCT02599675]71 participants (Actual)Interventional2015-11-30Completed
The Effects of Vitamin D3 Supplementation on the T Cell Compartment in Multiple Sclerosis; a Pilot Study [NCT00940719]15 participants (Anticipated)Interventional2009-08-31Completed
Evaluation of the Impact of a Dietary and Nutritional Intervention on the Physical, Cognitive, Behavioural and Emotional Symptoms of Patients With Persistent Post-concussive Symptoms [NCT05589064]120 participants (Anticipated)Interventional2022-10-31Not yet recruiting
Vitamin D Supplementation as an Adjuvant Therapy for Specific Immunotherapy in Patients With Allergic Rhinitis. [NCT02738619]Phase 2/Phase 360 participants (Anticipated)Interventional2016-03-31Recruiting
A Pilot Study Evaluating the Effect of Vitamin D on Clinical Outcome in Autistic Children [NCT02550912]Phase 242 participants (Actual)Interventional2015-08-31Completed
Use of Vitamin D to Improve Glucose Metabolism and Reduce Inflammation in Obese Adolescents on a Standard Weight Loss Program [NCT00994396]44 participants (Actual)Interventional2009-11-30Completed
A 2-Part, Open-Label, Randomized, Crossover Study to Evaluate the Bioequivalence of the 70 mg Alendronate/2800 IU Vitamin D3 Final Market Combination Tablet to a 70 mg Alendronate Marketed Tablet, and the Relative Bioavailability of Vitamin D3 [NCT00806416]Phase 1244 participants (Actual)Interventional2003-05-31Completed
A Pragmatic Randomized Controlled Trial on High Dose Vitamin D to Prevent Relapses of Crohn's Disease in Children [NCT03999580]Phase 3316 participants (Anticipated)Interventional2020-02-07Recruiting
A Double Blind Randomised Controlled Trial to Investigate the Effect of Vitamin D3 Supplementation on Iron Absorption and Hepcidin Response in Marginally Deficient and Iron Deficient Women [NCT02714361]50 participants (Actual)Interventional2015-09-30Completed
Dose-dependent Anti-inflammatory Effects of Vitamin D in a Human Gingivitis Model [NCT00779909]Early Phase 135 participants (Actual)Interventional2008-12-31Completed
Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis [NCT04118010]Phase 440 participants (Actual)Interventional2020-03-13Completed
Vitamin D Improves Osteoporosis in Postmenopausal Women With Denosumab Failure [NCT05372224]55 participants (Actual)Interventional2020-06-22Completed
Effect of 1 Year Vitamin D or D Plus B-vitamins on Bone Markers in Elderly People [NCT02586181]93 participants (Actual)Interventional2009-08-31Completed
Study of Serum 25(OH) D3 Level Variability in Response to Different Doses of Oral Vitamin D Supplementation in Prostate Cancer Patients [NCT00524680]Phase 2148 participants (Actual)Interventional2007-06-30Completed
[NCT01864616]9 participants (Actual)Interventional2013-07-31Terminated(stopped due to We couldn't recruit the sample the we required)
Effects of Cholecalciferol on Osteoprotegerin Levels and Other Clinical Outcomes in Chronic Kidney Disease Patients on Peritoneal Dialysis: a Randomized Controlled Trial [NCT02598635]Phase 458 participants (Anticipated)Interventional2015-10-31Active, not recruiting
Vehicles for the Absorption of Vitamin D in Cystic Fibrosis: Comparison of Powder vs Oil [NCT01880346]Phase 417 participants (Actual)Interventional2013-10-31Completed
Dry Eye Disease in the Vitamin D and Omega-3 Trial (VITAL) [NCT01880463]25,875 participants (Actual)Interventional2010-07-31Active, not recruiting
For 12months, the Multi Center, Randomized, Open-label Comparative Clinical Study to Evaluate the Efficacy and the Safety of Monthly(RisenexM Group) Versus Weekly Oral Risedronate(Risenexsplus Group) With Vitamin D in Compliance, Improvement of Vitamin D [NCT01904110]Phase 4196 participants (Actual)Interventional2012-12-31Completed
Depression - Can Vitamin D Alleviate Symptoms of Depression Not Cured by Antidepressants as Well as Alleviate Negative Skeletal Effects Caused by Antidepressants? [NCT01932931]71 participants (Actual)Interventional2013-10-01Completed
Pilot Study of Vitamin K2 (MK-7) and Vitamin D3 Supplementation and the Effects on PASC Symptomatology and Inflammatory Biomarkers [NCT05356936]150 participants (Anticipated)Interventional2022-06-01Active, not recruiting
A Phase 2 Randomized, Double-blind, Window of Opportunity Trial Evaluating Clinical and Correlative Effects of Vitamin D in Patients With Breast Cancer. The ICARUS Trial [NCT01948128]Phase 283 participants (Actual)Interventional2013-10-31Completed
Year-long Double Blind Study on the Efficacy of a Combination of Beta-hydroxy-beta-methylbutyrate and Vitamin D With and Without Exercise on Muscular Strength and Functionality in Older Adults. [NCT02043171]Phase 1238 participants (Actual)Interventional2014-08-31Completed
A Randomized, Double-blind, Controlled Trial of Vitamin D for the Prevention of Acute Respiratory Infections in Children Aged 18 to 36 Months in Santiago, Coyhaique and Punta Arenas, Chile [NCT02046577]Phase 2276 participants (Actual)Interventional2014-02-28Completed
Vitamin D and Chronic Renal Insufficiency [NCT00968877]Phase 356 participants (Actual)Interventional2009-09-30Completed
Effect of Supplementation With Vitamins D3 and K2 in Non-carboxyled Osteocalcine and Insulin Serum Levels in Patients With Diabetes Mellitus Type 2 [NCT04041492]100 participants (Actual)Interventional2017-02-14Completed
[NCT00788138]30 participants (Anticipated)Interventional2008-10-31Completed
"Vitamin D and Crohn's Disease From the Bench to the Clinic" [NCT00742781]Phase 121 participants (Actual)Interventional2009-05-31Completed
Vitamin D and Omega-3 Trial: Ancillary Study (VITAL-Echo) on the Impact of Vitamin D Supplementation on Cardiac Structure and Function [NCT01630213]1,025 participants (Actual)Interventional2010-07-01Completed
Vitamin D Supplementation Prevents Pneumonia in Institutionalized Elderly Subjects [NCT00877422]100 participants (Actual)Interventional2008-08-31Completed
Randomised, Multi-centre, Double-blind, Placebo-controlled Trial of Vitamin D Supplementation in Adult and Adolescent Patients With Asthma [NCT00978315]Phase 2/Phase 3250 participants (Actual)Interventional2009-09-30Completed
[NCT00804752]0 participants InterventionalRecruiting
Change in Free 25(OH)D After High Dose in Vitamin D Deficient Postmenopausal Women [NCT02553044]112 participants (Anticipated)Interventional2015-10-31Completed
Vitamin D AND Cardiovascular Disease [NCT00809744]Phase 2160 participants (Actual)Interventional2008-11-30Completed
Effect of High Dose Vitamin D3 Supplementation on Skeletal Muscle Mass and Body Compositions in Critically Ill Patients With Vitamin D Deficiency [NCT02594579]Phase 340 participants (Anticipated)Interventional2015-10-31Not yet recruiting
Long Term Changes in Bone Mineral Density and Fracture Risk in Patients Receiving Androgen Deprivation Therapy for Advanced Prostate Cancer, With Stratification of Treatment Based on Presenting Values [NCT00536653]618 participants (Actual)Interventional1999-10-31Completed
A One Year Prospective, Randomized, Double Blind Interventional Study to Assess Tolerability, Quality of Life and Immunomodulation With Interferon Beta Combined With Vitamin D in Patients With Relapsing Remitting Multiple Sclerosis [NCT01005095]Phase 445 participants (Actual)Interventional2010-10-31Terminated(stopped due to Interim analysis showed that the odds for proving primary hypothesis are low.)
The Effect of Vitamin D Supplementation on Calcium Excretion in Thalassemia: a Dose Response Study [NCT01323608]Phase 440 participants (Anticipated)Interventional2011-06-30Not yet recruiting
The Effect of Bio-impedance Analysis and Vitamin D Versus Usual Care on Left Ventricular Mass in Peritoneal Dialysis Patients: a Randomized Controlled Trial [NCT01045980]Phase 270 participants (Anticipated)Interventional2010-08-31Recruiting
A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium [NCT00529373]Phase 316,071 participants (Actual)Interventional2007-09-13Terminated
The Effect of Vitamin D Replacement Therapy on Pathological Response in Breast Cancer Patients Treated With Neoadjuvant Therapy [NCT03986268]50 participants (Anticipated)Interventional2019-05-10Recruiting
The Effect of Vitamin D Statues on Endothelial Function [NCT01049048]Early Phase 180 participants (Anticipated)Interventional2009-03-31Completed
A Pilot Study to Evaluate the Efficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents [NCT01058720]Phase 420 participants (Actual)Interventional2009-12-31Completed
A Randomized Phase II of Zoledronic Acid (Zometa) in the Prevention of Osteoporosis in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation [NCT00321932]Phase 261 participants (Actual)Interventional2005-07-31Completed
The Effect of Oral Cholecalciferol (Vitamin D3) on Calcium Absorption in Persons on Long-term Hemodialysis [NCT01325610]37 participants (Actual)Interventional2011-04-30Completed
A Randomized, Double-blind, Placebo-controlled Study on Oral Vitamin D Megadoses - 100 000 or 200 000 IU Vitamin D3 Every Three Months [NCT01067898]Phase 460 participants (Actual)Interventional2010-02-28Completed
Cluster-randomised, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation for the Prevention of Influenza and Other Respiratory Infections in Sheltered Accommodation (ViDiFlu) [NCT01069874]Phase 2/Phase 3240 participants (Actual)Interventional2010-03-31Completed
A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R206 and Bonviva for the Improvement of Vitamin D in Postmenopausal Women With Osteoporosis [NCT01581320]Phase 3201 participants (Actual)Interventional2011-12-31Completed
Efficacy of Vitamin D Supplementation in Vitamin D-deficient Subjects at Risk of Lung Cancer (The Pittsburgh Vitamin D Study) [NCT02532062]10 participants (Actual)Interventional2016-01-31Terminated(stopped due to lost funding, limited eligibility due to pre-existing vitamin D supplementation)
Effect of Supplementation With Vitamin D on the Acute Bronchitis Prevention During the First Year of Life [NCT01875757]Phase 3200 participants (Actual)Interventional2013-11-30Completed
Supplementation of Vitamin D3 (Cholecalciferol) in Patients With Inflammatory Bowel Diseases (IBD) and Hypovitaminosis D: A Prospective Randomized Controlled Trial. [NCT01877577]30 participants (Actual)Interventional2012-04-30Completed
Randomized Double-blind Study Investigating Dose-dependent Longitudinal Effects of Vitamin D Supplementation on Bone Health [NCT01900860]311 participants (Actual)Interventional2013-08-31Completed
A Randomized Controlled Trial Testing the Effect of a Multi-nutrient Fortified Juice [NCT01909063]180 participants (Actual)Interventional2005-01-31Completed
Randomized Trial of Two Maintenance Doses of Vitamin D and Trace Element Status in Children With Chronic Kidney Disease [NCT01909115]Phase 198 participants (Actual)Interventional2013-09-30Completed
A Randomized Trial of Milk Fortified With Vitamin D in Colombia [NCT01909622]Phase 380 participants (Actual)Interventional2013-06-30Completed
[NCT01912898]40 participants (Anticipated)Observational2013-03-31Recruiting
Randomized Placebo-controlled Trial of Maternal Vitamin D Supplementation During Pregnancy and Lactation to Improve Infant Linear Growth in Dhaka, Bangladesh. [NCT01924013]Phase 31,300 participants (Actual)Interventional2014-03-31Completed
Efficacy, Safety and Dose Response of Vitamin D in Prevention of Dengue Haemorrhagic Fever and Dengue Shock Syndrome- A Phase 2 Open-label Randomized Controlled Trial [NCT06071481]Phase 2120 participants (Anticipated)Interventional2023-06-01Recruiting
Vitamin D as a Nutritional Neoadjuvant During Photodynamic Therapy of Basal Cell Carcinoma in Basal Cell Nevus Syndrome [NCT03467789]Phase 137 participants (Anticipated)Interventional2018-10-01Recruiting
A Phase III Randomized Study of Zolendronate Bisphosphonate Therapy for the Prevention of Bone Loss in Men With Prostate Cancer Receiving Long-Term Androgen Deprivation [NCT00058188]Phase 353 participants (Actual)Interventional2003-03-31Terminated(stopped due to Closed by the research committee)
Calcium, Vitamin D, and Colon Cancer Risk Biomarkers [NCT00208793]Phase 292 participants (Actual)Interventional2005-05-31Completed
Effects of Maternal Vitamin D Supplementation on Markers of Vitamin D Status and Related Infant and Maternal Outcomes in Southern Ethiopia [NCT02210884]240 participants (Anticipated)Interventional2014-10-31Completed
Vitamin D Supplement for Patients With Tibial Fracture Treated With an External Ring Fixator. A Prospective Randomized Double-blind Study. [NCT01955577]Phase 1130 participants (Anticipated)Interventional2015-04-30Not yet recruiting
Anti-proliferative Effects of Vitamin D and Melatonin in Breast Cancer [NCT01965522]Phase 2100 participants (Actual)Interventional2013-10-31Completed
Effects of High and Low Dose Vitamin D Suppletion on Postprandial Leukocyte Activation, Oxidative Stress and Vascular Function in Healthy Overweight and Obese Females [NCT01967459]24 participants (Actual)Interventional2013-10-31Completed
Vitamin D Deficiency in Elderly African American Women in Central Texas [NCT01971411]60 participants Observational2006-03-31Completed
Vitamin D Supplementation in Older Adults With Urinary Incontinence [NCT01971801]243 participants (Actual)Interventional2014-01-31Completed
Randomized Controlled Trial to Explore the Inter-relationship Between Vitamin D Requirements and Calcium Intake [NCT01990872]125 participants (Actual)Interventional2012-10-31Completed
A Prospective, Double Blind, Randomized, Phase 4, Clinical Trial of The Effects of Vitamin D Supplementation on Patients With Type 2 Diabetes and Vitamin D Deficiency [NCT01991054]Phase 445 participants (Actual)Interventional2013-12-31Completed
The Effects of Vitamin D Supplementation on Blood Glucose and Markers of Metabolic Syndrome in Women With Vitamin D Deficiency and Previous Gestational Diabetes Mellitus [NCT01992133]26 participants (Actual)Interventional2011-06-30Completed
A Trial of Vitamin D Supplementation Among Tuberculosis Patients in South India [NCT01992263]200 participants (Anticipated)Interventional2021-06-30Not yet recruiting
Impact of Vitamin D Supplementation on Clinical Severity and Immunologic Tolerance of Pediatric Atopic Dermatitis [NCT01996423]101 participants (Actual)Interventional2014-04-30Completed
Knowledge Innovation Project of CAS - Genetic and Nutritional Association Studies on Metabolism-related Diseases in Chinese Population -- Vitamin D Intervention Study [NCT01998763]Phase 1448 participants (Actual)Interventional2013-11-30Completed
Vitamin D vs. Placebo in the Prevention of Viral-induced Exacerbations in Preschoolers With Asthma: a Pilot RCT [NCT01999907]Phase 222 participants (Actual)Interventional2013-11-30Completed
Chronic Pain and Vitamin D: a Randomized Pilot Study in General Practice [NCT02002000]100 participants (Anticipated)Interventional2013-12-31Not yet recruiting
Effect of Supplementation With 2000 International Units (IU) Vitamin D, 1gm Calcium or Both on Calcium Absorption and Bone Mineralization in Children With Juvenile Rheumatoid Arthritis [NCT00570934]Phase 324 participants (Actual)Interventional1995-03-31Completed
Clinical Effects of Vitamin D Repletion in Patients With Parkinson's Disease [NCT00571285]Phase 431 participants (Actual)Interventional2007-06-30Terminated
Study of Vitamin D2 Virus 1,25(OH)2-Vitamin D3 and Normal Protein Diet Virus Low Protein Diet in the Treatment of CKD-MBD and Malnutrition for Progressive CKD Patients [NCT02005302]Phase 4600 participants (Anticipated)Interventional2013-01-31Enrolling by invitation
Impact of Cholecalciferol on Endothelial Fucntion and Blood Biomarkers in Patients With Chronic Kidney Disease [NCT02005718]Phase 336 participants (Actual)Interventional2010-06-30Completed
Vitamin D Supplementation Requirement in Obese Subjects [NCT00996866]27 participants (Actual)Interventional2008-12-31Terminated(stopped due to Enable to further recruit study subjects)
Novel Combination Therapy for Osteoporosis in Men [NCT03994172]Phase 448 participants (Anticipated)Interventional2019-07-01Recruiting
Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome [NCT01748448]Phase 3436 participants (Actual)Interventional2012-12-31Completed
Modulation of Breast Cancer Risk Biomarkers by High Dose Vitamin D [NCT01166763]30 participants (Actual)Interventional2009-05-31Completed
Effect of Vitamin D and Statins on Plasma Lipid Profiles in Chinese Patients With Hypercholesterolemia [NCT02009787]56 participants (Anticipated)Interventional2013-12-31Recruiting
A Randomized Double Blinded Trial of Vitamin D Supplementation With or Without Vitamin A Supplementation in Allogeneic Stem Cell Transplantation [NCT03202849]83 participants (Actual)Interventional2018-02-19Completed
The Effects of Vitamin D and Calcium Supplementation at Tolerable Upper Limit Doses on Calcium Metabolism in Postmenopausal White Women. [NCT02019381]132 participants (Actual)Interventional2013-09-30Completed
Effect of Treatment of Vitamin D Deficiency During Pregnancy on Hypocalcemia [NCT02021864]120 participants (Anticipated)Interventional2014-01-31Recruiting
Effect of Peroral Vitamin D Versus Placebo on Self-reported Fatigue in Adults With Low 25-hydroxy-vitamin D Levels [NCT02022475]Phase 3120 participants (Actual)Interventional2013-12-31Completed
[NCT02026518]Phase 4100 participants (Actual)Interventional2014-01-31Completed
Efficacy of Vitamin D and Calcium Supplementation on the Prevention of Recurrences in Benign Paroxysmal Positional Vertigo: A Prospective Multicenter Randomized Trial [NCT02031692]Phase 41,050 participants (Actual)Interventional2013-12-31Completed
Baseline Vitamin D Deficiency and COVID-19 Disease Severity/Need for Escalation of Care [NCT04628000]50 participants (Actual)Observational2020-10-27Completed
Oral Vitamin D Supplementation in Elderly Women: Twice a Day or Three Times a Year? A Randomised Controlled Trial [NCT00575835]40 participants (Actual)Interventional2006-10-31Completed
Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN) [NCT02212223]147 participants (Actual)Interventional2014-09-30Completed
The Association of Vitamin D Supplementation With the Outcome in Critically Ill Children [NCT04536831]Phase 496 participants (Actual)Interventional2019-08-29Completed
The Effect of VItamin D Supplementation on Nutritional STatus and Adverse Outcomes in Bariatric Surgery (VISTA) [NCT02212652]70 participants (Actual)Interventional2017-01-31Terminated(stopped due to lack of support resources to complete study appropriately)
A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) in the Treatment of Men With Osteoporosis Treated With Vitamin D and Calcium [NCT01120600]Phase 3294 participants (Actual)Interventional2010-06-09Completed
Vitamin D Treatment in Ulcerative Colitis [NCT01640496]0 participants (Actual)Interventional2012-07-31Withdrawn
Home Exercise, Vitamin D and Dalcroze Eurhythmics for Seniors With Mild Cognitive Impairment (MCI) or Mild Dementia [NCT02279316]19 participants (Actual)Interventional2014-10-31Completed
A Multicentre, Randomised, Double-blind, Placebo-controlled Study of the Efficacy of Supplementary Treatment With Cholecalciferol (Vitamin D3) in Patients With Relapsing- Multiple Sclerosis (RMS) Treated With Subcutaneous Interferon Beta-1a 44 µg 3 Times [NCT01198132]Phase 2129 participants (Actual)Interventional2009-11-30Completed
Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients (CHAMBER): A Multicenter, Double-blind, Randomized, Placebo-controlled Trial [NCT02214563]Phase 490 participants (Anticipated)Interventional2014-08-31Completed
Effects of Vitamin D3 Supplementation in Asthma Control, Pulmonary Function and Th17 Inflammatory Biomarkers in Adolescents With Asthma, Obesity and Vitamin D Deficiency: a Randomized Clinical Trial [NCT05431920]264 participants (Anticipated)Interventional2022-10-01Recruiting
Effects of Vitamin K2 and D3 Supplementation on 18F-NaF PET/MRI in Patients With Carotid and Coronary Artery Disease [NCT04010578]52 participants (Anticipated)Interventional2024-01-01Not yet recruiting
VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture [NCT01747447]771 participants (Actual)Interventional2012-08-31Active, not recruiting
Vitamin D and Omega-3 Trial (VITAL) [NCT01169259]Phase 325,871 participants (Actual)Interventional2010-07-31Active, not recruiting
VItamiN D treatIng Chronic heArT Failure (the Effect of Vitamin D Supplementation on Hospitalisation and Mortality in Patients With Heart Failure): Multicentre, Phase III, Randomised Placebo-controlled Trial [NCT03416361]1,253 participants (Anticipated)Interventional2023-12-01Not yet recruiting
OSTPRE-FPS Prevention of Fractures and Falls in Postmenopausal Women With Calcium and Vitamin-D Supplementation - a Randomised Study [NCT00592917]Phase 43,432 participants (Actual)Interventional2002-08-31Completed
The Impact of Bisphosphonates on Bone Loss in Patients Undergoing Surgery and Postoperative Chemotherapy for Gynecologic Malignancies. [NCT00593580]Phase 260 participants (Anticipated)Interventional2008-02-29Completed
Effect of Vitamin D Supplementation on Metabolic Parameters of Patients With Moderate to Severe Psoriasis [NCT02271971]39 participants (Actual)Interventional2014-10-31Completed
Modifiable Effectors of Renin System Activation: Treatment Evaluation (MODERATE) [NCT01320722]Phase 3242 participants (Actual)Interventional2011-03-31Completed
The Impact of Antioxidants on MRI Markers of Cell Proliferation and Hypoxia Among Men on Active Surveillance With Early Stage Prostate Cancer [NCT00744549]Phase 216 participants (Actual)Interventional2008-05-31Completed
Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART) [NCT00920621]Phase 3876 participants (Actual)Interventional2009-09-30Active, not recruiting
A Randomized Controlled Trial of the Effect of Vitamin D Supplementation on Insulin Sensitivity and Secretion in Subjects With Type 2 Diabetes of Nordic and Sub-Indian Ethnicity . [NCT00992797]Phase 260 participants (Anticipated)Interventional2009-09-30Recruiting
A Phase IIa Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Overall Safety in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With Alendronate [NCT00885170]Phase 2246 participants (Actual)Interventional2009-04-13Completed
Intake of Dietary Vitamin D and K From Tailor-made Atlantic Salmon and Bone Health - A Randomized Intervention Study [NCT02615301]122 participants (Actual)Interventional2009-01-31Completed
Effect on Bone Biomarkers and Bone Mineral Density and Tolerability of Calcium and Vitamin D Supplementation With and Without Collagen Peptides in Postmenopausal Women With Osteopenia [NCT03999775]51 participants (Actual)Interventional2017-01-14Completed
Randomized Trial of the Effects of Vitamin D on Prostate Cancer-associated Lesions and on Vitamin D Metabolites in Prostate [NCT00741364]Phase 290 participants (Anticipated)Interventional2008-09-30Active, not recruiting
A Phase II Trial of a Combination Herbal Therapy for Men With Biochemical Recurrence of Prostate Cancer After Initial Local Therapy [NCT00669656]Phase 243 participants (Actual)Interventional2008-07-06Completed
The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors in Subjects With Low Serum 25-hydroxyvitamin D Levels [NCT02750293]Phase 3411 participants (Actual)Interventional2015-06-30Completed
Vitamin D for the Treatment of Painful Diabetic Neuropathy [NCT02737423]143 participants (Actual)Interventional2012-06-30Completed
Sustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation [NCT02742805]Phase 40 participants (Actual)Interventional2016-02-29Withdrawn
A Phase IIb, Randomized, Double-Blind, Placebo- and Active-Controlled, Dose-Range-Finding Study to Evaluate the Effects of MK-5442 on Bone Mineral Density (BMD) in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisph [NCT00996801]Phase 2526 participants (Actual)Interventional2009-11-30Completed
Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents [NCT01102374]Phase 2107 participants (Actual)Interventional2010-05-31Completed
Influence of Kidney Performance and Magnesium on the Biomarkers of Vitamin D [NCT04237480]50,000 participants (Actual)Observational2017-01-01Completed
Impact of Vitamin D Supplementation on Recurrent Respiratory Infections in Paediatric [NCT02617771]Phase 484 participants (Actual)Interventional2014-10-31Completed
Fortification of Milk and Butter With Either vitaminD3 or 25(OH)D3: The Effect on Vitamin D Status and Cardiovascular Disease Risk Markers in Humans [NCT02535910]18 participants (Anticipated)Interventional2015-08-31Enrolling by invitation
A Phase II Clinical Trial of High Dose Vitamin D3 Supplementation in Combination With FOLFOX + Bevacizumab in the 1st Line Treatment of Metastatic Colorectal Cancer [NCT01198548]Phase 210 participants (Actual)Interventional2010-08-31Terminated(stopped due to Lack of funding)
Effect of Once Daily Oral Vitamin D3 Supplementation on Inspiratory Muscle Strength in Vitamin D3-Deficient COPD Patients [NCT02877641]Phase 24 participants (Actual)Interventional2014-04-16Terminated(stopped due to low accrual)
Optimal Substitution Dose of the Vitamin D During Winter Time in Patient With Inflammatory Bowel Diseases (IBD) [NCT02958501]Phase 4176 participants (Anticipated)Interventional2016-11-30Not yet recruiting
Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma [NCT01248065]Phase 3408 participants (Actual)Interventional2011-04-30Completed
Vitamin D Deficiency, Renin Inhibitor Response, and Vitamin D Supplementation in Patients With Hypertension [NCT00974922]Phase 440 participants (Actual)Interventional2009-08-31Terminated(stopped due to Administrative/Sponsor Business Decision - terminated - study was not completed)
Effects of Vitamin D Supplementation on Biochemical Responses and Aerobic Capacity After Strenuous Endurance Exercise [NCT05779410]35 participants (Actual)Interventional2021-01-20Completed
Phase 2 Study of Routine Oral Calcium and Vitamine D Supplements to Prevent Hypocalcemia After Total Thyroidectomy in Papillary Thyroid Carcinoma Patients [NCT00630214]Phase 2200 participants (Actual)Interventional2004-05-31Completed
Phase 2 Study of Deferasirox-calcium-vitamin D3 to Treat Postmenopausal Osteoporosis (PMOP) [NCT02854722]Phase 210 participants (Anticipated)Interventional2018-01-15Recruiting
A Phase IIb, Randomized, Placebo-Controlled, Dose-Ranging Study of MK-5442 in the Treatment of Postmenopausal Women With Osteoporosis [NCT00960934]Phase 2383 participants (Actual)Interventional2009-10-31Terminated
DIVINE: Dialysis Infection and Vitamin D In New England [NCT00892099]105 participants (Actual)Interventional2009-11-30Completed
Vitamin D, Leptin, Vitamin D Receptor Polymorphism, and Treatment-Related Morbidity in Ovarian Cancer [NCT03028519]Early Phase 181 participants (Actual)Interventional2017-01-31Completed
Investigating the Effects of Hydroxyvitamin D3 Versus Vitamin D3 on Clinical, and Radiologic Progress and Th17/Tregs Balance in MS Patients: A Randomized, Clinical Trial- a Pilot Study [NCT05340985]Phase 454 participants (Anticipated)Interventional2022-07-31Not yet recruiting
Study of Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma in Patients With Chronic Hepatitis B [NCT02779465]Phase 41,500 participants (Anticipated)Interventional2016-06-30Not yet recruiting
A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline [NCT01669915]3,424 participants (Actual)Interventional2011-09-14Completed
Can Vitamin D Replacement Reduce Insulin Resistance In South Asians With Vitamin D Deficiency? [NCT01385345]3 participants (Actual)Interventional2012-08-31Terminated(stopped due to Recommended by DMEC. Poor recruitment, changes in current clinical management of Vit D deficiency. Research question no longer relevant)
Vitamin D and Staphylococcus Aureus in the Diabetes Study [NCT01395290]Phase 3280 participants (Actual)Interventional2011-04-30Completed
Effect of Weekly High-dose Vitamin D3 Supplementation on the Association Between Circulatory FGF-23 and A1c Levels in People With Vitamin D Deficiency [NCT04682626]150 participants (Actual)Interventional2020-12-25Completed
A Pilot Study for COVID-19 Outpatient Treatment With the Combination of Ivermectin-azithromycin-cholecalciferol [NCT04399746]30 participants (Actual)Interventional2020-03-15Completed
Assessment of Vitamin D Supplementation and Immune Function [NCT01399151]23 participants (Actual)Interventional2011-01-31Completed
Vitamin D Replacement in Statin-Induced Myopathy [NCT01400009]0 participants (Actual)Interventional2010-10-31Withdrawn(stopped due to lack of enrollment)
Evaluation of Immunologic Response After Vitamin D Supplementation in Patients With Systemic Lupus Erythematosus [NCT01413230]20 participants (Actual)Observational2010-01-31Completed
Vitamin D and COPD. A Randomised, Double-blind, Placebo-controlled Trial of the Effect of Vitamin D on Withdrawal From Pulmonary Rehabilitation and Exercise Endurance [NCT01416701]Phase 40 participants (Actual)Interventional2011-09-30Withdrawn(stopped due to It was not possible to enroll the planned amount of subjects. Many patients with chronic obstructive pulmonary disease already took large doses of vitamin D.)
Assessment of Inflammatory Markers and Pregnancy Outcomes in Vitamin D-Supplemented Women at Risk of Vitamin D Deficiency: A Double-Blind, Randomized Controlled Trial [NCT01417351]60 participants (Actual)Interventional2010-08-31Completed
A Study, Four Parallel Arms, Included Two Arms Open Randomisation to Different Doses of Vitamin D, for Assessment of Efficacy of Treatment With Vitamin D at Vitamin D Deficiency, Vitamin D Insufficiency and Suboptimal Levels of Vitamin D [NCT01419119]Phase 4160 participants (Actual)Interventional2011-09-30Completed
DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers [NCT01419262]Phase 3703 participants (Actual)Interventional2011-09-30Completed
The Effect of High-Dose Vitamin D and Physical Activity on Bone Health in Breast Cancer Patients Receiving Hormonal Therapy [NCT01419730]Phase 2191 participants (Actual)Interventional2011-08-31Active, not recruiting
Supplemental Vitamin D Administered to One Year Old Vitamin D Deficient Infants Until Age 3 and Its Affect on Growth Rates and Bone Mineral Density Until Age 5 [NCT01419821]200 participants (Anticipated)Interventional2013-09-30Not yet recruiting
The Effect of Vitamin D Supplementation on the Periodontal Health and Associated Outcomes in Pregnant Women [NCT01422122]115 participants (Actual)Interventional2010-06-30Completed
The Effect of the Combination of Low Glycemic Index Diet, Exercise and Vitamin D on Breast Cancer Recurrence: DEDiCa Study [NCT02786875]Phase 3506 participants (Actual)Interventional2016-11-04Active, not recruiting
Vitamin D for Enhancing the Immune System in Cystic Fibrosis [NCT01426256]Phase 391 participants (Actual)Interventional2011-10-31Completed
Vitamin D Dosing and Monitoring Study [NCT01430793]99 participants (Actual)Interventional2011-11-30Completed
Prospective Double Blind Multicentre Randomized Trial of Vitamine D Estimating the Profit of a Treatment by Vitamin D3 at the Dose of 100000 UI by Comparison With a Treatment in the Dose of 12 000 UI at Renal Transplanted Patients [NCT01431430]Phase 4538 participants (Actual)Interventional2012-01-06Completed
Daily Vitamin D for Sickle-cell Respiratory Complications [NCT04170348]Phase 269 participants (Actual)Interventional2020-09-15Active, not recruiting
Effect of Vitamin D Status and Repletion on Postoperative Total Joint Arthroplasty Complications [NCT04229368]900 participants (Anticipated)Interventional2019-09-01Recruiting
Pilot Study of Vitamin D3 Supplementation and Outcomes in Vitamin D Deficient Obese, African American Adolescents [NCT01546103]39 participants (Actual)Interventional2011-08-31Completed
Vitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People [NCT00696514]Phase 13,000 participants (Anticipated)Interventional2008-09-30Active, not recruiting
Analysis of the Response of Subjects With Atopic Dermatitis to Oral Vitamin D3 by Measurement of Antimicrobial Peptide Expression in Skin and Saliva [NCT00789880]Phase 282 participants (Actual)Interventional2008-12-31Completed
Vitamin D, Strength, and Bone Density in Collegiate Athletes [NCT03151174]Early Phase 168 participants (Actual)Interventional2017-04-29Completed
The Pharmacokinetics of a Single Large Dose of Vitamin D3 [NCT00473239]40 participants (Actual)Interventional2006-10-31Completed
Effects of Oral Cholecalciferol (Vitamin D3) on Bone Health, Neuromuscular Function, and Quality of Life in Adults With Chronic Kidney Disease [NCT00511225]47 participants (Actual)Interventional2007-09-30Completed
Efficacy and Safety of High Dose Vitamin D Supplementation for Overactive Bladder Dry in Children: A Randomized Clinical Trial [NCT05709990]300 participants (Anticipated)Interventional2023-01-15Recruiting
Study to Identify Transcriptional Targets of Vitamin D in Patients With Stage I-III Colon Cancer or Resectable Colon Cancer Liver Metastases Receiving Preoperative Vitamin D Supplementation. [NCT02172651]Early Phase 180 participants (Anticipated)Interventional2014-07-14Recruiting
Effects of Vitamin D Insufficiency in Man [NCT01848236]300 participants (Actual)Interventional2010-08-31Completed
The Effect of Vitamin D Supplementation on the Glycemic Control and Non-alcoholic Fatty Liver Disease in Type 2 Diabetes [NCT01854463]Phase 4158 participants (Actual)Interventional2011-12-31Completed
A Comparative Effectiveness Research Study Comparing Changes in Body Composition and Parent Ratings of Quality of Life in 5-19 Year Olds as a Function of Participation in One of Four Versions of the Good NEWS 4 Kids Program (GN4K) [NCT01855009]200 participants (Anticipated)Interventional2013-05-31Recruiting
Effects of Treating Vitamin D Deficiency in Poorly Controlled Type 2 Diabetes [NCT01855321]Phase 176 participants (Actual)Interventional2010-08-31Completed
Effect of 4,000 IU Vitamin D3 Supplementation on Oral Glucose Tolerance Among Vitamin D Deficient Obese Adolescent [NCT01856946]15 participants (Actual)Interventional2013-05-31Completed
A Double-Blinded Randomized Controlled CER Study of Changes in Bone Mineral Density, Blood Chemistries, Self-Reported Quality of Life and Compliance as a Function of Consuming Micronized Versus Non-micronized Calcium Carbonate [NCT01857154]160 participants (Anticipated)Interventional2013-05-31Recruiting
Bolus vs. Divided Cholecalciferol Dosing to Optimize Perioperative Vitamin D Status for Joint Replacement Surgery [NCT01858051]0 participants (Actual)Interventional2015-01-31Withdrawn
Dose Finding Study in Physically Frail Elderly to Measure 25(OH) Vitamin D Levels After Supplementation With Hy.D Calcifediol 25 SD/S and Vitamin D3 [NCT01868945]Phase 159 participants (Actual)Interventional2013-04-30Completed
Phase 1 Study of Combination Strontium, Melatonin and Nutritional Co-factors on Bone Health and Quality of Life in Postmenopausal Women With Osteopenia [NCT01870115]Phase 123 participants (Actual)Interventional2013-08-31Completed
Effect of Treating Vitamin D Deficiency on Glucose Homeostasis and Metabolic Markers in Apparently Healthy, Young or Aged, Normal-weight or Obese Lebanese People [NCT02942732]180 participants (Actual)Interventional2013-02-28Completed
Vitamin D and Omega-3 Trial (VITAL Rhythm Study) [NCT02178410]Phase 325,119 participants (Actual)Interventional2012-10-31Active, not recruiting
The Effect of Probiotics and Vitamin D Supplementation on Sport Performance and Intestinal Barrier Function in Trained Male Mixed-martial Arts Athletes [NCT04759729]25 participants (Actual)Interventional2020-12-01Enrolling by invitation
Vitamin D, Vitamin B12, and Folic Acid Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment. [NCT04355949]60 participants (Actual)Interventional2020-02-28Completed
A Prospective Trial on the Effects of Vitamin D Supplementation on 25(OH)D, Body Composition and Injury in Collegiate Swimmers and Divers [NCT01488227]Phase 345 participants (Actual)Interventional2011-08-31Completed
Treatment of Childhood Cancer Therapy-induced Osteopenia in Growth Hormone Deficient Adult Survivors: Does Bisphosphonate Treatment Improve Bone Mineral Density? [NCT00145704]6 participants (Actual)Interventional2002-06-30Terminated(stopped due to due to low enrollment, participants are no longer being examined or treated)
[NCT00004488]Phase 282 participants (Anticipated)Interventional1998-10-31Completed
Safe and Effective Vitamin D Supplementation in HIV [NCT01475890]Phase 2/Phase 358 participants (Actual)Interventional2011-07-31Completed
Vitamin D and Adipose Tissue Inflammation [NCT01477034]18 participants (Actual)Interventional2011-11-30Completed
Bioavailability and Biological Effects of Vitamin D2 Contained in Mushroom [NCT01488734]47 participants (Actual)Interventional2011-11-30Completed
Sunweavers: Supporting Native American Women's Vitamin D Research [NCT01490333]Phase 299 participants (Actual)Interventional2011-07-31Completed
Muscle-Related Side Effects of Statins: Functional Impact, Mechanisms, and Potential Relief With Vitamin D Supplementation [NCT01493648]78 participants (Actual)Interventional2011-12-31Completed
Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis - Comparative Study With Sodium Risedronate Hydrate(RIS) With Vertebral Fracture as an Index - [NCT00447915]Phase 31,265 participants (Actual)Interventional2007-03-31Completed
The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density In Postmenopausal Women With Primary Breast Cancer [NCT00354302]Phase 3497 participants (Actual)Interventional2006-04-24Completed
Local (Brazil) Study, Multicenter, Opened, Comparative, Randomized, With Parallel Groups, Phase IV, in Post Menopausal Woman With Colles' Fracture of the Risedronate Sodium Usage in the Consolidation and in the Callus of the Colles'Fracture. [NCT00460733]Phase 4141 participants (Actual)Interventional2007-03-31Completed
The Role of Vitamin D in Chronic Urticaria and Angioedema Treatment [NCT01371877]42 participants (Actual)Interventional2011-11-01Completed
Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma - Randomized, Controlled Trial. [NCT00487773]Phase 496 participants (Actual)Interventional2007-09-30Completed
Role of Oral Vitamin D as an Adjunct Therapy in Category I Pulmonary Tuberculosis Along With Assessment of Immunological Parameters. (Double-blind, Randomized, Placebo-Controlled, Clinical Trial) [NCT00507000]Phase 3150 participants (Anticipated)Interventional2008-05-31Active, not recruiting
A Pilot Study of Vitamin D in Boys With X-linked Adrenoleukodystrophy [NCT02595489]Phase 121 participants (Actual)Interventional2016-11-21Completed
Formulation, Characterization and In-vivo Evaluation of Controlled Release Intranasal Films of Vitamin D3 as an Optimistic Dosage Form for Rapid and Effective Healing of Cauterized Turbinectomy [NCT05142072]Early Phase 120 participants (Actual)Interventional2021-12-18Completed
The Effects of Red Clover Treatment on Bone Tissue Regulation in Postmenopausal Osteopenia. [NCT02174666]85 participants (Actual)Interventional2014-06-30Completed
Prevention of Bone Loss After Pediatric Hematopoietic Cell Transplantation [NCT02074631]Phase 280 participants (Actual)Interventional2015-02-28Completed
Daylight: The Effect of Vitamin D Supplementation on Blood Pressure in Vitamin D Deficient Individuals With Pre-Hypertension [NCT01240512]534 participants (Actual)Interventional2010-12-31Completed
A Randomized Controlled Trial of Vitamin D Supplementation in Multiple Sclerosis [NCT01490502]Phase 3172 participants (Actual)Interventional2012-03-31Completed
Genomics of Vitamin D Supplementation and Warfighter Nutritional Resilience [NCT02954549]131 participants (Actual)Interventional2016-01-31Completed
Efficacy of Vitamin D Treatment in Pediatric Patients Hospitalized by COVID-19: Open Controlled Clinical Trial [NCT04502667]Phase 345 participants (Actual)Interventional2020-07-15Completed
A Randomized Control Trial of Vitamin D Prophylaxis in the Prevention of Hypertensive Disorders of Pregnancy [NCT02920593]Phase 4412 participants (Anticipated)Interventional2016-10-31Recruiting
Serum 25-hydroxy Vitamin D [25(OH)D] Levels, Supplemental Vitamin D, and Parathyroid Hormone Levels in Premature Infants [NCT01469650]32 participants (Actual)Interventional2012-01-31Completed
Impact of Vitamin D Therapies on Monocyte Function in Chronic Kidney Disease [NCT01222234]56 participants (Actual)Interventional2010-10-31Completed
Vitamin D and Physical Performance Before and After Intervention and Birth Outcome in Pregnant Somali and Swedish Women [NCT02922803]123 participants (Actual)Interventional2010-05-31Completed
Association Between Baseline Vitamin D Metabolite Levels and Risk of Cardiovascular Events in Rheumatoid Arthritis Patients. A Cohort Study With Patient-record Evaluated Outcomes. [NCT02932644]160 participants (Actual)Observational1999-10-31Completed
Effect of a One Time Dose of Cholecalciferol on Serum Concentration of 25-Hydroxyvitamin D and Macrophages [NCT02920502]Phase 324 participants (Actual)Interventional2013-06-30Completed
Vitamin D Deficiency in Acutely Injured Pediatric Burn Patients: Incidence, Etiology, Metabolic Sequelae and Prevention [NCT00536276]Phase 150 participants (Actual)Interventional2003-03-31Completed
Coral Calcium's Effect on Bone Density in Postmenopausal Women With and Without Ibandronate [NCT04321837]Phase 260 participants (Anticipated)Interventional2020-02-05Recruiting
Identification of 24-Hydroxylase Polymorphisms and Splicing Variants That Modulate Vitamin D Oxidative Metabolism and Serum Pharmacokinetics in Patients With Colorectal Cancer on Cholecalciferol Therapy [NCT00550563]50 participants (Actual)Interventional2007-08-31Completed
Vitamin D (200 000 IU) for the Treatment of Painful Diabetic Neuropathy [NCT05080530]216 participants (Anticipated)Interventional2021-10-29Recruiting
D suppLementation In HearT FaiLure (DELIGHTFUL) [NCT01230307]Phase 428 participants (Actual)Interventional2010-10-31Terminated(stopped due to Unable to recruit sufficient number of patients.)
Effect of Vitamin D Supplementation on Sickle Cell Disease Hospitalisation and Related Complications Among Children in Mulago Hospital: A Randomised Clinical Trial [NCT04662476]662 participants (Anticipated)Interventional2021-05-17Not yet recruiting
Efficacy and Safety of Oral Ibandronate in Patients of Liver Cirrhosis With Hepatic Osteodystrophy: A Randomized, Double Blind, Placebo Controlled Trial [NCT06022237]80 participants (Anticipated)Interventional2023-09-01Not yet recruiting
β-hydroxy-β-methylbutyrate (HMB) Pilot Feasibility and Efficacy Study in Cerebral Palsy (CP) [NCT05384951]10 participants (Anticipated)Interventional2022-05-15Enrolling by invitation
Vitamin D Status and Dose Response in Infants [NCT01042561]64 participants (Actual)Interventional2009-08-07Completed
Regulation of Bone Formation in Renal Osteodystrophy [NCT00560300]Phase 261 participants (Actual)Interventional2000-11-30Completed
The Effect of Vitamin D on Factors Contributing Pre Cachexia and Cachexia, a Study on Epithelial Ovarian Cancer [NCT04864431]54 participants (Anticipated)Interventional2022-01-12Recruiting
Association of Cathelicidin and Vitamin D Levels With the Category and Course of COPD [NCT05431218]Phase 4120 participants (Actual)Interventional2020-02-18Completed
The Significance of Vitamin D Storage in Adipose Tissue [NCT01728987]Phase 20 participants (Actual)Interventional2016-08-31Withdrawn(stopped due to study stopped due to Financial problems)
Differential Effects of Ergocalciferol and Cholecalciferol Therapies in Chronic Kidney Disease [NCT01835691]44 participants (Actual)Interventional2011-10-31Completed
The Effect of Oral Vitamin D Supplements on Fusion Outcome in Patients Receiving Elective Lumbar Spinal Fusion [NCT05023122]34 participants (Actual)Interventional2016-01-01Completed
The D-VinCHI Study: 25-hydroxyvitamin D Concentration in School Children: Effects of Vitamin D3 Supplementation on 25-OH-D Concentration and Muscle Health Outcomes [NCT05018988]118 participants (Anticipated)Interventional2019-11-01Recruiting
Prephase Treatment With Prednisone +/- Vitamin D Supplementation Followed by Immunochemotherapy in Elderly Patients With Diffuse Large B-Cell Lymphoma (DLBCL) A Randomized, Open Label, Phase III Study by Fondazione Italiana Linfomi. [NCT04442412]Phase 3430 participants (Anticipated)Interventional2021-03-23Recruiting
A Phase I Study of Oral ILX23-7553 in Patients With Solid Tumors [NCT00004926]Phase 10 participants Interventional1999-10-31Completed
Effect of Vitamin D Supplementation on Rate of Partial Clinical Remission in Children and Adolescents With Type 1 Diabetes [NCT01724190]36 participants (Actual)Interventional2012-11-30Completed
Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension (VDATH) [NCT01472796]Phase 492 participants (Anticipated)Interventional2011-07-31Recruiting
Effects of Cholecalciferol Supplementation in Patients With Chronic Heart Failure and LOw vITamind D Levels. A Phase 2 Randomized Double Blind Study [NCT01477801]Phase 2/Phase 334 participants (Anticipated)Interventional2011-11-30Recruiting
Randomized Controlled Trial of Vitamin D Supplementation on Glucose Metabolism in Subjects With Components of the Metabolic Syndrome [NCT01479933]73 participants (Actual)Interventional2011-09-30Completed
Randomized Phase III Trial Comparing Conventional Vitamin D Supplementation vs. Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients Treated by Neoadjuvant or Adjuvant Chemotherapy. [NCT01480869]Phase 3215 participants (Actual)Interventional2011-07-31Completed
Vitamin D Supplementation to Patients With Type 2 Diabetes [NCT00400491]Phase 240 participants (Actual)Interventional2006-06-30Completed
[NCT00243256]Phase 2450 participants (Anticipated)Interventional2005-11-30Completed
Orthomolecular Vitamin D3 in Low-Risk Myelodysplastic Syndrome: An Open-Label Clinical Trial [NCT00068276]Phase 20 participants Interventional2003-07-31Completed
Randomised Controlled Trial to Evaluate the Preventive Effect on Mortality and Serious Morbidity/ Hospitalisations of Daily Vitamin D Supplements in Small for Gestational Age Term Infants [NCT00415402]2,000 participants (Actual)Interventional2007-03-31Completed
A Double-Blind, Randomized, Placebo Controlled Trial of High Dose Vitamin D Therapy On Musculoskeletal Symptoms and Bone Mineral Density in Anastrozole-Treated Early Stage Breast Cancer Patients With Marginal Vitamin D Status [NCT00263185]Early Phase 163 participants (Actual)Interventional2005-11-30Completed
Trial of Adjunctive Vitamin D in Tuberculosis Treatment [NCT00419068]Phase 3146 participants (Anticipated)Interventional2007-01-31Completed
A 15-Week, Double-Blind, Randomized, Active-Controlled, Multi-Center Study With 24-Week Extension to Evaluate the Safety, Tolerability, Efficacy of Alendronate 70 mg Plus Vitamin D3 2800 IU Combination Tablet in Men and Postmenopausal Women With Osteoporo [NCT00092079]Phase 3652 participants (Actual)Interventional2004-01-31Completed
Vitamin D Supplementation During Pregnancy for Prevention of Asthma in Childhood: An Interventional Trial in the ABC (Asthma Begins in Childhood) Cohort [NCT00856947]Phase 1600 participants (Anticipated)Interventional2009-03-31Active, not recruiting
Effect of High-Dose Vitamin D3 on Alveolar Macrophage Function, LL-37, and Oxidative Stress in Smokers and Non-Smokers With and Without HIV [NCT03270709]Phase 17 participants (Actual)Interventional2018-04-11Terminated(stopped due to Study terminated early due to lack of funding and the COVID-19 pandemic.)
Efficacy of Vitamin D Supplementation in Obese Children [NCT02956408]6 participants (Actual)Interventional2016-11-30Completed
High Dosage Vitamin D in the Treatment of Osteoporosis in Postmenopausal Women [NCT00491920]Phase 4297 participants (Actual)Interventional2007-02-28Completed
The Impact of Vitamin D Supplementation on Vascular Stiffness and Blood Pressure in Chronic Kidney Disease Patients [NCT01247311]129 participants (Actual)Interventional2010-11-30Completed
Placebo Controlled Study to Assess the Effects of Vitamin D Supplementation on Parameters of the Immune, Endocrine and Metabolic System in Healthy Women and Men. [NCT01248442]Phase 460 participants (Actual)Interventional2009-11-30Completed
Early Rehabilitation After Hip Fracture: A Randomized Controlled Trial Comparing Different Vitamin D and Rehabilitation Programs [NCT00133640]Phase 3204 participants Interventional2005-01-31Recruiting
The Effect of Glucocorticosteroid and Vitamin D3 Administration and Montelukast Treatment on Early Clinical and Immunological Effect of Allergen-Specific Immunotherapy in Asthmatic Children, Double-Blind, Placebo-Controlled Study [NCT00504946]Phase 385 participants (Actual)Interventional2005-09-30Completed
Pilot Trial of Vitamin D for the Prevention of Type 1 Diabetes [NCT00141986]Phase 19 participants (Actual)Interventional2003-11-30Completed
Effect of Vitamin D Status on A Disintegrin-like And Metalloprotease With Thrombospondin Type 1 Motif 13 (ADAMTS13) and Interleukin 6 (IL-6) in Patients With Acute Myeloid Leukemia [NCT05149339]Phase 1/Phase 238 participants (Actual)Interventional2019-03-01Completed
Effect of Vitamin D Supplementation on Salivary Biomarkers; Certain Proteins and Cariogenic Oral Microbiome for Medical Management of Dental Caries: A Randomized Controlled Trial [NCT06172764]Phase 490 participants (Anticipated)Interventional2023-12-12Recruiting
Establishing the Vitamin D Requirements During Lactation [NCT00412074]Phase 3460 participants (Actual)Interventional2006-08-31Completed
The Effect of Zinc, Beta-carotene, and Vitamin D3 Supplementation as Pro-inflammation Mediated Regulator in Preterm Delivery Through Placental Protein Adaptor MyD88 and TRIF, Transcription Factor NFkB, and Pro-inflammatory Cytokine IL-1β [NCT03005496]Phase 456 participants (Actual)Interventional2017-01-31Completed
A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Coadministration of C1-R215 and C2-R215 Compared to the Administration of C1-R215 and C2-R215 Independently in Healthy Male Volunteers [NCT03005340]Phase 124 participants (Actual)Interventional2016-12-31Enrolling by invitation
Vitamin D, Insulin Resistance, and Cardiovascular Disease [NCT00736632]125 participants (Actual)Interventional2006-05-31Completed
Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome) [NCT00743574]36 participants (Actual)Interventional2008-08-31Completed
The Addition of Vitamin D to Fluticasone Propionate in the Management of Seasonal Allergic Rhinitis [NCT01103934]Phase 435 participants (Actual)Interventional2010-06-30Completed
Improving Vitamin D Status in Home-bound Elders: a Pilot Study [NCT01410084]68 participants (Actual)Interventional2010-10-31Completed
Vitamin D Supplementation and HIV-related Complications in Children and Young Adults [NCT01523496]Phase 2/Phase 3190 participants (Actual)Interventional2011-12-31Completed
Effects of Orange Juice Enriched With Vitamin D3 and Encapsulated Probiotics in High Cardiometabolic Risk Individuals [NCT06114576]50 participants (Actual)Interventional2023-03-01Completed
Impact of Home Based Physical Exercise and Diet Management on Functional Performance and Depression Among Vitamin D Deficient Females [NCT06114381]120 participants (Actual)Interventional2023-01-01Completed
Open Controlled Trial to Explore the Effectiveness of Vitamin D Supplements on the Behaviours, Mental, and Physical Health of United Kingdom Prison Residents [NCT05724316]110 participants (Anticipated)Interventional2023-03-18Recruiting
Multi Ethnic Study of Atherosclerosis Individualized Response to Vitamin D Treatment Study [NCT02925195]666 participants (Actual)Interventional2017-01-11Completed
Calcium Supplementation for a Healthy Weight- LITE [NCT00386672]83 participants (Actual)Interventional2006-05-31Completed
Effects of Antarctic Environment on Vitamin D Status and Health Risk Biomarkers of Its Inhabitants [NCT02930434]75 participants (Actual)Interventional2016-10-31Completed
Double-blind Randomized Study to Determine the Efficacy of Intramuscular Vitamin D3 Supplementation in Tropical Calcific Pancreatitis [NCT00956839]Phase 440 participants (Actual)Interventional2009-07-31Completed
Effect of Different Vitamin D Vitamers on Vitamin D Status and Biomarkers for Bone Health and Cardiovascular Risk in Healthy Humans [NCT02860663]14 participants (Actual)Interventional2007-08-31Completed
Phase 4 Study of Paricalcitol and Calcitriol for Reparative Management of Chronic Allograft Dysfunction and Renocardiac Syndrome in Vitamin D Insufficient Renal Transplant Recipients [NCT01265615]Phase 4109 participants (Actual)Interventional2009-10-31Completed
Determination of RDA for Vitamin D in Caucasian and African American Women [NCT00472823]273 participants (Actual)Interventional2007-04-30Completed
The Effects of Vitamin D Supplementation in Respiratory Index of Severity in Children (RISC) of Hospitalized Patients With Community-acquired Pneumonia [NCT02936895]Phase 4100 participants (Actual)Interventional2015-01-31Completed
Comparison of UVB and Vitamin D Supplementation in Treatment of Vitamin D Deficiency [NCT01512537]32 participants (Actual)Interventional2010-02-28Completed
Cathelicidin and Vitamin D: Impact on Populations At-Risk and With COPD [NCT02464059]Phase 223 participants (Actual)Interventional2015-11-10Completed
The Effect of Vitamin D Supplementation on Muscle Power in Elite Cyclist [NCT01518725]Phase 4103 participants (Actual)Interventional2012-01-31Completed
Phase III, Controlled, Double-blind, Randomized Study of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases [NCT01518959]Phase 331 participants (Actual)Interventional2012-01-31Terminated(stopped due to Insufficient recruitment rate; technical issues with sample storage)
The Effect of Fat on Vitamin D Absorption After a Single Oral Dose [NCT01519986]64 participants (Actual)Interventional2011-09-30Completed
Vitamin D3 Supplementation in Acute Myeloid Leukemia: Pharmacokinetic Study [NCT01521936]Phase 24 participants (Actual)Interventional2011-12-31Terminated(stopped due to Lack of funding)
The Effect of Cholecalciferol on Frailty Syndrome in Pre-frail Elderly Receiving Calcium Supplementation : A Study on Handgrip Strength, Gait Speed, Vitamin D Receptor, Insulin Growth Factor-1 and Interleukin-6 [NCT04847947]Phase 3120 participants (Actual)Interventional2021-04-19Completed
A Comparative Effectiveness Trial of High-quality Vitamin D3 Nutritional Supplements to Replete Serum Vitamin D [NCT01524874]66 participants (Actual)Interventional2010-08-31Completed
Vitamin D Metabolism in Chronic Kidney Disease Patients With Vitamin D Deficiency Treated With Cholecalciferol [NCT01528176]70 participants (Actual)Interventional2010-11-30Active, not recruiting
The Effects of Single High-dose or Daily Low Dosage Oral Colecalciferol Treatment on Muscle Strength, Muscle Thickness and Independence in Spinal Cord Lesion [NCT04400747]60 participants (Actual)Interventional2020-09-01Completed
The Impact of Vitamin D Supplementation on Cardiometabolic Risk Factors in Schoolchildren [NCT01537809]691 participants (Actual)Interventional2011-06-30Completed
Pilot Study to Assess the Effects of Vitamin D Supplementation on the Number of Regulatory FoxP3+ T Cells in the Gastrointestinal Mucosa in Healthy Women and Men: Step 3 in the Austrian Diabetes Prevention Programme [NCT01538485]Phase 416 participants (Actual)Interventional2012-01-31Completed
Randomized, Controlled Trial of Vitamin D Replenishment in Metabolic Syndrome [NCT01545830]Phase 284 participants (Actual)Interventional2012-03-31Completed
Cholecalciferol Intervention to Prevent Respiratory Infections Study: a Double-blind Randomised Controlled Trial to Evaluate the Efficacy of 20,000 IU/wk Cholecalciferol in Reducing Respiratory Tract Infection in a Cohort of Healthy Young Adults [NCT01549938]Phase 232 participants (Actual)Interventional2012-05-31Completed
Pilot Biomarker Modulation Study of Vitamin D in Premenopausal Women at High Risk for Breast Cancer [NCT00976339]Phase 120 participants (Actual)Interventional2007-09-30Completed
A Phase III Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density, Tolerability, and Safety in the Treatment of Postmenopausal Women With Osteoporosis Previously Treated With A [NCT01552122]Phase 30 participants (Actual)Interventional2012-05-31Withdrawn
Phase II Trial of Arsenic Trioxide and Dose-Escalated Cholecalciferol in Myelodysplastic Syndrome [NCT00104806]Phase 25 participants (Actual)Interventional2004-11-30Terminated(stopped due to sponsor discontinues support)
Vitamin D for Established Type 2 Diabetes (DDM2) [NCT01736865]Phase 2/Phase 3127 participants (Actual)Interventional2012-12-31Completed
Phase III Trial of Intravenous Zoledronic Acid (Zometa) in the Prevention of Bone Loss in Localized Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure [NCT00022087]Phase 3439 participants (Actual)Interventional2001-12-31Completed
Osteoporosis Prevention in Prostate Cancer Patients Receiving Androgen Ablation Therapy: A Phase III Randomized, Placebo-Controlled, Double-Blind Study [NCT00043069]Phase 371 participants (Actual)Interventional2002-11-30Completed
A Ph2 Randomized Trial to Evaluate the Safety Preliminary Efficacy and Biomarker Response of Host Directed Therapies Added to Rifabutin-modified Standard Therapy in Adults With Drug-Sensitive Smear-Positive Pulmonary TB [NCT02968927]Phase 2200 participants (Actual)Interventional2016-11-30Active, not recruiting
The Effect of Vitamin D Therapy on Morbidity and Moratlity in Patients With SARS-CoV 2 Infection [NCT04733625]56 participants (Actual)Interventional2020-09-15Completed
For 4 Months, the Multi Center, Double Blinded, Randomized, Active Controlled, Comparative Clinical Study to Assess the Efficacy and the Safety to Improvement Effect of Vit.D of Risenex Plus M Tablet in Patients With In Post-menopausal Women Osteoporosis [NCT01806792]Phase 3150 participants (Actual)Interventional2009-11-30Completed
The Investigation Effect of Vitamin D on Retinal Changes in Patient With Optic Neuritis by Optic Coherence Tomography [NCT01465893]Phase 260 participants (Anticipated)Interventional2011-07-31Recruiting
Effect of Vitamin D Supplementation on 15-Prostaglandin Dehydrogenase Expression in Barrett's Esophagus [NCT01465113]Early Phase 126 participants (Actual)Interventional2010-05-31Completed
[NCT01466465]Phase 235 participants (Actual)Interventional2011-10-31Completed
A Randomized, Open-label, Cross-over Study Comparing Two Vitamin D Supplements for Infants: Liquid Versus D-Strips. [NCT00846677]Phase 450 participants (Actual)Interventional2009-01-31Completed
Mothers' Own Milk Optimization for Preterm Infants Project (MoMO PIP): Maternal Diet and Vitamin D Supplementation Effects on Preterm Infants, a Randomized Control Pilot Study. [NCT04629534]Phase 48 participants (Actual)Interventional2021-05-06Terminated(stopped due to low enrollment, lack of funding)
Impact of Correction of Vitamin D Deficiency in Oxidative Stress in Patients With Impaired Glucose Tolerance: A Randomized, Double-blind, Placebo-controlled Trial [NCT03356873]31 participants (Actual)Interventional2017-09-01Terminated(stopped due to COVID19)
Evaluation of Colecalciferol Substitution in Dialysis Patients [NCT00397475]50 participants (Anticipated)Interventional2006-11-30Completed
Cholecalciferol as a Modifier of Serum Hepcidin in Children With Chronic Kidney Disease [NCT01532349]Phase 234 participants (Actual)Interventional2012-05-31Completed
Efficacy of Bisphosphonate Therapy on Postmenopausal Osteoporotic Women With and Without Diabetes: a Prospective Trial [NCT05266261]121 participants (Actual)Interventional2018-10-01Completed
Vitamin D Status of Pregnant Women and Their Children in Eau Claire, South Carolina: A Prevalence and Supplementation Model for Community Health Care Centers in the U.S. [NCT00412087]Phase 3564 participants (Actual)Interventional2007-01-31Completed
Desktop Tanning Unit to Improve Vitamin D Status in Patients With Cystic Fibrosis and Short Bowel Syndrome: A Pilot Study [NCT00450073]30 participants (Actual)Interventional2006-11-30Completed
A Randomised, Controlled Comparison of Vitamin D Strategies is Acute Hip Fracture Patients [NCT00424619]Phase 464 participants (Actual)Interventional2007-10-31Completed
Efficacy of Cholecalciferol (Vitamin D3) Therapy in Correcting Vitamin D Insufficiency and Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease: A Randomized, Placebo Controlled Pilot Study [NCT00427037]34 participants (Actual)Interventional2005-12-31Completed
Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes [NCT00436475]Phase 1/Phase 292 participants (Actual)Interventional2007-09-30Completed
Strategies for the Prevention of Bone Loss Among Patients With HIV on Antiretroviral Therapy in China [NCT03598556]600 participants (Anticipated)Interventional2018-06-01Active, not recruiting
Effect of Vitamin D3 Combined With Extensor Muscle Strengthening Exercise in Lateral Epicondylitis of Elbow: a Randomized Controlled Trial [NCT06055491]100 participants (Anticipated)Interventional2023-09-25Recruiting
The Effect of Vitamin D Supplementation in Overweight and Obese Pregnant Women [NCT04841265]274 participants (Actual)Interventional2021-05-28Active, not recruiting
Randomized Control Trial of Bone Loading Exercises Versus Risedronate on Bone Health in Post-Menopausal Women [NCT02186600]Phase 3276 participants (Actual)Interventional2015-02-01Completed
Effect of Laser Acupuncture on Forearm Bone Mineral Density and Wrist Pain in Osteoporotic Postmenopausal Women [NCT05559619]68 participants (Actual)Interventional2021-07-11Completed
Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease [NCT00552409]Phase 2/Phase 322 participants (Actual)Interventional2007-12-31Completed
The Impact of Vitamin K2 and Inactive Vitamin D Supplementation on Vascular Calcification in Pediatric Patients on Regular Hemodialysis [NCT04145492]Phase 2/Phase 360 participants (Anticipated)Interventional2019-09-01Recruiting
Effects of Vitamin D and Omega-3 Supplementation on Telomeres in VITAL [NCT04386577]Phase 31,054 participants (Actual)Interventional2016-08-19Active, not recruiting
The Role of Vitamin D in Mitigating COVID-19 Infection Severity: Focusing on Reducing Health Disparities in South Carolina [NCT04482673]Phase 495 participants (Actual)Interventional2020-07-31Active, not recruiting
Effects of High-Dose Vitamin D on Circulating Vitamin D Levels and Breast Density in Postmenopausal Women at High Risk for Breast Cancer Development [NCT00859651]Phase 220 participants (Actual)Interventional2009-06-30Completed
A Randomized Trial to Evaluate the Benefit of High Dose Vitamin D3 on Aromatase Inhibitor Letrozole-Associated Musculoskeletal Symptoms and Fatigue (The VITAL Trial). [NCT00867217]Phase 2160 participants (Actual)Interventional2009-03-31Completed
Effect of Vitamin D Supplementation on Oral Glucose Tolerance in Subjects Exhibiting Marginal Vitamin D Status and an Increased Risk of Developing Diabetes. [NCT01726777]Phase 271 participants (Actual)Interventional2012-10-31Completed
LungVITamin D and OmegA-3 Trial [NCT01728571]25,871 participants (Actual)Interventional2010-07-31Active, not recruiting
Pharmacodynamic and Immunologic Effects of Vitamin D Supplementation in Patients With Multiple Sclerosis and Healthy Controls [NCT01667796]57 participants (Actual)Interventional2010-11-30Completed
Effect of Vitamin D Supplementation on Endothelial Function in Obese Adolescents [NCT01746264]Phase 119 participants (Actual)Interventional2012-11-30Completed
Comparison of Efficacy of Liquid Nitrogen Versus Vitamin D3 in The Treatment of Cutaneous Warts [NCT05739786]Phase 160 participants (Actual)Interventional2022-05-11Completed
Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Including Diversity and Stress Determinants, Among Veterans [NCT04621500]Phase 236 participants (Actual)Interventional2019-06-04Completed
Adolescent Girls-Impact of Vitamin D on Bone Accretion Work Package 1 (Danish Part) of OPTIFORD (Towards A Strategy for Optimal Vitamin D Fortification) [NCT00267540]225 participants Interventional2001-01-31Completed
Estudio Destinado a Valorar la Utilidad de Vitamina D Sobre Morbilidad y Mortalidad de la infección Por Virus SARS-COV-2 (COVID-19) en el Hospital Universitario Central de Asturias [NCT04552951]Phase 480 participants (Anticipated)Interventional2020-04-04Recruiting
The Effect of Vitamin D Supplementation on HIV-associated Platelet Hyperreactivity [NCT02217553]50 participants (Actual)Interventional2013-12-31Completed
Bone Mineral Density, Body Composition and Growth Following Severe Burn Injury [NCT00285090]Phase 160 participants (Anticipated)Interventional2005-02-28Terminated(stopped due to Lack of volunteers)
Evaluation of the Effect of a 4-Month Intervention of Exercise and/or Vitamin D on Mobility Function and Strength in Frail Elderly Subjects [NCT00249704]Phase 164 participants (Actual)Interventional2005-10-31Terminated(stopped due to See termination reason in detailed description.)
Vitamin D in TB Prevention in School Age Children [NCT02276755]Phase 38,851 participants (Actual)Interventional2015-09-30Completed
Characterization of Hyperparathyroidism and Vitamin D Deficiency in Obesity [NCT00288873]Phase 460 participants (Actual)Interventional2006-02-28Completed
Renal Denervation in Patients With Diabetic Nephropathy and Persistent Proteinuria [NCT01588795]Phase 425 participants (Actual)Interventional2012-04-30Completed
Impact of Vitamin D Level and Supplement on SLE Patients During COVID-19 Pandemic [NCT04709744]38 participants (Actual)Observational2020-04-01Completed
Is Vitamin D Insufficiency and Deficiency Associated With Antepartum and Postpartum Depression? [NCT02272387]151 participants (Actual)Interventional2014-10-31Terminated(stopped due to Low enrollment and limited research staffing)
Randomized Double-Blind Placebo-Controlled and Parallel Group Study to Evaluate the Impact of One Year Therapy With Monthly Oral Ibandronate 150 mg on Structural Properties of Bone in Postmenopausal Osteoporosis Without Vertebral Fractures [NCT00271713]Phase 470 participants (Actual)Interventional2006-03-31Completed
Phase 1 Study of Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE) [NCT00418587]Phase 118 participants Interventional2006-12-31Completed
Trial of Vitamin D to Reduce the Progression of Knee Osteoarthritis: A Double-Blind, Placebo-Controlled Once Daily Dosing Regimen [NCT00306774]Phase 2146 participants (Actual)Interventional2006-03-31Completed
Vitamin D Deficiency Causes Immune Dysfunction and Enables or Perpetuates the Development of Rheumatoid Arthritis: Clinical Trial and Investigations on Dendritic Cells [NCT00279461]Phase 20 participants (Actual)Interventional2009-05-31Withdrawn(stopped due to Dr. Levy terminated from IU in December 2009. Indiana University has no record that this study was initiated prior to his termination.)
Pamidronate, Vitamin D, and Calcium for the Bone Disease of Kidney and Heart Transplantation [NCT00302627]43 participants (Actual)Interventional1999-01-31Completed
The Prevalence of Vitamin D Deficiency and Effects of Vitamin D Supplementation in HIV-1 Infected Patients [NCT00306410]Phase 285 participants Interventional2006-01-31Recruiting
Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2 - EVIDENS [NCT01497132]Phase 444 participants (Actual)Interventional2012-01-31Completed
Vitamin D Status, Disease Specific and Quality of Life Outcomes in Patients With Cutaneous Lupus [NCT01498406]Phase 23 participants (Actual)Interventional2011-12-31Terminated(stopped due to secondary to funding issues and low enrollment)
Effect of Vitamin D3 on Cardiovascular Risk Factors: a Randomized Trial in Human [NCT01501916]250 participants (Actual)Interventional2012-12-31Completed
Safety and Bioefficacy of Vitamin D2 and Vitamin D3: Randomized Trial With Human Volunteers [NCT01503216]120 participants (Actual)Interventional2012-01-31Completed
Effect of Vitamin D Supplementation During Lactation on Vitamin D Status, Bone Mineralisation and Body Composition of Mother and Their Exclusively Breastfed Infants. [NCT01506557]Phase 4174 participants (Actual)Interventional2011-03-31Completed
A Pilot Study of the Effect of Dietary Fat Type and Amount on Vitamin D3 Absorption [NCT01508845]61 participants (Actual)Interventional2012-01-31Completed
Correction of Vitamin D Deficiency to Prevent Postoperative Hypocalcemia After Thyroidectomy [NCT01632514]Phase 490 participants (Anticipated)Interventional2012-06-30Active, not recruiting
Effects of Vitamin D and Marine Omega-3 Fatty Acids on Anemia in the Elderly [NCT01632761]2,000 participants (Anticipated)Interventional2012-11-30Enrolling by invitation
The Variability of 25-hydroxyvitamin D Response From Crystalline 25-hydroxyvitamin D3 Compared to Native Vitamin D3: A Short Term Pharmacokinetic Study [NCT01633658]0 participants (Actual)Interventional2012-11-30Withdrawn(stopped due to Protocol has changed)
Double-Blind, Placebo-Controlled Trial of Vitamin D3 (Cholecalciferol) Supplementation for Heart Failure Patients [NCT01636570]Phase 240 participants (Actual)Interventional2012-08-31Completed
Study to Evaluate the Pharmacokinetics of Vitamin D (Cholecalciferol) in Patients Undergoing Obesity Surgery in a Deficit Situation and After Standardization [NCT01637155]Phase 244 participants (Anticipated)InterventionalNot yet recruiting
The International Polycap Study 3 (TIPS-3) is a Randomized Double-blind Placebo-controlled Trial for the Evaluation of a Polycap, Low Dose Aspirin and Vitamin D Supplementation in Primary Prevention [NCT01646437]Phase 37,793 participants (Actual)Interventional2012-06-30Completed
A Randomized Prospective Open-label Comparison of Two Vitamin D3 Repletion Strategies in Vitamin D Deficient Patients [NCT01650883]56 participants (Actual)Interventional2009-03-31Completed
Vitamin D and Early Markers of Cardiovascular Disease in African Americans [NCT01655810]86 participants (Actual)Interventional2012-08-13Completed
Vitamin D Status and T Cell Phenotype in HIV-infected Youth Supplemented With Cholecalciferol: a Randomized Clinical Trial. [NCT01656070]Phase 250 participants (Actual)Interventional2011-04-30Completed
Effects of Vitamin D and Calcium Supplementation on Inflammatory Biomarkers and Adypocytokines in Diabetic Patients [NCT01662193]120 participants (Anticipated)Interventional2012-02-29Recruiting
Effect of Vitamin D Supplementation and Physical Activity in Preventing Sarcopenia in Older Adults With Osteoporosis [NCT01666522]145 participants (Actual)Interventional2011-04-30Completed
Bioavailability of Vitamin D in Children and Adolescents With Crohn's Disease. [NCT01692808]Phase 220 participants (Actual)Interventional2012-10-31Completed
Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effect of Vitamin D in Patients With Diabetic Peripheral Neuropathy to Alleviate Pain and Improvement of Symptoms [NCT04984044]72 participants (Actual)Interventional2020-11-07Completed
Effect of Vitamin D3 Supplementation on Chronic Granulomatous Disease Patients With BCGosis/Itis [NCT03984890]Phase 2/Phase 350 participants (Anticipated)Interventional2019-08-01Recruiting
Effects of VDR rs7311856, GC rs2282679 and CYP2R1 rs2060793 Variants on Vitamin D Status: A Randomised Control Trial [NCT05802433]67 participants (Anticipated)Interventional2022-05-16Recruiting
Treating Vitamin D Insufficiency in Community Dwelling Elderly to Improve Arterial Stiffness [NCT03649802]Phase 252 participants (Actual)Interventional2018-08-16Completed
Efficacy and Safety of High Dose Vitamin D Supplementation in Patients Undergoing Hematopoietic Stem Cell Transplantation [NCT03320915]Phase 288 participants (Anticipated)Interventional2017-10-01Recruiting
A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine [NCT01695460]Phase 348 participants (Actual)Interventional2012-09-30Completed
The Effect of Vitamin D on Measures of Bone Health and Gene Expression [NCT01696409]11 participants (Actual)Observational2009-07-31Completed
Immune Reconstitution in Tuberculosis Disease Using Antimicrobial Treatment With Vitamin D and Phenylbutyrate [NCT01698476]Phase 2390 participants (Actual)Interventional2012-09-30Completed
Immune Reconstitution in HIV Disease Using Antimicrobial Treatment With Vitamin D and Phenylbutyrate [NCT01702974]Phase 2279 participants (Actual)Interventional2012-09-30Completed
DIetary Supplements, Executive funcTions and Vitamin D (DIET-D): a Double-blind Randomized Controlled Trial [NCT01708005]Phase 2/Phase 3160 participants (Anticipated)Interventional2012-11-30Enrolling by invitation
Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers - a Randomized Trail [NCT01711905]107 participants (Actual)Interventional2012-11-30Completed
Effect of High-Dose Vitamin D on Bone Density in Osteogenesis Imperfecta [NCT01713231]Phase 460 participants (Actual)Interventional2012-09-30Completed
Vitamin D Intervention in Infants [NCT01723852]1,000 participants (Anticipated)Interventional2013-01-31Completed
Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2 and Low 25(OH)D Concentrations: Does it Help to Improve Endothelial Function-The DIMENSION TRIAL [NCT01741181]Phase 464 participants (Actual)Interventional2012-09-30Completed
[NCT01741324]220 participants (Actual)Interventional2012-11-30Completed
Vitamin D3 - Omega3 - Home Exercise - Healthy Ageing and Longevity Trial (Acronym: DO-HEALTH) [NCT01745263]Phase 32,157 participants (Actual)Interventional2012-12-20Completed
A Randomized Double-blind Placebo-controlled Trial of the Effect of Vitamin D Supplementation on Breast Density in Premenopausal Women [NCT01747720]405 participants (Actual)Interventional2012-10-31Completed
A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Effects of Vitamin D Supplementation on Androgen Levels in Hypogonadal Men [NCT01748370]Phase 4200 participants (Actual)Interventional2012-12-01Completed
Vitamin D Supplementation in Vitamin D Deficient/Insufficient Children Oral or Parenteral! D2 or D3, A Randomized Controlled Trial. [NCT06176157]Phase 4120 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Role of Vitamin D on the Relapse Rate of Multiple Sclerosis [NCT01753375]Phase 2200 participants (Anticipated)Interventional2013-01-31Not yet recruiting
Effects of Vitamin D on Inflammation in Liver Disease [NCT01754961]Phase 224 participants (Anticipated)Interventional2011-11-30Recruiting
Vitamin D Supplementation as Adjunct to Clozapine-treated Chronic Schizophrenia Patients [NCT01759485]47 participants (Actual)Interventional2014-05-31Completed
Vitamin D3 Supplementation for Low-Risk Prostate Cancer: A Randomized Trial [NCT01759771]Phase 2130 participants (Actual)Interventional2013-01-03Completed
Comparisons of the Effect of Inactive and Active Vitamin D on Serum Sclerostin/dickkopf1 Levels [NCT01765010]Phase 488 participants (Anticipated)Interventional2013-01-31Recruiting
Prostaglandin Inhibition to Prevent Breast Cancer [NCT01769625]Phase 1/Phase 231 participants (Actual)Interventional2009-01-31Completed
Bioavailability of Vitamin D2 and Vitamin D3 in Supplements Compared to Vitamin D3 and Vitamin D2 in Fortified Orange Juice [NCT01778114]86 participants (Actual)Interventional2006-12-31Completed
A Precision Nutrition Approach to Enhancing Physical Function in Older Adults: A Pilot, Feasibility Study [NCT05877846]25 participants (Anticipated)Interventional2023-11-01Recruiting
Interrelationship of Vitamin D Supplementation, Adiposity and CVD Risk Factors in a Randomized Clinical Trial [NCT01785004]600 participants (Anticipated)Interventional2012-07-31Active, not recruiting
Trial of Vitamin D in HIV Progression [NCT01798680]Phase 34,000 participants (Actual)Interventional2014-02-28Completed
Placebo-controlled Trial With Vitamin D to Prevent Worsening/Relieve Aromatase Inhibitor-induced Musculoskeletal Symptoms in Breast Cancer Patients [NCT01809171]Phase 2/Phase 315 participants (Actual)Interventional2013-10-31Terminated(stopped due to Inclusion problems)
Vitamin D Status Impacts Inflammation and Risk of Infections During Pregnancy [NCT01815047]85 participants (Actual)Interventional2012-12-31Completed
Evaluation of Vitamin D in a Mushroom Supplement [NCT01815437]80 participants (Actual)Interventional2012-01-31Completed
A Factorial Randomized Controlled Trial of Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients [NCT01817699]Phase 4161 participants (Actual)Interventional2013-04-30Terminated(stopped due to The independent Data Monitoring Committee recommended an early termination.)
Effect of the Treatment of Vitamin D Deficiency in Drug-resistant Epilepsy [NCT03475225]Phase 3400 participants (Anticipated)Interventional2018-04-30Not yet recruiting
Phase 4 Study of Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD [NCT01820832]Phase 460 participants (Anticipated)Interventional2013-03-31Not yet recruiting
The Effect of Oral Vitamin D (Cholecalciferol) Supplementation After Topical Application With Valchlor [NCT02968446]Early Phase 133 participants (Actual)Interventional2016-11-17Completed
Immunologic Functions of a Single Dose of 100.000 I.U. Cholecalciferol (Vitamin D3) [NCT01845142]Phase 440 participants (Actual)Interventional2013-02-28Completed
Immunomodulating and Clinical Effects of Vitamin D on Remission Induction in Patients With Moderate and Severe Ulcerative Colitis, Undergoing Treatment With Infliximab. [NCT01846026]Phase 1/Phase 20 participants (Actual)Interventional2013-04-30Withdrawn(stopped due to At the planned study start new treatment guidelines for this disease with new drugs were implemented in clinical practice.)
A Randomized Study to Evaluate the Effectiveness of Cholecalciferol Versus Ergocalciferol Following Kidney Disease Outcomes Quality Initiative (K/DOQI) Guidelines for Vitamin D Therapy in Stages 3 & 4 Chronic Kidney Disease (CKD) Patients [NCT01173848]Phase 319 participants (Actual)Interventional2010-07-31Terminated
Immunologic Impact of Vitamin D Repletion in Hemodialysis Patients: A Randomized Controlled Trial [NCT01175798]116 participants (Actual)Interventional2010-08-31Completed
The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients With Severe Vitamin D Deficiency: a Multicenter, Placebo-controlled Double-blind Phase III Randomized Controlled Trial (RCT) [NCT03188796]Phase 32,400 participants (Anticipated)Interventional2017-10-10Recruiting
Impact of Zinc and Vitamin D3 Supplementation on the Survival of Institutionalized Aged Patients Infected With COVID-19 [NCT04351490]0 participants (Actual)Interventional2020-04-30Withdrawn(stopped due to change study design and funding)
Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients [NCT05326841]Phase 360 participants (Actual)Interventional2021-10-03Completed
Effect of Vitamin D Supplementation on the Development of Respiratory Infections (COVID-19) in Health Personnel at Hospital Clínica NOVA With Serum Values> 20ng / ml [NCT04810949]41 participants (Actual)Interventional2020-08-05Terminated(stopped due to patients enrolled got vaccinated vs COVID-19 and Influenza)
Effect of Omega-3 Fatty Acid on Vitamin D Activation in Hemodialysis Patients [NCT01596842]Phase 417 participants (Actual)Interventional2012-05-31Completed
Effect of Vitamin D3 Supplementation on Arterial and Bone Remodeling in Chronic Kidney Disease Patients [NCT02999204]Phase 457 participants (Actual)Interventional2015-01-31Completed
Vitamin D3 Effects on Immune Function in Pediatric Systemic Lupus Erythematosus (SLE) [NCT01709474]Phase 27 participants (Actual)Interventional2013-06-30Terminated(stopped due to Due to slow enrollment)
Vitamin D Supplementation in Patients With Vitiligo Induced Additive Effects With Phototherapy [NCT05364567]29 participants (Actual)Interventional2018-05-01Completed
The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile [NCT01688102]118 participants (Actual)Interventional2012-09-30Completed
Impact of Treatment With Cholecalciferol on Immunological Markers in Patients With Hypovitaminosis D on Dialysis [NCT01974245]Phase 255 participants (Actual)Interventional2012-07-31Completed
THE EFFECTS OF VITAMIN D ON MAMMOGRAPHIC DENSITY AND BREAST TISSUE [NCT02239874]3,894 participants (Anticipated)Interventional2012-07-31Active, not recruiting
The Effect of Vitamin D Supplementation on Chromium Serum Levels and Insulin Resistance Among Overweight Jordanian Women With Polycystic Ovary Syndrome in Irbid [NCT02328404]Phase 360 participants (Actual)Interventional2014-02-28Completed
COvid-19 and Vitamin D Supplementation: a Multicenter Randomized Controlled Trial of High Dose Versus Standard Dose Vitamin D3 in High-risk COVID-19 Patients (CoVitTrial) [NCT04344041]Phase 3260 participants (Actual)Interventional2020-04-15Completed
Evaluation de l'Impact d'un Mode de supplémentation en Vitamine D (Dose séquentielle vs Dose Quotidienne) Sur l'Incidence de l'Hypercalciurie Chez Des Sujets Des départements du Gard et de l'Hérault agés de 2 à 18 Ans. Etude contrôlée randomisée en 2 Grou [NCT02975492]280 participants (Anticipated)Interventional2017-12-14Recruiting
For 12months, the Multi Center, Randomized, Open-label, Active Controlled Comparative Clinical Study to Assess the Efficacy and the Safety of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis [NCT01675297]Phase 41,053 participants (Actual)Interventional2011-07-04Completed
Vitamin D Replacement Using Oral Thin Film (OTF) Cholecalciferol in Patients Undergoing Hematopoietic Stem Cell Transplantation [NCT04818957]24 participants (Actual)Interventional2021-06-07Completed
Phase IV Study of Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS [NCT01432704]Phase 2/Phase 370 participants (Actual)Interventional2008-03-31Completed
Oral Cholecalciferol in Prevention of Type 2 DM in Prediabetic Population With Vitamin D Insufficiency [NCT01436916]Phase 450 participants (Actual)Interventional2011-09-30Completed
How Much Vitamin D is Required to be Protective Against Deficiency During the Winter Months? - An Investigation in Veterans Living at Ste-Anne's Hospital [NCT01437696]Phase 477 participants (Actual)Interventional2011-10-31Completed
Phase II Study of Efficacy of Vitamin D Supplementation in Multiple Sclerosis [NCT01440062]Phase 255 participants (Actual)Interventional2011-12-31Terminated
Effect of Consumption of Post-harvest UV-B Treated Mushrooms on Vitamin D Status of Healthy Adults [NCT01443897]48 participants (Actual)Interventional2010-05-31Completed
Pilot Study on the Bioactivity of Vitamin D in the Skin After Oral Supplementation [NCT01447355]Phase 125 participants (Actual)Interventional2012-08-31Completed
Is Involucrin Has a Role in Verruca Vulgaris? A Clinical and Immunohistochemical Study [NCT04793529]60 participants (Actual)Interventional2019-01-01Completed
[NCT01462058]Phase 450 participants (Actual)Interventional2011-10-31Completed
Finnish Vitamin D Trial (FIND) [NCT01463813]2,495 participants (Actual)Interventional2012-09-30Completed
Effect of Vitamin D Supplementation in Addition to Non-surgical Periodontal Treatment in Individuals With Type II Diabetes Mellitus and Periodontitis [NCT06077708]38 participants (Actual)Interventional2022-08-23Completed
A Single Wintertime Dose of Vitamin D3 to Prevent Winter Decline in Vitamin D Concentrations in Healthy Adults: A Pilot Study [NCT01924910]Phase 428 participants (Actual)Interventional2012-10-31Completed
Replenishing and Maintaining Vitamin D Status in Deficient Older Adults in Residential Care Facilities in Northern Ireland [NCT04395638]40 participants (Anticipated)Interventional2020-09-01Suspended(stopped due to COVID-19 study status being reviewed on an ongoing basis.)
Vitamin D Increases Serum Levels of the Soluble Receptor for Advanced Glycation End Products in Women With PCOS [NCT03644212]Phase 479 participants (Actual)Interventional2012-07-31Completed
Trial of Vitamin D in HIV Progression, Birth Outcomes, and Child Health [NCT02305927]Phase 32,300 participants (Actual)Interventional2015-06-15Completed
Do Vitamin D Levels Really Correlated With Disease Severity in COVID-19 Patients? [NCT04394390]100 participants (Anticipated)Observational [Patient Registry]2020-05-01Enrolling by invitation
Treatment of Vitamin D Deficiency With Large Bolus Cholecalciferol in the Outpatient Setting [NCT04120064]Phase 160 participants (Actual)Interventional2019-01-25Terminated(stopped due to Covid19, not able to finish recruitment)
Open-label Vitamin D Trial for Patients With Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis [NCT01222273]7 participants (Actual)Interventional2010-09-30Completed
A Multicentre, Phase-II, Randomised, Double Blind, Placebo-controlled Study to Assess the Safety and the Efficacy of a Weekly Administered Dose of 30,000 IU Vitamin D (Colecalciferol) in Deficient Patients Diagnosed With PCOS [NCT04840238]Phase 2168 participants (Anticipated)Interventional2016-12-08Suspended(stopped due to insufficient recruit activity)
Vitamin D and Type 2 Diabetes Study [NCT01942694]2,423 participants (Actual)Interventional2013-10-31Completed
Assessment of Fracture Healing by High-resolution Peripheral Quantitative Computed Tomography (HR-pQCT) and Bone Strength Analysis in Standard Care and After Immediate Administration of Calcium and Vitamin D Supplementation [NCT02889237]52 participants (Actual)Interventional2014-10-31Completed
Do Vitamin D Fortified Cheese and Yogurt Products Support Vitamin D Status and Functional Outcomes in Young Children? Phase 2 [NCT02387892]51 participants (Actual)Interventional2014-10-31Completed
Dietary Supplements to Reduce Symptom Severity and Duration in People With SARS-CoV-2: A Randomized, Double Blind, Placebo Controlled Clinical Trial [NCT04780061]Phase 390 participants (Actual)Interventional2021-07-12Terminated(stopped due to Public PCR testing stopped in Ontario)
Study of Vitamin D to Prevent Autism in Newborn Siblings [NCT01366885]Phase 220 participants (Actual)Interventional2008-02-29Completed
Multicenter Randomized Study : Does Correction of 25 OH-VITAmin D With Cholecalciferol Supplementation Increase Muscle Strength in hemoDIALysis Patients? [NCT04262934]Phase 3150 participants (Anticipated)Interventional2018-01-08Recruiting
Phase IIA, Randomized Placebo-Controlled Trial of Single High Dose Cholecalciferol and Daily Genistein (G-2535) Versus Placebo in Men With Early Stage Prostate Cancer Undergoing Prostatectomy [NCT01325311]Phase 215 participants (Actual)Interventional2011-12-31Completed
Low vs. Moderate to High Dose Vitamin D for Prevention of COVID-19 [NCT04868903]2,000 participants (Anticipated)Interventional2020-11-30Active, not recruiting
The Influence of Vitamin D Supplementation With and Without Glucosamine Sulfate and Omega-3 Fatty Acids in Patients With Osteoarthritis Symptoms [NCT04121533]73 participants (Actual)Interventional2011-07-28Completed
Effect of Vitamin D3-fortified Fruit Juice Supplementation on the Recovery of Iron Status in Childbearing-aged Women With Marginally Low Iron Stores [NCT04618289]120 participants (Anticipated)Interventional2021-08-14Active, not recruiting
Vitamin D and Arterial Function in Patients With Chronic Kidney Disease [NCT01384539]Phase 3128 participants (Actual)Interventional2011-07-31Completed
A Randomized, Open Label, Single Dose, Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of AD-102 in Healthy Male Subjects [NCT03824171]Phase 152 participants (Actual)Interventional2019-02-28Completed
Improving Vitamin D Status in the Management of COVID-19 [NCT04385940]Phase 364 participants (Anticipated)Interventional2021-03-19Recruiting
Correlation Between Vitamin D and Symptoms Severity of Autonomic Nervous Mediated Syncope(NMS) Child and it 's RAAS [NCT04844957]Early Phase 1100 participants (Anticipated)Interventional2020-05-20Recruiting
Immunomodulating Effects of Supplementation With 25 oh Vitamin D in Adults With Scleroderma and Hypovitaminosis D [NCT04822038]49 participants (Actual)Interventional2017-06-01Completed
Vitamin D and Breast Cancer: Does Weight Make a Difference? [NCT01472445]Phase 241 participants (Actual)Interventional2011-11-30Terminated(stopped due to Slow accrual)
The Effect of High Oral Loading Dose of Cholecalciferol in Non-Alcoholic Fatty Liver Disease Patients. A Randomized Placebo Controlled Trial [NCT05613192]Phase 3100 participants (Anticipated)Interventional2022-10-31Recruiting
Controlled Randomized Open Label Clinical Study to Compare the Efficacy and the Safety of the Loading Dose Schedules of Vitamin D3 (Colecalciferol) 30,000 IU Product in Deficient Patients [NCT04476511]Phase 375 participants (Actual)Interventional2018-09-05Completed
A Randomized Controlled Pilot Trial of Vitamin D3 Replacement of Placebo Followed by Bilateral Salpingo-Oophorectomy for Women at Increased Risk of Developing Ovarian, Fallopian, or Primary Peritoneal Cancer. [NCT01744821]7 participants (Actual)Interventional2012-10-31Terminated(stopped due to Inability to recruit study subjects)
EVITA Trial: Effect of VItamin D as add-on Therapy for Vitamin D Insufficient Patients With Severe Asthma: a Randomized, Double-blind, Placebo-controlled Trial [NCT02424552]Phase 454 participants (Actual)Interventional2015-06-26Terminated(stopped due to recruitment problems)
Improving the Understanding of the Response to Vitamin D Supplementation [NCT01465178]Phase 362 participants (Actual)Interventional2011-12-31Completed
Comparison of Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in CKD [NCT00285467]55 participants (Actual)Interventional2006-01-31Completed
Evaluation of Vitamin D Requirements During Pregnancy [NCT00292591]Phase 3501 participants (Actual)Interventional2004-01-31Completed
Effect of Combined Supplementation With Long-chain ω-3 Polyunsaturated Fatty Acids, Vitamin D, and Calcium as a Potential Adjuvant in the Preservation of Bone Mass and Bone Turnover Biomarkers in Patients With Acute Lymphoblastic Leukemia. [NCT05950204]40 participants (Anticipated)Interventional2022-09-10Recruiting
Effect of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors: a Randomized Controlled Study [NCT05552729]Phase 1/Phase 2114 participants (Anticipated)Interventional2022-09-22Not yet recruiting
Effectiveness of Vitamin D Supplementation on Reducing Blood Pressure and Improving Endothelial Function of Pre-menopausal African American Women [NCT02513823]27 participants (Actual)Interventional2015-12-01Terminated(stopped due to Reached power analysis goal and funds depleted)
Scottish Vitamin D Intervention Study [NCT04868227]190 participants (Actual)Interventional2014-03-28Completed
Metabolic, Endocrine, and Central Effects of Genistein Aglycone in Glucocorticoid Induced Osteoporosis [NCT03040531]Phase 2/Phase 3200 participants (Anticipated)Interventional2017-01-19Recruiting
Phase II RCT of High-dose Vitamin D Supplements in Older Adults [NCT03613116]Phase 2180 participants (Anticipated)Interventional2019-03-18Recruiting
The Role of Vitamin D3 in Pediatric Bronchiectasis Severity( CF Versus Non CF Bronchioectasis) [NCT04411901]Phase 2/Phase 340 participants (Actual)Interventional2018-03-01Completed
Impact of Vitamin D Supplementation on Vascular Function, Vascular Structure and Immune Regulation in Patients With Chronic Kidney Disease and Low Vitamin D Levels - A Pilot Randomised Trial [NCT04380467]36 participants (Actual)Interventional2016-01-31Completed
Pilot Study: Efficacy and Safety of Vitamin D Supplementation in Glomerular Disease [NCT01835639]32 participants (Actual)Interventional2013-04-30Completed
Effects of Vitamin D Supplementation on Depression and Inflammatory Markers in Adolescent and Youth With Major Depression and Vitamin D-deficiency: a Partially Randomized Preference Trial in Taiwan [NCT04898725]460 participants (Anticipated)Interventional2021-04-12Recruiting
The Assessment of the Effect of Vitamin D Supplementation on the Serum of AGES and Endothelialy Factors and Gene Expression of Glyoxalase Enzyme and YKL-40 Factor in PBMC Cells in the Patients With Type 2 Diabetes . [NCT03008057]Phase 2/Phase 342 participants (Anticipated)Interventional2017-01-31Enrolling by invitation
Effect of Vitamin D3 Supplementation on Insulin Resistance and Cardiovascular Risk Factors in People at High Risk of Type 2 Diabetes and Cardiovascular Disease (The DIR Study) [NCT01889810]81 participants (Actual)Interventional2013-08-31Completed
Phase 4 Study of 25-hydroxy-vitamin D in Patients With Peripheral Artery Occlusive Disease and Walking Ability [NCT01559974]Phase 44 participants (Actual)Interventional2011-11-30Terminated(stopped due to Insufficient recruitment)
[NCT01571063]Phase 222 participants (Actual)Interventional2013-01-31Completed
[NCT01574027]Phase 255 participants (Actual)Interventional2008-04-30Completed
The Effect of Vitamin D Repletion in Patients With Hepatocellular Carcinoma on the Orthotopic Liver Transplant List [NCT01575717]50 participants (Anticipated)Interventional2012-01-31Recruiting
Randomized, Open-label Crossover Study to Evaluate Comparative Pharmacokinetics of Vitamin D3 Between DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 Tablet) and a 24,000 IU Vitamin D3 in Healthy Adult Volunteers [NCT01577849]Phase 136 participants (Actual)Interventional2012-03-31Completed
Role of Calcium And Vitamin D In Nutritional Rickets And It's Management [NCT01578434]Phase 467 participants (Actual)Interventional2007-11-30Completed
How Does Magnesium Status Influence Calcium Homeostasis? [NCT01593501]Phase 439 participants (Actual)Interventional2012-05-31Completed
Vitamin D3 Supplementation in Polymorphic Light Eruption: Randomized Double-blinded Placebo-controlled Trial [NCT01595893]Phase 38 participants (Actual)Interventional2012-04-30Terminated(stopped due to Difficulties in recruiting the planned number of patients)
Effects of Vitamin D3 and Vitamin K2MK7 Supplementation on Vascular Function in Overweight or Obese Adults. [NCT05689632]100 participants (Anticipated)Interventional2022-07-15Recruiting
Early Vitamin D Supplementation for Prevention of Respiratory Morbidity in Extremely Preterm Infants: A Randomized Clinical Trial [NCT01600430]Phase 2/Phase 3100 participants (Actual)Interventional2012-06-30Completed
Outcome of High Dose Vitamin D on Prognosis of Sepsis Requiring Mechanical Ventilation; A Randomized Controlled Trial [NCT05244018]Phase 480 participants (Actual)Interventional2022-03-01Completed
Therapies to Prevent Progression of COVID-19, Including Hydroxychloroquine, Azithromycin, Zinc, Vitamin D, Vitamin B12 With or Without Vitamin C, a Multi-centre, International, Randomized Trial: The International ALLIANCE Study [NCT04395768]Phase 2200 participants (Anticipated)Interventional2020-09-09Recruiting
Effects of Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Onset Systemic Lupus Erythematosus. [NCT01892748]60 participants (Actual)Interventional2012-07-31Completed
Pilot Study of Vitamin D to Ameliorate Chronic Pain in Sickle Cell Disease [NCT01331148]Phase 246 participants (Actual)Interventional2009-02-28Completed
Impact of Vitamin D Supplementation on Strength and Lean Mass Accumulation During an Exercise Intervention [NCT01199926]Phase 434 participants (Actual)Interventional2008-08-31Completed
Impact of Vitamin D on Diabetic Kidney Disease in African Americans [NCT01214356]54 participants (Actual)Interventional2010-08-31Completed
Effect of Vitamin D and Omega-3 Fatty Acids on Blood Pressure and Hypertension [NCT01653678]25,875 participants (Actual)Interventional2011-11-30Active, not recruiting
Calcium and Vitamin D Malnutrition in Elderly Women [NCT00352170]Phase 31,180 participants (Actual)Interventional2000-05-31Completed
A Trial of Micronutrient Supplementation in Patients With Heart Failure [NCT01005303]Phase 2/Phase 379 participants (Actual)Interventional2009-02-28Completed
The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors Among Hispanics and African Americans With Type 2 Diabetes [NCT01412710]92 participants (Actual)Interventional2011-07-31Completed
Prevention of Post-Cardiac Surgery Vitamin D Deficiency in Children With Congenital Heart Disease: A Pilot Dose Evaluation Randomized Controlled Trial [NCT01838447]Phase 246 participants (Actual)Interventional2013-07-31Completed
A Randomized Controlled Trial of High-Dose Vitamin D in Crohn's Disease [NCT02208310]Phase 411 participants (Actual)Interventional2015-04-30Terminated(stopped due to Unable to enroll at rate anticipated, insufft low vitamin D in clin rem @ 5 sites)
A Phase II Study Examining the Use of Deferasirox, Cholecalciferol, and Azacitidine in the Treatment of Newly Diagnosed Acute Myelogenous Leukemia (AML) in Elderly Patients [NCT02341495]Phase 24 participants (Actual)Interventional2013-02-28Terminated(stopped due to Study was terminated early due to low patient accrual.)
Vitamin D as an Intervention for Improving Quadricep Muscle Strength in Patients After Anterior Cruciate Ligament Reconstruction: A Randomized Double-Blinded, Placebo-Controlled Clinical Trial [NCT05174611]Phase 260 participants (Anticipated)Interventional2021-03-19Recruiting
Vitamin D Dose-Response Study to Establish Dietary Requirements in Infants [NCT00381914]Phase 2132 participants (Actual)Interventional2007-03-31Completed
Trial of Vitamin D Supplements to Raise Calcidiol Levels of Pregnant Women in Mongolia [NCT02395081]360 participants (Actual)Interventional2015-02-28Completed
The Effects of Vitamin D Supplementation on VO2max in Athletes: a Randomised, Double-blind, Placebo-controlled Trial [NCT02278172]Phase 444 participants (Actual)Interventional2014-10-31Completed
The Potential Therapeutic Effect of Vitamin D Nasal Drops in the Treatment of Post COVID-19 Parosmia [NCT05269017]Phase 260 participants (Anticipated)Interventional2022-06-30Not yet recruiting
[NCT00004489]60 participants (Anticipated)Interventional1998-10-31Completed
Vitamin D Supplement to Women With Type 2 Diabetes [NCT01904032]Phase 2265 participants (Actual)Interventional2013-11-21Completed
Human Lung Responses to Respiratory Pathogens [NCT01967628]Phase 1/Phase 298 participants (Actual)Interventional2007-06-30Completed
An Exploratory Pilot Study of Vitamin D Supplementation in Women With DCIS and/or LCIS [NCT02936999]Early Phase 18 participants (Actual)Interventional2016-08-31Terminated(stopped due to Terminated for lack of patient samples and funding)
Effect of Vitamin D and Calcium Supplementation on Letrozole-induced Musculoskeletal Side Effects in Breast Cancer Egyptian Patients [NCT05523609]Phase 2/Phase 340 participants (Anticipated)Interventional2022-11-01Recruiting
Can Vitamin D3 Improve Cognitive Function in Individuals With Type 2 Diabetes? (THINK-D) [NCT02416193]Phase 256 participants (Actual)Interventional2015-09-23Terminated(stopped due to the study was halted prematurely due to slow recruitment and expiration of funding)
Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): A Multi-Centre 2x2 Factorial Randomized Trial Comparing Sliding Hip Screws Versus Cancellous Screws AND Vitamin D Versus Placebo on Patient Important Outcomes and Quality of [NCT01908751]Phase 391 participants (Actual)Interventional2014-09-30Terminated(stopped due to Continuing beyond the pilot phase of the trial was deemed unfeasible)
Vitamin D Repletion to Improve Endothelial Function in Lupus Patients [NCT01911169]Phase 29 participants (Actual)Interventional2011-06-30Completed
An Eight Week Double Blinded Randomized, Placebo-controlled Trial to Assess the Effect of Two Doses of 100,000 IU Vitamin D3 by Mouth on Select Genetic Responses in Overweight, Hypertensive African-Americans With Hypovitaminosis D [NCT02802449]330 participants (Actual)Interventional2013-09-30Completed
High Dose Vitamin-D Substitution in Patients With COVID-19: a Randomized Controlled, Multi Center Study [NCT04525820]80 participants (Actual)Interventional2020-12-15Completed
A Comparative Efficacy and Tolerability Study of Oral Iron Treatment in Healthy Iron Deficient and/or Iron-deficient Anaemic Adults: A Perspective, Randomized, Parallel Group, and Controlled Clinical Trial. [NCT05985070]60 participants (Anticipated)Interventional2023-07-17Recruiting
Pilot Study- Treat to Target Vitamin D in End Stage Renal Disease [NCT04167111]0 participants (Actual)Interventional2020-09-01Withdrawn(stopped due to Covid pandemic)
Effects of Vitamin D and Omega-3 Fatty Acids on Infectious Diseases and hCAP18 [NCT01758081]25,874 participants (Actual)Interventional2010-07-31Active, not recruiting
Impact of Cholecalciferol Supplementation in Hemodialysis Patients [NCT05922696]Phase 2/Phase 350 participants (Actual)Interventional2022-05-15Completed
Vitamin D and Resistance Exercise in Elderly [NCT04341818]100 participants (Actual)Interventional2019-01-15Active, not recruiting
A Phase IV, Double-blind, Randomised, Placebo-controlled Trial to Assess the Efficacy and Safety of Stoss Versus Daily Dose Oral Vitamin D Compared to Placebo for the Treatment of Atopic Dermatitis in Pre-school Aged Children- a Pilot Study [NCT03257215]Phase 450 participants (Anticipated)Interventional2017-10-16Suspended(stopped due to Recruitment very slow & funding difficult - exacerbated by COVID-19 pandemic)
Open Label Trial to Evaluate the Tolerability of a Combination Therapy Consisting of GAD-alum (Diamyd®), Etanercept and Vitamin D in Children and Adolescents Newly Diagnosed With Type 1 Diabetes [NCT02464033]Phase 220 participants (Actual)Interventional2015-05-31Completed
A Double Blind, Randomized, Parallel, Placebo Control Design Study to Determine the Effect of Addition of Vitamin D to Conventional Anti TB Therapy [NCT00366470]Phase 3250 participants (Actual)Interventional2009-11-30Completed
Efficacy of Potassium Citrate in the Treatment of Postmenopausal Osteopenia. A Randomized, Placebo-controlled, Double Blind Investigation. [NCT02731820]40 participants (Actual)Interventional2015-09-01Completed
The Role of Vitamin D3 Supplementation in Advanced Cancer Patients With Pain [NCT05450419]80 participants (Anticipated)Interventional2021-07-01Recruiting
Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm: A Randomized Trial [NCT05615311]Phase 1/Phase 2126 participants (Anticipated)Interventional2023-03-16Recruiting
Resolution of Hyperparathyroidism With High-dose Vitamin D Improves Osteoporosis in Multi-treated Postmenopausal Women [NCT05347082]47 participants (Actual)Interventional2021-04-29Completed
Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis [NCT04036188]Early Phase 124 participants (Anticipated)Interventional2019-10-16Recruiting
Maternal Vitamin D for Acute Respiratory Infections in Infancy (MDARI): a Nested Sub-study in a Randomized Controlled Trial of Vitamin D Supplementation During Pregnancy and Lactation in Dhaka, Bangladesh [NCT02388516]Phase 31,214 participants (Actual)Interventional2014-12-31Completed
A Daily 5000 IU Vitamin D Supplement for the Improvement of Lung Function and Asthma Control in Adults With Asthma: a Randomised Controlled Trial [NCT04117581]32 participants (Actual)Interventional2019-10-28Completed
A Study on Prevention Strategies for CKD-SHPT and Related Complications Based on General Vitamin D Supplementation [NCT05549154]372 participants (Anticipated)Interventional2022-12-05Recruiting
Clinical Trial Investigating the Role of Vitamin D in the Treatment of Depression in Patients With Chronic Liver Disease [NCT02359266]111 participants (Actual)Interventional2011-12-31Completed
Optimizing Vitamin D in the Elderly [NCT01554241]86 participants (Actual)Interventional2012-09-30Completed
The Effect of Calcifediol (Hy.D 25 SD/S) and Vitamin D3 on Muscle Strength in a Frail Elderly Population: a Randomized, Double-blind, Placebo-controlled Trial. [NCT02349282]78 participants (Actual)Interventional2014-12-31Completed
The Response of Serum 25-hydroxyvitamin D to Different Doses of Calcifediol Hy.D Compared to Vitamin D3 Supplementation: A Randomized, Controlled, Double Blind, Long Term Pharmacokinetic Study [NCT02333682]93 participants (Actual)Interventional2014-11-30Completed
Delineation of Therapeutic Potential and the Causal Relationship Between Vitamin D and Helicobacter Pylori (HP) Infection and Gastritis [NCT03142620]Phase 396 participants (Anticipated)Interventional2015-03-31Recruiting
Phase 2 Study Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors [NCT01509079]Phase 2116 participants (Actual)Interventional2012-03-31Completed
The 'Hidden' Biological Impact of Vitamin D Deficiency: a Biomarker Study [NCT02451787]Phase 227 participants (Actual)Interventional2015-12-31Completed
A Phase II Trial of High-Dose Vitamin D Induction in Optic Neuritis (VitaDON 2) [NCT03302585]Phase 266 participants (Anticipated)Interventional2017-11-23Recruiting
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Men Managed With Active Surveillance for Prostate Cancer [NCT03290417]37 participants (Actual)Interventional2017-09-07Completed
Vitamin D Absorbance Study - A Decentralized, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Pharmacokinetics of Vitamin D3 Absorption From Softgel Supplements Compared to Nano Liquid D3 Supplements in Humans. [NCT04885803]114 participants (Actual)Interventional2021-03-26Completed
A Randomized Single-Center Study of the Effects of High-Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High-Risk Pregnant Women [NCT03037593]Phase 1/Phase 20 participants (Actual)Interventional2017-06-01Withdrawn(stopped due to Failure to recruit adequate patients)
Randomized Controlled Trial to Evaluate the Independent and Combined Effects of Conjugated Linoleic Acids and Vitamin D on Muscle Protein Turnover in Older Adults [NCT03115775]40 participants (Actual)Interventional2017-05-12Completed
A Randomized Phase IV Control Trial of Single High Dose Oral Vitamin D3 (Stoss Therapy) in Pediatric Patients Undergoing HSCT to Prevent Vitamin D Deficiency and Insufficiency During Transplant [NCT03176849]Phase 449 participants (Actual)Interventional2017-11-01Completed
Design and Development of a Novel Food Supplement for Osteoporosis Based on Gut Microbiome Mechanisms: Efficacy and Tolerability Assessment [NCT05421819]150 participants (Anticipated)Interventional2022-06-15Recruiting
Effect Of Curcuma Xanthorrhiza Supplementation In Systemic Lupus Erythematosus Patients (SLE) With Hypovitamin D Which Were Given Vitamin D3 Towards Disease Activity (SLEDAI), Interleukin-6 (IL-6) And Tumor Growth Factor-β1 (TGF-β1) Serum [NCT03155477]39 participants (Actual)Interventional2016-06-10Completed
Periodontal and Cardiometabolic Responses to Vitamin D Intervention in African Americans [NCT02337257]Early Phase 124 participants (Anticipated)Interventional2014-04-30Recruiting
Endocrine Response of the Organism to Polytrauma [NCT03588767]60 participants (Actual)Interventional2017-05-31Completed
Oral Vitamin D Substitution Weekly or Monthly - Which Procedure Leads to Highest Adherence? A Prospective Intervention Study in Outpatient Care [NCT03141593]Phase 497 participants (Actual)Interventional2017-10-09Completed
Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors. Double Blind, 2x2 Factorial, Randomized Placebo--Controlled Clinical Trial [NCT02419105]Phase 391 participants (Actual)Interventional2015-09-30Terminated(stopped due to Delayed recruitment mainly due to a screening to inclusion rate much lower than expected. Due to the delayed recruitment IMP reached the end of its shelf life.)
Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight [NCT05694689]50 participants (Anticipated)Interventional2023-02-15Recruiting
Assessment of Serum Vitamin D Levels in Women With Polycystic Ovary Syndrome [NCT05101811]Phase 490 participants (Actual)Interventional2020-05-01Completed
Evaluation of Micronutrients With Topical Corticosteroid Versus Topical Corticosteroid in Management of Symptomatic Oral Lichen Planus: Three-arm Randomized Clinical Trial [NCT04765267]42 participants (Actual)Interventional2021-04-01Completed
Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients Receiving Neoadjuvant Chemotherapy for Operable Triple Negative Breast Cancer [NCT04677816]Phase 250 participants (Anticipated)Interventional2021-10-22Recruiting
Vitamin D to Prevent Severe Asthma Exacerbations [NCT02687815]Phase 2192 participants (Actual)Interventional2016-02-22Terminated(stopped due to Futility of vitamin D supplementation based on protocol threshold: <30% conditional power to detect pre-specified effect- 16% reduction in severe exacerbations.)
Personalized Nutrition, Physical Activity and Therapy to Modulate Gut Microbiota: a Randomized Clinical Study to Promote a Healthy Lifestyle in Students [NCT05073029]120 participants (Actual)Interventional2019-02-10Completed
Utilizing the Crosstalk Among Chicoric Acid, 13-Cis Retinoic Acid(Aerosolized), Minocycline and Vitamin D as a Potent Quadrate Therapy for Treating Patients With Multidrug-resistant TB and Patient With Both Multidrug-resistant TB and COVID-19 [NCT05077813]Phase 2250 participants (Anticipated)Interventional2021-12-31Not yet recruiting
Does Supplementing Vitamin D Deficiency Affect Fusion Healing Rates in Elective Foot and Ankle Surgery? [NCT04450199]Early Phase 1150 participants (Anticipated)Interventional2020-07-24Recruiting
Novel Functional Outcomes of Vitamin D in Infancy; Can Correction of Low Vitamin D Status Program for a Leaner Body Composition Phenotype? [NCT02563015]139 participants (Actual)Interventional2016-03-07Terminated(stopped due to Covid19 pandemic prevented continuation of study visits)
Effects of Vitamin D and Omega-3 on Cerebrovascular Disease [NCT04070833]290 participants (Actual)Interventional2016-08-01Completed
Vitamin D Intervention in Infants - Pilot [NCT01275885]Phase 4113 participants (Actual)Interventional2010-08-31Completed
A Prospective, Randomized, Double-Blind, Double-Dummy,Placebo-Controlled, Parallel-Group, Pilot Trial Of Paricalcitol and Cholecalciferol(Vitamin D3) in the Treatment Of Secondary Hyperparathyroidism in Patients After ROUX-EN-Y Gastric Bypass Surgery [NCT01138475]Phase 349 participants (Actual)Interventional2010-07-31Completed
Comparison of Efficacy of Vitamin D and Vitamin D-calcium Fortified Yogurt Drink on Glycemic, Metabolic, Inflammatory, Immunity and Oxidative Stress Markers in Type 2 Diabetes [NCT01229891]Phase 290 participants (Actual)Interventional2009-10-31Completed
Efficacy of Oral Vitamin D Supplementation in Reducing Body Mass Index and Lipid Profile in Adolescents and Young Adults in Colombia: a Pilot Clinical Trial Protocol Nested in the SIMBA Cohort [NCT04377386]150 participants (Anticipated)Interventional2020-08-03Not yet recruiting
Effectiveness of Vitamin D Supplementation in the Prevention of Vitamin D Deficiency in Children. [NCT03402698]73 participants (Actual)Interventional2018-01-09Completed
Study of Vitamin D2 Virus 1,25(OH)2-Vitamin D3 in the Treatment of Chronic Kidney Disease Mineral and Bone Disease [NCT01633853]Phase 4204 participants (Actual)Interventional2012-07-31Completed
Fitness and Health Characteristics in Conscripts With Supplementation of Vitamin D [NCT04359524]63 participants (Actual)Interventional2016-10-01Completed
Treatment of Vitamin D Deficit in Obese Children and Adolescents: a Multi-centre Open Label Randomized Controlled Study Comparing the Efficacy of Two Oral Supplementation Regimens: Monthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Level. A [NCT03516968]Phase 3156 participants (Anticipated)Interventional2023-01-31Not yet recruiting
Is Vitamin D2 Treatment-associated Decrease in 25(OH)D3 Level a Reciprocal Phenomena? A Randomized Controlled Trial [NCT03035084]Phase 4100 participants (Actual)Interventional2017-02-15Completed
Effect of High-dose Cholecalciferol Supplementation on Perioperative Vitamin D Status in Colorectal Surgery Patients [NCT01689779]Phase 360 participants (Actual)Interventional2013-01-31Completed
Normalization of Vitamin D Levels and Its Effect on Glucose Homeostasis in Obese Youth [NCT02168660]Phase 2109 participants (Actual)Interventional2011-03-31Completed
Safe and Effective Vitamin D Supplementation in HIV [NCT01092338]Phase 244 participants (Actual)Interventional2010-01-31Completed
Immune Responses to Influenza Vaccine Among Healthy Employees Working at Roswell Park Cancer Institute and the Relationship to Vitamin D Status [NCT01561989]11 participants (Actual)Interventional2011-10-31Terminated(stopped due to low accrual)
Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren [NCT02880982]Phase 31,743 participants (Actual)Interventional2017-03-14Completed
The DAGMAR Study. D-vitamin And Graves' Disease; Morbidity And Relapse Reduction: A Randomised, Clinical Trial. [NCT02384668]278 participants (Actual)Interventional2015-03-24Completed
Vitamin D and Sexual Health (the DASH Study) [NCT01450462]118 participants (Actual)Interventional2011-09-30Completed
A Randomized Placebo Controlled Trial of Vitamin D Therapy in Patients With Heart Failure [NCT01125436]64 participants (Actual)Interventional2008-07-31Completed
Vitamin D Oral Replacement in Asthma [NCT03686150]112 participants (Actual)Interventional2019-01-30Completed
Randomized Clinical Trial of RANKL Inhibition With Denosumab on Mammographic Density in Premenopausal Women With Dense Breasts (TRIDENT) [NCT04067726]Phase 2210 participants (Anticipated)Interventional2019-08-27Recruiting
The Role of Vitamin D Supplementation in the Prevention of Cardiovascular Risk Factors [NCT02020694]Phase 460 participants (Actual)Interventional2011-12-31Completed
Vitamin D and Vascular Function in Obese Children [NCT01797302]225 participants (Actual)Interventional2013-08-31Completed
A Phase III (Phase IV Program) Open-Label, Multicenter Clinical Trial in Thailand to Study the Effect of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus 70/5600) for 6 Months on 25-Hydroxyvitamin D Levels in the Treatm [NCT01437111]Phase 3200 participants (Actual)Interventional2011-10-26Completed
Phase II Trial of Vitamin D and Soy Supplementation for Biochemically Recurrent Prostate Cancer Following Definitive Local Therapy [NCT00499408]Phase 226 participants (Actual)Interventional2007-04-30Completed
Alendronate in an Weekly Effervescent Tablet Formulation for Preservation of Bone Mass After Denosumab Discontinuation in Postmenopausal Women With Low Bone Mass. An Observational Study (Binosto After Denosumab - The BAD Study) [NCT04338529]92 participants (Actual)Observational2020-04-01Active, not recruiting
Association Between Vitamin D and the Risk of Uterine Fibroids [NCT03586947]1,160 participants (Anticipated)Interventional2018-09-15Not yet recruiting
Association Between Vitamin D and the Development of Uterine Fibroids [NCT03584529]360 participants (Anticipated)Interventional2018-09-15Not yet recruiting
A Pilot Study on the Effect of Vitamin D Treatment in Patients With Statin-Associated Myalgia [NCT01274104]Phase 10 participants (Actual)Interventional2010-10-31Withdrawn(stopped due to PI resigned.)
Comparison of Two Standard High-dose Treatment Regimens for Vitamin D Deficiency in Minority Adolescents: Associations of Vitamin D Repletion With Changes in Markers of Musculoskeletal, Cardiometabolic, and Immune Function [NCT01784029]Phase 4183 participants (Actual)Interventional2013-02-28Completed
Randomized Double-Blind Placebo-Controlled Proof-of-Concept Trial of Resveratrol, a Plant Polyphenol, for the Outpatient Treatment of Mild Coronavirus Disease (COVID-19) [NCT04400890]Phase 2105 participants (Actual)Interventional2020-09-13Terminated(stopped due to Feasibility)
Analysis of Soluble Mediators of Inflammation and Angiogenesis in the Vitreous of Patients With Diabetic Retinopathy Treated With Curcumin/Homotaurine/Vit. D3 [NCT04378972]25 participants (Actual)Observational2019-09-16Completed
Dose-related Effects of Vitamin D3 on Immune Responses in Patients With Clinically Isolated Syndrome and Healthy Control Participants. An Exploratory Double Blind Placebo Randomised Controlled Study. [NCT01728922]Phase 1/Phase 264 participants (Actual)Interventional2012-11-06Completed
Study of the Efficacy and Safety of Cholecalciferol Supplementation on the Activity of Rheumatoid Arthritis in Patients With Vitamin D Deficiency [NCT02243800]Phase 3164 participants (Anticipated)Interventional2011-11-30Recruiting
Pharmacokinetic Comparison of Vitamin's D2 and D3 in Stage 5 Chronic Kidney [NCT01675557]Phase 430 participants (Actual)Interventional2012-09-30Completed
Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection (COLD) [NCT04368520]Phase 2195 participants (Anticipated)Interventional2020-06-30Not yet recruiting
Phase II Clinical Trial of Vitamin D3 for Reducing Recurrence of Recurrent Lower Urinary Tract Infections: a Multicenter, Randomized, Placebo-controlled Trial [NCT04859621]Phase 2150 participants (Anticipated)Interventional2021-05-08Recruiting
Vitamin D3 Levels in COVID-19 Outpatients From Western Mexico: Clinical Correlation and Effect of Its Supplementation [NCT04793243]42 participants (Actual)Interventional2020-08-17Completed
Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab [NCT04331639]Phase 250 participants (Anticipated)Interventional2020-11-01Recruiting
A Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Effectiveness of Vitamin D3 50,000 IU Every 4 Weeks to Increase Bone Mineral Density and Decrease Tenofovir-Induced Hyperparathyroidism in Youth With HIV Infection Being Treated With T [NCT01751646]214 participants (Actual)Interventional2012-10-31Completed
Optimization of Blood Levels of 25(OH)-Vitamin D in African Americans [NCT04939792]Early Phase 1165 participants (Actual)Interventional2020-11-06Completed
PREDIN: Pregnancy and Vitamin D Intervention Study - A Randomized Controlled Trial [NCT05329428]102 participants (Anticipated)Interventional2022-04-14Enrolling by invitation
Intervention With Vitamin D and Omega-3 Supplements and Incident Heart Failure [NCT02271230]Phase 325,871 participants (Actual)Interventional2014-08-31Completed
High Prevalence of Rickets and Subclinical Maternal and Childhood Vitamin D Deficiency in the Middle East: a Randomized Controlled Trial of Prenatal Vitamin D Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants [NCT00610688]Phase 3192 participants (Actual)Interventional2008-01-31Completed
The Effect of Vitamin D3 Repletion in Chronic Kidney Disease Stage 3 [NCT00772772]Early Phase 112 participants (Actual)Interventional2008-03-31Completed
Pilot Trial to Evaluate the Effect of Vitamin D on Melanocyte Biomarkers [NCT01477463]24 participants (Actual)Interventional2012-09-30Completed
Randomized Controlled Trial of High Dose of Vitamin D as Compared With Placebo to Prevent Complications Among COVID-19 Patients [NCT04411446]Phase 4218 participants (Actual)Interventional2020-08-11Completed
Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture [NCT01950169]79 participants (Actual)Interventional2004-12-31Completed
Preventing Health Disparities During Pregnancy Through Vitamin D Supplementation [NCT01932788]Phase 3342 participants (Actual)Interventional2013-01-31Completed
Preoperative Vitamin D Status and Efficacy of Therapeutic Vitamin D Supplementation Postoperatively in Bariatric Surgery Patients [NCT01385098]37 participants (Actual)Interventional2011-07-31Completed
A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics After Co-administration of HDDO-16141 and HDDO-16143 and Administration of HDDO-1614 in Healthy Adult Male Subjects [NCT03382314]Phase 138 participants (Actual)Interventional2017-10-16Completed
Vitamin D Supplementation on Physical and Cognitive Function-Pilot Study [NCT01229878]45 participants (Actual)Interventional2011-12-01Completed
A Two Period, One-sequence Open-label Study of a Newly Developed Calcium Carbonate-vitamin D3 Chewable Tablet Formulation (Calcium 500 mg and Vitamin D3 800) Dosed for Three Days to Investigate the Effect on Urine Calcium and Serum Parathyroid Hormone (PT [NCT01639222]Phase 155 participants (Actual)Interventional2012-07-31Completed
Randomized Double-Blind Phase III Trial of Vitamin D3 Supplementation in Patients With Previously Untreated Metastatic Colorectal Cancer (SOLARIS) [NCT04094688]Phase 3455 participants (Actual)Interventional2019-09-30Active, not recruiting
AK-R215 Pharmacokinetic Study Pharmacokinetic Characteristics of AK-R215 in Comparison to Each Component Coadministered in Healthy Adult Male or Menopausal Female Valunteers. [NCT03321318]Phase 152 participants (Anticipated)Interventional2017-07-13Active, not recruiting
Randomized Double-Blind Placebo-Controlled Pilot Study of Vitamin D Supplementation for the Treatment of Bipolar Depression [NCT01884844]33 participants (Actual)Interventional2013-06-30Completed
A Trial Evaluating Vitamin D Normalization on Major Adverse Cardiovascular-Related Events Among Myocardial Infarction Patients (The TARGET-D Study) [NCT02996721]Phase 4890 participants (Anticipated)Interventional2017-04-03Recruiting
The Effect of Cholecalciferol Supplementation on Vitamin D Status in Sepsis [NCT01896544]Phase 330 participants (Actual)Interventional2014-01-31Completed
A Phase I Trial for Children With Vitamin D Insufficiency and High Risk of Severe Asthma Exacerbations [NCT01921894]Phase 148 participants (Actual)Interventional2013-08-31Completed
Vitamin D Homeostasis in Sarcoidosis [NCT03621553]Phase 490 participants (Anticipated)Interventional2010-07-01Active, not recruiting
Vitamin D Supplementation and Bone Health in Adults With Diabetic Nephropathy [NCT01476501]Phase 2120 participants (Actual)Interventional2011-10-31Completed
Effect of Vitamin D Supplementation on Autoimmunity and Thyroid Function in Subjects With Hashimoto's Thyroiditis and Vitamin D Deficiency: Clinical Pilot Trial. [NCT04778865]50 participants (Anticipated)Interventional2020-11-20Recruiting
Vitamin D and Omega-3 Trial to Prevent and Treat Diabetic Kidney Disease [NCT01684722]1,312 participants (Actual)Interventional2010-07-31Completed
Phase II Study to Assess Prevention of Oxaliplatin-induced Neurotoxicity Through the Vitamin D Pathway [NCT01499940]Phase 29 participants (Actual)Interventional2012-01-31Terminated(stopped due to Research cancelled - no funding identified.)
The Effect of Vitamin D Supplementation on Vitamin D Status, Immunity and Physical Performance [NCT03132103]260 participants (Anticipated)Interventional2016-01-06Recruiting
Effect of Different Dosages Oral Vitamin D on Serum Interleukin-6 in Preterm Infants With Late-onset Sepsis [NCT02273843]Phase 150 participants (Actual)Interventional2013-09-30Completed
Parathyroid Hormone and Cardiometabolic Outcomes in Obesity: Role of Magnesium and Vitamin D Supplementation [NCT03134417]109 participants (Actual)Interventional2016-02-01Completed
VITamin D and OmegA-3 TriaL: Interrelationship of Vitamin D and Vitamin K on Bone [NCT04573946]25,871 participants (Actual)Interventional2019-07-01Active, not recruiting
VITamin D and OmegA-3 TriaL (VITAL): Fractures, Vitamin D and Genetic Markers [NCT01704859]25,871 participants (Actual)Interventional2018-06-01Active, not recruiting
Vit D3 Adjuvant Therapy for Early Mild Symptoms of COVID-19 [NCT05008003]50 participants (Anticipated)Interventional2022-09-02Not yet recruiting
Prospective Non-randomised Controlled Study of Vitamin D Metabolism in Patients With Endocrine Disorders (Acromegaly, Cushing's Disease, Primary Hyperparathyroidism, Diabetes Mellitus Type 1) Treated With Cholecalciferol Bolus Dose [NCT04844164]Phase 1261 participants (Actual)Interventional2019-04-16Completed
The Impact of Supplemental Vitamin D on Serum 25-hydroxyvitamin D Levels and Short Term Indicators of Physical Function [NCT02293187]100 participants (Actual)Interventional2015-03-23Completed
The Impact of Physical Activity and Vitamin D on Osteoarthritic Knee Pain in Older Obese People [NCT02293889]45 participants (Actual)Interventional2015-03-31Completed
The Effects of Vitamin D Supplementation on Transforming Growth Factor-beta1 and Vascular Endothelial Growth Factor in Vitamin D-Deficient Women With Polycystic Ovary Syndrome: A Randomized Placebo-Controlled Trial [NCT02460380]Phase 493 participants (Actual)Interventional2013-10-31Completed
A Multi-centre, Prospective, Randomised Trial of Short Course Alendronate Therapy or Placebo Combined With Vitamin D and Calcium to Prevent Loss of Bone Mineral Density in Antiretroviral-naïve, HIV-1 Infected Subjects Initiating Antiretroviral Therapy [NCT02322099]Phase 453 participants (Actual)Interventional2016-05-31Terminated(stopped due to Due to the COVID-19 pandemic the study was terminated prematurely)
The Effect of Vitamin D Supplementation on Toll-Like Receptor (TLR) 2, 4, and Clinical Outcomes of Spondylitis Tuberculosis [NCT05376189]Phase 2/Phase 337 participants (Anticipated)Interventional2022-07-01Not yet recruiting
The Effects of Combined Omega-3 and Vitamin D Supplementation on Nutritional Status, Quality of Life and Inflammatory Markers Among the Breast Cancer Women in Gaza Strip [NCT05331807]Early Phase 188 participants (Anticipated)Interventional2022-04-20Recruiting
Short Term, High Dose Vitamin D Supplementation in Moderate to Severe COVID-19 Disease [NCT04952857]Phase 490 participants (Actual)Interventional2021-08-01Completed
Effects of Vitamin D Supplementation on Immune Function in Infants [NCT04461665]59 participants (Actual)Interventional2015-08-18Completed
Effect of Vitamin D Treatment on Glucose Homeostasis and Metabolism in Lebanese Older Adults: a Randomized Controlled Trial [NCT03478475]115 participants (Actual)Interventional2015-07-02Completed
The Effect of Vitamin D3 Therapy in Post Menopausal Women and Assessment of Changes in Bone Mineral Density [NCT05389943]Phase 180 participants (Anticipated)Interventional2022-06-05Not yet recruiting
Vitamin D Intervention in Children With Sickle Cell Disease: A Pilot Randomized Controlled Trial [NCT03417947]Phase 342 participants (Actual)Interventional2018-11-30Completed
Efficacy of Vitamin D Supplementation to Prevent the Risk of Acquiring or Evolving Into the Severe Form of COVID-19 in Healthcare Workers Caring for Patients With the Disease. Blinded Randomized Clinical Trial [NCT04535791]Phase 3321 participants (Actual)Interventional2020-07-15Completed
A Randomized, Multicenter, Double-blinded, Phase III Study of Vitamin D3 in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine as First-line Chemotherapy in Previously Untreated Advanced or Metastatic Colorectal Ca [NCT03389659]Phase 3750 participants (Anticipated)Interventional2018-02-28Not yet recruiting
Vitamin D3 Supplementation and Stress Fracture Occurrence in High-Risk Collegiate Athletes [NCT03395171]118 participants (Actual)Interventional2015-11-30Completed
Randomized, Double-blind, Placebo-controlled Trial to Measure the Efficacy and Safety of Vitamin D3 in Patients With Fibromyalgia. [NCT03369379]Phase 480 participants (Actual)Interventional2017-05-31Completed
Effects of Vitamin D Supplementation in Muscle Strength and Postural Balance Training in Vulnerable Elderly Women [NCT03367585]46 participants (Actual)Interventional2018-02-01Completed
The Effect of Supplementation With Two Different Doses of Vitamin D (500 IU vs 1000IU)on Bone Mineral Density, Serum 25 Hydroxyvitamin D and Hand Grip Strength in Children With Diabetes Mellitus Type 1 - a Randomized Controlled Trial. [NCT01277913]Phase 460 participants (Actual)Interventional2011-01-31Completed
Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin D3 [NCT06010121]27 participants (Actual)Interventional2023-02-17Completed
Investigating the Potential Role of Aerosolized Retinoic Acid, a Potent Vitamin A Metabolite for Treating COVID-19 Anosmia and Retinoic Acid Insufficiency .A Novel Approach for Regaining Sense of Smell. [NCT05002530]Phase 410,000 participants (Anticipated)Interventional2021-11-30Not yet recruiting
Influence of Combined Vitamin D Supplementation and Resistance Exercise Training on Musculoskeletal Health in Frail Older Men and Women (EXVITD) [NCT02467153]19 participants (Actual)Interventional2017-01-01Completed
Effect of Maternal Vitamin D3 Supplementation on Iron Status During Pregnancy and Early Infancy [NCT04764955]Phase 31,300 participants (Actual)Interventional2014-03-31Completed
A Prospective, Randomized, Double-Blind Phase II Trial of High-Dose Vitamin D and Calcium for Bone Health in HIV-Infected Individuals Initiating Highly Active Antiretroviral Therapy (HAART) [NCT01403051]Phase 2167 participants (Actual)Interventional2011-09-30Completed
Safety, Feasibility and Efficacy of Vitamin D Supplementation in Women With Metastatic Breast Cancer (SAFE-D) [NCT02186015]Phase 243 participants (Actual)Interventional2015-02-28Completed
Effect of Vitamin D Supplementation on Exercise Adaptations in Patients on Statin Therapy [NCT02030041]Phase 333 participants (Actual)Interventional2013-12-31Completed
A Randomized, Controlled Trial of High Dose vs. Standard Dose Vitamin D for Aromatase-Inhibitor Induced Arthralgia in Breast Cancer Survivors [NCT01988090]Phase 293 participants (Actual)Interventional2013-12-31Terminated(stopped due to An interim analysis demonstrated no benefit of high dose vitamin D when compared to standard dose vitamin D in the reduction or prevention of arthralgia)
The Combination of Vitamin D and Curcumin Piperine Attenuates the Disease Activity and Pro-Inflammatory Cytokines Levels in Systemic Lupus Erythematosus Patients [NCT05430087]Phase 245 participants (Actual)Interventional2020-03-01Completed
Vitamin D and Prostate Cancer: A Randomized Clinical Study [NCT02726113]Phase 250 participants (Actual)Interventional2011-10-31Completed
Role of Vitamin D Supplementation in First Episode Schizophrenia: A Double Blind Controlled Study [NCT03101319]73 participants (Actual)Interventional2019-04-08Active, not recruiting
Effectiveness of Various Vitamin D Protocols on Raising and Maintaining Blood Serum 25(OH)D3 Levels Over a Three Month Period [NCT03099759]49 participants (Actual)Interventional2016-06-27Completed
Acute Effect of Systemic Stress on Measured Blood Concentrations of 25 (OH) Vitamin D [NCT02460211]150 participants (Actual)Interventional2015-07-31Completed
[NCT02518763]Phase 3120 participants (Anticipated)Interventional2011-06-30Active, not recruiting
The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis [NCT03264625]Phase 260 participants (Actual)Interventional2017-09-30Completed
The Effect of Colecalciferol (Vitamin D) on Hormonal, Metabolic and Cardiovascular Risk Factors in Patients With Polycystic Ovary Syndrome (PCOS) - a Double Blind Randomised Placebo-controlled Study [NCT02513381]40 participants (Actual)Interventional2015-07-31Completed
Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis: a Double-blind Randomised Controlled Trial [NCT02507843]Phase 4200 participants (Anticipated)Interventional2015-01-31Recruiting
Randomized Controlled Trial to Determine the Nutritional Requirement for Vitamin D for Prevention of Deficiency During Pregnancy and in the Early Neonatal Period (D-MAT) [NCT02506439]144 participants (Actual)Interventional2014-11-01Completed
The Role Of Vitamin D For Therapy Responses On Drug Resistant Epilepsy Through Glial-Cell-Line Derived Neurotrophic Factor (GDNF) And Interleukin 1ß (IL-1 ß) Modulation Pathway [NCT06053281]Early Phase 170 participants (Anticipated)Interventional2023-12-01Not yet recruiting
Effect of Single High Dose Vitamin D3 on Peri-operative and Post-operative Complications and Clinical Outcomes in Patients Under Craniotomy for Brain Tumor Resection [NCT03248544]60 participants (Actual)Interventional2017-07-06Completed
The Effect of Platelet-rich Fibrin and Vitamin Dꝫ Injections on Canine Retraction: A Randomized Controlled Clinical Trial [NCT06071455]14 participants (Anticipated)Interventional2023-05-11Recruiting
High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade [NCT03162432]Phase 350 participants (Anticipated)Interventional2017-08-01Active, not recruiting
A Pilot Study to Examine the Effects of Vitamin D Supplementation on Mitochondrial Bioenergetics in Older Adults - An EVIDENCE Sub-Study [NCT02445066]Early Phase 115 participants (Actual)Interventional2014-10-31Completed
Vitamin D Supplementation on Metabolic Syndrome Indicators Among Food Insecure, Vitamin D Deficient Older Adults in Karaj City, Alborz Province, Iran; [NCT03193944]Phase 2120 participants (Actual)Interventional2017-02-10Completed
The Effect of Single High Dose of Vitamin D on Serum Levels of Its Metabolites [NCT05591170]Phase 458 participants (Actual)Interventional2021-04-01Completed
Comparison Between Low and High Doses of Prophylactic Vitamin D in Prevention of Osteopenia of Prematurity [NCT04768439]Phase 280 participants (Actual)Interventional2020-08-10Completed
Wheezing in Black Preterm Infants: Impact of Vitamin D Supplementation Strategy [NCT01601847]Phase 4300 participants (Actual)Interventional2013-01-31Completed
Vitamin D Supplements to Prevent Falls in Older Adults: A Dose-Response Trial [NCT02166333]688 participants (Actual)Interventional2015-06-30Terminated
Pilot Study of the Biological Effects of Vitamin D in Patients With Resectable Urinary Tract Urothelial Carcinoma [NCT04197089]Phase 42 participants (Actual)Interventional2020-02-11Completed
Effects of Stoss Therapy of Vitamin D3 on Peri-operative Outcomes in Patients Receiving General Surgery [NCT05650268]0 participants (Actual)Interventional2021-09-01Withdrawn(stopped due to Because of impact from COVID-19 pandemic)
A Randomized Trial to Determine the Effect of Vitamin D and Zinc Supplementation for Improving Treatment Outcomes Among COVID-19 Patients in India [NCT04641195]Phase 3181 participants (Actual)Interventional2021-04-22Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Total Hip BMD at 12 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 24 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 36 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Trochanter BMD at 12 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 24 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 36 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-Terminal Propeptide of Type 1 Collagen [s-P1NP]) at 12 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-Terminal Propeptide of Type 1 Collagen [s-P1NP]) at 24 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-terminal Propeptide of Type 1 Collagen [s-P1NP]) at 36 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 12 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 12 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 24 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 36 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 24 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 36 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Distal Forearm BMD at 12 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Distal Forearm BMD at 24 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Distal Forearm BMD at 36 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Femoral Neck BMD at 12 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Femoral Neck BMD at 24 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Femoral Neck BMD at 36 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Lumbar Spine BMD at 120 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Lumbar Spine BMD at 24 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Lumbar Spine BMD at 36 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Lumbar Spine BMD at 60 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Total Body BMD at 12 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Total Body BMD at 24 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Total Body BMD at 36 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Total Hip BMD at 36 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 12 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Total Hip Bone Mineral Density at 24 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Trochanter BMD at 24 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Trochanter BMD at 36 Months
NCT00112437 (39) [back to overview]Number of Participants Who Discontinued Study Drug Due to an AE During Treatment Years 6-10 (60 Months)
NCT00112437 (39) [back to overview]Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment Years 6-10 (60 Months)
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b [TRAP 5-b]) at 36 Months
NCT00112437 (39) [back to overview]Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 12 Months
NCT00153816 (2) [back to overview]Advanced Colorectal Lesions
NCT00153816 (2) [back to overview]Colorectal Adenomas
NCT00285467 (2) [back to overview]Systolic Blood Pressure at 3 Months
NCT00285467 (2) [back to overview]Percent Reduction in PTH
NCT00292591 (1) [back to overview]25-Hydroxyvitamin D Concentration
NCT00321932 (9) [back to overview]Mean Change in Luteinizing Hormone
NCT00321932 (9) [back to overview]Mean Change in Follicle-Stimulating Hormone
NCT00321932 (9) [back to overview]Mean Change in Bone Mineral Density
NCT00321932 (9) [back to overview]Mean Change in Serum Bone Specific Alkaline Phosphate
NCT00321932 (9) [back to overview]Mean Change in Urinary N-terminal Telopeptide
NCT00321932 (9) [back to overview]Mean Change in Ultrasensitive Estradiol
NCT00321932 (9) [back to overview]Mean Change in Total Testosterone
NCT00321932 (9) [back to overview]Mean Change in Thyroid Function Test 4
NCT00321932 (9) [back to overview]Mean Change in Serum Osteocalcin
NCT00412074 (3) [back to overview]Maternal Health Status - Vitamin D Deficiency
NCT00412074 (3) [back to overview]Infant Health Status - Vitamin D Deficiency
NCT00412074 (3) [back to overview]25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery
NCT00412087 (2) [back to overview]Parathyroid Hormone at Visit 7
NCT00412087 (2) [back to overview]25-hydroxyvitamin D at Visit 7
NCT00416715 (2) [back to overview]Number of Early Breast Cancer Patients Prescribed Adjuvant Letrozole That Are Vitamin D Deficient and Who Experience Myalgias, Arthralgias and/or Joint Stiffness
NCT00416715 (2) [back to overview]Letrozole Serum Levels Before and After Vitamin D Repletion
NCT00421343 (1) [back to overview]Number Adherent With the Intervention
NCT00424619 (9) [back to overview]Parathyroid Hormone (PTH)
NCT00424619 (9) [back to overview]Hemoglobin
NCT00424619 (9) [back to overview]Creatinine
NCT00424619 (9) [back to overview]Alkaline Phosphatase
NCT00424619 (9) [back to overview]Phosphate
NCT00424619 (9) [back to overview]Calcium
NCT00424619 (9) [back to overview]25-hydroxyvitamin D3 (25-OHD)
NCT00424619 (9) [back to overview]Functional Assessment Using the Two Minute Walk Test (2MWT)After 3 Months
NCT00424619 (9) [back to overview]Functional Assessment Using the Timed Up and Go (TUG) Test After 3 Months
NCT00427037 (2) [back to overview]Bone Turnover Marker-CTX
NCT00427037 (2) [back to overview]25-hydroxyvitamin D
NCT00436475 (2) [back to overview]Chang in Disposition Index, a Measure of Beta Cell Function
NCT00436475 (2) [back to overview]Change in Hemoglobin A1c
NCT00450073 (1) [back to overview]25-hydroxyvitamin D
NCT00499408 (3) [back to overview]Time to Progression
NCT00499408 (3) [back to overview]Number of Participants Showing a 50% Reduction in Serum Prostate Specific Antigen(PSA) During Treatment
NCT00499408 (3) [back to overview]Number of Adverse Events, Grades 1-5
NCT00524680 (4) [back to overview]Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls
NCT00524680 (4) [back to overview]Toxicity
NCT00524680 (4) [back to overview]Pattern of Response of Parathormone
NCT00524680 (4) [back to overview]Pattern of Response of Serum 25(OH) D3 Levels
NCT00529373 (92) [back to overview]Base Study: Incidence Rate of Femoral Shaft Fractures Confirmed by Adjudication
NCT00529373 (92) [back to overview]Base Study: Incidence Rate of Atypical Femoral Shaft Fractures Confirmed by Adjudication
NCT00529373 (92) [back to overview]Base Study + First Extension: Time to First New Onset ECG-Confirmed Atrial Fibrillation or Atrial Flutter Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study + First Extension: Time to First New Onset Atrial Fibrillation or Atrial Flutter Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study + First Extension: Time to First Hospitalization for Unstable Angina Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study + First Extension: Time to First Fatal Stroke Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study + First Extension: Time to First Fatal or Non-Fatal Stroke Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study + First Extension: Time to First Fatal or Non-Fatal Myocardial Infarction Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study + First Extension: Time to First Fatal Myocardial Infarction Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study + First Extension: Time to First Cardiovascular Death Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study + First Extension: Time to First Any Atrial Fibrillation or Atrial Flutter Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study + First Extension: Time to First All-Cause Death Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study + First Extension: Time to First 4-Point MACE Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study + First Extension: Time to First 3-Point MACE Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study + First Extension: Time From Baseline to First Osteoporotic Clinical Vertebral Fracture (Adjudicated)
NCT00529373 (92) [back to overview]Base Study + First Extension: Time From Baseline to First Osteoporotic Clinical Non-Vertebral Fracture (Adjudicated)
NCT00529373 (92) [back to overview]Base Study + First Extension: Time From Baseline to First Osteoporotic Clinical Hip Fracture (Adjudicated)
NCT00529373 (92) [back to overview]Base Study + First Extension: Time From Baseline to First Osteoporotic Clinical Fracture (Adjudicated)
NCT00529373 (92) [back to overview]Base Study + First Extension: Time From Baseline to First Morphometrically-Assessed Vertebral Fracture
NCT00529373 (92) [back to overview]Base Study + First Extension: Rate of Discontinuations From Study Treatment Due to an Adverse Event
NCT00529373 (92) [back to overview]Base Study + First Extension: Rate of Adverse Events
NCT00529373 (92) [back to overview]Base Study + First Extension: Incidence Rate of Femoral Shaft Fractures Confirmed by Adjudication
NCT00529373 (92) [back to overview]Base Study + First Extension: Incidence Rate of Atypical Femoral Shaft Fractures Confirmed by Adjudication
NCT00529373 (92) [back to overview]Sarcopenia Substudy PN035: Change From Baseline in Short Physical Performance Battery (SPPB) Score
NCT00529373 (92) [back to overview]Sarcopenia Substudy PN035: Change From Baseline in Gait Speed
NCT00529373 (92) [back to overview]Sarcopenia Substudy PN035: Change From Baseline in Appendicular Lean Body Mass (aLBM)
NCT00529373 (92) [back to overview]Base Study: Percent Change From Baseline in Urinary N-Telopeptides of Type I Collagen/Creatinine (u-NTx/Cr) Ratio After Log-Transformation
NCT00529373 (92) [back to overview]Base Study: Percent Change From Baseline in Serum C-Telopeptides of Type I Collagen (s-CTx) After Log-Transformation
NCT00529373 (92) [back to overview]Base Study: Percent Change From Baseline in N-Terminal Propeptide of Type 1 Collagen (P1NP) After Log-Transformation
NCT00529373 (92) [back to overview]Base Study: Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) After Log-Transformation
NCT00529373 (92) [back to overview]Base Study: Percent Change From Baseline in BMD Measurements of the Trochanter in Bisphosphonate-Intolerant Participants
NCT00529373 (92) [back to overview]Base Study: Percent Change From Baseline in BMD Measurements of the Trochanter
NCT00529373 (92) [back to overview]Base Study: Percent Change From Baseline in BMD Measurements of the Total Hip in Bisphosphonate-Intolerant Participants
NCT00529373 (92) [back to overview]Base Study: Percent Change From Baseline in BMD Measurements of the Total Hip
NCT00529373 (92) [back to overview]Base Study: Percent Change From Baseline in BMD Measurements of the Lumbar Spine in Bisphosphonate-Intolerant Participants
NCT00529373 (92) [back to overview]Base Study: Percent Change From Baseline in BMD Measurements of the Lumbar Spine
NCT00529373 (92) [back to overview]Base Study: Percent Change From Baseline in BMD Measurements of the Femoral Neck in Bisphosphonate-Intolerant Participants
NCT00529373 (92) [back to overview]Base Study: Percent Change From Baseline in BMD Measurements of the Femoral Neck
NCT00529373 (92) [back to overview]Base Study: Percent Change From Baseline in BMD Measurements of the Distal-Third Forearm in Bisphosphonate-Intolerant Participants
NCT00529373 (92) [back to overview]Base Study: Percent Change From Baseline in BMD Measurements of the Distal-Third Forearm in Bisphosphonate-Intolerant Participants
NCT00529373 (92) [back to overview]Base Study: Percent Change From Baseline in BMD Measurements of the Distal-Third Forearm
NCT00529373 (92) [back to overview]Base Study: Number of Participants With Height Loss of > 1 cm
NCT00529373 (92) [back to overview]Base Study + First Extension: Percent Change From Baseline in BMD Measurements of the Trochanter
NCT00529373 (92) [back to overview]Base Study + First Extension: Percent Change From Baseline in BMD Measurements of the Total Hip
NCT00529373 (92) [back to overview]Base Study + First Extension: Percent Change From Baseline in BMD Measurements of the Lumbar Spine
NCT00529373 (92) [back to overview]Base Study + First Extension: Percent Change From Baseline in BMD Measurements of the Femoral Neck
NCT00529373 (92) [back to overview]Base Study + First Extension: Percent Change From Baseline in BMD Measurements of the Distal-Third Forearm
NCT00529373 (92) [back to overview]Base Study + First Extension + Second Extension: Percent Change From Baseline in Bone Mineral Density (BMD) Measurements of the Total Hip
NCT00529373 (92) [back to overview]Base Study + First Extension + Second Extension: Percent Change From Baseline in BMD Measurements of the Trochanter
NCT00529373 (92) [back to overview]Base Study + First Extension + Second Extension: Percent Change From Baseline in BMD Measurements of the Lumbar Spine
NCT00529373 (92) [back to overview]Base Study + First Extension + Second Extension: Percent Change From Baseline in BMD Measurements of the Femoral Neck
NCT00529373 (92) [back to overview]Second Extension: Time From Baseline to First Osteoporotic Clinical Fracture of Any Type (Adjudicated)
NCT00529373 (92) [back to overview]Second Extension: Number of Participants Who Experienced an Adverse Event
NCT00529373 (92) [back to overview]Second Extension: Number of Participants Discontinuing Study Treatment Due to an Adverse Event
NCT00529373 (92) [back to overview]Second Extension: Incidence of Osteoporotic Clinical Thoracic Vertebral Fracture (Adjudicated)
NCT00529373 (92) [back to overview]Second Extension: Incidence of Osteoporotic Clinical Lumbar Vertebral Fracture (Adjudicated)
NCT00529373 (92) [back to overview]Imaging Substudy PN032-Base: Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at the Lumbar Spine Using Quantitative Computed Tomography
NCT00529373 (92) [back to overview]Imaging Substudy PN032-Base: Percent Change From Baseline in u-NTx/Cr Ratio After Log-Transformation
NCT00529373 (92) [back to overview]Imaging Substudy PN032-Base: Percent Change From Baseline in s-CTx After Log-Transformation
NCT00529373 (92) [back to overview]Imaging Substudy PN032-Base: Percent Change From Baseline in P1NP After Log-Transformation
NCT00529373 (92) [back to overview]Imaging Substudy PN032-Base: Percent Change From Baseline in Cortical vBMD of the Total Hip Using Quantitative Computed Tomography
NCT00529373 (92) [back to overview]Imaging Substudy PN032-Base: Percent Change From Baseline in BSAP After Log-Transformation
NCT00529373 (92) [back to overview]Imaging Substudy PN032-Base: Percent Change From Baseline in Areal BMD (aBMD) of the Lumbar Spine Using DXA
NCT00529373 (92) [back to overview]Imaging Substudy PN032-Base: Percent Change From Baseline in aBMD of the Trochanter Using DXA
NCT00529373 (92) [back to overview]Imaging Substudy PN032-Base: Percent Change From Baseline in aBMD of the Total Hip Using DXA
NCT00529373 (92) [back to overview]Imaging Substudy PN032-Base: Percent Change From Baseline in aBMD of the Femoral Neck Using DXA
NCT00529373 (92) [back to overview]Imaging Substudy PN032-Base: Percent Change From Baseline in aBMD of the Distal-Third Forearm Using DXA
NCT00529373 (92) [back to overview]Imaging Substudy PN032-Base + Extension: Percent Change From Baseline in vBMD at the Lumbar Spine Using Quantitative Computed Tomography
NCT00529373 (92) [back to overview]Imaging Substudy PN032-Base + Extension: Percent Change From Baseline in Cortical vBMD of the Total Hip Using Quantitative Computed Tomography
NCT00529373 (92) [back to overview]Imaging Substudy PN032-Base + Extension: Percent Change From Baseline in aBMD of the Trochanter Using DXA
NCT00529373 (92) [back to overview]Imaging Substudy PN032-Base + Extension: Percent Change From Baseline in aBMD of the Total Hip Using DXA
NCT00529373 (92) [back to overview]Imaging Substudy PN032-Base + Extension: Percent Change From Baseline in aBMD of the Lumbar Spine Using DXA
NCT00529373 (92) [back to overview]Imaging Substudy PN032-Base + Extension: Percent Change From Baseline in aBMD of the Femoral Neck Using DXA
NCT00529373 (92) [back to overview]Base Study: Yearly Rate of Height Loss
NCT00529373 (92) [back to overview]Base Study: Time to First New Onset ECG-Confirmed Atrial Fibrillation or Atrial Flutter Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study: Time to First New Onset Atrial Fibrillation or Atrial Flutter Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study: Time to First Hospitalization for Unstable Angina Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study: Time to First Fatal Stroke Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study: Time to First Fatal or Non-Fatal Stroke Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study: Time to First Fatal or Non-Fatal Myocardial Infarction Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study: Time to First Fatal Myocardial Infarction Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study: Time to First Cardiovascular Death Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study: Time to First Any Atrial Fibrillation or Atrial Flutter Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study: Time to First All-Cause Death Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study: Time to First 4-Point MACE Confirmed by TIMI Adjudication
NCT00529373 (92) [back to overview]Base Study: Time to First 3-Point Major Adverse Cardiac Event (MACE) Confirmed by Thrombolysis in Myocardial Infarction Study Group (TIMI) Adjudication
NCT00529373 (92) [back to overview]Base Study: Time From Baseline to First Osteoporotic Clinical Vertebral Fracture (Adjudicated)
NCT00529373 (92) [back to overview]Base Study: Time From Baseline to First Osteoporotic Clinical Non-Vertebral Fracture (Adjudicated)
NCT00529373 (92) [back to overview]Base Study: Time From Baseline to First Osteoporotic Clinical Hip Fracture (Adjudicated)
NCT00529373 (92) [back to overview]Base Study: Time From Baseline to First Morphometrically-Assessed Vertebral Fracture
NCT00529373 (92) [back to overview]Base Study: Rate of Discontinuation From Study Treatment Due to an Adverse Event
NCT00529373 (92) [back to overview]Base Study: Rate of Adverse Events
NCT00552409 (1) [back to overview]Change in Urine Albumin Excretion
NCT00581828 (1) [back to overview]Change in Intestinal Calcium Absorption From Baseline to One Month
NCT00610688 (3) [back to overview]Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement
NCT00610688 (3) [back to overview]Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth
NCT00610688 (3) [back to overview]Birthweight of Newborn Infant
NCT00620113 (11) [back to overview]Number of Participants That Discontinued Study Drug Due to an AE
NCT00620113 (11) [back to overview]Number of Participants That Experienced an Adverse Event (AE)
NCT00620113 (11) [back to overview]Percent Change From Baseline to Week 52 in Femoral Neck BMD
NCT00620113 (11) [back to overview]Percent Change From Baseline to Week 52 in Lumbar Spine Bone Mineral Density (BMD) at Lumbar Vertebrae 1 to 4 (L1-L4)
NCT00620113 (11) [back to overview]Percent Change From Baseline to Week 52 in Serum Bone Specific Alkaline Phosphatase (s-BSAP) Level
NCT00620113 (11) [back to overview]Percent Change From Baseline to Week 52 in Serum C-Telopeptides of Type 1 Collagen (s-CTx) Level
NCT00620113 (11) [back to overview]Percent Change From Baseline to Week 52 in Serum N-Terminal Propeptides of Type 1 Collagen (s-P1NP) Level
NCT00620113 (11) [back to overview]Percent Change From Baseline to Week 52 in Total Hip BMD
NCT00620113 (11) [back to overview]Percent Change From Baseline to Week 52 in Trochanter BMD
NCT00620113 (11) [back to overview]Percent Change From Baseline to Week 52 in Urinary Deoxypyridinoline/Creatinine Ratio (u-DPD/Cre)
NCT00620113 (11) [back to overview]Percent Change From Baseline to Week 52 in Urinary N-telopeptides/Creatinine (u-NTx/Cre) Ratio
NCT00621257 (2) [back to overview]Treatment of Low 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease
NCT00621257 (2) [back to overview]Maintenance of 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease
NCT00674154 (1) [back to overview]Decrease in Preoperative P-PTH
NCT00677534 (1) [back to overview]Change in Monocyte VDR Expression With Vitamin D Therapy
NCT00681590 (2) [back to overview]Number of Participants Who Develop Hypercalcemia
NCT00681590 (2) [back to overview]Change From Baseline in Serum 25-hydroxyvitamin D Levels
NCT00692913 (8) [back to overview]Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density
NCT00692913 (8) [back to overview]Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52
NCT00692913 (8) [back to overview]Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26
NCT00692913 (8) [back to overview]Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio
NCT00692913 (8) [back to overview]Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase
NCT00692913 (8) [back to overview]Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio
NCT00692913 (8) [back to overview]Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase
NCT00692913 (8) [back to overview]Falls Per Participant
NCT00710021 (27) [back to overview]Change in Serum C4 Level From Baseline to Week 12
NCT00710021 (27) [back to overview]Change in Serum C4 Level From Baseline to Week 6
NCT00710021 (27) [back to overview]Constitutional BILAG Status at Week 12
NCT00710021 (27) [back to overview]Gastrointestinal BILAG Status at Week 12
NCT00710021 (27) [back to overview]Hematological BILAG Status at Week 12
NCT00710021 (27) [back to overview]Mucocutaneous BILAG Status at Week 12
NCT00710021 (27) [back to overview]Musculoskeletal BILAG Status at Week 12
NCT00710021 (27) [back to overview]Ophthalmic BILAG Status at Week 12
NCT00710021 (27) [back to overview]Neuropsychiatric BILAG Status at Week 12
NCT00710021 (27) [back to overview]Percent of Participants With Adverse Events of Grade 3 or Above
NCT00710021 (27) [back to overview]Percent of Participants With an IFN Alpha Signature Response at Week 12
NCT00710021 (27) [back to overview]Percent of Participants With an IFN Alpha Signature Response at Week 6
NCT00710021 (27) [back to overview]Percent of Participants With IFN Alpha Signature at Week 12
NCT00710021 (27) [back to overview]Percent of Participants With IFN Alpha Signature at Week 6
NCT00710021 (27) [back to overview]qRT-PCR Fold Change in Ifi44 Gene Expression From Baseline to Week 12
NCT00710021 (27) [back to overview]qRT-PCR Fold Change in Ifi44 Gene Expression From Baseline to Week 6
NCT00710021 (27) [back to overview]qRT-PCR Fold Change in Ifit1 Gene Expression From Baseline to Week 12
NCT00710021 (27) [back to overview]qRT-PCR Fold Change in Ifit1 Gene Expression From Baseline to Week 6
NCT00710021 (27) [back to overview]qRT-PCR Fold Change in Mx1 Gene Expression From Baseline to Week 12
NCT00710021 (27) [back to overview]Renal BILAG Status at Week 12
NCT00710021 (27) [back to overview]Change in Status for Anti-double-stranded DNA Autoantibody From Baseline to Week 12
NCT00710021 (27) [back to overview]Change in Status for Anti-double-stranded DNA Autoantibody From Baseline to Week 6
NCT00710021 (27) [back to overview]qRT-PCR Fold Change in Mx1 Gene Expression From Baseline to Week 6
NCT00710021 (27) [back to overview]Cardiorespiratory BILAG Status at Week 12
NCT00710021 (27) [back to overview]Change in SELENA-SLEDAI Total Score From Baseline to Week 12
NCT00710021 (27) [back to overview]Change in Serum C3 Level From Baseline to Week 12
NCT00710021 (27) [back to overview]Change in Serum C3 Level From Baseline to Week 6
NCT00729183 (14) [back to overview]Percent Change From Baseline in Serum N-Terminal Propeptides of Type 1 Collagen (s-P1NP) Level
NCT00729183 (14) [back to overview]Percent Change From Baseline in Total Hip aBMD
NCT00729183 (14) [back to overview]Percent Change From Baseline in Total Radius aBMD
NCT00729183 (14) [back to overview]Percent Change From Baseline in Trabecular vBMD at Central Section of Spine (L2)
NCT00729183 (14) [back to overview]Percent Change From Baseline in Trabecular Volumetric Bone Mineral Density (vBMD) at Central Section of Spine (L1)
NCT00729183 (14) [back to overview]Percent Change From Baseline in Ultradistal Radius aBMD
NCT00729183 (14) [back to overview]Percent Change From Baseline in Femoral Neck aBMD
NCT00729183 (14) [back to overview]Percent Change From Baseline in Hip Trochanter aBMD
NCT00729183 (14) [back to overview]Percent Change From Baseline in Serum C-Terminal Telopeptides of Type 1 Collagen (s-CTx) Level
NCT00729183 (14) [back to overview]Percent Change From Baseline to Month 24 in Lumbar Spine aBMD
NCT00729183 (14) [back to overview]Percent Change From Baseline to Month 12 in Lumbar Spine Areal Bone Mineral Density (aBMD)
NCT00729183 (14) [back to overview]Percentage of Participants That Discontinued Study Treatment Due to an AE
NCT00729183 (14) [back to overview]Percentage of Participants That Experienced an Adverse Event (AE)
NCT00729183 (14) [back to overview]Percent Change From Baseline in Distal Radius aBMD
NCT00729651 (4) [back to overview]Mean Serum 25 OHD(Serum 25-hydroxyvitamin D) at 16 Weeks of Treatment
NCT00729651 (4) [back to overview]Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment
NCT00729651 (4) [back to overview]Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment
NCT00729651 (4) [back to overview]Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Less and Greater Than 20 ng/ml at 16 Weeks of Treatment
NCT00732758 (4) [back to overview]Serum 25-hydroxyvitamin D
NCT00732758 (4) [back to overview]Osteocalcin (OC)
NCT00732758 (4) [back to overview]Parathyroid Hormone (PTH) Dietary Data
NCT00732758 (4) [back to overview]Collagen Type 1 Cross-linked C-telopeptide (CTx)
NCT00736632 (9) [back to overview]Serum Calcium
NCT00736632 (9) [back to overview]Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)
NCT00736632 (9) [back to overview]hsCRP
NCT00736632 (9) [back to overview]HbA1C
NCT00736632 (9) [back to overview]Fasting Glucose
NCT00736632 (9) [back to overview]Brachial Artery Reactivity Testing
NCT00736632 (9) [back to overview]Macrophage Cholesterol Metabolism
NCT00736632 (9) [back to overview]Vitamin D
NCT00736632 (9) [back to overview]Urine Calcium to Creatinine Ratio.
NCT00742781 (3) [back to overview]25(OH)D3 Serum Levels
NCT00742781 (3) [back to overview]Crohn's Disease Activity Index
NCT00742781 (3) [back to overview]Health Improvement
NCT00743574 (6) [back to overview]Serum Levels of C-reactive Protein at Completion of 3 Months Treatment
NCT00743574 (6) [back to overview]Fasting Glucose Levels at Completion of Treatment, at 3 Months
NCT00743574 (6) [back to overview]AUC (Area Under a Curve at 0, 0.5, 1, 1.5 and 2 Hours) Insulin During 2 Hour GTT at Completion, at 3 Months
NCT00743574 (6) [back to overview]Fasting Insulin Levels at Study Completion After 3 Month Treatment
NCT00743574 (6) [back to overview]AUC (Area Under the Curve at 0, 0.5, 1, 1.5 and 2 Hours) During Oral GTT at Completion, at 3 Months
NCT00743574 (6) [back to overview]Serum HbA1C at 3 Months
NCT00752557 (7) [back to overview]Number of Participants With Any Significant Changes in Serum Biomarkers of Bone Turnover From Baseline
NCT00752557 (7) [back to overview]Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA)
NCT00752557 (7) [back to overview]Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck
NCT00752557 (7) [back to overview]Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip
NCT00752557 (7) [back to overview]Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC)
NCT00752557 (7) [back to overview]Number Participant Responses to Injectability Questionnaire Injected Population
NCT00752557 (7) [back to overview]Percentage Change From Baseline in Areal Bone Mineral Density (BMD) for Contralateral Total Hip
NCT00772772 (2) [back to overview]Change in Endotoxin Activity
NCT00772772 (2) [back to overview]25-hydroxy Vitamin D (25-OH Vitamin D)
NCT00779909 (8) [back to overview]Maxillary Modified Gingival Index (MGI) Score
NCT00779909 (8) [back to overview]Urinary Calcium/Creatinine Ratio
NCT00779909 (8) [back to overview]Mandibular Modified Gingival Index (MGI) Score
NCT00779909 (8) [back to overview]Mandibular Plaque Index (PI) Score
NCT00779909 (8) [back to overview]Gingival Crevicular Fluid (GCF) Concentrations of TNF-alpha, IL1-beta, IL-2, IL-12
NCT00779909 (8) [back to overview]Gingival Crevicular Fluid (GCF) Volume
NCT00779909 (8) [back to overview]Serum Calcium
NCT00779909 (8) [back to overview]Maxillary Plaque Index (PI) Score
NCT00789880 (9) [back to overview]Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
NCT00789880 (9) [back to overview]Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
NCT00789880 (9) [back to overview]Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
NCT00789880 (9) [back to overview]Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
NCT00789880 (9) [back to overview]Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo
NCT00789880 (9) [back to overview]Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo
NCT00789880 (9) [back to overview]Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
NCT00789880 (9) [back to overview]Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo
NCT00789880 (9) [back to overview]Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo
NCT00803712 (30) [back to overview]Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 12
NCT00803712 (30) [back to overview]Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 12 Efficacy Assessment Phase
NCT00803712 (30) [back to overview]Subject Incidence of Hypercalcemia During the Maintenance Phase
NCT00803712 (30) [back to overview]Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 12
NCT00803712 (30) [back to overview]Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 6
NCT00803712 (30) [back to overview]Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 6
NCT00803712 (30) [back to overview]Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
NCT00803712 (30) [back to overview]Achievement of a >= 30% Reduction in Mean iPTH From Baseline to During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
NCT00803712 (30) [back to overview]Subject Incidence of Hyperphosphatemia During the Maintenance Phase
NCT00803712 (30) [back to overview]Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
NCT00803712 (30) [back to overview]Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
NCT00803712 (30) [back to overview]Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
NCT00803712 (30) [back to overview]Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
NCT00803712 (30) [back to overview]Achievement of a Mean iPTH <=300 pg/mL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
NCT00803712 (30) [back to overview]Summary of Percent Change From Baseline in Serum Phosphorus at Month 6 Efficacy Assessment Phase
NCT00803712 (30) [back to overview]Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
NCT00803712 (30) [back to overview]Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)
NCT00803712 (30) [back to overview]Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
NCT00803712 (30) [back to overview]Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)
NCT00803712 (30) [back to overview]Summary of Serum Phosphorus (mg/dL) at Month 6 Efficacy Assessment Phase
NCT00803712 (30) [back to overview]Summary of Serum Phosphorus (mg/dL) at Month 12 Efficacy Assessment Phase
NCT00803712 (30) [back to overview]Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)
NCT00803712 (30) [back to overview]Summary of Percent Change From Baseline in Serum Phosphorus at Month 12 Efficacy Assessment Phase
NCT00803712 (30) [back to overview]Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 6 Efficacy Assessment Phase
NCT00803712 (30) [back to overview]Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 6 Efficacy Assessment Phase
NCT00803712 (30) [back to overview]Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 12 Efficacy Assessment Phase
NCT00803712 (30) [back to overview]Summary of iPTH (pg/mL) at Month 6 Efficacy Assessment Phase
NCT00803712 (30) [back to overview]Summary of iPTH (pg/mL) at Month 12 Efficacy Assessment Phase
NCT00803712 (30) [back to overview]Summary of Corrected Serum Calcium (mg/dL) at Month 6 Efficacy Assessment Phase
NCT00803712 (30) [back to overview]Summary of Corrected Serum Calcium (mg/dL) at Month 12 Efficacy Assessment Phase
NCT00803790 (3) [back to overview]Part 1: Urinary Excretion of Alendronate
NCT00803790 (3) [back to overview]Part II: AUC (Area Under the Plasma Concentration-time Curve) of Vitamin D
NCT00803790 (3) [back to overview]Part II : Maximum Concentration (Cmax) of Vitamin D
NCT00806416 (3) [back to overview]Part 1: The Total Urinary Excretion of Alendronate With Alendronate/Vitamin D Combination Tablet Relative to Alendronate Tablet
NCT00806416 (3) [back to overview]Part II : The Pharmacokinetic Parameters Cmax of Vitamin D in Combination Tablet Relative to Vitamin D Tablet
NCT00806416 (3) [back to overview]Part II : The Pharmacokinetic Parameters AUC0-120 hr of Vitamin D in Combination Tablet Relative to Vitamin D Tablet
NCT00858247 (6) [back to overview]Change in High Density Lipoprotein (HDL) Cholesterol After 12 Weeks of Vitamin D Supplementation
NCT00858247 (6) [back to overview]Change in Insulin Resistance After 12 Weeks of Vitamin D3 Supplementation
NCT00858247 (6) [back to overview]Change in Low Density Lipoprotein (LDL) Cholesterol After 12 Weeks of Vitamin D Supplementation
NCT00858247 (6) [back to overview]Change in Total Cholesterol After 12 Weeks of Vitamin D Supplementation
NCT00858247 (6) [back to overview]Change in Triglycerides After 12 Weeks of Vitamin D Supplementation
NCT00858247 (6) [back to overview]Change in High-Sensitivity C-Reactive Protein After 12 Weeks of Vitamin D Supplementation
NCT00859651 (2) [back to overview]Change in Serum 25(OH)D
NCT00859651 (2) [back to overview]Change in Percent Density
NCT00867217 (1) [back to overview]Number of Participants With Worsening of Musculoskeletal Symptoms (MS)
NCT00885170 (25) [back to overview]Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 12
NCT00885170 (25) [back to overview]Percent Change From Baseline in Log-Transformed Serum C-Telopeptides of Type I Collagen (s-CTx) at Month 24
NCT00885170 (25) [back to overview]Percentage of Participants Discontinuing Study Drug Due to an AE
NCT00885170 (25) [back to overview]Percent Change From Baseline in Trochanter BMD at Month 24
NCT00885170 (25) [back to overview]Percent Change From Baseline in Trochanter BMD at Month 12
NCT00885170 (25) [back to overview]Percent Change From Baseline in Total Hip BMD at Month 24
NCT00885170 (25) [back to overview]Percent Change From Baseline in Total Hip BMD at Month 12
NCT00885170 (25) [back to overview]Percent Change From Baseline in Lumbar Spine BMD at Month 24
NCT00885170 (25) [back to overview]Percent Change From Baseline in Lumbar Spine BMD at Month 12
NCT00885170 (25) [back to overview]Percent Change From Baseline in Log-Transformed Urine N-Telopeptides/Creatinine Ratio at Month 24
NCT00885170 (25) [back to overview]Percent Change From Baseline in Log-Transformed u-NTx/Cr at Month 12
NCT00885170 (25) [back to overview]Percent Change From Baseline in Log-Transformed Serum Phosphate at Month 24
NCT00885170 (25) [back to overview]Percent Change From Baseline in Log-Transformed Serum Parathyroid Hormone at Month 24
NCT00885170 (25) [back to overview]Percent Change From Baseline in Log-Transformed Serum N-Terminal Propeptide of Type I Collagen at Month 24
NCT00885170 (25) [back to overview]Percent Change From Baseline in Log-Transformed Serum N-terminal Propeptide of Type I Collagen at Month 12
NCT00885170 (25) [back to overview]Percent Change From Baseline in Log-Transformed Serum Calcium at Month 24
NCT00885170 (25) [back to overview]Percentage of Participants Experiencing One or More Adverse Events (AEs)
NCT00885170 (25) [back to overview]Percent Change From Baseline in Log-Transformed Serum BSAP at Month 12
NCT00885170 (25) [back to overview]Percent Change From Baseline in Log-Transformed Serum Bone-Specific Alkaline Phosphatase at Month 24
NCT00885170 (25) [back to overview]Percent Change From Baseline in Log-Transformed Serum 25-Hydroxyvitamin D at Month 24
NCT00885170 (25) [back to overview]Percent Change From Baseline in Log-Transformed Serum 1,25 Dihydroxyvitamin D at Month 24
NCT00885170 (25) [back to overview]Percent Change From Baseline in Log-Transformed s-CTx at Month 12
NCT00885170 (25) [back to overview]Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24
NCT00885170 (25) [back to overview]Percent Change From Baseline in Femoral Neck BMD at Month 12
NCT00885170 (25) [back to overview]Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 24
NCT00886379 (1) [back to overview]Serum 25-hydroxyvitamin D Concentrations in Schoolchildren
NCT00887432 (2) [back to overview]PSA Response
NCT00887432 (2) [back to overview]Slope of PSA Concentration Over Time
NCT00892099 (6) [back to overview]Serum 25D Level
NCT00892099 (6) [back to overview]Serum Calcium
NCT00892099 (6) [back to overview]Serum 25-OH Vitamin D
NCT00892099 (6) [back to overview]Serum 1,25(OH)2 Levels
NCT00892099 (6) [back to overview]Parathyroid Hormone
NCT00892099 (6) [back to overview]Serum Phosphate
NCT00903344 (6) [back to overview]Change in Bone Mineral Density (BMD) at HIP at 3 Months
NCT00903344 (6) [back to overview]Change in Bone Mineral Density (BMD) in HIP at 6 Months
NCT00903344 (6) [back to overview]Change in 25-hyroxyvitamin D Levels at 3 Months
NCT00903344 (6) [back to overview]Change in 25-hyroxyvitamin D Levels at 6 Months
NCT00903344 (6) [back to overview]Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months
NCT00903344 (6) [back to overview]Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months
NCT00912782 (2) [back to overview]Arteriovenous Fistulae Maturation
NCT00912782 (2) [back to overview]25-hydroxyvitamin D and Serum Calcium
NCT00914810 (2) [back to overview]Change in Blood Level of Vitamin D (25-hydroxyvitamin D)
NCT00914810 (2) [back to overview]Change in Short Physical Performance Battery (SPPB) Score
NCT00920621 (8) [back to overview]Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 1 Year Visit.
NCT00920621 (8) [back to overview]Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 3 Year Visit.
NCT00920621 (8) [back to overview]Mass Spec Vitamin D Value From Cord Blood at Delivery
NCT00920621 (8) [back to overview]Parental Report of Physician Diagnosis of Lower Respiratory Tract Infection in the Child's First 3 Years of Life.
NCT00920621 (8) [back to overview]Fecal Microbiome Profile
NCT00920621 (8) [back to overview]Sphingolipid Profile
NCT00920621 (8) [back to overview]Sphingolipid Profile
NCT00920621 (8) [back to overview]Child Positive-specific IgE Tests From Blood Collection at 3 Year Visit.
NCT00933244 (4) [back to overview]Bone Mineral Density
NCT00933244 (4) [back to overview]Muscle Function: One Year Change in Timed Up and Go Test, Five Sit-to-Stand Test
NCT00933244 (4) [back to overview]Intestinal Calcium Absorption
NCT00933244 (4) [back to overview]Bone Turnover
NCT00953225 (2) [back to overview]Number of Positive Biopsy Cores (Out of Twelve) Compared to the Corresponding Values Assessed Before Enrollment
NCT00953225 (2) [back to overview]PSA Slope (Trajectory) or the Change in PSA Level Over Time
NCT00956839 (2) [back to overview]Serum Total Calcium
NCT00956839 (2) [back to overview]Percentage of Patients With Serum 25 Hydroxy Vitamin D3 > 30 ng/ml
NCT00960934 (17) [back to overview]LS Mean Percent Change From Baseline to Month 6 in Distal One-third Forearm Areal BMD
NCT00960934 (17) [back to overview]Percentage of Participants With Bone Neoplasms
NCT00960934 (17) [back to overview]Percentage of Participants With Albumin-Corrected Calcium Levels Outside the Pre-defined Limits of Change
NCT00960934 (17) [back to overview]LS Mean Percent Change From Baseline to Month 6 in Serum Procollagen Type I N-Terminal Propeptide (P1NP)
NCT00960934 (17) [back to overview]LS Mean Percent Change From Baseline to Month 6 in Serum Osteocalcin
NCT00960934 (17) [back to overview]LS Mean Percent Change From Baseline to Month 6 in Serum C-Terminal Telopeptide Collagen I (s-CTx)
NCT00960934 (17) [back to overview]Percentage of Participants With Total Serum Calcium Levels Outside the Pre-defined Limits of Change
NCT00960934 (17) [back to overview]LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Lumbar Spine
NCT00960934 (17) [back to overview]LS Mean Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (s-BSAP)
NCT00960934 (17) [back to overview]LS Mean Percent Change From Baseline to Month 6 in Femoral Neck aBMD
NCT00960934 (17) [back to overview]Least Squares (LS) Mean Percent Change From Baseline to Month 6 in Lumbar Spine Areal Bone Mineral Density (aBMD)
NCT00960934 (17) [back to overview]LS Mean Percent Change From Baseline to Month 6 in Trochanter aBMD
NCT00960934 (17) [back to overview]LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Hip
NCT00960934 (17) [back to overview]Percentage of Participants With Kidney Stones
NCT00960934 (17) [back to overview]LS Mean Percent Change From Baseline to Month 6 in Total Hip aBMD
NCT00960934 (17) [back to overview]LS Mean Percent Change From Baseline to Month 6 in Total Body aBMD
NCT00960934 (17) [back to overview]LS Mean Percent Change From Baseline to Month 6 in the Ratio of Urinary N-Telopeptides of Type I Collagen to Creatinine (u-NTx/Cr)
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Serum N-Terminal Propeptide (s-P1NP)
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Total Body Areal BMD
NCT00996801 (17) [back to overview]Number of Participants With Trough Serum Calcium Level Exceeding Predefined Limits At Least Once
NCT00996801 (17) [back to overview]Number of Participants With Predefined Tier 1 Adverse Events
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Urinary-N Telopeptides of Type 1 Collagen (u-NTx)
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Trochanter Areal BMD
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Trabecular Volumetric BMD of the Hip
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Serum C-Terminal Propeptide of Type 1 Collagen (s-CTx)
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Trabecular Volumetric BMD (vBMD) of the Lumbar Spine
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in 1/3 Distal Forearm Areal BMD
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline To Month 12 in Lumbar Spine Areal Bone Mineral Density (BMD)
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Femoral Neck Areal BMD
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Cortical Volumetric BMD of the Lumbar Spine
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Cortical Volumetric BMD of the Hip
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Total Hip Areal BMD
NCT00996801 (17) [back to overview]Number of Participants With Trough Albumin-Corrected Calcium Level Exceeding Predefined Limits At Least Once
NCT00996801 (17) [back to overview]Least Squares Mean Percent Change From Baseline to Month 12 in Serum Bone-Specific Alkaline Phosphatase (s-BSAP)
NCT00996866 (2) [back to overview]Mean Level of 25(OH)D
NCT00996866 (2) [back to overview]Mean Level of 25(OH)D
NCT01005303 (9) [back to overview]Serum Tumor Necrosis Factor-alpha (TNF-α) Concentration
NCT01005303 (9) [back to overview]Serum N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Concentration
NCT01005303 (9) [back to overview]Serum Interleukin-6 (IL-6) Concentration
NCT01005303 (9) [back to overview]Serum C-reactive Protein (CRP) Concentration
NCT01005303 (9) [back to overview]Urinary 8-iso-prostaglandin F2 Alpha (8-iso-PGF2α) Concentration
NCT01005303 (9) [back to overview]Left Ventricular Ejection Fraction
NCT01005303 (9) [back to overview]Quality of Life Questionnaire Score
NCT01005303 (9) [back to overview]Serum Interleukin-10 (IL-10) Concentration
NCT01005303 (9) [back to overview]Six Minute Walk Test Distance
NCT01029392 (2) [back to overview]Change in Insulin Requirements
NCT01029392 (2) [back to overview]Change in Hemoglobin A1c
NCT01068418 (2) [back to overview]The Change in the Mean Arterial Blood Pressure in Response to an Infusion of Angiotensin II
NCT01068418 (2) [back to overview]The Change in Renal Blood Flow in Response to an Infusion of Angiotensin II
NCT01074216 (1) [back to overview]To Achieve Target Vitamin D Level
NCT01092338 (2) [back to overview]Safety
NCT01092338 (2) [back to overview]Efficacy of the Two Doses (4000 and 7000 IU/d)
NCT01102374 (13) [back to overview]Number of Other Infections
NCT01102374 (13) [back to overview]Number of Acute Respiratory Infections (ARIs)
NCT01102374 (13) [back to overview]Incident Kidney Stones
NCT01102374 (13) [back to overview]Incident Hypercalcemia
NCT01102374 (13) [back to overview]Change in 25-hydroxyvitamin D (25OHD) Level
NCT01102374 (13) [back to overview]Death
NCT01102374 (13) [back to overview]Number of Lower Respiratory Infections
NCT01102374 (13) [back to overview]Number of Upper Respiratory Infections
NCT01102374 (13) [back to overview]Number of Urinary Tract Infections
NCT01102374 (13) [back to overview]Severity of Acute Respiratory Infections
NCT01102374 (13) [back to overview]Time to First ARI
NCT01102374 (13) [back to overview]Falls
NCT01102374 (13) [back to overview]Fractures
NCT01103934 (2) [back to overview]Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period
NCT01103934 (2) [back to overview]Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period
NCT01119131 (8) [back to overview]Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3)
NCT01119131 (8) [back to overview]Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration
NCT01119131 (8) [back to overview]Change in Cognition (Trail Making Test B-A)
NCT01119131 (8) [back to overview]Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6)
NCT01119131 (8) [back to overview]Change in Parkinsonism as Measured by the UPDRS
NCT01119131 (8) [back to overview]Change in Quality of Life as Recorded Using Quality of Life Scales (PDQ39)
NCT01119131 (8) [back to overview]Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work)
NCT01119131 (8) [back to overview]Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work)
NCT01120600 (10) [back to overview]Percentage Change From Baseline in Trochanter BMD at Month 24
NCT01120600 (10) [back to overview]Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24
NCT01120600 (10) [back to overview]Percentage Change From Baseline in Femoral Neck BMD at Month 24
NCT01120600 (10) [back to overview]Percentage Change From Baseline in Total Hip BMD at Month 24
NCT01120600 (10) [back to overview]Percentage Change From Baseline in Serum N-Terminal Propeptides of Type I Collagen (s-P1NP) at Month 24
NCT01120600 (10) [back to overview]Percentage Change From Baseline in Urine Collagen N-Telopeptide/Creatinine Ratio (U-NTx/Cr) at Month 24
NCT01120600 (10) [back to overview]Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 24
NCT01120600 (10) [back to overview]Number of Participants Who Discontinued Treatment Due to an AE
NCT01120600 (10) [back to overview]Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (s-BSAP) at Month 24
NCT01120600 (10) [back to overview]Number of Participants Who Experienced an Adverse Event (AE)
NCT01125436 (6) [back to overview]Plasma Renin Activity
NCT01125436 (6) [back to overview]Serum Aldosterone
NCT01125436 (6) [back to overview]Timed Get Up and Go
NCT01125436 (6) [back to overview]Leg Proximal Muscle Strength
NCT01125436 (6) [back to overview]Peak VO2
NCT01125436 (6) [back to overview]6 Minute Walk Distance
NCT01138475 (9) [back to overview]Osteocalcin
NCT01138475 (9) [back to overview]Serum 25 OH Vitamin D
NCT01138475 (9) [back to overview]Serum Calcium
NCT01138475 (9) [back to overview]Serum Phosphorus
NCT01138475 (9) [back to overview]The Primary Outcome Measure With iPTH
NCT01138475 (9) [back to overview]Alkaline Phosphatase
NCT01138475 (9) [back to overview]Bone Specific Alkaline Phosphatase
NCT01138475 (9) [back to overview]N-Telopeptide Cross Linked Urine
NCT01138475 (9) [back to overview]24 Hour Urine Calcium
NCT01166763 (3) [back to overview]Change in Mammographic Breast Density Over Course of Study
NCT01166763 (3) [back to overview]Change in Proliferation (as Assessed by Ki-67) Examined in Breast Epithelial Cells.
NCT01166763 (3) [back to overview]OH Vitamin D Levels in Serum
NCT01169259 (26) [back to overview]Number of Participants Who Died From Cardiovascular Causes
NCT01169259 (26) [back to overview]Number of Participants Who Died From Coronary Heart Disease
NCT01169259 (26) [back to overview]Number of Participants Who Died From Invasive Cancer of Any Type
NCT01169259 (26) [back to overview]Number of Participants Who Died From Invasive Cancer of Any Type, Excluding First 2 Years of Follow-up
NCT01169259 (26) [back to overview]Number of Participants Who Died From Myocardial Infarction
NCT01169259 (26) [back to overview]Number of Participants With Stroke
NCT01169259 (26) [back to overview]Number of Participants With Total Coronary Heart Disease
NCT01169259 (26) [back to overview]Number of Participants With a Major Cardiovascular Event, Excluding First 2 Years of Follow-up
NCT01169259 (26) [back to overview]Number of Participants With a Major Cardiovascular Event
NCT01169259 (26) [back to overview]Number of Participants With Invasive Cancer of Any Type, Excluding First 2 Years of Follow-up
NCT01169259 (26) [back to overview]Number of Participants With Ischemic Stroke
NCT01169259 (26) [back to overview]Number of Participants With Myocardial Infarction, Excluding First 2 Years of Follow-up
NCT01169259 (26) [back to overview]Number of Participants With Cardiovascular Event in Expanded Composite Cardiovascular Endpoint
NCT01169259 (26) [back to overview]Number of Participants With Percutaneous Coronary Intervention
NCT01169259 (26) [back to overview]Number of Participants With Myocardial Infarction
NCT01169259 (26) [back to overview]Number of Participants With Serrated Colorectal Polyps
NCT01169259 (26) [back to overview]Number of Female Participants With Breast Cancer
NCT01169259 (26) [back to overview]Number of Participants With Colorectal Cancer
NCT01169259 (26) [back to overview]Number of Participants With Conventional Colorectal Adenoma
NCT01169259 (26) [back to overview]Number of Male Participants With Prostate Cancer
NCT01169259 (26) [back to overview]Number of Participants Who Died From Any Cause
NCT01169259 (26) [back to overview]Number of Participants Who Died From Stroke
NCT01169259 (26) [back to overview]Number of Participants With Coronary-artery Bypass Grafting
NCT01169259 (26) [back to overview]Number of Participants With Hemorrhagic Stroke
NCT01169259 (26) [back to overview]Number of Participants Who Died From Any Cause, Excluding First 2 Years of Follow-up
NCT01169259 (26) [back to overview]Number of Participants With Invasive Cancer of Any Type
NCT01173848 (1) [back to overview]Subjects Achieving Normal Vitamin D Levels
NCT01175798 (1) [back to overview]Change in 25OH-Vitamin D Level
NCT01198132 (10) [back to overview]Number of Relapse-Free (Documented) Subjects
NCT01198132 (10) [back to overview]Annualized Relapse Rate
NCT01198132 (10) [back to overview]Cumulative Probability of Progression of Disability (Kaplan-Meier Curves)
NCT01198132 (10) [back to overview]Mean Number of Relapses Per Subject
NCT01198132 (10) [back to overview]Time to First Documented Relapse
NCT01198132 (10) [back to overview]Change From Baseline in Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L)
NCT01198132 (10) [back to overview]Change From Baseline in Measurement and Evaluation of Cognitive Ability by Paced Auditory Serial Addition Task (PASAT) Total Score At Week 96
NCT01198132 (10) [back to overview]Changes From Baseline in Measured Lesion Load (T2)
NCT01198132 (10) [back to overview]Number of New or Extended Lesions by T1- and T2-Weighted Magnetic Resonance Imaging (MRI)
NCT01198132 (10) [back to overview]Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Abnormal Clinical Laboratory
NCT01199926 (3) [back to overview]Glucose Tolerance
NCT01199926 (3) [back to overview]Inflammation
NCT01199926 (3) [back to overview]Muscle Function
NCT01214356 (1) [back to overview]Change in Urinary Albumin:Creatinine Ratio (ACR)
NCT01222234 (2) [back to overview]Monocyte Protein Expression
NCT01222234 (2) [back to overview]Change in 24,25(OH)2D Levels in CKD vs. Non-CKD Subjects Receiving Cholecalciferol
NCT01222273 (3) [back to overview]Number of Participants With Aspergillus Induced IL-13 Responses in CD4+ T-cells
NCT01222273 (3) [back to overview]Change in Patient Total IgE Levels
NCT01222273 (3) [back to overview]Change in Patient Aspergillus Specific IgE Levels
NCT01229891 (8) [back to overview]Serum Total Cholesterol (Tchol)
NCT01229891 (8) [back to overview]Serum Low Density Lipoprotein (LDL)
NCT01229891 (8) [back to overview]Serum 25-hydroxyvitamin D
NCT01229891 (8) [back to overview]Serum High Density Lipoprotein (HDL)
NCT01229891 (8) [back to overview]Insulin
NCT01229891 (8) [back to overview]Hemoglobin A1c (HbA1c)
NCT01229891 (8) [back to overview]Serum Triglyceride (TG)
NCT01229891 (8) [back to overview]Fasting Serum Glucose (FSG)
NCT01248065 (3) [back to overview]Lung Function Change From Baseline
NCT01248065 (3) [back to overview]Treatment Failure
NCT01248065 (3) [back to overview]Exacerbations
NCT01265615 (10) [back to overview]Coronary Calcium Score
NCT01265615 (10) [back to overview]GFR (Glomerular Filtration Rate)
NCT01265615 (10) [back to overview]Heart Failure (HF)
NCT01265615 (10) [back to overview]VDR (Vitamin D Receptor) Expression in Myocardium
NCT01265615 (10) [back to overview]VDR (Vitamin D Receptor) Expression in Kidney
NCT01265615 (10) [back to overview]Systolic Blood Pressure
NCT01265615 (10) [back to overview]CAD (Chronic Allograft Dysfunction) Degree
NCT01265615 (10) [back to overview]CAD (Chronic Allograft Dysfunction) Degree
NCT01265615 (10) [back to overview]Number of Circulating SP (Side Population) Stem-Progenitor Cells
NCT01265615 (10) [back to overview]Serum Creatinine
NCT01276587 (1) [back to overview]Serum 25-hydroxyvitamin D Concentration
NCT01295034 (2) [back to overview]CD4+T Cell Count
NCT01295034 (2) [back to overview]25(OH)D Levels
NCT01306656 (3) [back to overview]Trabecular Bone Density at the Forearm
NCT01306656 (3) [back to overview]Change in Urinary Calcium Level
NCT01306656 (3) [back to overview]Areal Bone Mineral Density of the Lumbar Spine
NCT01320722 (9) [back to overview]Plasma Renin Activity (PRA) [Vitamin D]
NCT01320722 (9) [back to overview]Change in Endothelium-Dependent Vasodilation (EDV)
NCT01320722 (9) [back to overview]Mean 24-Hour Ambulatory Blood Pressure (ABP)
NCT01320722 (9) [back to overview]Mean 24-Hour Ambulatory Blood Pressure (ABP) Nocturnal Dipping
NCT01320722 (9) [back to overview]Angiotensin II (ATII) Concentration [Vitamin D]
NCT01320722 (9) [back to overview]Change in Renal Plasma Flow (RPF) in Response to Captopril in High Sodium Balance [Vitamin D]
NCT01320722 (9) [back to overview]Plasma Renin Activity (PRA) [Uric Acid]
NCT01320722 (9) [back to overview]Change in Renal Plasma Flow (RPF) Response to Captopril in High Sodium Balance [Uric Acid]
NCT01320722 (9) [back to overview]Angiotensin II (ATII) Concentration [Uric Acid]
NCT01325311 (15) [back to overview]Total IGF-2 in Serum at Baseline and Pre-Surgery
NCT01325311 (15) [back to overview]Total IGF-1 in Serum at Baseline and Pre-Surgery
NCT01325311 (15) [back to overview]Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms
NCT01325311 (15) [back to overview]Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA)
NCT01325311 (15) [back to overview]Levels of Calcidiol in the Participants Serum
NCT01325311 (15) [back to overview]Tissue Levels of Calcitriol Between the Placebo and Cholecalciferol/Genistein Arms
NCT01325311 (15) [back to overview]PBMC CYP mRNA Expression of CYP24
NCT01325311 (15) [back to overview]Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)
NCT01325311 (15) [back to overview]Serum Calcium Levels at Baseline and Pre-Surgery
NCT01325311 (15) [back to overview]Levels of Calcitriol in Participants Serum
NCT01325311 (15) [back to overview]Immunohistochemistry Measurements in Benign Prostate Tissue (BPT)
NCT01325311 (15) [back to overview]Total PTH in Serum at Baseline and Pre-Surgery
NCT01325311 (15) [back to overview]Total PSA in Serum
NCT01325311 (15) [back to overview]Total IGFBP-3 in Serum at Baseline and Pre-Surgery
NCT01325311 (15) [back to overview]PBMC CYP mRNA Expression of CYP27B1
NCT01331148 (1) [back to overview]25 (OH)D in Nmol/L Between Baseline and 6 Months
NCT01344161 (4) [back to overview]Change in Post Load Glucose Concentrations
NCT01344161 (4) [back to overview]Change in Body Fat Mass
NCT01344161 (4) [back to overview]Change in Glucose Concentrations
NCT01344161 (4) [back to overview]Change in Insulin Concentrations
NCT01350934 (7) [back to overview]Extension Study: Percentage Change From Baseline in s-CTx at Month 12
NCT01350934 (7) [back to overview]Extension Study: Percentage Change From Baseline in s-P1NP at Month 12
NCT01350934 (7) [back to overview]Extension Study: Percentage of Participants With Serum 25-Hydroxyvitamin (OH) D <20 ng/mL at Month 12
NCT01350934 (7) [back to overview]Base Study: Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 6
NCT01350934 (7) [back to overview]Base Study: Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 6
NCT01350934 (7) [back to overview]Base Study: Percentage Change From Baseline in Serum Procollagen Type 1 N-Terminal Propeptide (s-P1NP) at Month 6
NCT01350934 (7) [back to overview]Extension Study: Percentage Change From Baseline in Lumbar Spine BMD at Month 12
NCT01351805 (5) [back to overview]Incident Autoimmune Diseases
NCT01351805 (5) [back to overview]Severity of Knee Pain in Subsample With Chronic, Frequent Knee Pain at Baseline- With n-3 FA & Vitamin D
NCT01351805 (5) [back to overview]Serum Levels of Biomarkers of Systemic Inflammation: C-reactive Protein (CRP)
NCT01351805 (5) [back to overview]Serum Levels of Biomarkers of Systemic Inflammation: Interleukin-6 (IL-6)
NCT01351805 (5) [back to overview]Serum Levels of Biomarkers of Systemic Inflammation: Tumor Necrosis Factor-receptor 2 (TNFR2)
NCT01354964 (6) [back to overview]Percent Change in Hepatic Insulin Sensitivity
NCT01354964 (6) [back to overview]Evaluated Expression of Pro-inflammatory Gene TNF-α
NCT01354964 (6) [back to overview]Percent Change in Peripheral Glucose Uptake
NCT01354964 (6) [back to overview]Evaluated Expression of Pro-inflammatory Gene PAI-1
NCT01354964 (6) [back to overview]Evaluated Expression of Pro-inflammatory Gene iNOS
NCT01354964 (6) [back to overview]Evaluated Expression of Pro-inflammatory Gene IL-6
NCT01366885 (2) [back to overview]Number of Children Who Developed Autism
NCT01366885 (2) [back to overview]Number of Mothers Who Developed Side Effects From Vitamin D
NCT01371877 (3) [back to overview]Number of Participants With Adverse Events
NCT01371877 (3) [back to overview]Total Urticaria Severity Score at 3 Months
NCT01371877 (3) [back to overview]Medication Usage
NCT01372995 (14) [back to overview]Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 84
NCT01372995 (14) [back to overview]Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 7
NCT01372995 (14) [back to overview]Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 28
NCT01372995 (14) [back to overview]Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 21
NCT01372995 (14) [back to overview]Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 14
NCT01372995 (14) [back to overview]Duration of Time in Hospital
NCT01372995 (14) [back to overview]Duration of Time in Intensive Care Unit (ICU)
NCT01372995 (14) [back to overview]Day 84 Mortality
NCT01372995 (14) [back to overview]Change in Sequential Organ Failure Assessment (SOFA) Score
NCT01372995 (14) [back to overview]Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Baseline
NCT01372995 (14) [back to overview]Number of Hospital Mortality Cases
NCT01372995 (14) [back to overview]Number of Hospital Acquired Infections
NCT01372995 (14) [back to overview]Duration of Time on Ventilator
NCT01372995 (14) [back to overview]Change in Plasma LL-37 Levels
NCT01375010 (5) [back to overview]Change in Volumetric Bone Mineral Density (vBMD)
NCT01375010 (5) [back to overview]Change in Vitamin D Levels
NCT01375010 (5) [back to overview]Areal Change in Bone Mineral Density (aBMD)
NCT01375010 (5) [back to overview]Change in Biochemical Markers
NCT01375010 (5) [back to overview]Change in Bone Mineral Density (BMD)
NCT01384539 (3) [back to overview]Compare the Effect of Calcitriol and Cholecalciferol Supplementation on Vascular Endothelial Cell Expression of Nf-kB
NCT01384539 (3) [back to overview]Compare the Efficacy of Calcitriol and Cholecalciferol Supplementation on Plasma Concentrations of C-reactive Protein
NCT01384539 (3) [back to overview]Compare the Difference Between the Calcitriol and Cholecalciferol Groups in Conduit Artery Endothelium-dependent Dilation (EDD) in Response to Treatment.
NCT01385098 (2) [back to overview]Vitamin D Concentrations, Pre Operative and Post Bariatric Surgery Following 12 Weeks of Vitamin D Supplementation
NCT01385098 (2) [back to overview]Serum 25-hydroxyvitamin D Levels at Baseline and 12 Weeks of Daily Vit D Supplementation Post Roux-en Y OR Sleeve Gastrectomy
NCT01403051 (14) [back to overview]The Changes From Baseline in P1NP to Weeks 24 and 48
NCT01403051 (14) [back to overview]Number of Participants With Primary Adverse Events
NCT01403051 (14) [back to overview]The Percent Change From Baseline in Bone Mineral Density (BMD) at Spine
NCT01403051 (14) [back to overview]The Percent Change From Baseline in Bone Mineral Density (BMD) at Total Hip
NCT01403051 (14) [back to overview]The Changes From Baseline in sCD14 to Weeks 24 and 48
NCT01403051 (14) [back to overview]The Changes From Baseline in Urinary Phosphate Excretion to Weeks 24 and 48
NCT01403051 (14) [back to overview]The Changes From Baseline in iPTH to Weeks 24 and 48
NCT01403051 (14) [back to overview]The Changes From Baseline in IL-6 to Weeks 24 and 48
NCT01403051 (14) [back to overview]The Changes From Baseline in HOMA-IR to Weeks 24 and 48
NCT01403051 (14) [back to overview]The Changes From Baseline in Fasting Total Cholesterol to Weeks 24 and 48
NCT01403051 (14) [back to overview]The Changes From Baseline in Fasting LDL to Weeks 24 and 48
NCT01403051 (14) [back to overview]The Changes From Baseline in CTX to Weeks 24 and 48
NCT01403051 (14) [back to overview]The Changes From Baseline in CD4 to Weeks 4, 12, 24 and 48
NCT01403051 (14) [back to overview]The Change in Total 25-OH Vitamin D Level From Baseline to Weeks 24 and 48
NCT01410084 (3) [back to overview]Change in 25-hydroxyvitamin D Levels Over 5 Months
NCT01410084 (3) [back to overview]Number of Participants Who Were Compliant to Intervention
NCT01410084 (3) [back to overview]Number of Falls
NCT01412710 (2) [back to overview]Glycemic Control
NCT01412710 (2) [back to overview]Blood Lipid
NCT01437111 (2) [back to overview]Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26
NCT01437111 (2) [back to overview]Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26
NCT01465178 (2) [back to overview]Change in Parameters of the Vitamin D Assay Panel
NCT01465178 (2) [back to overview]Change in Serum 25-hydroxy Vitamin D3
NCT01472445 (9) [back to overview]HOMA-IR to Adiponectin Ratio (HOMA-IR:Adiponectin) in Blood
NCT01472445 (9) [back to overview]Expression Level of MKI67 Gene
NCT01472445 (9) [back to overview]Expression Level of Insulin-like Growth Factor-binding Protein 3 (IGFBP-3) Gene
NCT01472445 (9) [back to overview]Expression Level of ESR1 Gene
NCT01472445 (9) [back to overview]Expression Level of Cyclin-dependent Kinase Inhibitor 1 (CDKI1; p21) Gene
NCT01472445 (9) [back to overview]cRP (C-reactive Protein) to Adiponectin Ratio (cRP:Adiponectin) in Blood
NCT01472445 (9) [back to overview]Expression Level of Matrix Metalloproteinase-11 (MMP-11) Gene
NCT01472445 (9) [back to overview]Pharmacokinetics of Vitamin D Metabolite Calcitriol
NCT01472445 (9) [back to overview]Leptin to Adiponectin Ratio (Leptin:Adiponectin) in Blood
NCT01477463 (4) [back to overview]Number of Genes That Showed Changes in Expression After Vitamin D Treatment
NCT01477463 (4) [back to overview]Incidence of Hypercalcemia for Vitamin D Toxicity
NCT01477463 (4) [back to overview]Number of Genes Differentialy Regulated in Melanoma That Showed Changes in Expression After Vitamin D Treatment
NCT01477463 (4) [back to overview]Vitamin D Toxicity
NCT01490502 (12) [back to overview]Proportion of Participants With Sustained Disability Progression
NCT01490502 (12) [back to overview]Number of Relapses Requiring Treatment
NCT01490502 (12) [back to overview]Number of New or Enlarging T2 Lesions
NCT01490502 (12) [back to overview]Development of Nephrolithiasis
NCT01490502 (12) [back to overview]Proportion of Subjects That Experience a Relapse
NCT01490502 (12) [back to overview]Change in Multiple Sclerosis Functional Composite (MSFC) Score
NCT01490502 (12) [back to overview]Change in Normalized Gray Matter Volume
NCT01490502 (12) [back to overview]Development of Hypercalcemia
NCT01490502 (12) [back to overview]Annualized Relapse Rate
NCT01490502 (12) [back to overview]Change in Brain Parenchymal Volume
NCT01490502 (12) [back to overview]Change in Health-related Quality of Life
NCT01490502 (12) [back to overview]Change in Low-contrast Acuity
NCT01499940 (1) [back to overview]Number of Participants With Peripheral Neurotoxic Reactions
NCT01509079 (7) [back to overview]Change in Steady State Concentrations of Serum Anastrazole and Letrozole
NCT01509079 (7) [back to overview]Serum Estradiol Concentrations
NCT01509079 (7) [back to overview]Average Percent Adherence to Vitamin D Interventio
NCT01509079 (7) [back to overview]Change in Hand Grip Strength
NCT01509079 (7) [back to overview]Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale
NCT01509079 (7) [back to overview]Change in PROMIS Physical Functioning Questionnaire
NCT01509079 (7) [back to overview]Whole Body Bone Mineral Density
NCT01523496 (2) [back to overview]Changes in Serum 25(OH)D3 Levels
NCT01523496 (2) [back to overview]Changes in Vitamin D Binding Protein (VDBP)
NCT01532349 (1) [back to overview]Change in Serum Hepcidin With Vitamin D Intervention for Children With Chronic Kidney Disease
NCT01554241 (2) [back to overview]Total 25-OH Vitamin D3 Level
NCT01554241 (2) [back to overview]Free 25-OH Vitamin D3
NCT01596842 (2) [back to overview]25-hydroxyvitamin D Levels at 12 Weeks
NCT01596842 (2) [back to overview]Hemoglobin Levels at 12 Weeks
NCT01601847 (3) [back to overview]Bone Density
NCT01601847 (3) [back to overview]Number With Infants With Allergic Sensitization as Measured by the PhadiaTop Infant Assay
NCT01601847 (3) [back to overview]Number of Infants With Recurrent Wheezing
NCT01633853 (5) [back to overview]The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up.
NCT01633853 (5) [back to overview]The Blood 25(OH)Vitamin D Level.
NCT01633853 (5) [back to overview]The Blood Levels of Phosphorus at the 24th Month of Following up.
NCT01633853 (5) [back to overview]The Blood Levels of Calcium at the 24th Month of Following up.
NCT01633853 (5) [back to overview]The Incidence Rate of Secondary Hyperparathyroidism.
NCT01639222 (3) [back to overview]Area Under the Curve From 0 to 6 Hours Post Dose of Parathyroid Hormone (PTH AUC0-6h) in Serum
NCT01639222 (3) [back to overview]Amount of Calcium Excreted in Urine From 0 Hours up to 6 Hours Post Dose (Ca2+ Ae0-6h)
NCT01639222 (3) [back to overview]Amount of Calcium Excreted in Urine From 0 to 6 Hours Post Dose Corected for Creatinine (Ae0-6h/Creatinine)
NCT01667796 (2) [back to overview]Change in Percentages of T Cell Subsets (IFNγ+ and IL-17+)
NCT01667796 (2) [back to overview]Change in Mean Serum Level of 25-hydroxyvitamin D
NCT01669915 (4) [back to overview]Change in Executive Function Score for Cognitive Decline
NCT01669915 (4) [back to overview]Change in Episodic Memory Score for Cognitive Decline
NCT01669915 (4) [back to overview]Change in Telephone Interview of Cognitive Status (TICS) for Cognitive Decline.
NCT01669915 (4) [back to overview]Change in Global Composite Score for Cognitive Decline
NCT01675297 (3) [back to overview]The Change of Bone Mineral Density (BMD) Value
NCT01675297 (3) [back to overview]The Change of 25OHD(25-hydroxyvitamin D)
NCT01675297 (3) [back to overview]PTH(Parathyroid Hormone Value)
NCT01684722 (5) [back to overview]Change in NT-proBNP
NCT01684722 (5) [back to overview]Change in Interleukin-6
NCT01684722 (5) [back to overview]Change in Estimated Glomerular Filtration Rate
NCT01684722 (5) [back to overview]Change in C-reactive Protein
NCT01684722 (5) [back to overview]Change in Urine Albumin Excretion
NCT01688102 (12) [back to overview]Change in LDL Cholesterol Level
NCT01688102 (12) [back to overview]Change in Parathyroid Hormone (PTH)
NCT01688102 (12) [back to overview]Change in Total Cholesterol
NCT01688102 (12) [back to overview]Change in Serum Calcium
NCT01688102 (12) [back to overview]Change in Triglycerides
NCT01688102 (12) [back to overview]Correlation Between Change in LDL Cholesterol and Change in Calcium
NCT01688102 (12) [back to overview]Correlation Between Change in LDL Cholesterol and Change in PTH
NCT01688102 (12) [back to overview]Gene Expression Changes in Peripheral Blood
NCT01688102 (12) [back to overview]Gene Expression Changes in Skin
NCT01688102 (12) [back to overview]Change in 25(OH)D
NCT01688102 (12) [back to overview]Change in C Reactive Protein
NCT01688102 (12) [back to overview]Change in HDL Cholesterol
NCT01689779 (6) [back to overview]Percent (%) Change in Pre-surgical 25(OH)D 2 Weeks After Surgery
NCT01689779 (6) [back to overview]Percent (%) Change in 25(OH)D 5 Days Following Supplementation With 100,000 IU Cholecalciferol
NCT01689779 (6) [back to overview]Percent (%) Change in Pre-surgical 25(OH)D Within 24 Hours of Surgery
NCT01689779 (6) [back to overview]Percent (%) Change in Pre-surgical LL-37 2 Weeks After Surgery
NCT01689779 (6) [back to overview]Percent (%) Change in LL-37 5 Days Following Supplementation With 100,000 IU Cholecalciferol
NCT01689779 (6) [back to overview]Percent (%) Change in Pre-surgical LL-37 Within 24 Hours of Surgery
NCT01696435 (4) [back to overview]Number of Participants With an Incident Depression Event
NCT01696435 (4) [back to overview]Number of Participants With a Depression Event
NCT01696435 (4) [back to overview]Number of Participants With a Recurrent Depression Event
NCT01696435 (4) [back to overview]Mood Scores
NCT01709474 (1) [back to overview]Percentage of Subjects by Treatment Arm Experiencing Any Adverse Event (AE) ≥ Grade 3
NCT01736865 (4) [back to overview]Effect of Vitamin D Supplementation on Blood 25-hydroxyvitaminD Concentration
NCT01736865 (4) [back to overview]Hemoglobin A1c
NCT01736865 (4) [back to overview]Number of Participants With Change in Glycemia
NCT01736865 (4) [back to overview]Disposition Index
NCT01744821 (1) [back to overview]Review of the Differences in the Types and Incidence of Toxicities Associated With Vitamin D3 Replacement.
NCT01746264 (16) [back to overview]High Sensitivity C-reactive Protein (Hs-CRP)
NCT01746264 (16) [back to overview]Homeostatic Model Assessment of Insulin Resistance Index (HOMA-IR)
NCT01746264 (16) [back to overview]International Physical Activity Questionnaire (IPAQ) Short Form Score
NCT01746264 (16) [back to overview]Low-density Lipoprotein Cholesterol (LDL) Cholesterol Levels
NCT01746264 (16) [back to overview]Reactive Hyperemia Index (RHI)
NCT01746264 (16) [back to overview]Serum Parathyroid Hormone (PTH)
NCT01746264 (16) [back to overview]Total Cholesterol
NCT01746264 (16) [back to overview]Triglycerides
NCT01746264 (16) [back to overview]Urine Calcium to Creatinine Ratio
NCT01746264 (16) [back to overview]High Density Lipoprotein (HDL) Cholesterol Levels
NCT01746264 (16) [back to overview]25-hydroxy Vitamin D (25[OH]D) Levels
NCT01746264 (16) [back to overview]Body Mass Index
NCT01746264 (16) [back to overview]Calcium Intake Per Day
NCT01746264 (16) [back to overview]Fasting Glucose
NCT01746264 (16) [back to overview]Fasting Insulin
NCT01746264 (16) [back to overview]Flow Mediated Dilatation (FMD)
NCT01747447 (5) [back to overview]Change in Bone Structure
NCT01747447 (5) [back to overview]Body Composition
NCT01747447 (5) [back to overview]Bone Turnover P1NP
NCT01747447 (5) [back to overview]Change in Bone Density
NCT01747447 (5) [back to overview]Bone Turnover Beta Crosslaps
NCT01751646 (72) [back to overview]Change in Estimated GFR From Baseline to Week 48.
NCT01751646 (72) [back to overview]Change in Estimated GFR From Baseline to Week 24.
NCT01751646 (72) [back to overview]Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Ritonavir Use
NCT01751646 (72) [back to overview]Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Week 48 by Efavirenz Use
NCT01751646 (72) [back to overview]Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Baseline by Efavirenz Use
NCT01751646 (72) [back to overview]Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Efavirenz Use
NCT01751646 (72) [back to overview]Change in URBP/UCr Ratio From Baseline to Week 48
NCT01751646 (72) [back to overview]Change in UProt/ UCr Ratio From Baseline to Week 48
NCT01751646 (72) [back to overview]Change in UGluc From Baseline to Week 48
NCT01751646 (72) [back to overview]Change in UB2MG From Baseline to Week 48
NCT01751646 (72) [back to overview]Change in Estimated GFR From Baseline to Week 12.
NCT01751646 (72) [back to overview]Change From Baseline to Week 48 of Total Hip BMD Z-score for the Randomized Study Groups
NCT01751646 (72) [back to overview]Change From Baseline to Week 48 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups
NCT01751646 (72) [back to overview]Change From Baseline to Week 48 of Femoral Neck BMD Z-score for the Randomized Study Groups
NCT01751646 (72) [back to overview]Change From Baseline to Week 48 in UCa/Ucr
NCT01751646 (72) [back to overview]Change From Baseline to Week 48 in SPO4
NCT01751646 (72) [back to overview]Change From Baseline to Week 48 in Serum Calcium (SCa)
NCT01751646 (72) [back to overview]Change From Baseline to Week 48 in PTH
NCT01751646 (72) [back to overview]Change From Baseline to Week 48 in OC
NCT01751646 (72) [back to overview]Change From Baseline to Week 48 in Glucose Homeostasis (Homeostasis Model Assessment of Insulin Resistance (HOMA-IR))
NCT01751646 (72) [back to overview]Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Insulin)
NCT01751646 (72) [back to overview]Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Glucose)
NCT01751646 (72) [back to overview]Percent Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD for the Randomized Study Groups
NCT01751646 (72) [back to overview]Change From Baseline to Week 48 in FGF23
NCT01751646 (72) [back to overview]Change From Baseline to Week 48 in CTX
NCT01751646 (72) [back to overview]Change From Baseline to Week 48 in BAP
NCT01751646 (72) [back to overview]Change From Baseline to Week 48 in Actual Free 1,25-OHD
NCT01751646 (72) [back to overview]Change From Baseline to Week 48 in 25-OHD
NCT01751646 (72) [back to overview]Change From Baseline to Week 48 in TRP %
NCT01751646 (72) [back to overview]Change From Baseline to Week 48 in 1,25-OHD
NCT01751646 (72) [back to overview]Change From Baseline to Week 24 of Total Hip BMD Z-score for the Randomized Study Groups
NCT01751646 (72) [back to overview]Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups
NCT01751646 (72) [back to overview]Change From Baseline to Week 24 of Femoral Neck BMD Z-score for the Randomized Study Groups
NCT01751646 (72) [back to overview]Change From Baseline to Week 24 in UCa/Ucr
NCT01751646 (72) [back to overview]Change From Baseline to Week 24 in FGF23
NCT01751646 (72) [back to overview]Change From Baseline to Week 24 in CTX
NCT01751646 (72) [back to overview]Percent Change From Baseline to Week 24 of Total Hip BMD for the Randomized Study Groups
NCT01751646 (72) [back to overview]Change in SCr From Baseline to Week 12.
NCT01751646 (72) [back to overview]Change in SCr From Baseline to Week 24.
NCT01751646 (72) [back to overview]Change From Baseline to Week 24 in TRP %
NCT01751646 (72) [back to overview]Change From Baseline to Week 24 in SPO4
NCT01751646 (72) [back to overview]Change From Baseline to Week 24 in Serum Calcium (SCa)
NCT01751646 (72) [back to overview]Percent Change From Baseline to Week 48 of Total Hip BMD for the Randomized Study Groups
NCT01751646 (72) [back to overview]Percent Change From Baseline to Week 48 of Femoral Neck BMD for the Randomized Study Groups
NCT01751646 (72) [back to overview]Change in SCr From Baseline to Week 48.
NCT01751646 (72) [back to overview]Percent Change From Baseline to Week 48 of BMC of Whole Body for the Randomized Study Groups
NCT01751646 (72) [back to overview]Percent Change From Baseline to Week 48 in Dual Energy X-ray Absorptiometry (DXA)-Measured BMD at the Spine for the Randomized Study Groups
NCT01751646 (72) [back to overview]25-OHD Serum Concentration by Randomized Study Group at Week 12
NCT01751646 (72) [back to overview]Percent Change From Baseline to Week 24 of Femoral Neck BMD for the Randomized Study Groups
NCT01751646 (72) [back to overview]25-OHD Serum Concentration by Randomized Study Group at Week 48
NCT01751646 (72) [back to overview]Percent Change From Baseline to Week 24 of BMC of Whole Body for the Randomized Study Groups
NCT01751646 (72) [back to overview]Change From Baseline to Week 12 in 1,25-OHD
NCT01751646 (72) [back to overview]Change From Baseline to Week 12 in 25-OHD
NCT01751646 (72) [back to overview]Change From Baseline to Week 12 in Actual Free 1,25-OHD
NCT01751646 (72) [back to overview]Change From Baseline to Week 12 in BAP
NCT01751646 (72) [back to overview]Change From Baseline to Week 12 in CTX
NCT01751646 (72) [back to overview]Change From Baseline to Week 12 in FGF23
NCT01751646 (72) [back to overview]Change From Baseline to Week 12 in OC
NCT01751646 (72) [back to overview]Change From Baseline to Week 12 in PTH
NCT01751646 (72) [back to overview]Change From Baseline to Week 12 in Serum Calcium (SCa)
NCT01751646 (72) [back to overview]Change From Baseline to Week 12 in SPO4
NCT01751646 (72) [back to overview]Change From Baseline to Week 12 in TRP %
NCT01751646 (72) [back to overview]Change From Baseline to Week 12 in UCa/Ucr
NCT01751646 (72) [back to overview]Change From Baseline to Week 24 in 1,25-OHD
NCT01751646 (72) [back to overview]Change From Baseline to Week 24 in 25-OHD
NCT01751646 (72) [back to overview]Change From Baseline to Week 24 in Actual Free 1,25-OHD
NCT01751646 (72) [back to overview]Change From Baseline to Week 24 in BAP
NCT01751646 (72) [back to overview]Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Week 48 by Ritonavir Use
NCT01751646 (72) [back to overview]Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Baseline by Ritonavir Use
NCT01751646 (72) [back to overview]25-OHD Serum Concentration by Randomized Study Group at Week 24
NCT01751646 (72) [back to overview]Change From Baseline to Week 24 in PTH
NCT01751646 (72) [back to overview]Change From Baseline to Week 24 in OC
NCT01782352 (6) [back to overview]Number of Participants With Incident Visually-Significant AMD
NCT01782352 (6) [back to overview]Number of Participants With Incident AMD
NCT01782352 (6) [back to overview]Number of Participants With an AMD Event, Excluding the First Two Years of Follow-up
NCT01782352 (6) [back to overview]Number of Participants With an AMD Event
NCT01782352 (6) [back to overview]Number of Participants With Incident Advanced AMD
NCT01782352 (6) [back to overview]Number of Participants With AMD Progression
NCT01784029 (1) [back to overview]Change in 25(OH)D Serum Level After Treatment for Vitamin D Deficiency (Deficiency Defined as 25(OH)D <20 ng/dL)
NCT01797302 (10) [back to overview]Pulse-wave Velocity (PWV)
NCT01797302 (10) [back to overview]Systemic Diastolic Blood Pressure
NCT01797302 (10) [back to overview]Systemic Systolic Blood Pressure
NCT01797302 (10) [back to overview]Body Mass Index (BMI)
NCT01797302 (10) [back to overview]1/Fasting Insulin Ratio
NCT01797302 (10) [back to overview]Central Diastolic Blood Pressure
NCT01797302 (10) [back to overview]Central Systolic Blood Pressure
NCT01797302 (10) [back to overview]Augmentation Index at Heart Rate of 75 Beats/Min (AIx-75)
NCT01797302 (10) [back to overview]Fasting Blood Glucose
NCT01797302 (10) [back to overview]Flow-mediated Dilation (FMD) Percentage
NCT01838447 (4) [back to overview]Blood 25 Hydroxyvitamin D (25OHD) Concentrations
NCT01838447 (4) [back to overview]Post-operative PICU Catecholamine Requirements
NCT01838447 (4) [back to overview]Number of Participants With Hypercalciuria
NCT01838447 (4) [back to overview]Number of Participants With Hypercalcemia as a Vitamin D Related Adverse Event
NCT01884844 (1) [back to overview]Change in Montgomery-Åsberg Depression Rating Scale
NCT01889810 (1) [back to overview]Change in Insulin Resistance
NCT01896544 (5) [back to overview]Change in Immunological Profile 5 Days Following Supplementation With Cholecalciferol
NCT01896544 (5) [back to overview]Change in Immunological Profile 5 Days Following Supplementation With Cholecalciferol
NCT01896544 (5) [back to overview]Incidence of Infection-related Complications Within 90 Days From the Onset of a Suspected Case of Sepsis
NCT01896544 (5) [back to overview]Incidence of Infection-related Complications Within 90 Days From the Onset of a Suspected Case of Sepsis
NCT01896544 (5) [back to overview]Change in Vitamin D Status 5 Days Following Supplementation With Cholecalciferol
NCT01904032 (4) [back to overview]Change in Systolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort
NCT01904032 (4) [back to overview]Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort
NCT01904032 (4) [back to overview]Change in Diastolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort
NCT01904032 (4) [back to overview]Change in Problem Areas in Diabetes (PAIDS) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort
NCT01908751 (7) [back to overview]Short Form-12 (SF-12) Physical Composite Scale (PCS)
NCT01908751 (7) [back to overview]Short Form-12 (SF-12) Mental Health Composite Scale (MCS)
NCT01908751 (7) [back to overview]Number of Participants With Patient Important Outcomes
NCT01908751 (7) [back to overview]Hip Outcome Score (HOS) Sports Scale
NCT01908751 (7) [back to overview]Hip Outcome Score (HOS) Activities of Daily Living Scale
NCT01908751 (7) [back to overview]Radiographic Fracture Healing
NCT01908751 (7) [back to overview]Number of Participants With Non-Operatively-Treated Fracture Healing Complications
NCT01911169 (1) [back to overview]Change at Week 16 in % Flow Mediated Dilation in Those Who Did and Did Not Replete Vitamin D
NCT01921894 (5) [back to overview]Number of Participants With FEV1 < 80% of Predicted
NCT01921894 (5) [back to overview]Number of Participants With Elevated Urinary Calcium/Creatinine Ratio
NCT01921894 (5) [back to overview]Number of Participants With Vitamin D Toxicity
NCT01921894 (5) [back to overview]Number of Participants With Vitamin D Sufficiency (Vitamin D ≥30 ng/ml) After 4 Weeks of Supplementation
NCT01921894 (5) [back to overview]Number of Participants With Sufficient Vitamin D Levels (≥30 ng/ml) After 8 Weeks of Supplementation
NCT01932788 (1) [back to overview]Number of Participants With Greater Than 100 Nmol/L 25(OH)D (Converted Vitamin D)
NCT01942694 (8) [back to overview]Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Pre-diabetes Criteria (Two vs. Three Criteria)
NCT01942694 (8) [back to overview]Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Waist Circumference
NCT01942694 (8) [back to overview]Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Age
NCT01942694 (8) [back to overview]Time to Development of Diabetes
NCT01942694 (8) [back to overview]Variability of Response to Vitamin D Supplementation by Baseline Characteristic: BMI
NCT01942694 (8) [back to overview]Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Calcium Intake From Supplements
NCT01942694 (8) [back to overview]Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Geographic Location (as a Proxy for Sun Exposure)
NCT01942694 (8) [back to overview]Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Race (as a Proxy for Skin Pigmentation)
NCT01950169 (4) [back to overview]Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture.
NCT01950169 (4) [back to overview]Body Composition, Including Fat Mass at Baseline, 6 and 12 Months After Hip Fracture.
NCT01950169 (4) [back to overview]Body Composition, Including Lean Mass at Baseline, 6 and 12 Months After Hip Fracture.
NCT01950169 (4) [back to overview]Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture.
NCT01967628 (1) [back to overview]Antimicrobial Activity by Airway Surface Liquid (ASL) as Measured by Relative Light Units (RLU)
NCT01974245 (1) [back to overview]Change From Baseline in Interleukin-6 at 12 Weeks.
NCT01988090 (2) [back to overview]Compliance With Anti-Cancer Treatment
NCT01988090 (2) [back to overview]Association Between Vitamin D Levels Changes and Treatment.
NCT02030041 (2) [back to overview]Peak Oxygen Consumption
NCT02030041 (2) [back to overview]Skeletal Muscle Mitochondrial Content
NCT02166333 (2) [back to overview]Change in Gait Speed
NCT02166333 (2) [back to overview]Incidence of First Fall or Death (Whichever Comes First)
NCT02168660 (2) [back to overview]Change in HOMA-IR
NCT02168660 (2) [back to overview]Change in BMI Z-score
NCT02186015 (8) [back to overview]Change in Fatigue
NCT02186015 (8) [back to overview]Change in Muscle Function
NCT02186015 (8) [back to overview]Change in Mood
NCT02186015 (8) [back to overview]Change in Worst Pain Rating From the Beck Pain Scale
NCT02186015 (8) [back to overview]Change in Sleep Quality Assessment
NCT02186015 (8) [back to overview]Change in Serum 25(OH)D
NCT02186015 (8) [back to overview]Change in Functional Assessment of Cancer Therapy-endocrine
NCT02186015 (8) [back to overview]Change in Functional Assessment of Cancer Therapy-breast
NCT02186600 (3) [back to overview]Change in Bone Strength Index of the Distal Tibia Based on Randomization to Control, Risedronate, or Exercise Group.
NCT02186600 (3) [back to overview]Change in Serum Measures of Bone Resorption (Serum NTx) Based on Randomization to Control, Risedronate, or Exercise Group.
NCT02186600 (3) [back to overview]Change in Bone Mineral Density (BMD) at the Spine (L1-L4) Based on Randomization to Control, Risedronate, or Exercise Group.
NCT02195895 (5) [back to overview]BMD by DXA at the Lumbar Spine
NCT02195895 (5) [back to overview]BMD of Total Hip by DXA
NCT02195895 (5) [back to overview]C-terminal Telopeptide (CTX)
NCT02195895 (5) [back to overview]Bone-specific Alkaline Phosphatase (BSAP)
NCT02195895 (5) [back to overview]Amino-terminal Propeptide of Type 1 Collagen (P1NP)
NCT02208310 (12) [back to overview]Hypercalcemia
NCT02208310 (12) [back to overview]Crohn's Related Surgeries (Dichotomous 0/1 Per Subject)
NCT02208310 (12) [back to overview]Crohn's Related Hospitalizations
NCT02208310 (12) [back to overview]Steroid Prescription Given (Dichotomous 0/1)
NCT02208310 (12) [back to overview]Incidence of Nephrolithiasis
NCT02208310 (12) [back to overview]Change in Fatigue Measurements
NCT02208310 (12) [back to overview]Change in C-reactive Protein
NCT02208310 (12) [back to overview]Change in Modified Harvey-Bradshaw Index (HBI Without Examination)
NCT02208310 (12) [back to overview]Composite Endpoint: Number of Participants With (Any of) a CD-related Hospitalization, CD-related Surgery, CD-related ER Visits and Steroid Prescriptions
NCT02208310 (12) [back to overview]Participants With at Least One Crohn's Related Emergency Department (ED) Visit
NCT02208310 (12) [back to overview]Percent With Escalation of Therapy
NCT02208310 (12) [back to overview]Quality of Life Measure Changes
NCT02271230 (2) [back to overview]Number of Participants With New Heart Failure Hospitalization
NCT02271230 (2) [back to overview]Number of Recurrent Heart Failure Hospitalization
NCT02328404 (15) [back to overview]Serum Glucose Concentration in Oral Glucose Tolerance Test 1st hr After Treatment
NCT02328404 (15) [back to overview]Serum Parathyroid Hormone Concentration
NCT02328404 (15) [back to overview]Serum Calcium Concentration
NCT02328404 (15) [back to overview]Menstrual Regularity
NCT02328404 (15) [back to overview]Total Testosterone Level
NCT02328404 (15) [back to overview]Sex Hormone Binding Globulin Concentration
NCT02328404 (15) [back to overview]Serum Progesterone Level
NCT02328404 (15) [back to overview]Serum Phosphorous Concentration
NCT02328404 (15) [back to overview]Serum Chromium Concentration
NCT02328404 (15) [back to overview]Body Mass Index
NCT02328404 (15) [back to overview]Free Androgen Index
NCT02328404 (15) [back to overview]Hirsutism Score
NCT02328404 (15) [back to overview]Serum 25-Hydroxy Vitamin D3 Level
NCT02328404 (15) [back to overview]Serum C-Reactive Protien Concentration
NCT02328404 (15) [back to overview]Ultrasound Examination of Number of Follicles and Ovarian Volume
NCT02387164 (5) [back to overview]Change From Baseline in GADA Month 12
NCT02387164 (5) [back to overview]Change From Baseline in GADA Month 1
NCT02387164 (5) [back to overview]Change From Baseline in GADA Month 24
NCT02387164 (5) [back to overview]Injection Site Reactions Month 1
NCT02387164 (5) [back to overview]Injection Site Reactions Day 1
NCT02395081 (13) [back to overview]Number of Patients With Proteinuria as Measured by Urine Dipstick
NCT02395081 (13) [back to overview]Assisted Vaginal Delivery as Measured by Medical Record Abstraction
NCT02395081 (13) [back to overview]Casarean Section as Measured by Medical Record Abstraction
NCT02395081 (13) [back to overview]Average Monthly Blood Pressure
NCT02395081 (13) [back to overview]Number of Large for Gestational Age (LGA) Neonates as Measured by Medical Record Abstraction
NCT02395081 (13) [back to overview]Total Serum 25(OH)D Concentration
NCT02395081 (13) [back to overview]Number of Small for Gestational Age (SGA) Neonates as Measured by Medical Record Abstraction
NCT02395081 (13) [back to overview]Mean Calcemia as Measured by Serum Calcium Test (2mo)
NCT02395081 (13) [back to overview]Mean Calcemia as Measured by Serum Calcium Test (36-40 Weeks)
NCT02395081 (13) [back to overview]Number of Patients With Preterm Delivery as Measured by Clinical Diagnosis
NCT02395081 (13) [back to overview]Number of Patients With Hypertensive Disorders of Pregnancy as Measured by Clinical Diagnosis
NCT02395081 (13) [back to overview]Number of Patients With Bacterial Vaginosis as Measured by Potassium Hydroxide (KOH) Wet Mount
NCT02395081 (13) [back to overview]The Number of Participants With Preeclampsia
NCT02416193 (7) [back to overview]Trail Making Test Part B
NCT02416193 (7) [back to overview]Controlled Oral Word Association Test
NCT02416193 (7) [back to overview]Hopkins Verbal Learning Total Recall Test
NCT02416193 (7) [back to overview]Stroop Interference Test
NCT02416193 (7) [back to overview]Letter-Number Sequencing
NCT02416193 (7) [back to overview]Semantic Fluency Test
NCT02416193 (7) [back to overview]Symbol-Digit Modality Test
NCT02452762 (3) [back to overview]Vitamin D Axis Function - Calcium
NCT02452762 (3) [back to overview]Vitamin D Status
NCT02452762 (3) [back to overview]Patient Accrual Rate
NCT02460380 (8) [back to overview]The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
NCT02460380 (8) [back to overview]The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
NCT02460380 (8) [back to overview]Effect of Vitamin D on Angiogenic Factors
NCT02460380 (8) [back to overview]Effect of Vitamin D on Angiogenic Factors
NCT02460380 (8) [back to overview]The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
NCT02460380 (8) [back to overview]The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
NCT02460380 (8) [back to overview]The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
NCT02460380 (8) [back to overview]The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS
NCT02464033 (34) [back to overview]Spontaneous IL-17a Secretion
NCT02464033 (34) [back to overview]Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability
NCT02464033 (34) [back to overview]Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability
NCT02464033 (34) [back to overview]Number of Patients With Clinically Significant Laboratory Findings
NCT02464033 (34) [back to overview]Number of Patients With Any Abnormal Findings From Physical Examinations After Baseline
NCT02464033 (34) [back to overview]Number of Patients With an Infection Reported as Adverse Event Related to Study Treatment
NCT02464033 (34) [back to overview]Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L
NCT02464033 (34) [back to overview]Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L
NCT02464033 (34) [back to overview]Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L
NCT02464033 (34) [back to overview]Hemoglobin A1c (HbA1c), Change From Baseline
NCT02464033 (34) [back to overview]Hemoglobin A1c (HbA1c), Change From Baseline
NCT02464033 (34) [back to overview]GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)
NCT02464033 (34) [back to overview]Hemoglobin A1c (HbA1c), Change From Baseline
NCT02464033 (34) [back to overview]GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)
NCT02464033 (34) [back to overview]GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)
NCT02464033 (34) [back to overview]Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline
NCT02464033 (34) [back to overview]Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline
NCT02464033 (34) [back to overview]Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline
NCT02464033 (34) [back to overview]C-peptide: Stimulated, 90 Minute Value, Change From Baseline
NCT02464033 (34) [back to overview]C-peptide: Stimulated, 90 Minute Value, Change From Baseline
NCT02464033 (34) [back to overview]C-peptide: Stimulated, 90 Minute Value, Change From Baseline
NCT02464033 (34) [back to overview]C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline
NCT02464033 (34) [back to overview]C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline
NCT02464033 (34) [back to overview]C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline
NCT02464033 (34) [back to overview]C-peptide Fasting Concentration, Change From Baseline
NCT02464033 (34) [back to overview]C-peptide Fasting Concentration, Change From Baseline
NCT02464033 (34) [back to overview]C-peptide Fasting Concentration, Change From Baseline
NCT02464033 (34) [back to overview]GAD65-induced TNF-alpha Secretion
NCT02464033 (34) [back to overview]GAD65-induced GM-CSF Secretion
NCT02464033 (34) [back to overview]GAD65-induced IFN-gamma Secretion
NCT02464033 (34) [back to overview]GAD65-induced IL-13 Secretion
NCT02464033 (34) [back to overview]GAD65-induced IL-4 Secretion
NCT02464033 (34) [back to overview]GAD65-induced MCP-1 Secretion
NCT02464033 (34) [back to overview]GAD65-induced MIP-1b Secretion
NCT02464059 (2) [back to overview]Change From Baseline in Lung Cathelicidin Level at 8 Weeks
NCT02464059 (2) [back to overview]Change From Baseline in Blood Cathelicidin at 8 Weeks
NCT02513823 (2) [back to overview]Effectiveness of Vitamin d Supplementation on Improving Endothelial Function
NCT02513823 (2) [back to overview]Effectiveness of Vitamin D Supplementation on Reducing Blood Pressure
NCT02687815 (4) [back to overview]Proportion of Participants in Whom Fluticasone Dose Was Halved at Visit 6
NCT02687815 (4) [back to overview]Days to a Severe Asthma Exacerbation
NCT02687815 (4) [back to overview]Average Cumulative Prescribed Dose of ICS at the End of the Trial
NCT02687815 (4) [back to overview]Days to Viral-induced Severe Exacerbation
NCT02726113 (2) [back to overview]Number of Gene Transcripts Identified Regulated by Vitamin D Supplementation in Both AA and European American Participants
NCT02726113 (2) [back to overview]Changes in Serum Levels of Vitamin D [25(OH)D3] in Subjects in the Supplementation Group and Those in the Control Group (Placebo).
NCT02731820 (4) [back to overview]"Changes in Serum Levels of Tartrate-resistant Acid Phosphatase 5b Isoenzyme (TRAcP5b) Over Time, i.e. Baseline, 3 Months, 6 Months."
NCT02731820 (4) [back to overview]"Changes in Serum Levels of N-terminal Propeptide of Type I Procollagen (P1NP) Over Time, i.e. Baseline, 3 Months, 6 Months."
NCT02731820 (4) [back to overview]Changes in Serum Level of Carboxyterminal Cross-linked Telopeptide of Type I Collagen (CTX); Over Time, i.e. Baseline, 3 Months, 6 Months.
NCT02731820 (4) [back to overview]"Changes in Serum Levels of Bone-specific Alkaline Phosphatase (BAP) Over Time, i.e. Baseline, 3 Months, 6 Months."
NCT02735200 (1) [back to overview]Level of Serum 25 OHD Level Pre-treatment and Post Treatment
NCT02786498 (11) [back to overview]Number of Participants With Adverse Events (AE)
NCT02786498 (11) [back to overview]Serum Levels of Calcium
NCT02786498 (11) [back to overview]Serum Levels of Parathyroid Hormone
NCT02786498 (11) [back to overview]Count of Participants Who Completed Radiographic Imaging Measures
NCT02786498 (11) [back to overview]Count of Participants Who Completed Blood Measures
NCT02786498 (11) [back to overview]Serum Level of 25(OH)D
NCT02786498 (11) [back to overview]Fracture Healing Will be Assessed Radiographically Using Radiographic Union Score for Tibial Fractures (RUST)
NCT02786498 (11) [back to overview]Fracture Healing Will be Assessed Clinically Using Function IndeX for Trauma (FIX-IT)
NCT02786498 (11) [back to overview]Fracture Healing Will be Assessed Biochemically Using Serum Levels of the Bone Turnover Marker N-terminal Propeptide of Type I Procollagen (P1NP)
NCT02786498 (11) [back to overview]Fracture Healing Will be Assessed Biochemically Using Serum Levels of the Bone Turnover Marker (BTM) C-terminal Telopeptide of Type I Collagen (CTX)
NCT02786498 (11) [back to overview]Number of Participants With Adherence With Vitamin D Supplementation
NCT02802449 (6) [back to overview]Vitamin D3 Level
NCT02802449 (6) [back to overview]Oxidative Stress Markers: Isoprostane
NCT02802449 (6) [back to overview]Plasma PTH Level
NCT02802449 (6) [back to overview]Oxidative Stress Markers: Homocysteine
NCT02802449 (6) [back to overview]Oxidative Stress Markers: Cysteine
NCT02802449 (6) [back to overview]Oxidative Stress Markers: GSH
NCT02881957 (10) [back to overview]As-treated Hospital Length of Stay
NCT02881957 (10) [back to overview]As-treated ICU Length of Stay
NCT02881957 (10) [back to overview]Number of Participants With Pneumonia
NCT02881957 (10) [back to overview]Intent-to-treat Hospital Length-of-stay
NCT02881957 (10) [back to overview]Intent-to-treat ICU Length of Stay
NCT02881957 (10) [back to overview]Number of Participants With Urinary Tract Infection
NCT02881957 (10) [back to overview]Number of Participants With Sepsis
NCT02881957 (10) [back to overview]Number of Participants With Study Drug Related Adverse Events
NCT02881957 (10) [back to overview]In-hospital Mortality
NCT02881957 (10) [back to overview]Number of Participants With Deep Vein Thrombosis
NCT02925195 (5) [back to overview]Change in Serum PTH Concentration
NCT02925195 (5) [back to overview]Change in Serum Calcium Concentrations
NCT02925195 (5) [back to overview]Change in Serum 1,25(OH)2D Concentration
NCT02925195 (5) [back to overview]Change in Urine Calcium Excretion
NCT02925195 (5) [back to overview]Change in Systolic Blood Pressure
NCT03070483 (4) [back to overview]Change in Intact Parathyroid Hormone Levels From Baseline to 12 Weeks
NCT03070483 (4) [back to overview]Change in Mean Blood Pressure From Baseline to 12 Weeks
NCT03070483 (4) [back to overview]Change in Total 25-hydroxyvitamin D From Baseline to 12 Weeks
NCT03070483 (4) [back to overview]Change in 24-hour Urine Calcium Excretion From Baseline to 12 Weeks
NCT03096314 (21) [back to overview]Highest Ionized Calcium to Day 14
NCT03096314 (21) [back to overview]Number of Participants Who Developed (New) ARDS to Day 7
NCT03096314 (21) [back to overview]Highest Total Calcium to Day 14
NCT03096314 (21) [back to overview]Hospital Length of Stay to Day 90
NCT03096314 (21) [back to overview]Hospital Mortality to Day 90
NCT03096314 (21) [back to overview]Hypercalcemia to Day 14
NCT03096314 (21) [back to overview]Kidney Stones to Day 90
NCT03096314 (21) [back to overview]New Renal Replacement Therapy (RRT)
NCT03096314 (21) [back to overview]New Vasopressor Use to Day 7
NCT03096314 (21) [back to overview]Ventilator-free Days (VFDs) to Day 28
NCT03096314 (21) [back to overview]Severity of Acute Respiratory Distress Syndrome (ARDS)
NCT03096314 (21) [back to overview]Highest Creatinine Levels
NCT03096314 (21) [back to overview]25OHD Levels at Day 3
NCT03096314 (21) [back to overview]Alive and Home (Prior Level of Care) at Day 90
NCT03096314 (21) [back to overview]All-cause, All Location Mortality to Day 28
NCT03096314 (21) [back to overview]All-cause, All-location Mortality to Day 90
NCT03096314 (21) [back to overview]Fall-related Fractures to Day 90
NCT03096314 (21) [back to overview]Falls to Day 90
NCT03096314 (21) [back to overview]Health-related Quality of Life by EuroQol (EQ-5D-5L)
NCT03096314 (21) [back to overview]Healthcare Facility Length of Stay to Day 90
NCT03096314 (21) [back to overview]Highest Cardiovascular SOFA (Sepsis Related Organ Failure Assessment) Score
NCT03101150 (3) [back to overview]Number of Participants With Pre-eclampsia in Both Arms
NCT03101150 (3) [back to overview]Number of Patients With Intrauterine Growth Retardation
NCT03101150 (3) [back to overview]Change in Vitamin D Level
NCT03103152 (2) [back to overview]Rate of Patient Recruitment to a Randomised Chemoprevention Study in Men Enrolled on an Active Surveillance Programme for Prostate Cancer. Number Accrued Per Month.
NCT03103152 (2) [back to overview]Number of Participants With Histological Disease Progression
NCT03313076 (7) [back to overview]Qualitative Review of Treatment-Related Adverse Events
NCT03313076 (7) [back to overview]Sex Differences in Treatment Response Based on Pain Scores
NCT03313076 (7) [back to overview]General Mental Health as Measured by the Short Form (SF)-12 General Mental Health Component Scores
NCT03313076 (7) [back to overview]General Physical Health by Treatment Group Measured by the SF-12 General Physical Health Component Scores
NCT03313076 (7) [back to overview]Pain Interference by Treatment Group Measured by the Brief Pain Inventory
NCT03313076 (7) [back to overview]Percent of Participants Who Are Compliant With Follow-up (Feasibility)
NCT03313076 (7) [back to overview]By Group Efficacy Estimates Over Year Following Thermal Burn Injury
NCT03345004 (21) [back to overview]Change in Insulin Consumption
NCT03345004 (21) [back to overview]Change in Maximum C-peptide
NCT03345004 (21) [back to overview]Number of Clinically Significant Abnormal Results in Vital Signs
NCT03345004 (21) [back to overview]Change in Stimulated C-peptide During a MMTT
NCT03345004 (21) [back to overview]Change in HbA1c
NCT03345004 (21) [back to overview]Number of Hypoglycemias
NCT03345004 (21) [back to overview]Number of Patients Having at Least 1 Severe Hypoglycemic Event
NCT03345004 (21) [back to overview]Stimulated C-peptide Above 0.2 Nmol/L at 90 Min
NCT03345004 (21) [back to overview]Stimulated Maximum C-peptide Above 0.2 Nmol/L
NCT03345004 (21) [back to overview]C-peptide Levels During a MMTT
NCT03345004 (21) [back to overview]Change in Glycemic Variability/Fluctuations
NCT03345004 (21) [back to overview]Number of Clinically Significant Abnormal Results From Physical and Neurological Examinations
NCT03345004 (21) [back to overview]Change in Body Mass Index (BMI)
NCT03345004 (21) [back to overview]Change in Body Weight
NCT03345004 (21) [back to overview]Change in Fasting C-peptide
NCT03345004 (21) [back to overview]Change in IDAA1c
NCT03345004 (21) [back to overview]Number of Clinically Significant Abnormal Results From Laboratory Measurements (Haematology and Clinical Chemistry) and Urinalysis.
NCT03345004 (21) [back to overview]Percentage of Patients With IDAA1c ≤ 9
NCT03345004 (21) [back to overview]Change in Quality of Life (QoL)
NCT03345004 (21) [back to overview]GAD65A Titer
NCT03345004 (21) [back to overview]Injection Site Reactions
NCT03380091 (4) [back to overview]Changes From Baseline Week in Vitamin D 25-hydroxy Levels at Week 12.
NCT03380091 (4) [back to overview]Changes From Baseline Week in Insulin Resistance Score at Week 12.
NCT03380091 (4) [back to overview]Change From Baseline in State-Trait Anxiety Inventory Score (STAI-S) at 12 Weeks
NCT03380091 (4) [back to overview]Change From Baseline in Depression Score on the Beck Depression Inventory (BDI-II) at 12 Weeks
NCT03424239 (6) [back to overview]Change From Baseline of Femoral Neck Bone Density Measured by DXA
NCT03424239 (6) [back to overview]Change From Baseline of Spine Bone Density Measured by DXA
NCT03424239 (6) [back to overview]Change in Serum CTX
NCT03424239 (6) [back to overview]Change in Total Hip Bone Mineral Density by DXA
NCT03424239 (6) [back to overview]Change in Trabecular Spine Bone Mineral Density by QCT
NCT03424239 (6) [back to overview]Number of Participants With Treatment-related Hypocalcemia Events as Assessed by CTCAE v4.0
NCT03588884 (1) [back to overview]Incidence and Severity of Treatment-Emergent Adverse Events (TEAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
NCT03644212 (1) [back to overview]AMH Levels in Women With PCOS
NCT03686150 (2) [back to overview]Part 1: Optimal Dosing Level to Use in Part 2
NCT03686150 (2) [back to overview]Part 2: Proportion of Participants With Vitamin D Levels >= 40 ng/ml
NCT04070833 (4) [back to overview]Number of Participants With a Physical Disability After Stroke as Measured by the Modified Katz Activities of Daily Living (ADL) Scale
NCT04070833 (4) [back to overview]Number of Participants With a Physical Disability After Stroke as Measured by the Rosow-Breslau Functional Health Scale
NCT04070833 (4) [back to overview]Number of Participants With at Least One Functional Limitation After Stroke According to the Scale Adapted From Nagi
NCT04070833 (4) [back to overview]Number of Participants With Social Disability After Stroke as Measured by FHS Social Disability Scale
NCT04140292 (3) [back to overview]Clinical PDT Response as Measured by Percent Change in AK Lesions From Baseline to 3 Months
NCT04140292 (3) [back to overview]Number of Participants Reporting 1 or Higher on the Pain Scale
NCT04140292 (3) [back to overview]Tolerability as Measured by Participants' Symptom Score Sheets
NCT04179461 (4) [back to overview]Change in Composite Asthma Severity Index (CASI)
NCT04179461 (4) [back to overview]Asthma Control Test (ACT)
NCT04179461 (4) [back to overview]Adherence of Asthma Controller Medication
NCT04179461 (4) [back to overview]Pulmonary Function Measured by Spirometry: Forced Expiratory Volume in 1 Second (FEV1) / Forced Vital Capacity (FVC)
NCT04400890 (6) [back to overview]Death
NCT04400890 (6) [back to overview]Pneumonia
NCT04400890 (6) [back to overview]Hospitalization Rates for COVID-19
NCT04400890 (6) [back to overview]ICU Admission Rates
NCT04400890 (6) [back to overview]Invasive Ventilation Rates
NCT04400890 (6) [back to overview]Pulmonary Embolism
NCT04629534 (11) [back to overview]Number of Mothers With Elevated Calcium Concentrations at 1 Month
NCT04629534 (11) [back to overview]Number of Mothers With Elevated Calcium Concentrations at Month 2
NCT04629534 (11) [back to overview]Number of Infants With Elevated Calcium Concentration at Month 1
NCT04629534 (11) [back to overview]Number of Mothers With Sufficient 25(OH)D Stores at 3 Months
NCT04629534 (11) [back to overview]Number of Mothers With Elevated Calcium Concentrations at Month 3
NCT04629534 (11) [back to overview]Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 1
NCT04629534 (11) [back to overview]Number of Infants With Elevated Calcium Concentration at Month 2
NCT04629534 (11) [back to overview]Number of Infants With Elevated Calcium Concentration at Month 3
NCT04629534 (11) [back to overview]Number of Infants With Sufficient 25(OH)D Stores at 3 Months
NCT04629534 (11) [back to overview]Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 2
NCT04629534 (11) [back to overview]Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 3

Percentage Change From Baseline in Total Hip BMD at 12 Months

Percentage change in total hip BMD (relative to baseline) at 12 months (NCT00112437)
Timeframe: Baseline and 12 months

InterventionPercentage Change (Least Squares Mean)
Placebo-Base-0.61
Odanacatib 3 Mg-Base-1.36
Odanacatib 10 Mg-Base1.05
Odanacatib 25 Mg-Base1.45
Odanacatib 50 Mg-Base1.87

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Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 24 Months

Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase (s-BSAP)) (relative to baseline) at 24 Months (NCT00112437)
Timeframe: Baseline and 24 months

InterventionGeometric LS Mean percent change (Least Squares Mean)
Placebo-Ext 13.38
Odanacatib 3 Mg-Ext 140.17
Odanacatib 10 Mg-Ext 12.99
Odanacatib 25 Mg-Ext 110.62
Odanacatib 50 Mg-Ext 1-13.62

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Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 36 Months

Geometric Mean Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase [s-BSAP]) at 36 Months (NCT00112437)
Timeframe: Baseline and 36 months

InterventionGeometric Mean Percent Change (Least Squares Mean)
Placebo / Placebo-Ext 27.73
Placebo / Odanacatib 50 Mg-Ext 210.86
Odanacatib 3 mg / Placebo-Ext 214.26
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 29.13
Odanacatib 10 mg / Placebo-Ext 212.95
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 28.49
Odanacatib 25 mg / 50 Mg-Ext 233.74
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 211.12
Odanacatib 50 mg / Placebo-Ext 21.30
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 217.90

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Percentage Change From Baseline in Trochanter BMD at 12 Months

Percentage change in trochanter BMD (relative to baseline) at 12 months (NCT00112437)
Timeframe: Baseline and 12 Months

InterventionPercentage change (Least Squares Mean)
Placebo-Base-0.73
Odanacatib 3 Mg-Base-1.02
Odanacatib 10 Mg-Base1.65
Odanacatib 25 Mg-Base1.91
Odanacatib 50 Mg-Base2.21

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Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 24 Months

Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen (s-CTx)) (relative to baseline) at 24 Months (NCT00112437)
Timeframe: Baseline and 24 months

InterventionPercentage change (Least Squares Mean)
Placebo-Ext 132.77
Odanacatib 3 Mg-Ext 154.94
Odanacatib 10 Mg-Ext 18.79
Odanacatib 25 Mg-Ext 1-6.52
Odanacatib 50 Mg-Ext 1-30.57

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Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 36 Months

Percentage change from baseline in biochemical marker of bone turnover (s-CTx) at 36 Months (NCT00112437)
Timeframe: Baseline and 36 months

InterventionPercentage change (Least Squares Mean)
Placebo / Placebo-Ext 2-0.09
Placebo / Odanacatib 50 Mg-Ext 2-41.30
Odanacatib 3 mg / Placebo-Ext 2-4.69
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2-44.62
Odanacatib 10 mg / Placebo-Ext 218.24
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2-26.26
Odanacatib 25 mg / 50 Mg-Ext 261.14
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2-36.71
Odanacatib 50 mg / Placebo-Ext 210.32
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2-23.93

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Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months

Percentage change from baseline in biochemical marker of bone turnover (serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months (NCT00112437)
Timeframe: Baseline and 36 months

InterventionPercentage change (Least Squares Mean)
Placebo / Placebo-Ext 27.40
Placebo / Odanacatib 50 Mg-Ext 2193.91
Odanacatib 3 mg / Placebo-Ext 21.67
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2187.37
Odanacatib 10 mg / Placebo-Ext 258.76
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2188.50
Odanacatib 25 mg / Placebo 50 Mg-Ext 277.94
Odanacatib 25 mg / 50 Mg-Ext 2231.93
Odanacatib 50 mg / Placebo-Ext 227.20
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2236.64

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Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-Terminal Propeptide of Type 1 Collagen [s-P1NP]) at 12 Months

Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change in Biochemical Marker of Bone turnover (serum N-terminal propeptide of Type 1 collagen (s-P1NP) (relative to baseline) at 12 Months (NCT00112437)
Timeframe: Baseline and 12 months

InterventionPercentage change (Least Squares Mean)
Placebo-Base3.91
Odanacatib 3 Mg-Base50.81
Odanacatib 10 Mg-Base2.33
Odanacatib 25 Mg-Base2.23
Odanacatib 50 Mg-Base-31.83

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Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-Terminal Propeptide of Type 1 Collagen [s-P1NP]) at 24 Months

Back-transformation (geometric mean) of the least squares mean of the log-values percentage change from baseline in biochemical marker of bone turnover (s-P1NP) (relative to baseline) at 24 months (NCT00112437)
Timeframe: Baseline and 24 months

InterventionGeometric LS Mean percent change (Least Squares Mean)
Placebo-Ext 11.29
Odanacatib 3 Mg-Ext 150.52
Odanacatib 10 Mg-Ext 19.07
Odanacatib 25 Mg-Ext 114.60
Odanacatib 50 Mg-Ext 1-20.20

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Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum N-terminal Propeptide of Type 1 Collagen [s-P1NP]) at 36 Months

Percentage change from baseline in biochemical marker of bone turnover (serum N-terminal propeptide of Type 1 collagen [s-P1NP]) at 36 months (NCT00112437)
Timeframe: Baseline and 36 months

InterventionPercentage change (Least Squares Mean)
Placebo / Placebo-Ext 2-20.79
Placebo / Odanacatib 50 Mg-Ext 2-18.79
Odanacatib 3 mg / Placebo-Ext 2-13.11
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2-21.08
Odanacatib 10 mg / Placebo-Ext 28.58
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 212.44
Odanacatib 25 mg / 50 Mg-Ext 222.57
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2-8.14
Odanacatib 50 mg / Placebo-Ext 2-0.77
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2-6.20

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Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 12 Months

Back-transformation (geometric mean) of the Least Squares Mean of the log-values percentage change from baseline in biochemical marker of bone turnover (urinary total deoxypyridinolines (u-DPyr)) (relative to baseline) at 12 Months (NCT00112437)
Timeframe: Baseline and 12 months

InterventionPercentage change (Least Squares Mean)
Placebo-Base-7.25
Odanacatib 3 Mg-Base20.91
Odanacatib 10 Mg-Base-8.58
Odanacatib 25 Mg-Base-8.50
Odanacatib 50 Mg-Base-25.52

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Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 12 Months

Back-transformation (geometric mean) of the Least Squares (LS) Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary N-telopeptides of Type I collagen (u-NTx)) at 12 Months (NCT00112437)
Timeframe: Baseline and 12 Months

InterventionPercentage change (Least Squares Mean)
Placebo-Base-2.37
Odanacatib 3 Mg-Base8.80
Odanacatib 10 Mg-Base-34.21
Odanacatib 25 Mg-Base-48.29
Odanacatib 50 Mg-Base-60.23

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Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 24 Months

Back-transformation (geometric mean) of the Least Squares Mean of the log-values percentage change from baseline in biochemical marker of bone turnover (u-NTx) (relative to baseline) at 24 Months (NCT00112437)
Timeframe: Baseline and 24 months

InterventionPercentage change (Least Squares Mean)
Placebo-Base-4.62
Odanacatib 3 Mg-Base12.89
Odanacatib 10 Mg-Ext 1-40.57
Odanacatib 25 Mg-Base-38.30
Odanacatib 50 Mg-Base-51.83

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Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary N-Telopeptides of Type I Collagen [u-NTx]) at 36 Months

Percentage change from baseline in biochemical marker of bone turnover (u-NTx) at 36 Months (NCT00112437)
Timeframe: Baseline and 36 months

InterventionPercentage change (Least Squares Mean)
Placebo / Placebo-Ext 2-17.43
Placebo / Odanacatib 50 Mg-Ext 2-55.12
Odanacatib 3 mg / Placebo-Ext 2-11.90
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2-57.17
Odanacatib 10 mg / Placebo-Ext 2-12.15
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2-49.10
Odanacatib 25 mg / 50 Mg-Ext 214.26
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2-52.11
Odanacatib 50 mg / Placebo-Ext 227.55
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2-50.51

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Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 24 Months

Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary total deoxypyridinolines (u-DPyr)) (relative to baseline) at 24 Months (NCT00112437)
Timeframe: Baseline and 24 months

InterventionGeometric LS Mean percent change (Least Squares Mean)
Placebo-Ext 1-5.78
Odanacatib 3 Mg-Ext 115.96
Odanacatib 10 Mg-Ext 1-7.57
Odanacatib 25 Mg-Ext 1-14.30
Odanacatib 50 Mg-Ext 1-22.49

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Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 36 Months

Percentage change from baseline in biochemical marker of bone turnover u-DPyr at 36 Months (NCT00112437)
Timeframe: Baseline and 36 months

InterventionPercentage change (Least Squares Mean)
Placebo / Placebo-Ext 2-18.69
Placebo / Odanacatib 50 Mg-Ext 2-14.95
Odanacatib 3 mg / Placebo-Ext 2-7.82
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2-26.27
Odanacatib 10 mg / Placebo-Ext 2-4.69
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 20.43
Odanacatib 25 mg / 50 Mg-Ext 2-9.16
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 2-16.41
Odanacatib 50 mg / Placebo-Ext 222.41
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2-16.84

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Percentage Change From Baseline in Distal Forearm BMD at 12 Months

Percentage change in distal forearm BMD (relative to baseline) at 12 months (NCT00112437)
Timeframe: Baseline and 12 Months

InterventionPercentage change (Least Squares Mean)
Placebo-Base-1.27
Odanacatib 3 Mg-Base-2.55
Odanacatib 10 Mg-Base-1.00
Odanacatib 25 Mg-Base-0.17
Odanacatib 50 Mg-Base-0.04

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Percentage Change From Baseline in Distal Forearm BMD at 24 Months

Percentage change in distal forearm BMD (relative to baseline) at 24 Months (NCT00112437)
Timeframe: Baseline and 24 months

InterventionPercentage change (Least Squares Mean)
Placebo-Base-2.75
Odanacatib 3 Mg-Base-5.70
Odanacatib 10 Mg-Ext 1-1.22
Odanacatib 25 Mg-Base-0.65
Odanacatib 50 Mg-Base0.15

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Percentage Change From Baseline in Distal Forearm BMD at 36 Months

Percentage change in distal forearm BMD (relative to baseline) at 36 Months (NCT00112437)
Timeframe: Baseline and 36 months

InterventionPercentage Change (Least Squares Mean)
Placebo / Placebo-Ext 2-2.08
Placebo / Odanacatib 50 Mg-Ext 2-4.04
Odanacatib 3 mg / Placebo-Ext 2-6.59
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 2-6.34
Odanacatib 10 mg / Placebo-Ext 2-1.74
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2-3.74
Odanacatib 25 mg / 50 Mg-Ext 2-2.39
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 20.53
Odanacatib 50 mg / Placebo-Ext 2-2.73
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2-0.26

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Percentage Change From Baseline in Femoral Neck BMD at 12 Months

Percentage change in femoral neck BMD (relative to baseline) at 12 months (NCT00112437)
Timeframe: Baseline and 12 months

InterventionPercentage change (Least Squares Mean)
Placebo-Base-0.13
Odanacatib 3 Mg-Base-0.32
Odanacatib 10 Mg-Base0.74
Odanacatib 25 Mg-Base1.76
Odanacatib 50 Mg-Base2.53

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Percentage Change From Baseline in Femoral Neck BMD at 24 Months

Percentage change in femoral neck Bone Mineral Density (relative to baseline) at 24 Months (NCT00112437)
Timeframe: Baseline and 24 months

InterventionPercentage change (Least Squares Mean)
Placebo-Ext 1-0.85
Odanacatib 3 Mg-Ext 1-1.25
Odanacatib 10 Mg-Ext 11.97
Odanacatib 25 Mg-Ext 12.73
Odanacatib 50 Mg-Ext 13.84

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Percentage Change From Baseline in Femoral Neck BMD at 36 Months

Percentage change in femoral neck BMD (relative to baseline) at 36 Months (NCT00112437)
Timeframe: Baseline and 36 months

InterventionPercentage change (Least Squares Mean)
Placebo / Placebo-Ext 2-0.52
Placebo / Odanacatib 50 Mg-Ext 21.03
Odanacatib 3 mg / Placebo-Ext 2-1.04
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 22.26
Odanacatib 10 mg / Placebo-Ext 2-0.14
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 25.06
Odanacatib 25 mg / 50 Mg-Ext 20.80
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 27.23
Odanacatib 50 mg / Placebo-Ext 22.26
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 24.97

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Percentage Change From Baseline in Lumbar Spine BMD at 120 Months

Percentage change from baseline in lumbar spine BMD at 120 Months. (NCT00112437)
Timeframe: Baseline and Month 120

InterventionPercentage Change (Mean)
Group A: Odanacatib 50 mg Once Weekly16.92
Group B: Odanacatib 50 mg Once Weekly14.56
Group C: Odanacatib 50 mg Once Weekly17.18
Group D: Odanacatib 50 mg Once Weekly7.71

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Percentage Change From Baseline in Lumbar Spine BMD at 24 Months

Percentage change in lumbar spine BMD (relative to baseline) at 24 Months. (NCT00112437)
Timeframe: Baseline and 24 months

InterventionPercentage Change (Least Squares Mean)
Placebo-Ext 1-0.19
Odanacatib 3 Mg-Ext 1-1.03
Odanacatib 10 Mg-Ext 13.20
Odanacatib 25 Mg-Ext 14.26
Odanacatib 50 Mg-Ext 15.48

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Percentage Change From Baseline in Lumbar Spine BMD at 36 Months

Percentage change in lumbar spine BMD (relative to baseline) at 36 months (NCT00112437)
Timeframe: Baseline and 36 months

InterventionPercent Change (Least Squares Mean)
Placebo / Placebo-Ext 20.42
Placebo / Odanacatib 50 Mg-Ext 22.95
Odanacatib 3 mg / Placebo-Ext 2-1.57
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 24.41
Odanacatib 10 mg / Placebo-Ext 22.03
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 26.11
Odanacatib 25 mg / Placebo-Ext 20.32
Odanacatib 25 mg / 50 Mg-Ext 27.45
Odanacatib 50 mg / Placebo-Ext 21.39
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 27.85

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Percentage Change From Baseline in Lumbar Spine BMD at 60 Months

Percentage change from baseline in lumbar spine BMD at 60 months. (NCT00112437)
Timeframe: Baseline and Month 60

InterventionPercentage change (Mean)
Placebo Once Weekly-0.41
Odanacatib 50 mg Once Weekly11.88

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Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months

Percentage change in lumbar spine BMD (relative to baseline) at 12 Months. (NCT00112437)
Timeframe: Baseline and 12 months

InterventionPercentage change (Least Squares Mean)
Placebo-Base-0.13
Odanacatib 3 Mg-Base-0.62
Odanacatib 10 Mg-Base1.50
Odanacatib 25 Mg-Base2.65
Odanacatib 50 Mg-Base3.37

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Percentage Change From Baseline in Total Body BMD at 12 Months

Percentage change in total body BMD (relative to baseline) at 12 months (NCT00112437)
Timeframe: Baseline and 12 Months

InterventionPercentage change (Least Squares Mean)
Placebo-Base-0.42
Odanacatib 3 Mg-Base-1.89
Odanacatib 10 Mg-Base-1.06
Odanacatib 25 Mg-Base-0.51
Odanacatib 50 Mg-Base-0.13

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Percentage Change From Baseline in Total Body BMD at 24 Months

Percentage change in total body BMD (relative to baseline) at 24 Months (NCT00112437)
Timeframe: Baseline and 24 months

InterventionPercentage change (Least Squares Mean)
Placebo-Ext 1-1.54
Odanacatib 3 Mg-Ext 1-2.70
Odanacatib 10 Mg-Ext 1-1.35
Odanacatib 25 Mg-Ext 1-0.43
Odanacatib 50 Mg-Ext 10.19

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Percentage Change From Baseline in Total Body BMD at 36 Months

Percentage change from baseline in total body BMD (relative to baseline) at 36 Months (NCT00112437)
Timeframe: Baseline and 36 months

InterventionPercentage change (Least Squares Mean)
Placebo / Placebo-Ext 20.13
Placebo / Odanacatib 50 Mg-Ext 2-2.20
Odanacatib 3 mg / Placebo-Ext 2-3.63
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 20.28
Odanacatib 10 mg / Placebo-Ext 2-2.28
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 2-1.22
Odanacatib 25 mg / 50 Mg-Ext 2-0.85
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 20.56
Odanacatib 50 mg / Placebo-Ext 2-1.84
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 2-0.38

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Percentage Change From Baseline in Total Hip BMD at 36 Months

Percentage change in total hip BMD (relative to baseline) at 36 months (NCT00112437)
Timeframe: Baseline and 36 months

InterventionPercentage change (Least Squares Mean)
Placebo / Placebo-Ext 2-0.77
Placebo / Odanacatib 50 Mg-Ext 21.16
Odanacatib 3 mg / Placebo-Ext 2-0.63
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 22.75
Odanacatib 10 mg / Placebo-Ext 20.96
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 24.61
Odanacatib 25 mg / 50 Mg-Ext 21.64
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 25.70
Odanacatib 50 mg / Placebo-Ext 2-0.48
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 25.83

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Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum C-Telopeptides of Type 1 Collagen [s-CTx]) at 12 Months

Back-transformation (geometric mean) of the Least Squares (LS) Mean of the log-values Percentage change from baseline in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen (s-CTx)) at 12 Months. (NCT00112437)
Timeframe: Baseline and 12 Months

InterventionPercentage change (Least Squares Mean)
Placebo-Base-0.58
Odanacatib 3 Mg-Base19.12
Odanacatib 10 Mg-Base-22.24
Odanacatib 25 Mg-Base-36.15
Odanacatib 50 Mg-Base-56.91

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Percentage Change From Baseline in Total Hip Bone Mineral Density at 24 Months

Percentage change in total hip Bone Mineral Density (relative to baseline) at 24 Months (NCT00112437)
Timeframe: Baseline and 24 months

InterventionPercentage change (Least Squares Mean)
Placebo-Ext 1-0.93
Odanacatib 3 Mg-Ext 1-1.44
Odanacatib 10 Mg-Ext 11.82
Odanacatib 25 Mg-Ext 12.55
Odanacatib 50 Mg-Ext 13.16

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Percentage Change From Baseline in Trochanter BMD at 24 Months

Percentage change from baseline in trochanter BMD (relative to baseline) at 24 Months (NCT00112437)
Timeframe: Baseline and 24 months

InterventionPercentage Change (Least Squares Mean)
Placebo-Ext 1-0.81
Odanacatib 3 Mg-Ext 1-0.85
Odanacatib 10 Mg-Ext 13.61
Odanacatib 25 Mg-Ext 13.75
Odanacatib 50 Mg-Ext 14.28

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Percentage Change From Baseline in Trochanter BMD at 36 Months

Percentage change in trochanter BMD (relative to baseline) at 36 months (NCT00112437)
Timeframe: Baseline and 36 months

InterventionPercentage Change (Least Squares Mean)
Placebo / Placebo-Ext 2-0.46
Placebo / Odanacatib 50 Mg-Ext 22.32
Odanacatib 3 mg / Placebo-Ext 2-1.04
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 24.53
Odanacatib 10 mg / Placebo-Ext 20.66
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 28.21
Odanacatib 25 mg / 50 Mg-Ext 21.14
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 27.97
Odanacatib 50 mg / Placebo-Ext 2-0.69
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 27.44

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Number of Participants Who Discontinued Study Drug Due to an AE During Treatment Years 6-10 (60 Months)

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. (NCT00112437)
Timeframe: Years 6-10 (up to 60 months)

InterventionParticipants (Number)
Group A: Odanacatib 50 mg Once Weekly1
Group B: Odanacatib 50 mg Once Weekly2
Group C: Odanacatib 50 mg Once Weekly0
Group D: Odanacatib 50 mg Once Weekly1

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Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment Years 6-10 (60 Months)

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. (NCT00112437)
Timeframe: Years 6-10 (up to 60 months, up to 14 days after the last dose of study drug)

InterventionParticipants (Number)
Group A: Odanacatib 50 mg Once Weekly27
Group B: Odanacatib 50 mg Once Weekly34
Group C: Odanacatib 50 mg Once Weekly23
Group D: Odanacatib 50 mg Once Weekly32

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Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b [TRAP 5-b]) at 36 Months

Percentage change from baseline in biochemical marker of bone turnover (serum bone tartrate-resistant acid phosphatase isoform 5b [TRAP 5-b]) at 36 Months (NCT00112437)
Timeframe: Baseline and 36 months

InterventionPercentage change (Least Squares Mean)
Placebo / Placebo-Ext 252.98
Placebo / Odanacatib 50 Mg-Ext 252.37
Odanacatib 3 mg / Placebo-Ext 233.25
Odanacatib 3 mg / Odanacatib 50 Mg-Ext 259.37
Odanacatib 10 mg / Placebo-Ext 256.71
Odanacatib 10 mg / Odanacatib 50 Mg-Ext 282.94
Odanacatib 25 mg / 50 Mg-Ext 256.42
Odanacatib 25 mg / Odanacatib 50 Mg-Ext 277.90
Odanacatib 50 mg / Placebo-Ext 247.61
Odanacatib 50 mg / Odanacatib 50 Mg-Ext 296.70

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Percentage Change From Baseline in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 12 Months

Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase (s-BSAP)), at 12 Months (NCT00112437)
Timeframe: Baseline and 12 months

InterventionPercentage change (Least Squares Mean)
Placebo-Base-2.77
Odanacatib 3 Mg-Base42.08
Odanacatib 10 Mg-Base8.95
Odanacatib 25 Mg-Base2.66
Odanacatib 50 Mg-Base-18.35

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Advanced Colorectal Lesions

Includes: adenomas >=1 cm, adenomas with high grade dysplasia, adenomas with villous features, or cancer. (NCT00153816)
Timeframe: 1 to 10 years

Interventionpercentage of subjects (Number)
Full Factorial Placebo9.2
Full Factorial Calcium11.4
Full Factorial Vitamin D10.9
Full Factorial Calcium Plus Vitamin D9.6
Two Arm Placebo6.9
Two Arm Vitamin D7.3

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Colorectal Adenomas

(NCT00153816)
Timeframe: 1 to 10 years

Interventionpercentage of subjects (Number)
Full Factorial Placebo48.2
Full Factorial Calcium44.9
Full Factorial Vitamin D47.0
Full Factorial Calcium Plus Vitamin D45.7
Two Arm Placebo32.1
Two Arm Vitamin D32.4

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Systolic Blood Pressure at 3 Months

systolic blood pressure at 3 months (NCT00285467)
Timeframe: 3 month

InterventionmmHg (Mean)
Doxercalciferol, Active Vitamin D120
Cholecalciferol, Inactive Vitamin D128

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Percent Reduction in PTH

Percent reduction in PTH from baseline to 3 months (NCT00285467)
Timeframe: 3 month

Intervention% change in PTH baseline to 3 months (Mean)
Doxercalciferol, Active Vitamin D27
Cholecalciferol, Inactive Vitamin D10

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25-Hydroxyvitamin D Concentration

Circulating total 25(OH)D concentration measured in serum at visit 7, one month prior to delivery (NCT00292591)
Timeframe: 7 months

Interventionng/mL (Mean)
Cholecalciferol-400 IU32.5
Cholecalciferol 2000 IU41.0
Cholecalciferol 4000 IU45.7

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Mean Change in Luteinizing Hormone

Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Luteinizing hormone is a hormone produced by the anterior pituitary gland. (NCT00321932)
Timeframe: From Time of Transplant to 12 Months Post-Transplant

InterventionIU/L (Mean)
Arm I (Standard of Care)18.8
Arm II (Treatment With Zometa)12.8

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Mean Change in Follicle-Stimulating Hormone

Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Follicle-stimulating hormone is a hormone produced by the anterior pituitary gland. (NCT00321932)
Timeframe: From Time of Transplant to 12 Months Post-Transplant

InterventionIU/L (Mean)
Arm I (Standard of Care)14.0
Arm II (Treatment With Zometa)6.6

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Mean Change in Bone Mineral Density

"Change in bone mineral density of the femoral neck measured from baseline to 12 months after transplant utilizing Dual-energy X-ray absorptiometry (DEXA) scan. Comparison of difference between the standard of care group (receiving calcium and vitamin D)and the Zometa group. The measurement consists of baseline bone mineral density measurements with followup measurements at 12 months.~This will be analyzed as a continuous variable. Percent change in bone mineral density (BMD) will be calculated as (BMD change) x 100/BMD baseline." (NCT00321932)
Timeframe: From Time of Transplant to 12 Months Post-Transplant

Interventionpercent (Mean)
Arm I (Standard of Care)-0.0714
Arm II (Treatment With Zometa)-0.0036

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Mean Change in Serum Bone Specific Alkaline Phosphate

Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. The decrease in serum bone-specific alkaline phosphatase predicts bone mineral density response to hormone replacement therapy in early postmenopausal women. (NCT00321932)
Timeframe: From Time of Transplant to 12 Months Post-Transplant

InterventionU/L (Mean)
Arm I (Standard of Care)-3.0
Arm II (Treatment With Zometa)-4.3

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Mean Change in Urinary N-terminal Telopeptide

Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. In bone physiology, the N-terminal telopeptide is a biomarker used to measure the rate of bone turnover. (NCT00321932)
Timeframe: From Time of Transplant to 12 Months Post-Transplant

InterventionnM Bone Collagen Equivalents/mM creatini (Mean)
Arm I (Standard of Care)-22.5
Arm II (Treatment With Zometa)-103.0

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Mean Change in Ultrasensitive Estradiol

Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. In women estradiol is responsible for growth of the breast and reproductive epithelia, maturation of long bones and development of the secondary sexual characteristics. (NCT00321932)
Timeframe: From Time of Transplant to 12 Months Post-Transplant

Interventionpg/ml (Mean)
Arm I (Standard of Care)-3.6
Arm II (Treatment With Zometa)-6.3

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Mean Change in Total Testosterone

Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Testosterone affects the brain, bone and muscle mass, fat distribution, the vascular system, energy levels, genital tissues, and sexual functioning. (NCT00321932)
Timeframe: From Time of Transplant to 12 Months Post-Transplant

Interventionng/dL (Mean)
Arm I (Standard of Care)-65.4
Arm II (Treatment With Zometa)-23.6

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Mean Change in Thyroid Function Test 4

Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Individuals who have hyperthyroidism will have an elevated thyroxine (FT4). Low serum thyroxine can also indicate a pituitary problem. (NCT00321932)
Timeframe: From Time of Transplant to 12 Months Post-Transplant

Interventionng/dL (Mean)
Arm I (Standard of Care)-0.6
Arm II (Treatment With Zometa)-0.2

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Mean Change in Serum Osteocalcin

Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. As osteocalcin is produced by osteoblasts, it is often used as a marker for the bone formation process. (NCT00321932)
Timeframe: From Time of Transplant to 12 Months Post-Transplant

Interventionng/ml (Mean)
Arm I (Standard of Care)-3.6
Arm II (Treatment With Zometa)-11.3

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Maternal Health Status - Vitamin D Deficiency

Percentage of subjects with 25-hydroxyvitamin D [25(OH)D] concentration <20 ng/mL at Visit 7 (NCT00412074)
Timeframe: to 7 months postpartum

Interventionpercentage of participants (Number)
Control 400 IU Vitamin D322.95
2400 IU Vitamin D3 (Cholecalciferol)11.36
6400 IU Vitamin D3 (Cholecalciferol)4.69

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Infant Health Status - Vitamin D Deficiency

Percentage of infants with 25-hydroxyvitamin D [25(OH)D] concentration <20 ng/mL at Visit 7 (NCT00412074)
Timeframe: to 7 months of age

Interventionpercentage of infants (Number)
Control 400 IU Vitamin D32.78
2400 IU Vitamin D3 (Cholecalciferol)8.11
6400 IU Vitamin D3 (Cholecalciferol)2.63

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25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery

(NCT00412074)
Timeframe: to 7 months postpartum

Interventionng/mL (Mean)
Control 400 IU Vitamin D328.5
2400 IU Vitamin D3 (Cholecalciferol)38.0
6400 Vitamin D3 (Cholecalciferol)55.6

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Parathyroid Hormone at Visit 7

Intact parathyroid hormone at Visit 7, one month prior to delivery (NCT00412087)
Timeframe: 7 months

Interventionpg/mL (Mean)
Cholecalciferol 2000 IU17.3
Cholecalciferol 4000 IU14.3

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25-hydroxyvitamin D at Visit 7

25-hydroxyvitamin D at Visit 7, one month prior to delivery (NCT00412087)
Timeframe: 7 months

Interventionng/mL (Mean)
Cholecalciferol 2000 IU36.7
Cholecalciferol 4000 IU39.8

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Number of Early Breast Cancer Patients Prescribed Adjuvant Letrozole That Are Vitamin D Deficient and Who Experience Myalgias, Arthralgias and/or Joint Stiffness

Count of early breast cancer patients prescribed adjuvant letrozole that are vitamin D deficient and who experience myalgias, arthralgias and/or joint stiffness, assessed at baseline and 1 month after vitamin D repletion. (NCT00416715)
Timeframe: Baseline and 1 month post vitamin D repletion

InterventionParticipants (Count of Participants)
Baseline12
Post Vitamin D Repletion (1 Month)1

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Letrozole Serum Levels Before and After Vitamin D Repletion

Letrezole serum level concentration in patients that were vitamin D deficient and experienced myalgias, arthralgias and/or joint stiffness. (NCT00416715)
Timeframe: Baseline and 1 month post vitamin D repletion

Interventionmicro-grams/mL (Median)
Baseline85
Post Vitamin D Repletion (1 Month)70

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Number Adherent With the Intervention

(NCT00421343)
Timeframe: 6 months

Interventionparticipants (Number)
Osteoporosis Medication29

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Parathyroid Hormone (PTH)

Baseline blood samples were drawn in-hospital. In additional PTH was accessed at baseline. (NCT00424619)
Timeframe: Baseline

Interventionpmol/L (Mean)
50 000 IU Vitamin D25.35
100 000 IU Vitamin D25.10
Placebo4.2

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Hemoglobin

Baseline blood samples were drawn in-hospital. In additional hemoglobin was accessed at baseline. (NCT00424619)
Timeframe: Baseline

Interventiong/L (Mean)
50 000 IU Vitamin D2102.2
100 000 IU Vitamin D2107.9
Placebo108.6

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Creatinine

Baseline blood samples were drawn in-hospital. In additional creatinine was accessed at baseline. (NCT00424619)
Timeframe: Baseline

Interventionµmol/L (Mean)
50 000 IU Vitamin D270.5
100 000 IU Vitamin D277.4
Placebo73.7

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Alkaline Phosphatase

Baseline blood samples were drawn in-hospital. In additional Alkaline Phosphatase was accessed at baseline. (NCT00424619)
Timeframe: Baseline

InterventionU/L (Mean)
50 000 IU Vitamin D298.6
100 000 IU Vitamin D278.7
Placebo79.4

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Phosphate

Baseline blood samples were drawn in-hospital. In additional phosphate was accessed at baseline. (NCT00424619)
Timeframe: Baseline

Interventionmmol/L (Mean)
50 000 IU Vitamin D20.86
100 000 IU Vitamin D20.97
Placebo0.94

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Calcium

Baseline blood samples were drawn in-hospital. In additional Calcium was accessed at baseline and approximately 4 weeks. (NCT00424619)
Timeframe: Baseline, 4 weeks

,,
Interventionmmol/L (Mean)
Baseline4 Weeks
100 000 IU Vitamin D22.122.31
50 000 IU Vitamin D22.102.26
Placebo2.082.28

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25-hydroxyvitamin D3 (25-OHD)

Serum 25-hydroxyvitamin D3 (25-OHD) was measured at baseline, at discharge from hospital (approximately 4-weeks), and at a follow-up study visit at approximately 3-months.Baseline and 4-week blood samples were drawn in-hospital; venipunctures performed at 3-months were either in-hospital (if patient remained in acute care or rehabilitation) or at the out-patient clinic visit.Serum 25-OHD was analyzed with the DiaSorin, 25-hydroxyvitamin D radioimmunoassay (Stillwater, Minnesota 55082-0285, U.S.A) at the central laboratory with the exception of 3 patients (data analyzed at other laboratories). (NCT00424619)
Timeframe: Baseline, 4 weeks and 3 months

,,
Interventionnmol/L (Mean)
Baseline4-week3-month
100 000 IU Vitamin D258.475.673.3
50 000 IU Vitamin D253.584.584.2
Placebo46.769.386.7

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Functional Assessment Using the Two Minute Walk Test (2MWT)After 3 Months

The 2MWT was collected for patients who attended the 3-month clinic appointment by study coordinators or for patients who attended rehabilitation, it was abstracted from their charts. The 2MWT test was given in a carpeted corridor and the subject was instructed to wear regular footwear and to use their customary walking aid. The distance the participant could comfortably walk in two-minutes (without physical assistance) was measured in metres. (NCT00424619)
Timeframe: 3 months

Interventionmeters (Mean)
50 000 IU Vitamin D260.2
100 000 IU Vitamin D280.3
Placebo63.4

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Functional Assessment Using the Timed Up and Go (TUG) Test After 3 Months

"The Timed Up and Go (TUG) was collected for patients who attended the 3-month clinic appointment by study coordinators or for patients who attended the rehabilitation unit this is routinely collected and was abstracted from chart. The TUG was conducted using a standard armchair and a line marked 3-metres from the chair. Participants were given the following instructions (no physical assistance was given): Rise from the chair, walk to the line on the floor, turn, return to the chair and sit down again. Scores are measured as time in seconds to complete the task." (NCT00424619)
Timeframe: 3 months

Interventionseconds (Mean)
50 000 IU Vitamin D226.2
100 000 IU Vitamin D219.1
Placebo18.1

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Bone Turnover Marker-CTX

Blood levels of C-telopeptide (NCT00427037)
Timeframe: 12 weeks

Interventionpg/mL (Geometric Mean)
Placebo0.24
Cholecalciferol0.29

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25-hydroxyvitamin D

25-hydroxyvitamin D measured in serum by ELISA (NCT00427037)
Timeframe: 3 months

,
Interventionng/mL (Mean)
Baseline12 weeks
Cholecalciferol17.349.4
Placebo18.619.5

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Chang in Disposition Index, a Measure of Beta Cell Function

Range is 0 to infinity Lower is better. (NCT00436475)
Timeframe: baseline and 4 months

Interventionunits on a scale (Mean)
Vitamin D-Calcium287
Vitamin D Only314
Calcium Only-122
Placebo-Placebo-129

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Change in Hemoglobin A1c

This outcome measures change in Hemoglobin A1c, a measure of glycemia (NCT00436475)
Timeframe: Baseline to 4 months

Intervention% of hemoglobin (Mean)
Vitamin D-Calcium0.05
Vitamin D Only0.08
Calcium Only0.09
Placebo-Placebo0.18

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25-hydroxyvitamin D

This is a marker of vitamin D status (NCT00450073)
Timeframe: 12 weeks

Interventionng/mL (Mean)
Vitamin D321.2
Vitamin D224.4
Sunlamp28.2

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Time to Progression

Progression will be defined as a 50% rise in serum PSA compared to the baseline value confirmed on at least two measurements at least two weeks apart. (NCT00499408)
Timeframe: up to three years

Interventionmonths (Median)
Vitamin D and Soy Supplementation10.3

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Number of Participants Showing a 50% Reduction in Serum Prostate Specific Antigen(PSA) During Treatment

(NCT00499408)
Timeframe: up to one year

Interventionparticipants (Number)
Vitamin D and Soy Supplementation0

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Number of Adverse Events, Grades 1-5

Toxicity will be graded according to the revised NCI Common Terminology Criteria for Adverse Events v 3.0, (CTCAE). Number of events with grade 1-5 will be reported. (NCT00499408)
Timeframe: up to one year

Interventionevents (Number)
Grade 1Grade 2Grade 3Grade 4Grade 5
Vitamin D and Soy Supplementation9330701

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Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls

Number of participant with occurrence of infections, deep venous thrombosis, vascular events and falls (NCT00524680)
Timeframe: Baseline, at 1, 3 ,6 months

Interventionparticipants (Number)
Arm I: Vitamin D 4000 IU Daily2
Arm II: Vitamin D 6000 IU Daily0
Arm III: Vitamin D 8000 IU Daily2
Arm IV: Vitamin D 10,000 IU Daily2

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Toxicity

Number of treated patients that had serious adverse events. (NCT00524680)
Timeframe: Baseline, at 1, 3 and 6 months

Interventionparticipants (Number)
Arm I: Vitamin D 4000 IU Daily2
Arm II: Vitamin D 6000 IU Daily0
Arm III: Vitamin D 8000 IU Daily1
Arm IV: Vitamin D 10,000 IU Daily5

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Pattern of Response of Parathormone

Change from Baseline in PTH Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test. (NCT00524680)
Timeframe: Baseline, at 1, 3, 6 months

,,,
Interventionpg/mL (Mean)
1-month3-month6-month
Arm I: Vitamin D 4000 IU Daily-.73-11.3-8.4
Arm II: Vitamin D 6000 IU Daily-12.18.24-24.05
Arm III: Vitamin D 8000 IU Daily-1.28-8.03-9.78
Arm IV: Vitamin D 10,000 IU Daily-10.37-18.06-16.51

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Pattern of Response of Serum 25(OH) D3 Levels

Change from Baseline in Serum 25(OH) D3 Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test. (NCT00524680)
Timeframe: Baseline, at 1, 3, 6 months

,,,
Interventionng/mL (Mean)
1-month3-month6-month
Arm I: Vitamin D 4000 IU Daily11.3423.4527.16
Arm II: Vitamin D 6000 IU Daily24.8438.3143.4
Arm III: Vitamin D 8000 IU Daily18.8735.7641.7
Arm IV: Vitamin D 10,000 IU Daily26.9145.6757.59

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Base Study: Incidence Rate of Femoral Shaft Fractures Confirmed by Adjudication

The incidence rate of femoral shaft fracture events (including both atypical and non-atypical; of any etiology including traumatic) confirmed by adjudication was determined for the base study. Results are expressed as number of participants with an event per 100 person-years of follow-up. (NCT00529373)
Timeframe: Up to approximately 60 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.10
Placebo0.06

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Base Study: Incidence Rate of Atypical Femoral Shaft Fractures Confirmed by Adjudication

Atypical subtrochanteric/diaphyseal femoral fractures (AFF) are an uncommon type of low-energy (eg, osteoporotic) femoral shaft fracture of unclear causation infrequently reported in osteoporotic persons treated with long-term anti-resorptive therapy (eg, bisphosphonates). All femoral (femur, femur-distal, femur-shaft) fractures in the base study were adjudicated against both ASBMR 2010 and 2013 criteria. All 5 major features (ie, location along femoral shaft, no/minimal trauma, transverse/short oblique fracture, non-comminuted, complete/incomplete fracture) were required for ASBMR 2010 AFF case definition; while 4 of 5 major features (ie, no/minimal trauma, substantially transverse orientation at cortical origin with possible oblique orientation medially, non-comminuted/minimally comminuted, complete/incomplete fracture, localized periosteal reaction of lateral cortex) with requirement for location along femoral shaft were required for ASBMR 2013 AFF case definition. (NCT00529373)
Timeframe: Up to approximately 60 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.02
Placebo0.00

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Base Study + First Extension: Time to First New Onset ECG-Confirmed Atrial Fibrillation or Atrial Flutter Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated new or presumed new onset atrial fibrillation or atrial flutter was determined for the base study + first extension using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Participants with known history of atrial fibrillation or atrial flutter were excluded and electrocardiogram confirmation was required. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 74 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.27
Placebo0.22

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Base Study + First Extension: Time to First New Onset Atrial Fibrillation or Atrial Flutter Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated new or presumed new onset atrial fibrillation or atrial flutter was determined for the base study + first extension using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Participants with known history of atrial fibrillation or atrial flutter were excluded and electrocardiogram confirmation was not required. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 74 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.51
Placebo0.43

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Base Study + First Extension: Time to First Hospitalization for Unstable Angina Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated hospitalization for unstable angina was determined for the base study + first extension using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 74 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.08
Placebo0.10

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Base Study + First Extension: Time to First Fatal Stroke Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated fatal definite stroke was determined for the base study + first extension using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 74 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.09
Placebo0.05

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Base Study + First Extension: Time to First Fatal or Non-Fatal Stroke Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated fatal or non-fatal definite stroke was determined for the base study + first extension using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 74 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.58
Placebo0.42

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Base Study + First Extension: Time to First Fatal or Non-Fatal Myocardial Infarction Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated fatal or non-fatal definite myocardial infarction was determined for the base study + first extension using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 74 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.26
Placebo0.28

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Base Study + First Extension: Time to First Fatal Myocardial Infarction Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated fatal definite myocardial infarction was determined for the base study + first extension using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 74 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.02
Placebo0.03

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Base Study + First Extension: Time to First Cardiovascular Death Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated cardiovascular death was determined for the base study + first extension using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. The analysis includes data obtained from vital status data collections of participants no longer followed in the base study. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 74 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.48
Placebo0.43

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Base Study + First Extension: Time to First Any Atrial Fibrillation or Atrial Flutter Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated any reported episode of atrial fibrillation or atrial flutter was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Participants with known history of atrial fibrillation or atrial flutter were included and electrocardiogram confirmation was not required. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 74 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.61
Placebo0.50

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Base Study + First Extension: Time to First All-Cause Death Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated all-cause death was determined for the base study + first extension using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. The analysis includes data obtained from vital status data collections of participants no longer followed in the base study. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 74 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW1.79
Placebo1.70

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Base Study + First Extension: Time to First 4-Point MACE Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated 4-point MACE (a composite outcome measure of 1. cardiovascular death, 2. non-fatal definite MI, 3. non-fatal definite stroke, or 4. hospitalization for unstable angina) was determined for the base study + first extension using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 74 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW1.31
Placebo1.15

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Base Study + First Extension: Time to First 3-Point MACE Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated 3-point MACE (a composite outcome measure of 1. cardiovascular death, 2. non-fatal definite MI, or 3. non-fatal definite stroke) was determined for the base study + first extension using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 74 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW1.24
Placebo1.06

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Base Study + First Extension: Time From Baseline to First Osteoporotic Clinical Vertebral Fracture (Adjudicated)

Osteoporotic vertebral clinical fractures were confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Vertebral fractures were assessed for all vertebral levels (C7, T1 to T12, L1 to L5). Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence rate of participants with fracture (number of participants with a fracture per 100 person-years of follow-up) is provided. (NCT00529373)
Timeframe: Up to approximately 74 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.18
Placebo0.56

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Base Study + First Extension: Time From Baseline to First Osteoporotic Clinical Non-Vertebral Fracture (Adjudicated)

Osteoporotic non-vertebral clinical fractures were confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Non-vertebral fractures were assessed across multiple anatomical sites including clavicle, distal femur and shaft, fibula, hip, humerus, pelvis, radius, ribs, sacrum, tibia, ulna, and wrist. Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence rate of participants with fracture (number of participants with a fracture per 100 person-years of follow-up) is provided. (NCT00529373)
Timeframe: Up to approximately 74 months of observation

InterventionParts. w/ fracture per 100 person-years (Number)
Odanacatib 50 mg OW1.78
Placebo2.41

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Base Study + First Extension: Time From Baseline to First Osteoporotic Clinical Hip Fracture (Adjudicated)

Osteoporotic clinical hip fractures was confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Hip fractures were fractures of the proximal femur confirmed as being located in the hip (i.e., sub-region not specified; cervical, and intertrochanteric). Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence rate of participants with fracture (number of participants with a fracture per 100 person-years of follow-up) is provided. (NCT00529373)
Timeframe: Up to approximately 74 months of observation

InterventionParts. w/ fracture per 100 person-years (Number)
Odanacatib 50 mg OW0.29
Placebo0.56

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Base Study + First Extension: Time From Baseline to First Osteoporotic Clinical Fracture (Adjudicated)

Osteoporotic clinical fractures (combining vertebral and non-vertebral) were confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Vertebral fractures were assessed for all vertebral levels (C7, T1 to T12, L1 to L5). Non-vertebral fractures were assessed across multiple anatomical sites including clavicle, distal femur or shaft, fibula, hip, humerus, pelvis, radius, ribs, sacrum, tibia, ulna, and wrist. Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence rate of participants with fracture (number of participants with a fracture per 100 person-years of follow-up) is provided. (NCT00529373)
Timeframe: Up to approximately 74 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW1.95
Placebo2.93

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Base Study + First Extension: Time From Baseline to First Morphometrically-Assessed Vertebral Fracture

Morphometric vertebral fractures were confirmed by central adjudication on lumbar and thoracic spinal radiographs acquired at baseline and at Months 6, 12, and subsequent yearly time points. Incident fractures (i.e., occurring after baseline) in previously normal vertebral bodies and/or those occurring after baseline in previously fractured vertebral bodies (Genant SQ Grade 1-3) (T4 to L4) were confirmed by QM and either SQ or binary SQ (yes/no) methodologies. A time-to-event methodology was used to evaluate results: life-table estimates of the incidence proportion (cumulative incidence) of participants with at least one morphometric vertebral fracture were assessed at Months 6, 12, and subsequent yearly intervals; an interval-censored approach was then used to determine incidence rate (number of participants with a morphometric fracture per 100 person-years of follow-up). (NCT00529373)
Timeframe: Up to approximately 74 months of observation

InterventionParts. w/ fracture per 100 person-years (Number)
Odanacatib 50 mg OW1.33
Placebo2.74

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Base Study + First Extension: Rate of Discontinuations From Study Treatment Due to an Adverse Event

An adverse event is defined as any untoward medical occurrence in a person or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The incidence rate of participant discontinuations from treatment due to adverse events (number of participants with an event per 100 person-years of follow-up) is provided. (NCT00529373)
Timeframe: Up to approximately 74 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW2.66
Placebo2.55

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Base Study + First Extension: Rate of Adverse Events

An adverse event is defined as any untoward medical occurrence in a person or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The incidence rate of participants with adverse events (number of participants with an event per 100 person-years of follow-up) is provided. (NCT00529373)
Timeframe: Up to approximately 74 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW97.25
Placebo96.36

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Base Study + First Extension: Incidence Rate of Femoral Shaft Fractures Confirmed by Adjudication

The incidence rate of femoral shaft fracture events (including both atypical and non-atypical; of any etiology including traumatic) confirmed by adjudication was determined for the base study + first extension. Results are expressed as number of participants with an event per 100 person-years of follow-up. (NCT00529373)
Timeframe: Up to approximately 74 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.09
Placebo0.02

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Base Study + First Extension: Incidence Rate of Atypical Femoral Shaft Fractures Confirmed by Adjudication

Atypical subtrochanteric/diaphyseal femoral fractures (AFF) are an uncommon type of low-energy (eg, osteoporotic) femoral shaft fracture of unclear causation infrequently reported in osteoporotic persons treated with long-term anti-resorptive therapy (eg, bisphosphonates). All femoral (femur, femur-distal, femur-shaft) fractures in the base study + first extension were adjudicated against both ASBMR 2010 & 2013 criteria. All 5 major features (ie, location along femoral shaft, no/minimal trauma, transverse/short oblique fracture, non-comminuted, complete/incomplete fracture) were required for ASBMR 2010 AFF case definition; while 4 of 5 major features (ie, no/minimal trauma, substantially transverse orientation at cortical origin with possible oblique orientation medially, non-comminuted/minimally comminuted, complete/incomplete fracture, localized periosteal reaction of lateral cortex) with requirement for location along femoral shaft were required for ASBMR 2013 AFF case definition. (NCT00529373)
Timeframe: Up to approximately 74 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.03
Placebo0.00

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Sarcopenia Substudy PN035: Change From Baseline in Short Physical Performance Battery (SPPB) Score

The Short Physical Performance Battery (SPPB) Score is used to assess physical function in older persons. The SPPB consists of 3 types of physical activities: standing balance, gait speed, and chair rise. Component activities are timed and then reduced to a categorical 0 to 4 scale based on time achieved. A higher composite score (range 0 to 12) indicates an improved function level. The change from baseline at yearly intervals was then assessed using a longitudinal data analysis model with terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size). (NCT00529373)
Timeframe: Baseline and once yearly up to 4 years

,
InterventionScore on a scale (Least Squares Mean)
Month 12Month 24Month 36Month 48
Odanacatib 50 mg OW0.03-0.04-0.18-0.05
Placebo-0.08-0.19-0.37-0.24

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Sarcopenia Substudy PN035: Change From Baseline in Gait Speed

Gait speed is a component of the Short Physical Performance Battery (SPPB) Score. Participants are asked to walk a distance of 4 meters at their normal pace. The test is performed 2 times, and the walk done in the shortest time is used for scoring. The activity is timed and then reduced to a categorical 0 to 4 scale based on time achieved. Higher scores indicate an improved function level. The change from baseline at yearly intervals was then assessed using a longitudinal data analysis model with terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size). (NCT00529373)
Timeframe: Baseline and once yearly up to 4 years.

,
InterventionScore on a scale (Least Squares Mean)
Month 12Month 24Month 36Month 48
Odanacatib 50 mg OW-0.02-0.02-0.09-0.15
Placebo-0.06-0.10-0.11-0.24

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Sarcopenia Substudy PN035: Change From Baseline in Appendicular Lean Body Mass (aLBM)

Sarcopenia is the age-related loss of skeletal muscle mass and associated loss of strength. Progression of sarcopenia was assessed using aLBM as measured by total body DXA. The change from baseline at yearly intervals was then assessed using a longitudinal data analysis model with terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size). (NCT00529373)
Timeframe: Baseline and once yearly up to 4 years

,
Interventionkg (Least Squares Mean)
Month 12Month 24Month 36Month 48
Odanacatib 50 mg OW-0.20-0.19-0.36-0.44
Placebo-0.18-0.19-0.32-0.23

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Base Study: Percent Change From Baseline in Urinary N-Telopeptides of Type I Collagen/Creatinine (u-NTx/Cr) Ratio After Log-Transformation

u-NTx, a biochemical marker of bone resorption, was assessed at randomization, Month 6, and at yearly intervals until the end of the study (base study) in an approximate 10% random subset participants at selected sites. Urine NTx measurements (in bone collagen equivalents [BCE]) were normalized to urine Cr concentration (i.e., u-NTx/Cr ratio) and the log-transformed fraction from baseline in u-NTx/Cr ratio was then determined using a longitudinal model with terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS means weighted for region and stratum size). Back-transformed weighted geometric LS means values for percent change from baseline are provided. (NCT00529373)
Timeframe: Baseline, Month 6, and once yearly up to 4 years

,
InterventionPercent change (Geometric Mean)
Month 6Month 12Month 24Month 36Month 48
Odanacatib 50 mg OW-56.46-55.58-47.21-43.91-38.01
Placebo-4.76-1.999.4615.236.53

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Base Study: Percent Change From Baseline in Serum C-Telopeptides of Type I Collagen (s-CTx) After Log-Transformation

s-CTx, a biochemical marker of bone resorption by osteoclasts reflecting collagen breakdown products, was assessed at randomization, Month 6, and at yearly intervals until the end of the study (base study) in an approximate 10% random subset participants at selected sites. The log-transformed fraction from baseline in s-CTx was determined using a longitudinal model with terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS means weighted for region and stratum size). Back-transformed weighted geometric LS means values for percent change from baseline are provided. (NCT00529373)
Timeframe: Baseline, Month 6, and once yearly up to 4 years

,
InterventionPercent change (Geometric Mean)
Month 6Month 12Month 24Month 36Month 48
Odanacatib 50 mg OW-61.27-53.47-39.47-23.71-4.61
Placebo-2.286.547.2320.9614.12

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Base Study: Percent Change From Baseline in N-Terminal Propeptide of Type 1 Collagen (P1NP) After Log-Transformation

P1NP is a cleavage fragment produced during the synthesis of collagenous bone matrix (type 1 collagen) used as a biochemical marker of bone formation. Serum P1NP was assessed at randomization, Month 6, and at yearly intervals until the end of the study (base study) in an approximate 10% random subset participants at selected sites. The log-transformed fraction from baseline in P1NP was determined using a longitudinal model with terms for treatment, stratum, and interaction between treatment and time as fixed effects (LS means weighted for stratum size). Back-transformed weighted geometric LS means values for percent change from baseline are provided. (NCT00529373)
Timeframe: Baseline, Month 6, and once yearly up to 4 years

,
InterventionPercent change (Geometric Mean)
Month 6Month 12Month 24Month 36Month 48
Odanacatib 50 mg OW-44.51-37.49-22.46-11.89-3.61
Placebo-15.08-11.55-6.200.22-0.28

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Base Study: Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP) After Log-Transformation

BSAP is an enzyme produced by matrix-synthesizing osteoblasts during the synthesis of collagenous bone matrix (type 1 collagen) used as a biochemical marker of bone formation. Serum BSAP was assessed at randomization, Month 6, and at yearly intervals until the end of the study (base study) in an approximate 10% random subset participants at selected sites. The log-transformed fraction from baseline in BSAP was determined using a longitudinal model with terms for treatment, stratum, and interaction between treatment and time as fixed effects (LS means weighted for stratum size). Back-transformed weighted geometric LS means values for percent change from baseline are provided. (NCT00529373)
Timeframe: Baseline, Month 6, and once yearly up to 4 years

,
InterventionPercent change (Geometric Mean)
Month 6Month 12Month 24Month 36Month 48
Odanacatib 50 mg OW-23.27-21.43-9.33-8.41-0.63
Placebo-9.13-9.42-0.04-0.770.15

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Base Study: Percent Change From Baseline in BMD Measurements of the Trochanter in Bisphosphonate-Intolerant Participants

BMD was measured by DXA in bisphosphonate-intolerant participants at the trochanter-hip at screening, and at yearly intervals until the end of the study (base study). Bisphosphonates are anti-resorptive agents used in the treatment of osteoporosis. Bisphosphonate-intolerance was defined by contraindication or history of intolerance to bisphosphonates, or physician's determination of unsuitability for bisphosphonate treatment. (NCT00529373)
Timeframe: Baseline, Month 6, and once yearly, up to approximately 60 months of observation

,
InterventionPercent change (Least Squares Mean)
Month 6Month 12Month 24Month 36Month 48Month 60
Odanacatib 50 mg OWNA4.025.737.476.68NA
PlaceboNA0.58-0.30-1.02-5.07NA

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Base Study: Percent Change From Baseline in BMD Measurements of the Trochanter

BMD was measured by DXA for all participants at the trochanter-hip at screening, Months 6, 12, and subsequent yearly intervals until the end of the study (base study). (NCT00529373)
Timeframe: Baseline, Month 6, and once yearly, up to approximately 60 months of observation

,
InterventionPercent change (Least Squares Mean)
Month 6Month 12Month 24Month 36Month 48Month 60
Odanacatib 50 mg OW2.654.326.178.019.4610.16
Placebo0.910.82-0.24-1.26-2.98-3.65

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Base Study: Percent Change From Baseline in BMD Measurements of the Total Hip in Bisphosphonate-Intolerant Participants

BMD was measured by DXA in bisphosphonate-intolerant participants at the total hip at screening, and at yearly intervals until the end of the study (base study). Bisphosphonates are anti-resorptive agents used in the treatment of osteoporosis. Bisphosphonate-intolerance was defined by contraindication or history of intolerance to bisphosphonates, or physician's determination of unsuitability for bisphosphonate treatment. (NCT00529373)
Timeframe: Baseline, Month 6, and once yearly, up to approximately 60 months of observation

,
InterventionPercent change (Least Squares Mean)
Month 6Month 12Month 24Month 36Month 48Month 60
Odanacatib 50 mg OWNA2.633.564.454.07NA
PlaceboNA0.24-0.64-1.41-4.47NA

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Base Study: Percent Change From Baseline in BMD Measurements of the Total Hip

BMD was measured by DXA for all participants at the total hip at screening, Months 6, 12, and subsequent yearly intervals until the end of the study (base study). (NCT00529373)
Timeframe: Baseline, Month 6, and once yearly, up to approximately 60 months of observation

,
InterventionPercent change (Least Squares Mean)
Month 6Month 12Month 24Month 36Month 48Month 60
Odanacatib 50 mg OW1.852.823.794.815.395.67
Placebo0.530.33-0.68-1.64-3.23-3.82

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Base Study: Percent Change From Baseline in BMD Measurements of the Lumbar Spine in Bisphosphonate-Intolerant Participants

BMD was measured by DXA in bisphosphonate-intolerant participants at the lumbar spine at randomization, and at yearly intervals until the end of the study (base study). Measurements were made on at least 3 vertebrae for all time points; vertebrae with fractures were excluded from analyses. Bisphosphonates are anti-resorptive agents used in the treatment of osteoporosis. Bisphosphonate-intolerance was defined by contraindication or history of intolerance to bisphosphonates, or physician's determination of unsuitability for bisphosphonate treatment. (NCT00529373)
Timeframe: Baseline, Month 6, and once yearly, up to approximately 60 months of observation

,
InterventionPercent change (Least Squares Mean)
Month 6Month 12Month 24Month 36Month 48Month 60
Odanacatib 50 mg OWNA4.566.608.4910.31NA
PlaceboNA0.540.820.870.80NA

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Base Study: Percent Change From Baseline in BMD Measurements of the Lumbar Spine

"BMD was measured by DXA for all participants at the lumbar spine at randomization, Months 6, 12, and subsequent yearly intervals until the end of the study (base study). Measurements were made on at least 3 vertebrae for all time points; vertebrae with fractures were excluded from analyses.~at" (NCT00529373)
Timeframe: Baseline, Month 6, and once yearly, approximately 60 months of observation

,
InterventionPercent change (Least Squares Mean)
Month 6Month 12Month 24Month 36Month 48Month 60
Odanacatib 50 mg OW3.754.676.778.5910.4711.49
Placebo0.780.590.720.750.760.26

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Base Study: Percent Change From Baseline in BMD Measurements of the Femoral Neck in Bisphosphonate-Intolerant Participants

BMD was measured by DXA in bisphosphonate-intolerant participants at the femoral neck-hip at screening, and at yearly intervals until the end of the study (base study). Bisphosphonates are anti-resorptive agents used in the treatment of osteoporosis. Bisphosphonate-intolerance was defined by contraindication or history of intolerance to bisphosphonates, or physician's determination of unsuitability for bisphosphonate treatment. (NCT00529373)
Timeframe: Baseline, Month 6, and once yearly, up to approximately 60 months of observation

,
InterventionPercent change (Least Squares Mean)
Month 6Month 12Month 24Month 36Month 48Month 60
Odanacatib 50 mg OWNA2.713.885.126.75NA
PlaceboNA0.50-0.45-0.97-2.32NA

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Base Study: Percent Change From Baseline in BMD Measurements of the Femoral Neck

BMD was measured by DXA for all participants at the femoral neck-hip at screening, Months 6, 12, and subsequent yearly intervals until the end of the study (base study). (NCT00529373)
Timeframe: Baseline, Month 6, and once yearly, up to approximately 60 months of observation

,
InterventionPercent change (Least Squares Mean)
Month 6Month 12Month 24Month 36Month 48Month 60
Odanacatib 50 mg OW2.172.804.015.456.156.69
Placebo0.680.59-0.37-1.01-2.27-1.84

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Base Study: Percent Change From Baseline in BMD Measurements of the Distal-Third Forearm in Bisphosphonate-Intolerant Participants

BMD was measured by DXA at the distal one-third radius at randomization and at yearly intervals until the end of the study (base study) in an approximate 10% random subset of bisphosphonate-intolerant participants at selected sites. Bisphosphonates are anti-resorptive agents used in the treatment of osteoporosis. Bisphosphonate-intolerance was defined by contraindication or history of intolerance to bisphosphonates, or physician's determination of unsuitability for bisphosphonate treatment. (NCT00529373)
Timeframe: Baseline and once yearly, up to approximately 60 months of observation

InterventionPercent change (Least Squares Mean)
Month 12Month 24Month 36Month 48Month 60
Placebo-0.09-0.80-1.87-2.27NA

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Base Study: Percent Change From Baseline in BMD Measurements of the Distal-Third Forearm in Bisphosphonate-Intolerant Participants

BMD was measured by DXA at the distal one-third radius at randomization and at yearly intervals until the end of the study (base study) in an approximate 10% random subset of bisphosphonate-intolerant participants at selected sites. Bisphosphonates are anti-resorptive agents used in the treatment of osteoporosis. Bisphosphonate-intolerance was defined by contraindication or history of intolerance to bisphosphonates, or physician's determination of unsuitability for bisphosphonate treatment. (NCT00529373)
Timeframe: Baseline and once yearly, up to approximately 60 months of observation

InterventionPercent change (Least Squares Mean)
Month 12Month 24Month 36Month 48
Odanacatib 50 mg OW0.990.24-0.66-0.72

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Base Study: Percent Change From Baseline in BMD Measurements of the Distal-Third Forearm

BMD was measured by DXA at the distal one-third radius at randomization and at yearly intervals until the end of the study (base study) in an approximate 10% random subset of participants at selected sites. (NCT00529373)
Timeframe: Baseline and once yearly, up to approximately 60 months of observation

,
InterventionPercent change (Least Squares Mean)
Month 12Month 24Month 36Month 48Month 60
Odanacatib 50 mg OW0.510.330.02-0.620.29
Placebo-0.60-1.02-1.90-2.82-3.21

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Base Study: Number of Participants With Height Loss of > 1 cm

Height was measured by wall-mounted stadiometer at randomization and at yearly intervals in the base study. (NCT00529373)
Timeframe: Baseline and once yearly, up to approximately 60 months of observation

,
InterventionParticipants (Count of Participants)
Up to Month 12Up to Month 24Up to Month 36Up to Month 48Up to Month 60Overall/At any time
Odanacatib 50 mg OW31659287590231022
Placebo36566994459121149

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Base Study + First Extension: Percent Change From Baseline in BMD Measurements of the Trochanter

BMD was measured by DXA for all participants at the trochanter-hip at screening, Months 6, 12, and subsequent yearly intervals until the end of the study (base study + first extension-dbp). (NCT00529373)
Timeframe: Baseline, Month 6, and once yearly, up to approximately 74 months of observation

,
InterventionPercent change (Least Squares Mean)
Month 6Month 12Month 24Month 36Month 48Month 60
Odanacatib 50 mg OW2.704.336.177.969.2710.66
Placebo0.950.83-0.23-1.29-2.86-3.90

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Base Study + First Extension: Percent Change From Baseline in BMD Measurements of the Total Hip

BMD was measured by DXA for all participants at the total hip at screening, Months 6, 12, and subsequent yearly intervals until the end of the study (base study + first extension-dbp). (NCT00529373)
Timeframe: Baseline, Month 6, and once yearly, up to approximately 74 months of observation

,
InterventionPercent change (Least Squares Mean)
Month 6Month 12Month 24Month 36Month 48Month 60
Odanacatib 50 mg OW1.892.843.794.785.526.23
Placebo0.550.34-0.67-1.67-2.97-4.06

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Base Study + First Extension: Percent Change From Baseline in BMD Measurements of the Lumbar Spine

BMD was measured by DXA for all participants at the lumbar spine at randomization, Months 6, 12, and subsequent yearly intervals until the end of the study (base study + first extension-dbp). Measurements were made on at least 3 vertebrae for all time points; vertebrae with fractures were excluded from analyses. (NCT00529373)
Timeframe: Baseline, Month 6, and once yearly, up to approximately 74 months of observation

,
InterventionPercent change (Least Squares Mean)
Month 6Month 12Month 24Month 36Month 48Month 60
Odanacatib 50 mg OW3.724.616.638.4110.1911.93
Placebo0.820.600.700.720.851.06

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Base Study + First Extension: Percent Change From Baseline in BMD Measurements of the Femoral Neck

BMD was measured by DXA for all participants at the femoral neck-hip at screening, Months 6, 12, and subsequent yearly intervals until the end of the study (base study + first extension-dbp). (NCT00529373)
Timeframe: Baseline, Month 6, and once yearly, up to approximately 74 months of observation

,
InterventionPercent change (Least Squares Mean)
Month 6Month 12Month 24Month 36Month 48Month 60
Odanacatib 50 mg OW2.172.814.035.486.377.30
Placebo0.700.60-0.36-1.02-1.93-2.75

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Base Study + First Extension: Percent Change From Baseline in BMD Measurements of the Distal-Third Forearm

BMD was measured by DXA at the distal one-third radius at randomization and at yearly intervals until the end of the study (base study + first extension-dbp) in an approximate 10% random subset of participants at selected sites. (NCT00529373)
Timeframe: Baseline and once yearly, up to approximately 74 months of observation

,
InterventionPercent change (Least Squares Mean)
Month 12Month 24Month 36Month 48Month 60
Odanacatib 50 mg OW0.500.330.05-0.30-0.84
Placebo-0.61-1.02-1.91-2.49-3.17

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Base Study + First Extension + Second Extension: Percent Change From Baseline in Bone Mineral Density (BMD) Measurements of the Total Hip

BMD was measured by dual-energy x-ray absorptiometry (DXA) at the total hip starting at screening, and at yearly intervals until the end of the study (second extension study) for all participants who entered the second extension study. Least squares (LS) means percent change in BMD from original baseline are provided through Month 108 (Year 9). At Months 96 (Year 8) and 108 (Year 9), approximately 3% or fewer participants in each treatment group had BMD data, and results at those time points should be viewed with caution. NOTE: The mean percent change in BMD from baseline in participants originally randomized to placebo includes BMD results obtained after those participants were switched to open-label odanacatib, which occurred at different times relative to their start of blinded study medication in the base study. (NCT00529373)
Timeframe: Baseline and once yearly, up to approximately 108 months of observation

,
InterventionPercent change (Least Squares Mean)
Month 12Month 24Month 36Month 48Month 60Month 72Month 84Month 96Month 108
Odanacatib 50 mg OW3.034.325.606.567.457.887.947.877.03
Placebo1.080.580.04-0.74-1.40-0.010.971.571.11

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Base Study + First Extension + Second Extension: Percent Change From Baseline in BMD Measurements of the Trochanter

BMD was measured by DXA at the trochanter starting at screening, and at yearly intervals until the end of the study (2nd extension study) for all participants who entered the 2nd extension study. LS means percent change in BMD from original baseline are provided through Month 108. At Months 96 and 108, approximately 3% or fewer participants in each treatment group had BMD data, and results at those time points should be viewed with caution. NOTE: The mean percent change in BMD from baseline in participants originally randomized to placebo includes BMD results obtained after those participants were switched to open-label odanacatib, which occurred at different times relative to their start of blinded study medication in the base study. A longitudinal model with terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS means weighted for region and stratum size) was used for analysis. (NCT00529373)
Timeframe: Baseline and once yearly, up to approximately 108 months of observation

,
InterventionPercent change (Least Squares Mean)
Month 12Month 24Month 36Month 48Month 60Month 72Month 84Month 96Month 108
Odanacatib 50 mg OW4.556.859.0010.5812.2112.9513.3013.4412.69
Placebo1.811.450.89-0.16-0.681.223.174.662.97

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Base Study + First Extension + Second Extension: Percent Change From Baseline in BMD Measurements of the Lumbar Spine

BMD was measured by DXA at the lumbar spine starting at randomization, and at yearly intervals until the end of the study (2nd extension study) for all participants who entered the 2nd extension study. Measurements were made on at least 3 vertebrae for all time points; vertebrae with fractures were excluded from analyses. At Months 96 and 108, approximately 3% or fewer participants in each treatment group had BMD data, and results at those time points should be viewed with caution. NOTE: The mean percent change in BMD from baseline in participants originally randomized to placebo includes BMD results obtained after those participants were switched to open-label odanacatib, which occurred at different times relative to their start of blinded study medication in the base study. A longitudinal model with terms for treatment, stratum, region & interaction between treatment and time as fixed effects (LS means weighted for region & stratum size) was used for analysis. (NCT00529373)
Timeframe: Baseline and once yearly, up to approximately 108 months of observation

,
InterventionPercent change (Least Squares Mean)
Month 12Month 24Month 36Month 48Month 60Month 72Month 84Month 96Month 108
Odanacatib 50 mg OW4.686.958.8410.7412.5513.7614.9115.1315.54
Placebo1.011.401.612.062.456.258.379.6610.85

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Base Study + First Extension + Second Extension: Percent Change From Baseline in BMD Measurements of the Femoral Neck

BMD was measured by DXA at the femoral neck starting at screening, and at yearly intervals until the end of the study (2nd extension study) for all participants who entered the 2nd extension study. LS means percent change in BMD from original baseline are provided through Month 108. At Months 96 and 108, approximately 3% or fewer participants in each treatment group had BMD data, and results at those time points should be viewed with caution. NOTE: The mean percent change in BMD from baseline in participants originally randomized to placebo includes BMD results obtained after those participants were switched to open-label odanacatib, which occurred at different times relative to their start of blinded study medication in the base study. A longitudinal model with terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS means weighted for region and stratum size) was used for analysis. (NCT00529373)
Timeframe: Baseline and once yearly, up to approximately 108 months of observation

,
InterventionPercent change (Least Squares Mean)
Month 12Month 24Month 36Month 48Month 60Month 72Month 84Month 96Month 108
Odanacatib 50 mg OW2.894.396.027.017.988.519.118.849.38
Placebo1.060.38-0.03-0.73-1.320.411.561.953.63

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Second Extension: Time From Baseline to First Osteoporotic Clinical Fracture of Any Type (Adjudicated)

Osteoporotic clinical fractures of any type were confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Non-vertebral fractures were assessed across multiple anatomical sites including clavicle, distal femur or shaft, fibula, hip, humerus, pelvis, radius, ribs, sacrum, tibia, ulna, and wrist; Vertebral fractures assessed across all vertebral levels (C7, T1 to T12, L1 to L5) were included in the analysis. Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence proportion (cumulative incidence) of participants in the second extension study with at least one osteoporotic clinical fracture of any type is provided. (NCT00529373)
Timeframe: Up to approximately 34 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW2.04
Placebo2.64

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Second Extension: Number of Participants Who Experienced an Adverse Event

An adverse event is defined as any untoward medical occurrence in a person or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT00529373)
Timeframe: Up to approximately 34 months of observation

InterventionParticipants (Count of Participants)
Odanacatib 50 mg OW2173
Placebo (Originally Assigned to Placebo)1587

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Second Extension: Number of Participants Discontinuing Study Treatment Due to an Adverse Event

An adverse event is defined as any untoward medical occurrence in a person or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT00529373)
Timeframe: Up to approximately 34 months of observation

InterventionParticipants (Count of Participants)
Odanacatib 50 mg OW55
Placebo (Originally Assigned to Placebo)36

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Second Extension: Incidence of Osteoporotic Clinical Thoracic Vertebral Fracture (Adjudicated)

Osteoporotic vertebral clinical fractures were confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Vertebral fractures were assessed for all thoracic vertebral levels (T1 to T12). Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence of participants in the second extension study with osteoporotic vertebral clinical fractures is provided. Due to early termination of the study, the cumulative incidence using a time-to-event methodology was not assessed across base and extension studies. (NCT00529373)
Timeframe: Up to approximately 34 months of observation

InterventionPercentage of Participants (Number)
Odanacatib 50 mg OW0.13
Placebo0.09

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Second Extension: Incidence of Osteoporotic Clinical Lumbar Vertebral Fracture (Adjudicated)

Osteoporotic vertebral clinical fractures were confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Vertebral fractures were assessed for all lumbar vertebral levels (L1 to L5). Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence of participants in the second extension study with osteoporotic vertebral clinical fractures is provided. Due to early termination of the study, the cumulative incidence using a time-to-event methodology was not assessed across base and extension studies. (NCT00529373)
Timeframe: Up to approximately 34 months of observation

InterventionPercentage of Participants (Number)
Odanacatib 50 mg OW0.22
Placebo0.04

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Imaging Substudy PN032-Base: Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at the Lumbar Spine Using Quantitative Computed Tomography

Compartment-specific effects of osteoporosis were assessed by measuring trabecular vBMD at the lumbar spine (L1 total vertebral body) using quantitative computed tomography. The percent change from baseline at Month 24 (base study) was then assessed using a longitudinal data analysis model including terms for treatment, stratum (prior vertebral fracture [yes/no]) and interaction between treatment and time as fixed effects (LS means weighted for stratum size). (NCT00529373)
Timeframe: Baseline, Month 24

InterventionPercent change (Least Squares Mean)
Odanacatib 50 mg OW8.05
Placebo-0.87

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Imaging Substudy PN032-Base: Percent Change From Baseline in u-NTx/Cr Ratio After Log-Transformation

u-NTx, a biochemical marker of bone resorption by osteoclasts reflecting collagen breakdown products, was assessed at baseline and Month 24 in an approximate 10% random subset participants at selected sites in the P018 base study who were additionally included in the imaging substudy PN032-base study. Urine NTx measurements (in BCE) were normalized to urine Cr concentration (i.e., u-NTx/Cr ratio) and the log-transformed fraction from baseline in u-NTx/Cr ratio was then determined using a longitudinal model with terms for treatment, stratum, and interaction between treatment and time as fixed effects (LS means weighted for stratum size). Back-transformed weighted geometric LS means values for percent change from baseline are provided. (NCT00529373)
Timeframe: Baseline, Month 24

InterventionPercent change (Geometric Mean)
Odanacatib 50 mg OW-47.87
Placebo16.56

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Imaging Substudy PN032-Base: Percent Change From Baseline in s-CTx After Log-Transformation

s-CTx, a biochemical marker of bone resorption by osteoclasts reflecting collagen breakdown products, was assessed at baseline and Month 24 in an approximate 10% random subset participants at selected sites in the P018 base study who were additionally included in the imaging substudy PN032-base study. The log-transformed fraction from baseline in s-CTx was determined using a longitudinal model with terms for treatment, stratum, and interaction between treatment and time as fixed effects (LS means weighted for stratum size). Back-transformed weighted geometric LS means values for percent change from baseline are provided. (NCT00529373)
Timeframe: Baseline, Month 24

InterventionPercent change (Geometric Mean)
Odanacatib 50 mg OW-55.62
Placebo6.62

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Imaging Substudy PN032-Base: Percent Change From Baseline in P1NP After Log-Transformation

P1NP is a cleavage fragment produced during the synthesis of collagenous bone matrix (type 1 collagen) used as a biochemical marker of bone formation. Serum P1NP was assessed at baseline and Month 24 in an approximate 10% random subset participants at selected sites in the P018 base study who were additionally included in the imaging substudy PN032-base study. The log-transformed fraction change from baseline in P1NP was determined using a longitudinal model with terms for treatment, stratum, and interaction between treatment and time as fixed effects (LS means weighted for stratum size). Back-transformed weighted geometric LS means values for percent change from baseline are provided. (NCT00529373)
Timeframe: Baseline, Month 24

InterventionPercent change (Geometric Mean)
Odanacatib 50 mg OW-33.56
Placebo-6.86

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Imaging Substudy PN032-Base: Percent Change From Baseline in Cortical vBMD of the Total Hip Using Quantitative Computed Tomography

Compartment-specific effects of osteoporosis were assessed by measuring cortical vBMD at the total hip using quantitative computed tomography. The percent change from baseline at Month 24 was then assessed using a longitudinal data analysis model including terms for treatment, stratum (prior vertebral fracture [yes/no]) and interaction between treatment and time as fixed effects (LS means weighted for stratum size). (NCT00529373)
Timeframe: Baseline, Month 24

InterventionPercent change (Least Squares Mean)
Odanacatib 50 mg OW3.29
Placebo0.52

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Imaging Substudy PN032-Base: Percent Change From Baseline in BSAP After Log-Transformation

BSAP is an enzyme produced by matrix-synthesizing osteoblasts during the synthesis of collagenous bone matrix (type 1 collagen) used as a biochemical marker of bone formation. Serum BSAP was assessed at baseline and Month 24 in an approximate 10% random subset participants at selected sites in the P018 base study who were additionally included in the imaging substudy PN032-base study. The log-transformed fraction from baseline in BSAP was determined using a longitudinal model with terms for treatment, stratum, and interaction between treatment and time as fixed effects (LS means weighted for stratum size). Back-transformed weighted geometric LS means values for percent change from baseline are provided. (NCT00529373)
Timeframe: Baseline, Month 24

InterventionPercent change (Geometric Mean)
Odanacatib 50 mg OW-12.39
Placebo12.64

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Imaging Substudy PN032-Base: Percent Change From Baseline in Areal BMD (aBMD) of the Lumbar Spine Using DXA

aBMD was measured at the lumbar spine (L1 to L4) at baseline and Month 24 using DXA . If a vertebra was fractured at baseline or became fractured during the study, its BMD measurement was excluded from analysis. The percent change from baseline was assessed using a longitudinal data analysis model including terms for treatment, stratum and interaction between treatment and time as fixed effects (LS means weighted for stratum size). (NCT00529373)
Timeframe: Baseline, Month 24

InterventionPercent change (Least Squares Mean)
Odanacatib 50 mg OW5.63
Placebo0.08

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Imaging Substudy PN032-Base: Percent Change From Baseline in aBMD of the Trochanter Using DXA

aBMD was measured at the trochanter at baseline and Month 24 using DXA. The percent change from baseline was assessed using a longitudinal data analysis model including terms for treatment, stratum and interaction between treatment and time as fixed effects (LS means weighted for stratum size). (NCT00529373)
Timeframe: Baseline, Month 24

InterventionPercent change (Least Squares Mean)
Odanacatib 50 mg OW5.10
Placebo-0.55

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Imaging Substudy PN032-Base: Percent Change From Baseline in aBMD of the Total Hip Using DXA

aBMD was measured at the total hip at baseline and Month 24 using DXA. The percent change from baseline was assessed using a longitudinal data analysis model including terms for treatment, stratum and interaction between treatment and time as fixed effects (LS means weighted for stratum size). (NCT00529373)
Timeframe: Baseline, Month 24

InterventionPercent change (Least Squares Mean)
Odanacatib 50 mg OW2.96
Placebo-0.66

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Imaging Substudy PN032-Base: Percent Change From Baseline in aBMD of the Femoral Neck Using DXA

aBMD was measured at the femoral neck at baseline and Month 24 using DXA. The percent change from baseline was assessed using a longitudinal data analysis model including terms for treatment, stratum and interaction between treatment and time as fixed effects (LS means weighted for stratum size). (NCT00529373)
Timeframe: Baseline, Month 24

InterventionPercent change (Least Squares Mean)
Odanacatib 50 mg OW3.15
Placebo0.36

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Imaging Substudy PN032-Base: Percent Change From Baseline in aBMD of the Distal-Third Forearm Using DXA

aBMD was measured at the the distal one-third radius at baseline and Month 24 using DXA. The percent change from baseline was assessed using a longitudinal data analysis model including terms for treatment, stratum and interaction between treatment and time as fixed effects (LS means weighted for stratum size). (NCT00529373)
Timeframe: Baseline, Month 24

InterventionPercent change (Least Squares Mean)
Odanacatib 50 mg OW0.40
Placebo-1.27

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Imaging Substudy PN032-Base + Extension: Percent Change From Baseline in vBMD at the Lumbar Spine Using Quantitative Computed Tomography

Compartment-specific effects of osteoporosis were assessed by measuring trabecular vBMD at the lumbar spine (L1 total vertebral body) using quantitative computed tomography. The percent change from baseline at Month 60 (base study + extension study) was then assessed using a longitudinal data analysis model including terms for treatment, stratum (prior vertebral fracture [yes/no]) and interaction between treatment and time as fixed effects (LS means weighted for stratum size). (NCT00529373)
Timeframe: Baseline, Month 60

InterventionPercent change (Least Squares Mean)
Odanacatib 50 mg OW14.76
Placebo-11.69

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Imaging Substudy PN032-Base + Extension: Percent Change From Baseline in Cortical vBMD of the Total Hip Using Quantitative Computed Tomography

Compartment-specific effects of osteoporosis were assessed by measuring cortical vBMD at the total hip using quantitative computed tomography. The percent change from baseline at Month 60 (base study + extension study) was then assessed using a longitudinal data analysis model including terms for treatment, stratum (prior vertebral fracture [yes/no]) and interaction between treatment and time as fixed effects (LS means weighted for stratum size). (NCT00529373)
Timeframe: Baseline, Month 60

InterventionPercent change (Least Squares Mean)
Odanacatib 50 mg OW6.00
Placebo-2.53

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Imaging Substudy PN032-Base + Extension: Percent Change From Baseline in aBMD of the Trochanter Using DXA

aBMD was measured at the trochanter at baseline and Month 60 using DXA. The percent change from baseline was assessed using a longitudinal data analysis model including terms for treatment, stratum and interaction between treatment and time as fixed effects (LS means weighted for stratum size). (NCT00529373)
Timeframe: Baseline, Month 60

InterventionPercent change (Least Squares Mean)
Odanacatib 50 mg OW10.44
Placebo-4.50

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Imaging Substudy PN032-Base + Extension: Percent Change From Baseline in aBMD of the Total Hip Using DXA

aBMD was measured at the total hip at baseline and Month 60 using DXA. The percent change from baseline was assessed using a longitudinal data analysis model including terms for treatment, stratum and interaction between treatment and time as fixed effects (LS means weighted for stratum size). (NCT00529373)
Timeframe: Baseline, Month 60

InterventionPercent change (Least Squares Mean)
Odanacatib 50 mg OW5.34
Placebo-5.07

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Imaging Substudy PN032-Base + Extension: Percent Change From Baseline in aBMD of the Lumbar Spine Using DXA

aBMD was measured at the lumbar spine (L1 to L4) at baseline and Month 60 using DXA . If a vertebra was fractured at baseline or became fractured during the study, its BMD measurement was excluded from analysis. The percent change from baseline was assessed using a longitudinal data analysis model including terms for treatment, stratum and interaction between treatment and time as fixed effects (LS means weighted for stratum size). (NCT00529373)
Timeframe: Baseline, Month 60

InterventionPercent change (Least Squares Mean)
Odanacatib 50 mg OW11.80
Placebo0.72

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Imaging Substudy PN032-Base + Extension: Percent Change From Baseline in aBMD of the Femoral Neck Using DXA

aBMD was measured at the femoral neck at baseline and Month 60 using DXA. The percent change from baseline was assessed using a longitudinal data analysis model including terms for treatment, stratum and interaction between treatment and time as fixed effects (LS means weighted for stratum size). (NCT00529373)
Timeframe: Baseline, Month 60

InterventionPercent change (Least Squares Mean)
Odanacatib 50 mg OW6.87
Placebo-3.11

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Base Study: Yearly Rate of Height Loss

Height was measured by wall-mounted stadiometer at randomization and at yearly intervals in the base study. (NCT00529373)
Timeframe: Up to approximately 60 months of observation

Interventioncm/year (Least Squares Mean)
Odanacatib 50 mg OW-0.13
Placebo-0.15

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Base Study: Time to First New Onset ECG-Confirmed Atrial Fibrillation or Atrial Flutter Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated new or presumed new onset atrial fibrillation or atrial flutter was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Participants with known history of atrial fibrillation or atrial flutter were excluded and electrocardiogram confirmation was required. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 60 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.25
Placebo0.23

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Base Study: Time to First New Onset Atrial Fibrillation or Atrial Flutter Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated new or presumed new onset atrial fibrillation or atrial flutter was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Participants with known history of atrial fibrillation or atrial flutter were excluded and electrocardiogram confirmation was not required. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 60 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.48
Placebo0.41

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Base Study: Time to First Hospitalization for Unstable Angina Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated hospitalization for unstable angina was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 60 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.10
Placebo0.09

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Base Study: Time to First Fatal Stroke Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated fatal definite stroke was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 60 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.09
Placebo0.05

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Base Study: Time to First Fatal or Non-Fatal Stroke Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated fatal or non-fatal definite stroke was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 60 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.58
Placebo0.44

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Base Study: Time to First Fatal or Non-Fatal Myocardial Infarction Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated fatal or non-fatal definite myocardial infarction was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 60 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.25
Placebo0.31

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Base Study: Time to First Fatal Myocardial Infarction Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated fatal definite myocardial infarction was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 60 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.03
Placebo0.03

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Base Study: Time to First Cardiovascular Death Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated cardiovascular death was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. The analysis includes data obtained from vital status data collections of participants no longer followed in the base study. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 60 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.45
Placebo0.39

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Base Study: Time to First Any Atrial Fibrillation or Atrial Flutter Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated any reported episode of atrial fibrillation or atrial flutter was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Participants with known history of atrial fibrillation or atrial flutter were included and electrocardiogram confirmation was not required. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 60 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW0.60
Placebo0.48

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Base Study: Time to First All-Cause Death Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated all-cause death was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. The analysis includes data obtained from vital status data collections of participants no longer followed in the base study. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 60 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW1.55
Placebo1.38

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Base Study: Time to First 4-Point MACE Confirmed by TIMI Adjudication

The time to first TIMI-adjudicated 4-point MACE (a composite outcome measure of 1. cardiovascular death, 2. non-fatal definite MI, 3. non-fatal definite stroke, or 4. hospitalization for unstable angina) was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 60 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW1.28
Placebo1.14

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Base Study: Time to First 3-Point Major Adverse Cardiac Event (MACE) Confirmed by Thrombolysis in Myocardial Infarction Study Group (TIMI) Adjudication

The time to first TIMI-adjudicated 3-point MACE (a composite outcome measure of 1. cardiovascular death, 2. non-fatal definite MI, or 3. non-fatal definite stroke) was determined for the base study using a Cox proportional hazards model with terms for treatment, stratum and geographic region. Results are expressed as number of participants with an event per 100 person-years of follow-up. Results from MK-0822-083, a follow up study to the MK-088-018 base study and the double-blind period of the first extension study for participants who discontinued prior to 5 years follow-up, are not included. (NCT00529373)
Timeframe: Up to approximately 60 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW1.17
Placebo1.04

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Base Study: Time From Baseline to First Osteoporotic Clinical Vertebral Fracture (Adjudicated)

Osteoporotic vertebral clinical fractures were confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Vertebral fractures were assessed for all vertebral levels (C7, T1 to T12, L1 to L5). Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence rate of participants with fracture (number of participants with a fracture per 100 person-years of follow-up) is provided. (NCT00529373)
Timeframe: Up to approximately 60 months of observation

InterventionParts. w/ fracture per 100 person-years (Number)
Odanacatib 50 mg OW0.16
Placebo0.58

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Base Study: Time From Baseline to First Osteoporotic Clinical Non-Vertebral Fracture (Adjudicated)

Osteoporotic non-vertebral clinical fractures were confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Non-vertebral fractures were assessed across multiple anatomical sites including clavicle, distal femur or shaft, fibula, hip, humerus, pelvis, radius, ribs, sacrum, tibia, ulna, and wrist. Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence rate of participants with fracture (number of participants with a fracture per 100 person-years of follow-up) is provided. (NCT00529373)
Timeframe: Up to approximately 60 months of observation

InterventionParts. w/ fracture per 100 person-years (Number)
Odanacatib 50 mg OW1.85
Placebo2.41

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Base Study: Time From Baseline to First Osteoporotic Clinical Hip Fracture (Adjudicated)

Osteoporotic clinical hip fractures were confirmed by central adjudication using radiographic evidence on all symptomatic fractures reported as adverse experiences (excluding fractures of the fingers, toes, face, and skull). Hip fractures were fractures of the proximal femur confirmed as being located in the hip (i.e., sub-region not specified; cervical, and intertrochanteric). Osteoporotic (fragility) fractures did not include fractures with traumatic or pathological etiologies. A clinical fracture was defined as a fracture with clinical fracture-related symptoms (e.g., pain). A time-to-event methodology was used to evaluate results: the incidence rate of participants with fracture (number of participants with a fracture per 100 person-years of follow-up) is provided. (NCT00529373)
Timeframe: Up to approximately 60 months of observation

InterventionParts. w/ fracture per 100 person-years (Number)
Odanacatib 50 mg OW0.28
Placebo0.54

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Base Study: Time From Baseline to First Morphometrically-Assessed Vertebral Fracture

Morphometric vertebral fractures were assessed by central adjudication on lumbar and thoracic spinal radiographs acquired at baseline and at Months 6, 12, and subsequent yearly time points. Incident fractures (i.e., occurring after baseline) in previously normal vertebral bodies and/or those occurring after baseline in previously fractured vertebral bodies (Genant semiquantitative [SQ] Grade 1-3) (T4 to L4) were confirmed by quantitative morphometric (QM) and either SQ or binary SQ (yes/no) methodologies. A time-to-event methodology was used to evaluate results: life-table estimates of the incidence proportion (cumulative incidence) of participants with at least one morphometric vertebral fracture were assessed at Months 6, 12, and subsequent yearly intervals; an interval-censored approach was then used to determine incidence rate (number of participants with a morphometric fracture per 100 person-years of follow-up). (NCT00529373)
Timeframe: Up to approximately 60 months of observation

InterventionParts. w/ fracture per 100 person-years (Number)
Odanacatib 50 mg OW1.27
Placebo2.74

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Base Study: Rate of Discontinuation From Study Treatment Due to an Adverse Event

An adverse event is defined as any untoward medical occurrence in a person or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The incidence rate of participant discontinuations from treatment due to adverse events (number of participants with an event per 100 person-years of follow-up) is provided. (NCT00529373)
Timeframe: Up to approximately 60 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW2.97
Placebo2.70

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Base Study: Rate of Adverse Events

An adverse event is defined as any untoward medical occurrence in a person or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The incidence rate of participants with adverse events (number of participants with an event per 100 person-years of follow-up) is provided. (NCT00529373)
Timeframe: Up to approximately 60 months of observation

InterventionParts. with event per 100 person-years (Number)
Odanacatib 50 mg OW100.16
Placebo98.65

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Change in Urine Albumin Excretion

Albumin and creatinine concentrations were measured in 24hr urine collections at baseline, 3 months after randomization, and one year after randomization. We analyzed the difference in log-transformed albumin-creatinine ratio (ACR, mg/g) after randomization (3 months and one year, analyzed together with all available data included) compared with baseline, by treatment assignment. Results are transformed to present percent difference in urine ACR. (NCT00552409)
Timeframe: Baseline, 3 months, and one year

Interventionpercent difference (Mean)
Cholecalciferol-21
Placebo-5

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Change in Intestinal Calcium Absorption From Baseline to One Month

percent and true fractional calcium absorption (NCT00581828)
Timeframe: 1 month

Interventionpercent calcium absorption (Mean)
Vitamin D3

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Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement

Maternal serum 25-hydroxyvitamin D measurement at 12, 16, 28 weeks during pregnancy and at delivery and cord blood or neonatal serum 25-hydroxyvitamin D measurement (NCT00610688)
Timeframe: 12, 16, 28 weeks and at maternal delivery and neonatal birth

,,
Interventionnmol/L (Mean)
Maternal at 12 WeeksMaternal at 16 WeeksMaternal at 28 WeeksMaternal at DeliveryNeonatal at Birth
2000 IU20.553.782.364.948.3
400 IU21.540.753.948.236.9
4000 IU19.660.788.289.866.1

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Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth

Growth of the newborn infant as measured by crown-heel length in centimeters and head circumference in centimeters at birth (NCT00610688)
Timeframe: At delivery

,,
Interventioncm (Mean)
Heel Crown LengthHead Circumference
2000 IU51.634.5
400 IU51.934.1
4000 IU50.933.9

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Birthweight of Newborn Infant

Growth of the Newborn Infant as Measured by Birthweight in grams. (NCT00610688)
Timeframe: Measured at birth.

InterventionGrams (Mean)
400 IU3100
2000 IU3191
4000 IU3103

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Number of Participants That Discontinued Study Drug Due to an AE

An AE was defined as any unfavorable and unintended change in the structure (sign), function (symptoms), or chemistry of the body (laboratory data) temporally associated with the use of the SPONSOR's products (including placebo), whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The number of participants that discontinued study drug due to an AE was reported for each treatment arm. Participants may have discontinued study drug but continued on the trial. (NCT00620113)
Timeframe: From first dose up to end of treatment (up to 52 weeks)

Interventionparticipants (Number)
Placebo3
Odanacatib 10 mg2
Odanacatib 25 mg1
Odanacatib 50 mg1

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Number of Participants That Experienced an Adverse Event (AE)

An AE was defined as any unfavorable and unintended change in the structure (sign), function (symptoms), or chemistry of the body (laboratory data) temporally associated with the use of the SPONSOR's products (including placebo), whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The number of participants that experienced at least one AE was reported for each treatment arm. (NCT00620113)
Timeframe: From first dose up to Post-Study (up to 54 weeks)

Interventionparticipants (Number)
Placebo57
Odanacatib 10 mg63
Odanacatib 25 mg62
Odanacatib 50 mg58

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Percent Change From Baseline to Week 52 in Femoral Neck BMD

BMD (g/cm2) data was measured by DXA at the femoral neck subregion of the hip at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = ([BMD at Week 52 visit] - [baseline BMD] ÷ baseline BMD) × 100. Measurements were performed using the Hologic QDR Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged. (NCT00620113)
Timeframe: Baseline (Observation visit to Wk 0 treatment visit), Week 52

Interventionpercent change (Least Squares Mean)
Placebo-0.72
Odanacatib 10 mg1.51
Odanacatib 25 mg1.14
Odanacatib 50 mg2.35

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Percent Change From Baseline to Week 52 in Lumbar Spine Bone Mineral Density (BMD) at Lumbar Vertebrae 1 to 4 (L1-L4)

BMD (g/cm2) data was measured by dual-energy X-ray absorptiometry (DXA) at lumbar spine vertebrae 1 through 4 (L1-L4) from anterior view at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = ([BMD at Week 52 visit] - [baseline BMD] ÷ baseline BMD) × 100. Measurements were performed using the Hologic Quantitative Digital Radiography (QDR) Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged. (NCT00620113)
Timeframe: Baseline (Observation visit to Wk 0 treatment visit), Week 52

Interventionpercent change (Least Squares Mean)
Placebo0.55
Odanacatib 10 mg4.09
Odanacatib 25 mg5.67
Odanacatib 50 mg5.94

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Percent Change From Baseline to Week 52 in Serum Bone Specific Alkaline Phosphatase (s-BSAP) Level

s-BSAP is a biochemical marker index of bone formation. Blood samples were collected in the morning and in fasting state for measurement of s-BSAP. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] - [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed. (NCT00620113)
Timeframe: Baseline (Wk 0), Week 52

Interventionpercent change (Least Squares Mean)
Placebo-9.91
Odanacatib 10 mg-7.44
Odanacatib 25 mg-22.47
Odanacatib 50 mg-25.43

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Percent Change From Baseline to Week 52 in Serum C-Telopeptides of Type 1 Collagen (s-CTx) Level

s-CTx is a biochemical marker index of bone resorption. Blood samples were collected in the morning and in fasting state for measurement of s-CTx. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] - [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed. (NCT00620113)
Timeframe: Baseline (Wk 0), Week 52

Interventionpercent change (Least Squares Mean)
Placebo-10.95
Odanacatib 10 mg-49.68
Odanacatib 25 mg-71.64
Odanacatib 50 mg-71.36

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Percent Change From Baseline to Week 52 in Serum N-Terminal Propeptides of Type 1 Collagen (s-P1NP) Level

s-P1NP is a biochemical marker index of bone formation. Blood samples were collected in the morning and in fasting state for measurement of s- P1NP. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] - [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed. (NCT00620113)
Timeframe: Baseline (Wk 0), Week 52

Interventionpercent change (Least Squares Mean)
Placebo-20.14
Odanacatib 10 mg-25.75
Odanacatib 25 mg-48.99
Odanacatib 50 mg-47.00

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Percent Change From Baseline to Week 52 in Total Hip BMD

BMD (g/cm2) data was measured by DXA for total hip at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = ([BMD at Week 52 visit] - [baseline BMD] ÷ baseline BMD) × 100. Measurements were performed using the Hologic QDR Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged. (NCT00620113)
Timeframe: Baseline (Observation visit to Wk 0 treatment visit), Week 52

Interventionpercent change (Least Squares Mean)
Placebo-0.35
Odanacatib 10 mg1.31
Odanacatib 25 mg1.85
Odanacatib 50 mg2.70

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Percent Change From Baseline to Week 52 in Trochanter BMD

BMD (g/cm2) data was measured by DXA at the trochanter subregion of the hip (near bony protrusions along outside edge of femur) at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = ([BMD at Week 52 visit] - [baseline BMD] ÷ baseline BMD) × 100. Measurements were performed using the Hologic QDR Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged. (NCT00620113)
Timeframe: Baseline (Observation visit to Wk 0 treatment visit), Week 52

Interventionpercent change (Least Squares Mean)
Placebo-0.28
Odanacatib 10 mg2.16
Odanacatib 25 mg3.56
Odanacatib 50 mg4.38

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Percent Change From Baseline to Week 52 in Urinary Deoxypyridinoline/Creatinine Ratio (u-DPD/Cre)

The u-DPD/Cre ratio is a biochemical marker index of bone resorption. Urine samples were collected from second void morning urine specimens to assess the u-DPD/Cre ratio. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] - [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed. (NCT00620113)
Timeframe: Baseline (Wk 0), Week 52

Interventionpercent change (Least Squares Mean)
Placebo16.45
Odanacatib 10 mg-10.32
Odanacatib 25 mg-21.00
Odanacatib 50 mg-26.46

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Percent Change From Baseline to Week 52 in Urinary N-telopeptides/Creatinine (u-NTx/Cre) Ratio

The u-NTx/Cre ratio is a biochemical marker index of bone resorption. Urine samples were collected from second void morning urine specimens to assess the u-NTx/Cre ratio. Percent change from baseline in biomarker = ([biomarker value at Week 52 visit] - [baseline biomarker value] ÷ baseline biomarker value) × 100. All measurements of bone biochemical markers were centrally performed. (NCT00620113)
Timeframe: Baseline (Wk 0), Week 52

Interventionpercent change (Least Squares Mean)
Placebo-7.84
Odanacatib 10 mg-43.59
Odanacatib 25 mg-52.16
Odanacatib 50 mg-58.48

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Treatment of Low 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease

"Change in serum 25OHD levels after treatment with vitamin D formulations for 6 weeks in pediatric patients with inflammatory bowel disease.~25OHD is the most abundant vitamin D metabolite, which is bound to vitamin D binding protein. The measurement of its concentration in serum, reflects vitamin D stores." (NCT00621257)
Timeframe: 6 weeks

Interventionng/ml (Mean)
Treatment A9.3
Treatment B16.4
Treatment C25.4

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Maintenance of 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease

Percentage of pediatric patients with inflammatory bowel disease who maintained their serum 25OHD level at or above 32 ng/mL at all study visits over the duration of the maintenance study 25OHD is the most abundant vitamin D metabolite, which is bound to vitamin D binding protein. The measurement of its concentration in serum, reflects vitamin D stores. Concentration at or above 32 ng/mL has been identified as optimal vitamin D level for bone health by majority of experts. (NCT00621257)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Maintenance A3
Maintenance B3

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Decrease in Preoperative P-PTH

Decrease in plasma PTH after 25 weeks of preoperative vitamin D treatment compared with the plasebo Group. (NCT00674154)
Timeframe: 25 weeks

Interventionpmol/l (Mean)
Vitamin D-2.2
Placebo0.2

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Change in Monocyte VDR Expression With Vitamin D Therapy

Monocytes will be analyzed pre- and post-cholecalciferol by flow cytometry to measure changes in monocyte VDR expression. Unit of measure is represented by mean florescence intensity (MFI), which is a relative measure. (NCT00677534)
Timeframe: Change from End of Washout to Week 12

Interventionunits on a scale (Mean)
Cholecalciferol 50,000 U1899

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Number of Participants Who Develop Hypercalcemia

calcium serum levels measured at baseline and at the end of the intervention (6-months) (NCT00681590)
Timeframe: 6 months

Interventionparticipants (Number)
Vitamin D 400 IU0
Vitamin D 2000 IU2

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Change From Baseline in Serum 25-hydroxyvitamin D Levels

(NCT00681590)
Timeframe: baseline and 6 months

Interventionng/ml (Mean)
Vitamin D 400 IU-0.5
Vitamin D 2000 IU6.5

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Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density

Bone Mineral Density (BMD) as measured by Dual Energy X-Ray Absorptiometry (DEXA) and measured in g/cm^2 was obtained at baseline (visit 1) and Week 52 (visit 13) or at early study discontinuation visit. The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent change from baseline, the greater the response to therapy. (NCT00692913)
Timeframe: Baseline and Week 52

,
InterventionPercent Change (Least Squares Mean)
Lumbar Spine (n= 226/ n=219)Total Hip (n=227/ n=218)
FOSAVANCE 56004.922.22
Referred-Care3.911.40

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Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52

"Percentage of participants with serum levels of 25-hydroxyvitamin D below~20 ng/mL after 52 weeks of treatment (6 month extension study) with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls." (NCT00692913)
Timeframe: Week 52

InterventionPercentage of Participants (Number)
FOSAVANCE 560011.3
Referred-Care36.9

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Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26

"Percentage of participants with serum levels of 25-hydroxyvitamin D below~20 nanograms/milliliter (ng/mL) after 26 weeks of treatment with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls." (NCT00692913)
Timeframe: Week 26

InterventionPercentage of Participants (Number)
FOSAVANCE 56008.6
Referred-Care31.0

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Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio

NTx is a urine biochemical marker of bone resorption and measured in nanomoles (nmol) Bone Collagen Equivalents (BCE)/millimoles (mmol) creatinine. The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy. (NCT00692913)
Timeframe: Baseline and Week 52

InterventionPercent Change (Least Squares Mean)
FOSAVANCE 5600-58.42
Referred-Care-50.07

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Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase

BSAP is a serum biochemical marker of bone formation and measured in micrograms/Liter (mcg/L). The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy. (NCT00692913)
Timeframe: Baseline and Week 52

InterventionPercent Change (Least Squares Mean)
FOSAVANCE 5600-51.21
Referred-Care-43.13

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Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio

N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (NTx) is a urine biochemical marker of bone resorption and measured in nanomoles (nmol) Bone Collagen Equivalents (BCE)/millimoles (mmol) creatinine. The percent change was calculated as: [100 * ((Week 26/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy. (NCT00692913)
Timeframe: Baseline and Week 26

InterventionPercent Change (Least Squares Mean)
FOSAVANCE 5600-57.06
Referred-Care-47.36

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Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase

Bone-Specific Alkaline Phosphatase (BSAP) is a serum biochemical marker of bone formation and measured in micrograms/Liter (mcg/L). The percent change was calculated as: [100 * ((Week 26/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy. (NCT00692913)
Timeframe: Baseline and Week 26

InterventionPercent Change (Least Squares Mean)
FOSAVANCE 5600-46.67
Referred-Care-39.60

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Falls Per Participant

"Number of falls per participant was measured.~The fall event rate during the study period was defined as the number of adjudicated falls during the study period divided by the total patient-years in the study. Each participant was to be in the study for approximately one year.~In order to guide and standardize all procedures during the fall adjudication process, a Standard Operating Procedure for Fall Adjudication was created by the~SPONSOR and served as a guideline to standardize operational procedures for fall adjudication." (NCT00692913)
Timeframe: Up to Week 52

InterventionNumber of Falls (Mean)
FOSAVANCE 56000.51
Referred-Care0.45

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Change in Serum C4 Level From Baseline to Week 12

C4 is a blood test that measures the activity of the complement component 4 (C4) protein. The normal range for males is 12 to 72 mg/dL and the normal range for females is 13 to 75 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C4. A decrease in C4 level over time may indicate disease activity. An increase in C4 from baseline to Week 12 is represented as a positive value (and vice versa). (NCT00710021)
Timeframe: 0, Week 12

Interventionmg/dL (Mean)
Placebo0.2
Vitamin D3 2000 IU-0.3
Vitamin D3 4000 IU1.9
Vitamin D3 2000 and 4000 IU (Pooled ).9

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Change in Serum C4 Level From Baseline to Week 6

Outcome measure description: C4 is a blood test that measures the activity of the complement component 4 (C4) protein. The normal range for males is 12 to 72 mg/dL and the normal range for females is 13 to 75 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C4. A decrease in C4 level over time may indicate disease activity. An increase in C4 from baseline to Week 6 is represented as a positive value (and vice versa). (NCT00710021)
Timeframe: 0, Week 6

Interventionmg/dL (Mean)
Placebo0.3
Vitamin D3 2000 IU-0.8
Vitamin D3 4000 IU0.4
Vitamin D3 2000 and 4000 IU (Pooled )-0.2

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Constitutional BILAG Status at Week 12

"The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the Constitutional-specific body system." (NCT00710021)
Timeframe: Week 12

InterventionPercent with grade A or B (Number)
Placebo0.0
Vitamin D3 2000 IU0.0
Vitamin D3 4000 IU0.0
Vitamin D3 2000 and 4000 IU (Pooled )0.0

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Gastrointestinal BILAG Status at Week 12

"The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the Gastrointestinal-specific body system." (NCT00710021)
Timeframe: Week 12

InterventionPercent with grade A or B (Number)
Placebo0.0
Vitamin D3 2000 IU0.0
Vitamin D3 4000 IU0.0
Vitamin D3 2000 and 4000 IU (Pooled )0.0

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Hematological BILAG Status at Week 12

"The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the Hematological-specific body system." (NCT00710021)
Timeframe: Week 12

InterventionPercent with grade A or B (Number)
Placebo0.0
Vitamin D3 2000 IU0.0
Vitamin D3 4000 IU0.0
Vitamin D3 2000 and 4000 IU (Pooled )0.0

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Mucocutaneous BILAG Status at Week 12

"The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the Mucocutaneous-specific body system." (NCT00710021)
Timeframe: Week 12

InterventionPercent with grade A or B (Number)
Placebo5.6
Vitamin D3 2000 IU12.5
Vitamin D3 4000 IU0.0
Vitamin D3 2000 and 4000 IU (Pooled )5.9

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Musculoskeletal BILAG Status at Week 12

"Outcome measure description: The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the Musculoskeletal-specific body system." (NCT00710021)
Timeframe: Week 12

InterventionPercent with grade A or B (Number)
Placebo5.6
Vitamin D3 2000 IU0.0
Vitamin D3 4000 IU11.1
Vitamin D3 2000 and 4000 IU (Pooled )5.9

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Ophthalmic BILAG Status at Week 12

"The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the Ophthalmic-specific body system." (NCT00710021)
Timeframe: Week 12

InterventionPercent with grade A or B (Number)
Placebo0.0
Vitamin D3 2000 IU0.0
Vitamin D3 4000 IU0.0
Vitamin D3 2000 and 4000 IU (Pooled )0.0

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Neuropsychiatric BILAG Status at Week 12

"The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the Neuropsychiatric-specific body system." (NCT00710021)
Timeframe: Week 12

InterventionPercent with grade A or B (Number)
Placebo0.0
Vitamin D3 2000 IU0.0
Vitamin D3 4000 IU0.0
Vitamin D3 2000 and 4000 IU (Pooled )0.0

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Percent of Participants With Adverse Events of Grade 3 or Above

Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0 over the duration of the study. Participants who experienced at least one grade 3 or higher adverse event (AE) are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug. (NCT00710021)
Timeframe: From start of study treatment through Week 12

InterventionPercent of participants (Number)
Placebo5.3
Vitamin D3 2000 IU23.5
Vitamin D3 4000 IU22.2
Vitamin D3 2000 and 4000 IU (Pooled )22.9

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Percent of Participants With an IFN Alpha Signature Response at Week 12

Presence of an Interferon (IFN) Alpha signature response is defined as: a reduction in expression from baseline (Screening) of at least 50% for 1 of 3 IFN Alpha responsive genes (Ifit1, Ifi44, Mx1) with concurrent expression in the remaining 2 genes at a level not more than 25% above baseline, or a reduction in expression from baseline of at least 25% for 2 of the 3 IFN Alpha responsive genes with concurrent expression in the third gene at a level of no more than 25% above baseline. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were considered as response failures during calculation. (NCT00710021)
Timeframe: 0, Week 12

InterventionPercent of participants (Number)
Placebo36.8
Vitamin D3 2000 IU23.5
Vitamin D3 4000 IU27.8
Vitamin D3 2000 and 4000 IU (Pooled )25.7

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Percent of Participants With an IFN Alpha Signature Response at Week 6

Presence of an Interferon (IFN) Alpha signature response is defined as: a reduction in expression from baseline (Screening) of at least 50% for 1 of 3 IFN Alpha responsive genes (Ifit1, Ifi44, Mx1) with concurrent expression in the remaining 2 genes at a level not more than 25% above baseline, or a reduction in expression from baseline of at least 25% for 2 of the 3 IFN Alpha responsive genes with concurrent expression in the third gene at a level of no more than 25% above baseline. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were considered as response failures during calculation. (NCT00710021)
Timeframe: 0, Week 6

InterventionPercent of participants (Number)
Placebo36.8
Vitamin D3 2000 IU17.6
Vitamin D3 4000 IU5.6
Vitamin D3 2000 and 4000 IU (Pooled )11.4

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Percent of Participants With IFN Alpha Signature at Week 12

An Interferon (IFN) Alpha signature is defined as: expression of Mx1, Ifit1, or Ifi44 at a level greater than or equal to 4 standard deviations above the mean of a set of normal controls, or expression of 2 of the 3 genes at a level greater than or equal to 2 standard deviations above the mean of a set of normal controls. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were assumed as signatures during calculation. (NCT00710021)
Timeframe: 0, Week 12

InterventionPercent of participants (Number)
Placebo78.9
Vitamin D3 2000 IU94.1
Vitamin D3 4000 IU100.0
Vitamin D3 2000 and 4000 IU (Pooled )97.1

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Percent of Participants With IFN Alpha Signature at Week 6

An Interferon (IFN) Alpha signature is defined as: expression of Mx1, Ifit1, or Ifi44 at a level greater than or equal to 4 standard deviations above the mean of a set of normal controls, or expression of 2 of the 3 genes at a level greater than or equal to 2 standard deviations above the mean of a set of normal controls. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were assumed as signatures during calculation. (NCT00710021)
Timeframe: Week 6

InterventionPercent of participants (Number)
Placebo84.2
Vitamin D3 2000 IU94.1
Vitamin D3 4000 IU100.0
Vitamin D3 2000 and 4000 IU (Pooled )97.1

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qRT-PCR Fold Change in Ifi44 Gene Expression From Baseline to Week 12

"The Ifi44 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes interferon-induced protein 44. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as fold change relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 12 is represented as a negative value (and vice versa)." (NCT00710021)
Timeframe: 0, Week 12

InterventionqRT-PCR fold change (Mean)
Placebo-2.5
Vitamin D3 2000 IU-0.3
Vitamin D3 4000 IU2.9
Vitamin D3 2000 and 4000 IU (Pooled )1.4

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qRT-PCR Fold Change in Ifi44 Gene Expression From Baseline to Week 6

"The Ifi44 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes interferon-induced protein 44. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as fold change relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 6 is represented as a negative value (and vice versa)." (NCT00710021)
Timeframe: 0, Week 6

InterventionqRT-PCR fold change (Mean)
Placebo-3.9
Vitamin D3 2000 IU-4.6
Vitamin D3 4000 IU4.1
Vitamin D3 2000 and 4000 IU (Pooled )0.3

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qRT-PCR Fold Change in Ifit1 Gene Expression From Baseline to Week 12

"The Ifit1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. This gene encodes an interferon-induced protein with tetratricopeptide repeats. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as fold change relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 12 is represented as a negative value (and vice versa)." (NCT00710021)
Timeframe: 0, Week 12

InterventionqRT-PCR fold change (Mean)
Placebo-8.6
Vitamin D3 2000 IU-2.9
Vitamin D3 4000 IU5.2
Vitamin D3 2000 and 4000 IU (Pooled )1.5

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qRT-PCR Fold Change in Ifit1 Gene Expression From Baseline to Week 6

"The Ifit1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes an interferon-induced protein with tetratricopeptide repeats. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as fold change relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 6 is represented as a negative value (and vice versa)." (NCT00710021)
Timeframe: 0, Week 6

InterventionqRT-PCR fold change (Mean)
Placebo-15.5
Vitamin D3 2000 IU-11.6
Vitamin D3 4000 IU6.3
Vitamin D3 2000 and 4000 IU (Pooled )-1.4

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qRT-PCR Fold Change in Mx1 Gene Expression From Baseline to Week 12

"The Mx1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes for the homolog of mouse myxovirus (influenza virus) resistance 1 protein. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as fold change relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 12 is represented as a negative value (and vice versa)." (NCT00710021)
Timeframe: 0, Week 12

InterventionqRT-PCR fold change (Mean)
Placebo-1.6
Vitamin D3 2000 IU2.0
Vitamin D3 4000 IU4.8
Vitamin D3 2000 and 4000 IU (Pooled )3.5

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Renal BILAG Status at Week 12

"The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the Renal-specific body system." (NCT00710021)
Timeframe: Week 12

InterventionPercent with grade A or B (Number)
Placebo0.0
Vitamin D3 2000 IU0.0
Vitamin D3 4000 IU0.0
Vitamin D3 2000 and 4000 IU (Pooled )0.0

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Change in Status for Anti-double-stranded DNA Autoantibody From Baseline to Week 12

Patients with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. A positive test for autoantibodies to double-stranded DNA is based on the normal range from the local laboratory. Change in status (+ or -) from baseline is evaluated. (NCT00710021)
Timeframe: 0, Week 12

,,,
InterventionPercent of participants (Number)
Positive at Baseline, Positive at Week 12Positive at Baseline, Negative at Week 12Negative at Baseline, Positive at Week 12Negative at Baseline, Negative at Week 12
Placebo94.10.00.05.9
Vitamin D3 2000 and 4000 IU (Pooled )88.26.02.92.9
Vitamin D3 2000 IU100.00.00.00.0
Vitamin D3 4000 IU77.811.05.65.6

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Change in Status for Anti-double-stranded DNA Autoantibody From Baseline to Week 6

Patients with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. A positive test for autoantibodies to double-stranded DNA is based on the normal range from the local laboratory. Change in status (+ or -) from baseline is evaluated. (NCT00710021)
Timeframe: 0, Week 6

,,,
InterventionPercent of participants (Number)
Positive at Baseline, Positive at Week 6Positive at Baseline, Negative at Week 6Negative at Baseline, Positive at Week 6Negative at Baseline, Negative at Week 6
Placebo94.70.00.05.3
Vitamin D3 2000 and 4000 IU (Pooled )91.22.90.05.9
Vitamin D3 2000 IU93.76.30.00.0
Vitamin D3 4000 IU88.90.00.011.1

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qRT-PCR Fold Change in Mx1 Gene Expression From Baseline to Week 6

"The Mx1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes for the homolog of mouse myxovirus (influenza virus) resistance 1 protein. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as fold change relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 6 is represented as a negative value (and vice versa)." (NCT00710021)
Timeframe: 0, Week 6

InterventionqRT-PCR fold change (Mean)
Placebo-4.8
Vitamin D3 2000 IU1.4
Vitamin D3 4000 IU0.7
Vitamin D3 2000 and 4000 IU (Pooled )1.0

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Cardiorespiratory BILAG Status at Week 12

"The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the Cardiorespiratory-specific body system." (NCT00710021)
Timeframe: Week 12

InterventionPercent with grade A or B (Number)
Placebo0.0
Vitamin D3 2000 IU6.3
Vitamin D3 4000 IU0.0
Vitamin D3 2000 and 4000 IU (Pooled )2.9

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Change in SELENA-SLEDAI Total Score From Baseline to Week 12

The modified Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus (SLE) Disease Activity Index (SELENA-SLEDAI) score is a weighted scale score ranging from 0 to 105 based on the presence or absence of 24 manifestations of SLE. The SELENA-SLEDAI assesses disease activity for 10 days prior to and including the day of assessment. For this study, the SELENA-SLEDAI score was modified to include proteinuria defined by dipstick rather than 24 hour urine. Positive change in the SELENA-SLEDAI score indicate increased disease activity. (NCT00710021)
Timeframe: 0, Week 12

InterventionChange in Scores on a Scale (Mean)
Placebo0.0
Vitamin D3 2000 IU0.2
Vitamin D3 4000 IU0.2
Vitamin D3 2000 and 4000 IU (Pooled )0.2

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Change in Serum C3 Level From Baseline to Week 12

C3 is a blood test that measures the activity of the complement component 3 (C3) protein. The normal C3 range is 75 to 135 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C3. A decrease in C3 level over time may indicate disease activity. An increase in C3 from baseline to Week 12 is represented as a positive value (and vice versa). (NCT00710021)
Timeframe: 0, Week 12

Interventionmg/dL (Mean)
Placebo1.8
Vitamin D3 2000 IU0.7
Vitamin D3 4000 IU2.9
Vitamin D3 2000 and 4000 IU (Pooled )1.9

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Change in Serum C3 Level From Baseline to Week 6

C3 is a blood test that measures the activity of the complement component 3 (C3) protein. The normal C3 range is 75 to 135 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C3. A decrease in C3 level over time may indicate disease activity. An increase in C3 from baseline to Week 6 is represented as a positive value (and vice versa). (NCT00710021)
Timeframe: 0, Week 6

Interventionmg/dL (Mean)
Placebo3.3
Vitamin D3 2000 IU3.8
Vitamin D3 4000 IU3.7
Vitamin D3 2000 and 4000 IU (Pooled )3.8

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Percent Change From Baseline in Serum N-Terminal Propeptides of Type 1 Collagen (s-P1NP) Level

s-P1NP is a biochemical marker index of bone formation. s-P1NP was measured via fasting blood draws at Baseline (Randomization), Month 6, Month 12, Month 18, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures. s-P1NP was analyzed using the log-transformed fraction from baseline using the per-protocol approach. Data were back-transformed for presentation and geometric LS mean percent change from baseline was reported with 95% CI. (NCT00729183)
Timeframe: Baseline, 12 months, 24 months

,
Interventionpercent change (Least Squares Mean)
Month 12 (n=90, n=88)Month 24 (n=76, n=80)
Odanacatib 50 mg-28.32-11.06
Placebo-2.97-1.99

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Percent Change From Baseline in Total Hip aBMD

aBMD (g/cm^2) data was measured by DXA at the total hip. All measurements utilized the same hip and at least 2 vertebrae for all time points. The left hip only was scanned. If the left hip was unevaluable, then the right hip was scanned. Once the appropriate leg was identified for scanning, it was used for all subsequent measurements. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the total hip was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures. (NCT00729183)
Timeframe: Baseline, 12 months, 24 months

,
Interventionpercent change (Least Squares Mean)
Month 12 (n=96, n=97)Month 24 (n=82, n=90)
Odanacatib 50 mg1.412.43
Placebo-0.16-0.89

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Percent Change From Baseline in Total Radius aBMD

aBMD (g/cm^2) data was measured by DXA at the total radius (forearm). aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the total radius was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures. (NCT00729183)
Timeframe: Baseline, 12 months, 24 months

,
Interventionpercent change (Least Squares Mean)
Month 12 (n=96, n=96)Month 24 (n=82, n=90)
Odanacatib 50 mg0.01-0.19
Placebo-0.70-1.89

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Percent Change From Baseline in Trabecular vBMD at Central Section of Spine (L2)

Trabecular vBMD at the lumbar spine (L2) was measured by quantitative computed tomography (QCT). All QCT-derived vBMD measurements were evaluated centrally (and possibly locally) for bone and soft tissue abnormalities. Trabecular vBMD at the lumbar spine (L2) was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures. (NCT00729183)
Timeframe: Baseline, 12 months, 24 months

,
Interventionpercent change (Least Squares Mean)
Month 12 (n=84, n=86)Month 24 (n=73, n=79)
Odanacatib 50 mg5.675.97
Placebo-0.00-3.41

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Percent Change From Baseline in Trabecular Volumetric Bone Mineral Density (vBMD) at Central Section of Spine (L1)

Trabecular vBMD at the lumbar spine (L1) was measured by quantitative computed tomography (QCT). All QCT-derived vBMD measurements were evaluated centrally (and possibly locally) for bone and soft tissue abnormalities. Trabecular vBMD at the lumbar spine (L1) was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures. (NCT00729183)
Timeframe: Baseline, 12 months, 24 months

,
Interventionpercent change (Least Squares Mean)
Month 12 (n=82, n=86)Month 24 (n=72, n=79)
Odanacatib 50 mg6.586.44
Placebo-1.43-5.02

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Percent Change From Baseline in Ultradistal Radius aBMD

aBMD (g/cm^2) data was measured by DXA at the ultradistal radius (forearm). aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the ultradistal radius was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures. (NCT00729183)
Timeframe: Baseline, 12 months, 24 months

,
Interventionpercent change (Least Squares Mean)
Month 12 (n=96, n=96)Month 24 (n=82, n=90)
Odanacatib 50 mg0.981.25
Placebo-0.73-1.45

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Percent Change From Baseline in Femoral Neck aBMD

aBMD (g/cm^2) data was measured by DXA at the femoral neck (hip). All measurements utilized the same hip and at least 2 vertebrae for all time points. The left hip only was scanned. If the left hip was unevaluable, then the right hip was scanned. Once the appropriate leg was identified for scanning, it was used for all subsequent measurements. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the femoral neck was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures. (NCT00729183)
Timeframe: Baseline, 12 months, 24 months

,
Interventionpercent change (Least Squares Mean)
Month 12 (n=96, n=97)Month 24 (n=82, n=90)
Odanacatib 50 mg1.032.47
Placebo-0.45-1.33

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Percent Change From Baseline in Hip Trochanter aBMD

aBMD (g/cm^2) data was measured by DXA at the hip trochanter. All measurements utilized the same hip and at least 2 vertebrae for all time points. The left hip only was scanned. If the left hip was unevaluable, then the right hip was scanned. Once the appropriate leg was identified for scanning, it was used for all subsequent measurements. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the hip trochanter was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures. (NCT00729183)
Timeframe: Baseline, 12 months, 24 months

,
Interventionpercent change (Least Squares Mean)
Month 12 (n=96, n=97)Month 24 (n=82, n=90)
Odanacatib 50 mg2.374.75
Placebo0.18-0.73

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Percent Change From Baseline in Serum C-Terminal Telopeptides of Type 1 Collagen (s-CTx) Level

s-CTx is a biochemical marker index of bone resorption. s-CTx was measured via fasting blood draws at Baseline (Randomization), Month 6, Month 12, Month 18, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures. S-CTx was analyzed using the log-transformed fraction from baseline using the per-protocol approach. Data were back-transformed for presentation and geometric LS mean percent change from baseline was reported with 95% CI. (NCT00729183)
Timeframe: Baseline, 12 months, 24 months

,
Interventionpercent change (Least Squares Mean)
Month 12 (n=89, n=87)Month 24 (n=74, n=78)
Odanacatib 50 mg-53.33-42.56
Placebo0.703.03

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Percent Change From Baseline to Month 24 in Lumbar Spine aBMD

aBMD (g/cm^2) was measured by DXA at the lumbar spine and mean BMD measurements from at least 3 evaluable vertebrae from L1 through L4 were used. If a vertebra was fractured at baseline or became fractured during the study, its BMD measurement was excluded from the analysis and the lumbar spine BMD was recalculated based on the three remaining vertebrae. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the lumbar spine was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as primary and secondary outcome measures, respectively. (NCT00729183)
Timeframe: Baseline, 24 months

Interventionpercent change (Least Squares Mean)
Odanacatib 50 mg5.02
Placebo-0.38

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Percent Change From Baseline to Month 12 in Lumbar Spine Areal Bone Mineral Density (aBMD)

aBMD (g/cm^2) was measured by dual-energy X-ray absorptiometry (DXA) at the lumbar spine and mean BMD measurements from at least 3 evaluable lumbar spine vertebrae (L1-L4) were used. If a vertebra was fractured at baseline or became fractured during the study, its BMD measurement was excluded from the analysis and the lumbar spine BMD was recalculated based on the three remaining vertebrae. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the lumbar spine was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal Analysis of Covariates (ANCOVA) model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as primary and secondary outcome measures, respectively. (NCT00729183)
Timeframe: Baseline, 12 months

Interventionpercent change (Least Squares Mean)
Odanacatib 50 mg3.63
Placebo0.14

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Percentage of Participants That Discontinued Study Treatment Due to an AE

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The percentage of participants that discontinued study treatment (different from discontinuation of the study) due to an AE was reported for each treatment arm. (NCT00729183)
Timeframe: Up to ~14 days post study end (up to ~24 months)

Interventionpercentage of participants (Number)
Odanacatib 50 mg10.1
Placebo5.7

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Percentage of Participants That Experienced an Adverse Event (AE)

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The percentage of participants that experienced at least one AE was reported for each treatment arm. (NCT00729183)
Timeframe: Up to ~14 days post study end (up to ~24 months)

Interventionpercentage of participants (Number)
Odanacatib 50 mg82.6
Placebo84.8

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Percent Change From Baseline in Distal Radius aBMD

aBMD (g/cm^2) data was measured by DXA at the one-third distal radius (forearm). aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the distal radius was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures. (NCT00729183)
Timeframe: Baseline, 12 months, 24 months

,
Interventionpercent change (Least Squares Mean)
Month 12 (n=96, n=96)Month 24 (n=82, n=90)
Odanacatib 50 mg-0.21-0.57
Placebo-0.37-1.79

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Mean Serum 25 OHD(Serum 25-hydroxyvitamin D) at 16 Weeks of Treatment

(NCT00729651)
Timeframe: 16 weeks

Interventionng/ml (Mean)
Fosamax Plus D30.08
Fosamax17.14

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Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment

(NCT00729651)
Timeframe: 16 weeks

,
Interventionparticipants (Number)
With Vitamin D DeficiencyWithout Vitamin D Deficiency
Fosamax5577
Fosamax Plus D2134

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Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment

(NCT00729651)
Timeframe: Baseline and 16 weeks

InterventionPercentage Change Serum PTH (Least Squares Mean)
Fosamax Plus D8.17
Fosamax29.98

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Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Less and Greater Than 20 ng/ml at 16 Weeks of Treatment

(NCT00729651)
Timeframe: 16 weeks

,
Interventionparticipants (Number)
With 25 OHD < 20ng/ml at 16 weeks of treatmentWith 25 OHD >= 20ng/ml at 16 weeks of treatment
Fosamax9339
Fosamax Plus D7129

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Serum 25-hydroxyvitamin D

Circulating concentration of 25 hydroxyvitamin D is a biomarker of vitamin D status. Vitamin D deficiency was defined as serum 25-hydroxyvitamin D concentrations <20 ng/mL. (NCT00732758)
Timeframe: 6 months

Interventionng/mL (Mean)
Vitamin D3 Group26.7
Placebo Group22.4

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Osteocalcin (OC)

Marker of bone formation (NCT00732758)
Timeframe: 6 months

Interventionng/mL (Mean)
Vitamin D3 Group101.1
Placebo Group104.8

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Parathyroid Hormone (PTH) Dietary Data

(NCT00732758)
Timeframe: 6 months

Interventionpg/mL (Mean)
Vitamin D3 Group35.5
Placebo Group33.5

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Collagen Type 1 Cross-linked C-telopeptide (CTx)

Collagen type 1 cross-linked C-telopeptide (CTx) is a marker of bone resorption. (NCT00732758)
Timeframe: 6 months

Interventionng/mL (Mean)
Vitamin D3 Group1.4
Placebo Group1.6

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Serum Calcium

Serum calcium assessed by photometric assessment after calcium reaction with NM-BAPTA, then with EDTA (NCT00736632)
Timeframe: 0, 2, and 4 Month

,
Interventionmg/dL (Mean)
0 Month, serum ca2 Month, serum ca4 Month, serum ca
Placebo9.19.29.1
Vitamin D9.19.19.3

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Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)

24-hour blood pressure collected by ambulatory automated arm cuff, central mean arterial blood pressure (MAP) collected by non-invasive arterial tonometry and pulse wave analysis/pulse wave velocity, office blood pressure collected by manual aneroid sphygmomanometry. (NCT00736632)
Timeframe: 0, 2, and 4 months

,
Interventionmm Hg (Mean)
0 Month, Office SBP0 Month, Office DBP2 Month, Office SBP2 Month, Office DBP4 Month, Office SBP4 Month, Office DBP0 Month, Central MAP2 Month, Central MAP4 Month, Central MAP0 Month, Daytime MAP0 Month, Nighttime MAP2 Month, Daytime MAP2 Month, Nighttime MAP4 Month, Daytime MAP4 Month, Nighttime MAP
Placebo126.679.2127.679.2129.679.6103.9100.6102.699.889.497.686.6100.089.1
Vitamin D131.178.9133.279.9132.777.9107.2107.8105.2101.692.2101.794.099.190.3

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hsCRP

High sensitivity C-reactive protein assessed by particle-enhanced immunoturbidimetric assay (NCT00736632)
Timeframe: 0, 2, and 4 Month

,
Interventionmg/L (Mean)
0 Month, hsCRP2 Month, hsCRP4 Month, hsCRP
Placebo3.73.64.2
Vitamin D6.05.96.7

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HbA1C

HbA1c percentage assessed by turbidimetric inhibition immunoassay for hemolyzed whole blood (NCT00736632)
Timeframe: 0, 2, and 4 month

,
Interventionpercentage (Mean)
HbA1c 0 monthHbA1c 2 monthHbA1c 4 month
Placebo7.07.47.4
Vitamin D7.06.97.0

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Fasting Glucose

Serum fasting glucose assessed by hexokinase method (NCT00736632)
Timeframe: 0, 2, and 4 Month

,
Interventionmg/dL (Mean)
0 Month, Fasting Glucose2 Month, Fasting Glucose4 Month, Fasting Glucose
Placebo126.7137.4138.4
Vitamin D123.3124.9128.7

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Brachial Artery Reactivity Testing

Brachial artery response to hyperemia assessed by measuring brachial artery diameter every 30 seconds for 180 seconds after a 5-minute occlusion with arm cuff above systolic blood pressure, with response defined as maximal percentage increase above baseline. (NCT00736632)
Timeframe: 0, 2, and 4 months

,
Interventionpercentage of dilation (Mean)
0 Month2 Month4 Month
Placebo7.88.57.8
Vitamin D8.67.57.8

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Macrophage Cholesterol Metabolism

Macrophage uptake of labeled oxidized low density lipoprotein, assessed by the ratio of post-treatment cholesterol uptake to baseline uptake. (NCT00736632)
Timeframe: 0 and 4 months

Interventionunitless (ratio) (Mean)
Placebo1.01
Vitamin D0.47

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Vitamin D

25(OH) Vitamin D assess by liquid chromatography with tandem mass spectrometry (NCT00736632)
Timeframe: 0, 2, and 4 Month

,
Interventionpg/mL (Mean)
0 Month, Vitamin D2 Month, Vitamin D4 Month, Vitamin D
Placebo46.137.744.5
Vitamin D40.140.742.7

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Urine Calcium to Creatinine Ratio.

Urine calcium to creatinine ratio assessed by spectrophotometry (NCT00736632)
Timeframe: 0, 2 and 4 Months

,
Interventionmg/gm (Mean)
0 Month, ca to creatinine ratio2 Month, ca to creatinine ratio4 Month, ca to creatinine ratio
Placebo69.8102.389.9
Vitamin D88.1114.1134.5

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25(OH)D3 Serum Levels

25(OH)D3 levels before and after vitamin D supplementation. (NCT00742781)
Timeframe: 6 months

Interventionng/ml 25(OH)D3 (Mean)
Baseline16
Vitamin D Supplemented45

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Crohn's Disease Activity Index

Questionnaire and physical measurements combine to generate a score. Scores below 150 indicate remission, 150-350 mild to moderate disease, over 350 severe disease. The total range of scores are from 0- Don't have Crohn's disease to 600 severe Crohn's disease. 0-150 is remission, 151-219 is mild, 220-450 is moderate disease and over 451 is severe. (NCT00742781)
Timeframe: 6 months

Interventionunits on a scale (Mean)
Baseline230
Vitamin D Supplemented112

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Health Improvement

International Physical Activity Questionnaire. Minutes/week for 30 min/day, 5days (MET) are calculated for different activity intensities. Total range of scores 0-600 MET low activity, 600-1200 Moderate activity, Over 1200-3000 High activity. (NCT00742781)
Timeframe: 6 months

Interventionunits on a scale (Mean)
Baseline5778
Vitamin D Supplemented6714

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Serum Levels of C-reactive Protein at Completion of 3 Months Treatment

Serum levels of C-reactive protein upon completion, at 3 months (NCT00743574)
Timeframe: 3 months

Interventionmg/L (Median)
Vitamin D Plus Calcium (Ca) Supplementation5.3

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Fasting Glucose Levels at Completion of Treatment, at 3 Months

Fasting glucose levels drawn after 3 months completion during oral GTT (NCT00743574)
Timeframe: 3 months

Interventionmg/dl (Mean)
Vitamin D Plus Calcium (Ca) Supplementation103.79

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AUC (Area Under a Curve at 0, 0.5, 1, 1.5 and 2 Hours) Insulin During 2 Hour GTT at Completion, at 3 Months

Following 3 months intervention, AUC insulin was determined during 2 hour oral GTT (NCT00743574)
Timeframe: 3 months

InterventionµIU/ml/120min (Mean)
Vitamin D Plus Calcium (Ca) Supplementation16715.57

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Fasting Insulin Levels at Study Completion After 3 Month Treatment

Fasting insulin levels at study completion after 3 month treatment (NCT00743574)
Timeframe: 3 months intervention

InterventionµIU/ml (Mean)
Vitamin D Plus Calcium (Ca) Supplementation25.17

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AUC (Area Under the Curve at 0, 0.5, 1, 1.5 and 2 Hours) During Oral GTT at Completion, at 3 Months

AUC (Area under the curve at 0, 0.5, 1, 1.5 and 2 hours)for glucose was determined at completion of 3 months intervention for 2 hour oral GTT (NCT00743574)
Timeframe: 3 months

Interventionmg/min/120min (Mean)
Vitamin D Plus Calcium (Ca) Supplementation16726.56

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Serum HbA1C at 3 Months

Fasting HbA1C levels at study completion after 3 month treatment (NCT00743574)
Timeframe: Completion

Interventionpercentage (Mean)
Vitamin D Plus Calcium (Ca) Supplementation5.55

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Number of Participants With Any Significant Changes in Serum Biomarkers of Bone Turnover From Baseline

Participants with significant change in serum biomarkers of bone formation and resorption from baseline are reported. Significant changes were judged by investigator. (NCT00752557)
Timeframe: Baseline up to 12 months

Interventionparticipants (Number)
Standard of Care Control0
rhBMP-2/CPM 1.0 mg/mL0
rhBMP-2/CPm 2.0 mg/mL0

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Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA)

Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure. BMD is defined as a derived measure of bone density, generated by dividing the bone mineral content value obtained from a bone densitometry technique (for example, DXA) by the total area of the region scanned. (NCT00752557)
Timeframe: Baseline, 12 months post dose

,,
Interventiongram per centimeter squared (g/cm^2) (Mean)
Total hipIntertrochanterTrochanterFemoral neck
rhBMP-2/CPM 1.0 mg/mL0.12990.10630.11970.2408
rhBMP-2/CPm 2.0 mg/mL0.11960.11920.08690.2120
Standard of Care Control-0.0026-0.0029-0.00910.0058

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Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck

Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure. (NCT00752557)
Timeframe: At Month 12

,,
Interventionmg/cm^3 (Mean)
Cortical +Sub CorticalPeeled TrabecularIntegral
rhBMP-2/CPM 1.0 mg/mL166.3165.0331.3
rhBMP-2/CPm 2.0 mg/mL164.4159.3323.7
Standard of Care Control144.361.1205.4

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Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip

Time course distribution of volumetric Bone mineral density (BMD) for hip is assessed by volumetric Quantitative Computed Tomography (vQCT) technique which is a 4-detector spiral (helical) computed tomography (CT) scanner with designated calibration phantom, obtain a CT scan of the proximal femora (bilateral simultaneous acquisition with volumetric rendering) to identify the specified region of interests (ROIs) for volumetric parameter to be quantified, reconstruct images of both hips and send reconstructed data (in electronic format). The vQCT regions of interest are cortical, the subcortical and trabecular. Cortical and the subcortical BMD are distinguished from trabecular effects. Peeled trabecular BMD reflects the subtraction of the extended CPM. Integral BMD reflects the cortical, subcortical, and peeled trabecular regions (minus the extended Calcium phosphate matrix [CPM]). (NCT00752557)
Timeframe: At Month 12

,,
Interventionmilligram per centimeter cubed (mg/cm^3) (Mean)
Cortical + Sub-CorticalPeeled TrabecularIntegral
rhBMP-2/CPM 1.0 mg/mL165.677.8243.4
rhBMP-2/CPm 2.0 mg/mL151.688.4240.0
Standard of Care Control136.845.1181.9

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Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC)

Here, measurement of density of cortical and trabecular bone in various regions of interest (ROIs) in the femoral neck, proximal shaft, and individual trochanters and was calculated by Quantitative Computed Tomography (vQTC) in ROIs. (NCT00752557)
Timeframe: 24 months

,,
Interventionmg/cm^3 (Mean)
Cortical BoneTrabecular Bone
rhBMP-2/CPM 1.0 mg/mL2.42594.7073
rhBMP-2/CPm 2.0 mg/mL2.51284.2205
Standard of Care Control2.57820

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Number Participant Responses to Injectability Questionnaire Injected Population

Investigator documents preparation of the study medication evaluates injectability and product placement relative to desired location (for participants in active treatment groups). Surgeon performing the injection had to complete the questionnaire that evaluates ease of preparing the study medication, ability to administer study medication, and ability for the study medication to remain in the location it was administered. (NCT00752557)
Timeframe: Participants were monitored after treatment administration (dosing period)

,
InterventionParticipants (Number)
Ease of Preparing-satisfactoryEase of Preparing-unsatisfactoryEase of Injecting-satisfactoryEase of Injecting-unsatisfactoryAbility to inject entire volume- satisfactoryAbility to inject entire volume- unsatisfactoryLocalization within Proximal Femur-satisfactoryLocalization within Proximal Femur-unsatisfactoryMissing
rhBMP-2/CPM 1.0 mg/mL1501501321500
rhBMP-2/CPm 2.0 mg/mL1401131221121

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Percentage Change From Baseline in Areal Bone Mineral Density (BMD) for Contralateral Total Hip

Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. The percentage change from baseline in BMD for total hip (assessed by DXA) is presented for the contralateral (untreated) hip below. (NCT00752557)
Timeframe: 36 months

InterventionPercent change (Mean)
Standard of Care Control0.73
rhBMP-2/CPM 1.0 mg/mL0.71
rhBMP-2/CPm 2.0 mg/mL0.71

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Change in Endotoxin Activity

Endotoxin Activity as measured by the Endotoxin Activity Assay. This measurement was made at baseline and after 8 weeks of therapy with Vitamin D3. The measurement of the assay is unitless. It is not based on an absolute amount of endotoxin, but rather the proportion of the theoretical maximal response of the patient and ranges from 0 (lowest) to 1 (highest). (NCT00772772)
Timeframe: baseline and 8 weeks

InterventionEA units (Mean)
Patients With Chronic Kidney Disease (CKD)-.057

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25-hydroxy Vitamin D (25-OH Vitamin D)

25-OH Vitamin D levels were measured in patients with chronic kidney disease at baseline and after 8 weeks of treatment with Vitamin D3 30000 units weekly. (NCT00772772)
Timeframe: after 8 weeks of vitamin D therapy

Interventionng/ml (Mean)
CKD Patients37.4

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Maxillary Modified Gingival Index (MGI) Score

The Modified Gingival Index (MGI) uses non-invasive/no probing and rates mild and moderate inflammation where: 0 = absence of inflammation; 1 = mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary; 2 = mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary; 3 = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary; 4 = severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration. The MGI can be obtained by adding the values of each tooth and dividing by the number of teeth examined. The MGI may be scored for all surfaces of all or selected teeth or for selected areas of all or selected teeth. A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation. (NCT00779909)
Timeframe: week 8 and week 12

,,,
Interventionunits on a scale (Mean)
8wk maxillary MGI score12wk maxillary MGI score
1- Placebo1.782.11
2- Vitamin D3, 500 IU1.631.87
3- Vitamin D3 2500 IU1.571.9
4- Vitamin D3 5000 IU1.612.1

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Urinary Calcium/Creatinine Ratio

Urinary calcium ratios were calculated from urine samples at week 4, 7, and 12. A normal reference interval for the urine calcium (mg/dL):urine creatinine (mg/dL) ratio is <0.14. (NCT00779909)
Timeframe: week 4, week 7, week 12

,,,
Interventionratio (Mean)
4wk calcium/creatinine ratio7wk calcium/creatinine ratio12wk calcium/creatinine ratio
1-Placebo0.070.090.12
2-Vitamin D3, 500 IU0.060.070.07
3-Vitamin D3, 2500 IU0.070.090.11
4-Vitamin D3, 5000 IU0.090.130.11

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Mandibular Modified Gingival Index (MGI) Score

The Modified Gingival Index (MGI) uses non-invasive/no probing and rates mild and moderate inflammation where: 0 = absence of inflammation; 1 = mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary; 2 = mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary; 3 = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary; 4 = severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration. The MGI can be obtained by adding the values of each tooth and dividing by the number of teeth examined. The MGI may be scored for all surfaces of all or selected teeth or for selected areas of all or selected teeth. A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation. (NCT00779909)
Timeframe: week 8 and week 12

,,,
Interventionunits on a scale (Mean)
8wk mandibular MGI score12wk mandibular MGI score
1- Placebo1.832.12
2- Vitamin D3, 500 IU1.761.97
3- Vitamin D3 2500 IU1.622.02
4- Vitamin D3 5000 IU1.672.19

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Mandibular Plaque Index (PI) Score

The Turesky plaque index was used. In this index, plaque is identified using a disclosing solution and scored using a 0 to 5 scale in which a score of 0= No plaque, 1= Separate flecks of plaque, 2= continuous band of plaque less or equal 1 mm, 3= Continuous band of plaque greater than 1 mm but less than 1/3 of crown height, 4= Continuous band of plaque greater or equal 1/3 but less or equal 2/3 of crown height, and 5= Continuous band of plaque greater 2/3 of crown height. Each tooth receives 6 individual scores at: mesial, middle, and distal scores for both the facial and lingual surfaces. An individual's score is derived by adding the scores at each site and dividing by the number of sites evaluated. Higher scores denote higher plaque accumulation. Lower scores are more favorable. (NCT00779909)
Timeframe: week 8 and week 12

,,,
Interventionunits on a scale (Mean)
8wk mandibular PI score12wk mandibular PI score
1- Placebo1.842.92
2- Vitamin D3, 500 IU1.772.93
3- Vitamin D3 2500 IU1.822.74
4- Vitamin D3 5000 IU1.822.89

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Gingival Crevicular Fluid (GCF) Concentrations of TNF-alpha, IL1-beta, IL-2, IL-12

"GCF will be collected by placing a filter paper strip at the opening of the gingival crevice. After carefully removing the supragingival plaque from the sampling area, a paper strip will be placed for 30s or until visibly wet. Sampling time will be recorded and GCF volume collected with each sample will be quantified using a Periotron device.~GCF volume will be sampled from three mesial sites per subject: The upper left central incisor, the first upper left premolar and the first upper left molar. Should any of these teeth be missing, substitution will occur in the following order (i) the contralateral tooth, (ii) the distally adjacent tooth, or (iii) the distally adjacent tooth of the contralateral tooth. Should a sample be visibly contaminated with blood, the sample will be discarded and substitution will occur as described above. Concentrations of TNF-alpha, IL-1 beta, IL-2, and IL-12 will be measured and means and SDs will be calculated for each study arm." (NCT00779909)
Timeframe: week 8 and week 12

,,,
Interventionpg/site (Mean)
8wk TNF-alpha12wk TNF-alpha8wk IL-1 beta12wk IL-1 beta8wk IL-212wk IL-28wk IL-1212wk IL-12
1-Placebo0.971.000.040.0424.1120.780.650.62
2-Vitamin D3, 500 IU1.531.110.050.0413.4412.50.110.06
3-Vitamin D3, 2500 IU1.341.730.040.0413.1312.560.030.02
4-Vitamin D3, 5000 IU1.877.940.040.0413.0713.360.961.08

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Gingival Crevicular Fluid (GCF) Volume

GCF will be collected by placing a filter paper strip at the opening of the gingival crevice. After carefully removing the supragingival plaque from the sampling area, a paper strip will be placed for 30s or until visibly wet. Sampling time will be recorded and GCF volume collected with each sample will be quantified using a Periotron device. GCF volume will be sampled from three mesial sites per subject: The upper left central incisor, the first upper left premolar and the first upper left molar. Should any of these teeth be missing, substitution will occur in the following order (i) the contralateral tooth, (ii) the distally adjacent tooth, or (iii) the distally adjacent tooth of the contralateral tooth. Should a sample be visibly contaminated with blood, the sample will be discarded and substitution will occur as described above. (NCT00779909)
Timeframe: week 8 and week 12

,,,
Interventionul (Mean)
8wk GCF volume site 112wk GCF volume site 18wk GCF volume site 212wk GCF volume site 28wk GCF volume site 312wk GCF volume site 3
1-Placebo38.150.853.783.670.495.9
2-Vitamin D3, 500 IU49.166.553.571.992.999.1
3-Vitamin D3, 2500 IU37.135.142.554.358.464.8
4-Vitamin D3, 5000 IU57.655.961.072.459.992

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Serum Calcium

The serum calcium blood test measures the total calcium in the participants' blood. The normal range for total serum calcium concentration in adults is 8.9-10.2 mg/dL. (NCT00779909)
Timeframe: week 7, week 12

,,,
Interventionmg/dl (Mean)
7wk serum calcium12wk serum calcium
1-Placebo9.69.4
2-Vitamin D3, 500 IU9.19.2
3-Vitamin D3, 2500 IU9.29.2
4-Vitamin D3, 5000 IU9.19.3

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Maxillary Plaque Index (PI) Score

The Turesky plaque index was used. In this index, plaque is identified using a disclosing solution and scored using a 0 to 5 scale in which a score of 0= No plaque, 1= Separate flecks of plaque, 2= continuous band of plaque less or equal 1 mm, 3= Continuous band of plaque greater than 1 mm but less than 1/3 of crown height, 4= Continuous band of plaque greater or equal 1/3 but less or equal 2/3 of crown height, and 5= Continuous band of plaque greater 2/3 of crown height. Each tooth receives 6 individual scores at: mesial, middle, and distal scores for both the facial and lingual surfaces. An individual's score is derived by adding the scores at each site and dividing by the number of sites evaluated. Higher scores denote higher plaque accumulation. Lower scores are more favorable. (NCT00779909)
Timeframe: week 8 and week 12

,,,
Interventionunits on a scale (Mean)
8wk maxillary PI score12 wk maxillary PI score
1- Placebo1.562.77
2- Vitamin D3, 500 IU1.713
3- Vitamin D3 2500 IU1.692.81
4- Vitamin D3 5000 IU1.682.89

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Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo

Cathelicidin (CAMP) messenger ribonucleic acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline, Cathelicidin abundance in psoriasis has been hypothesized to correlate with increased inflammation. No direct clinical correlation is known. (NCT00789880)
Timeframe: Baseline to Day 21

,
InterventionCycle Number (Mean)
Lesional Skin TypeNon-Lesional Skin Type
Placebo (Psoriasis)0.20.7
Vitamin D (Psoriasis)-0.9-0.6

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Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo

Cytokine interleukin-13 ( IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. There is no known clinical correlation between IL-13 and psoriasis. (NCT00789880)
Timeframe: Baseline to Day 21

,
InterventionCycle Number (Mean)
Lesional Skin TypeNon-Lesional Skin Type
Placebo (Psoriasis)-0.10.9
Vitamin D (Psoriasis)-2.1-0.3

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Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo

Cytokine interleukin-13 (IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. A decrease in IL-13 may be clinically correlated with improvement of AD. (NCT00789880)
Timeframe: Baseline to Day 21

,
InterventionCycle Number (Mean)
Lesional Skin TypeNon-Lesional Skin Type
Placebo (AD)1.1-0.1
Vitamin D (AD)-0.7-0.8

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Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo

Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. There is no known clinical correlation between HBD-3 and psoriasis. (NCT00789880)
Timeframe: Baseline to Day 21

,
InterventionCycle Number (Mean)
Lesional Skin TypeNon-Lesional Skin Type
Placebo (Psoriasis)-1.6-1.5
Vitamin D (Psoriasis)0.8-1.5

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Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo

Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies as measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. HBD-3 amount is clinically significant as it is necessary to resist infection. HBD-3 amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD. (NCT00789880)
Timeframe: Baseline to Day 21

,
InterventionCycle Number (Mean)
Lesional Skin TypeNon-Lesional Skin Type
Placebo (AD)-0.81.4
Vitamin D (AD)-0.1-0.1

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Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo

Cathelicidin (CAMP) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. Cathelicidin amount is clinically significant as it is necessary to resist infection. Cathelicidin amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD. (NCT00789880)
Timeframe: Baseline to Day 21

,
InterventionCycle Number (Mean)
Lesional Skin TypeNon-Lesional Skin Type
Placebo (AD)0.10.7
Vitamin D (AD)-0.4-0.6

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Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo

Cytokine interleukin-13 ( IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. A decrease in IL-13 may be clinically correlated with improvement of AD. (NCT00789880)
Timeframe: Baseline to Day 21

InterventionCycle Number (Mean)
Vitamin D (Non-AD)0.2
Placebo (Non-AD)0.5

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Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo

Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis, therefore the lesional skin-type was not measured in this group. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. HBD-3 amount is clinically significant as it is necessary to resist infection. HBD-3 amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD. (NCT00789880)
Timeframe: Baseline to Day 21

InterventionCycle Number (Mean)
Vitamin D (Non-AD)0.2
Placebo (Non-AD)1.2

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Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo

Cathelicidin (CAMP) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis, therefore the lesional skin-type was not measured in this group. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. Cathelicidin amount is clinically significant as it is necessary to resist infection. Cathelicidin amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD. (NCT00789880)
Timeframe: Baseline to Day 21

InterventionCycle Number (Mean)
Vitamin D (Non-AD)1.2
Placebo (Non-AD)0.3

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Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 12

Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL (NCT00803712)
Timeframe: Weeks 48-52

Interventionparticipants (Number)
Cinacalcet74
Control Group83

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Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 12 Efficacy Assessment Phase

All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 48-52

Interventionpercent change (Least Squares Mean)
Cinacalcet-34.15
Control Group-12.41

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Subject Incidence of Hypercalcemia During the Maintenance Phase

Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL (NCT00803712)
Timeframe: Weeks 26-48

Interventionparticipants (Number)
Cinacalcet16
Control Group25

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Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 12

Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL (NCT00803712)
Timeframe: Weeks 48-52

Interventionparticipants (Number)
Cinacalcet15
Control Group21

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Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 6

Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL (NCT00803712)
Timeframe: Weeks 22-26

Interventionparticipants (Number)
Cinacalcet71
Control Group93

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Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 6

Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL (NCT00803712)
Timeframe: Weeks 22-26

Interventionparticipants (Number)
Cinacalcet11
Control Group22

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Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)

All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 48-52

,
Interventionparticipants (Number)
Responders defined as >= 30% reduction in mean PTHNon responders
Cinacalcet9756
Control Group7279

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Achievement of a >= 30% Reduction in Mean iPTH From Baseline to During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)

All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 22-26 and Weeks 48-52

,
Interventionparticipants (Number)
Responders, a >= 30% reduction in mean iPTHNon responders
Cinacalcet7479
Control Group42109

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Subject Incidence of Hyperphosphatemia During the Maintenance Phase

Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL (NCT00803712)
Timeframe: Weeks 26-48

Interventionparticipants (Number)
Cinacalcet71
Control Group87

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Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)

All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For participants with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 22-26

,
Interventionparticipants (Number)
Responders defined as >= 30% reduction in Mean PTHNon responders
Cinacalcet9657
Control Group5893

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Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)

All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 22-26 and Weeks 48-52

,
Interventionparticipants (Number)
Responders, a mean corrected calcium < 10.2 mg/dLNon responders
Cinacalcet1458
Control Group13912

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Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)

All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 48-52

,
Interventionparticipants (Number)
Responders, a mean corrected calcium < 10.2 mg/dLNon responders
Cinacalcet1467
Control Group14110

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Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)

All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 22-26

,
Interventionparticipants (Number)
Responders, a mean corrected calcium < 10.2 mg/dLNon responders
Cinacalcet1512
Control Group1447

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Achievement of a Mean iPTH <=300 pg/mL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)

All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 22-26 and Weeks 48-52

,
Interventionparticipants (Number)
Responders, a mean iPTH <= 300 pg/mLNon responders
Cinacalcet5499
Control Group39112

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Summary of Percent Change From Baseline in Serum Phosphorus at Month 6 Efficacy Assessment Phase

All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 22-26

Interventionpercent change (Least Squares Mean)
Cinacalcet-1.79
Control Group3.94

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Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)

All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 22-26

,
Interventionparticipants (Number)
Responders defined as a mean PTH <= 300 pg/mLNon responders
Cinacalcet8766
Control Group5398

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Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)

All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 22-26 and Weeks 48-52

,
Interventionparticipants (Number)
Responders, a mean serum phosphorus < 5.5 mg/dLNon responders
Cinacalcet7182
Control Group6487

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Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)

All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 48-52

,
Interventionparticipants (Number)
Responders, a mean serum phosphorus < 5.5 mg/dLNon responders
Cinacalcet8172
Control Group8071

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Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)

All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 22-26

,
Interventionparticipants (Number)
Responders, a mean phosphorus < 5.5 mg/dLNon responders
Cinacalcet10053
Control Group8566

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Summary of Serum Phosphorus (mg/dL) at Month 6 Efficacy Assessment Phase

All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 22-26

Interventionmg/dL (Least Squares Mean)
Cinacalcet5.11
Control Group5.52

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Summary of Serum Phosphorus (mg/dL) at Month 12 Efficacy Assessment Phase

All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 48-52

Interventionmg/dL (Least Squares Mean)
Cinacalcet5.37
Control Group5.53

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Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)

All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 48-52

,
Interventionparticipants (Number)
Responders defined as a mean PTH <= 300 pg/mLNon responders
Cinacalcet8073
Control Group6784

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Summary of Percent Change From Baseline in Serum Phosphorus at Month 12 Efficacy Assessment Phase

All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 48-52

Interventionpercent change (Least Squares Mean)
Cinacalcet3.21
Control Group4.26

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Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 6 Efficacy Assessment Phase

All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 22-26

Interventionpercent change (Least Squares Mean)
Cinacalcet-34.62
Control Group-9.69

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Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 6 Efficacy Assessment Phase

All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 22-26

Interventionpercent change (Least Squares Mean)
Cinacalcet-5.68
Control Group1.05

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Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 12 Efficacy Assessment Phase

All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 48-52

Interventionpercent change (Least Squares Mean)
Cinacalcet-2.62
Control Group2.37

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Summary of iPTH (pg/mL) at Month 6 Efficacy Assessment Phase

All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 22-26

Interventionpg/mL (Least Squares Mean)
Cinacalcet291.15
Control Group402.11

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Summary of iPTH (pg/mL) at Month 12 Efficacy Assessment Phase

All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 48-52

Interventionpg/mL (Least Squares Mean)
Cinacalcet293.95
Control Group364.79

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Summary of Corrected Serum Calcium (mg/dL) at Month 6 Efficacy Assessment Phase

All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 22-26

Interventionmg/dL (Least Squares Mean)
Cinacalcet8.66
Control Group9.30

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Summary of Corrected Serum Calcium (mg/dL) at Month 12 Efficacy Assessment Phase

All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP. (NCT00803712)
Timeframe: Weeks 48-52

Interventionmg/dL (Least Squares Mean)
Cinacalcet8.95
Control Group9.42

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Part 1: Urinary Excretion of Alendronate

Bioequivalence was demonstrated by measuring the total urinary excretion of alendronate which was determined over a 36-hour period following single dose administration of 70-mg alendronate+5600 International Units (IU) vitamin D combination tablet and 70mg alendronate tablet alone. Urine for each treatment period was collected at -2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose on Days 1 and 2. (NCT00803790)
Timeframe: Day 1-2 across the 36 hour urinary collection period (Periods 1 and 2)

Interventionμg (Least Squares Mean)
Alendronate+Vitamin D Combo133.6
Alendronate132.2

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Part II: AUC (Area Under the Plasma Concentration-time Curve) of Vitamin D

The serum vitamin D pharmacokinetic parameter was calculated following the treatment of 70mg alendronate+5600 IU vitamin D combination tablet and 5600 IU vitamin D tablet on Day 1: area under the plasma concentration-time curve (AUC0-80hr). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period. (NCT00803790)
Timeframe: Day 1 across the 80-hour plasma collection period (Period 1 and 2)

Interventionng*hr/mL (Least Squares Mean)
Alendronate+Vitamin D Combo490.2
Vitamin D518.7

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Part II : Maximum Concentration (Cmax) of Vitamin D

Serum vitamin D pharmacokinetic parameter was calculated for the following: maximum concentration of drug observed in serum (Cmax). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period. (NCT00803790)
Timeframe: Day 1 across the 80-hour plasma collection period (Periods 1 and 2)

Interventionng/ml (Least Squares Mean)
Alendronate+Vitamin D Combo12.2
Vitamin D13.0

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Part 1: The Total Urinary Excretion of Alendronate With Alendronate/Vitamin D Combination Tablet Relative to Alendronate Tablet

Urinary excretion of alendronate was determined over a 36-hour period following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 70 mg alendronate alone tablet. Urine for each treatment period was collected at -2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose. (NCT00806416)
Timeframe: On Day 1 across the 36-hour urinary collection period (Periods 1 and 2).

Interventionmicrograms (μg) (Least Squares Mean)
Alendronate/Vitamin D Combination197.5
Alendronate191.9

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Part II : The Pharmacokinetic Parameters Cmax of Vitamin D in Combination Tablet Relative to Vitamin D Tablet

Serum vitamin D3 pharmacokinetic parameter Cmax (maximum concentration observed in serum) after treatmen on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet. Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose. (NCT00806416)
Timeframe: On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).

Interventionng/mL (Least Squares Mean)
Alendronate/Vitamin D Combination5.9
Vitamin D6.6

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Part II : The Pharmacokinetic Parameters AUC0-120 hr of Vitamin D in Combination Tablet Relative to Vitamin D Tablet

"Serum vitamin D3 pharmacokinetic parameter AUC0-120 hr (area under the serum concentration-time curve) after treatment on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet.~Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose." (NCT00806416)
Timeframe: On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).

Interventionng*hr/mL (Least Squares Mean)
Alendronate/Vitamin D Combination296.4
Vitamin D337.9

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Change in High Density Lipoprotein (HDL) Cholesterol After 12 Weeks of Vitamin D Supplementation

HDL (good) cholesterol protects against heart disease, so for HDL, higher numbers are better. A level less than 40 mg/dL is low and is considered a major risk factor because it increases your risk for developing heart disease. HDL levels of 60 mg/dL or more help to lower your risk for heart disease. (NCT00858247)
Timeframe: baseline, 12 weeks

Interventionmg/dL (Mean)
Vitamin D3-low Dose1.3
Vitamin D3-high Dose1.9

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Change in Insulin Resistance After 12 Weeks of Vitamin D3 Supplementation

"Insulin resistance (IR) is a physiological condition in which cells fail to respond to the normal actions of the hormone insulin. The body produces insulin, but the cells in the body become resistant to insulin and are unable to use it as effectively, leading to hyperglycemia. Beta cells in the pancreas subsequently increase their production of insulin, further contributing to hyperinsulinemia.~From the fasting glucose and insulin measurements, insulin resistance was calculated by the homeostasis model assessment of insulin resistance (HOMA -IR) as: HOMA -IR = fasting insulin concentration (µU/mL) x fasting glucose concentration (mmol/L)/22.5. High HOMA-IR scores denote increased insulin resistance." (NCT00858247)
Timeframe: Baseline, 12 weeks

InterventionHOMA score (Mean)
Vitamin D3-low Dose0.01
Vitamin D3-high Dose-0.27

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Change in Low Density Lipoprotein (LDL) Cholesterol After 12 Weeks of Vitamin D Supplementation

LDL cholesterol is considered to be the main source of cholesterol buildup and blockage in the arteries. Less than 100 mg/dL is optimal, >130 mg/dL is borderline high, >160 mg/dL is high, >190 mg/dL is very high. (NCT00858247)
Timeframe: baseline, 12 weeks

Interventionmg/dL (Mean)
Vitamin D3-low Dose4.6
Vitamin D3-high Dose1.3

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Change in Total Cholesterol After 12 Weeks of Vitamin D Supplementation

Less than 200 mg/dL is desirable, >200 mg/dL is borderline high, >240 mg/dL is High (NCT00858247)
Timeframe: baseline, 12 weeks

Interventionmg/dL (Mean)
Vitamin D3-low Dose4.7
Vitamin D3-high Dose3.5

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Change in Triglycerides After 12 Weeks of Vitamin D Supplementation

The current recommendation on fasting blood triglyceride levels: < 150 mg/dL is normal, >150 mg/dL is borderline high, and >200 mg/dL is high. (NCT00858247)
Timeframe: baseline, 12 weeks

Interventionmg/dL (Mean)
Vitamin D3-low Dose-4.7
Vitamin D3-high Dose1.7

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Change in High-Sensitivity C-Reactive Protein After 12 Weeks of Vitamin D Supplementation

The high-sensitivity C-reactive protein test measures your risk for heart problems. <1.0 mg/L is lowest risk, 1.0-3.0 mg/L is average risk, and >3.0 mg/L is highest risk. (NCT00858247)
Timeframe: baseline, 12 weeks

Interventionmg/L (Mean)
Vitamin D3-low Dose-0.2
Vitamin D3-high Dose-0.5

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Change in Serum 25(OH)D

25(OH)D level at the end of one year intervention (NCT00859651)
Timeframe: Baseline to 1 year

Interventionng/ml (Mean)
Cholecalciferol 20,000 IU Group25
Cholecalciferol 30,000 IU Group33

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Change in Percent Density

Assessed by mammography and breast MRI. (NCT00859651)
Timeframe: Baseline to 1 year

Interventionpercentage of breast density (Mean)
Cholecalciferol 20,000 IU Group3
Cholecalciferol 30,000 IU Group1

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Number of Participants With Worsening of Musculoskeletal Symptoms (MS)

Worsening of Musculoskeletal Symptoms (MS) is defined as any one of the following three events: (a) an increase by at least 0.25 in the Health Assessment Questionnaire II (HAQ II, a measure of disability from joint pain) score, (b) an increase in patient reported severity of joint and/or muscle pain, or (c) discontinuation from trial prior to 24 weeks specifically because of problems with musculoskeletal symptoms. (NCT00867217)
Timeframe: Change from Baseline to 24 Weeks

,
Interventionparticipants (Number)
HAQ II increase by 0.25Subjective Pain increaseDiscontinuation due to AEsAny of the three measures
Placebo2324339
Vitamin D1818026

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Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 12

BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 12. (NCT00885170)
Timeframe: Baseline and 12 Months

InterventionPercent Change (Least Squares Mean)
Odanacatib 50 mg-0.11
Placebo-0.49

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Percent Change From Baseline in Log-Transformed Serum C-Telopeptides of Type I Collagen (s-CTx) at Month 24

s-CTx is a biochemical marker of bone resorption. (NCT00885170)
Timeframe: Baseline and Month 24

InterventionPercent change (Least Squares Mean)
Odanacatib 50 mg93.86
Placebo83.70

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Percentage of Participants Discontinuing Study Drug Due to an AE

An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. (NCT00885170)
Timeframe: Up to 24 months

InterventionPercentage of participants (Number)
Odanacatib 50 mg9.0
Placebo3.3

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Percent Change From Baseline in Trochanter BMD at Month 24

BMD at the trochanter was assessed by DXA at baseline and Month 24. (NCT00885170)
Timeframe: Baseline and 24 Months

InterventionPercent Change (Least Squares Mean)
Odanacatib 50 mg1.83
Placebo-1.35

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Percent Change From Baseline in Trochanter BMD at Month 12

BMD at the trochanter was assessed by DXA at baseline and Month 12. (NCT00885170)
Timeframe: Baseline and 12 Months

InterventionPercent Change (Least Squares Mean)
Odanacatib 50 mg0.86
Placebo-0.14

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Percent Change From Baseline in Total Hip BMD at Month 24

BMD at the total hip was assessed by DXA at baseline and Month 24. (NCT00885170)
Timeframe: Baseline and 24 Months

InterventionPercent Change (Least Squares Mean)
Odanacatib 50 mg0.83
Placebo-1.87

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Percent Change From Baseline in Total Hip BMD at Month 12

BMD at the total hip was assessed by DXA at baseline and Month 12. (NCT00885170)
Timeframe: Baseline and 12 Months

InterventionPercent Change (Least Squares Mean)
Odanacatib 50 mg0.26
Placebo-0.80

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Percent Change From Baseline in Lumbar Spine BMD at Month 24

BMD at the lumbar spine was assessed by DXA at baseline and Month 24. (NCT00885170)
Timeframe: Baseline and 24 Months

InterventionPercent Change (Least Squares Mean)
Odanacatib 50 mg2.28
Placebo-0.30

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Percent Change From Baseline in Lumbar Spine BMD at Month 12

BMD at the lumbar spine was assessed by DXA at baseline and Month 12. (NCT00885170)
Timeframe: Baseline and 12 Months

InterventionPercent Change (Least Squares Mean)
Odanacatib 50 mg0.69
Placebo-0.12

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Percent Change From Baseline in Log-Transformed Urine N-Telopeptides/Creatinine Ratio at Month 24

N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (u-NTx/Cr) is a biochemical marker of bone resorption. (NCT00885170)
Timeframe: Baseline and Month 24

InterventionPercent change (Least Squares Mean)
Odanacatib 50 mg-15.55
Placebo31.48

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Percent Change From Baseline in Log-Transformed u-NTx/Cr at Month 12

u-NTx/Cr is a biochemical marker of bone resorption. (NCT00885170)
Timeframe: Baseline and Month 12

InterventionPercent change (Least Squares Mean)
Odanacatib 50 mg-17.23
Placebo29.06

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Percent Change From Baseline in Log-Transformed Serum Phosphate at Month 24

Serum phosphate is an index of mineral homeostasis. (NCT00885170)
Timeframe: Baseline and Month 24

InterventionPercent Change (Least Squares Mean)
Odanacatib 50 mg2.37
Placebo0.99

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Percent Change From Baseline in Log-Transformed Serum Parathyroid Hormone at Month 24

Serum parathyroid hormone (SPH) regulates calcium, phosphorus, and vitamin D levels in the blood. (NCT00885170)
Timeframe: Baseline and Month 24

InterventionPercent Change (Least Squares Mean)
Odanacatib 50 mg4.38
Placebo10.28

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Percent Change From Baseline in Log-Transformed Serum N-Terminal Propeptide of Type I Collagen at Month 24

Serum N-terminal propeptide of Type I collagen (s-P1NP) is a biochemical marker of bone formation. (NCT00885170)
Timeframe: Baseline and Month 24

InterventionPercent change (Least Squares Mean)
Odanacatib 50 mg90.70
Placebo59.53

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Percent Change From Baseline in Log-Transformed Serum N-terminal Propeptide of Type I Collagen at Month 12

s-P1NP is a biochemical marker of bone formation. (NCT00885170)
Timeframe: Baseline and Month 12

InterventionPercent change (Least Squares Mean)
Odanacatib 50 mg80.37
Placebo56.37

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Percent Change From Baseline in Log-Transformed Serum Calcium at Month 24

Serum calcium is an index of calcium homeostasis. (NCT00885170)
Timeframe: Baseline and Month 24

InterventionPercent Change (Least Squares Mean)
Odanacatib 50 mg-2.40
Placebo-2.51

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Percentage of Participants Experiencing One or More Adverse Events (AEs)

An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. (NCT00885170)
Timeframe: Up to 25 months

InterventionPercentage of participants (Number)
Odanacatib 50 mg68.0
Placebo73.6

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Percent Change From Baseline in Log-Transformed Serum BSAP at Month 12

BSAP is a biochemical marker of bone formation. (NCT00885170)
Timeframe: Baseline and Month 12

InterventionPercent change (Least Squares Mean)
Odanacatib 50 mg30.91
Placebo18.10

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Percent Change From Baseline in Log-Transformed Serum Bone-Specific Alkaline Phosphatase at Month 24

Bone-Specific Alkaline Phosphatase (BSAP) is a biochemical marker of bone formation. (NCT00885170)
Timeframe: Baseline and Month 24

InterventionPercent change (Least Squares Mean)
Odanacatib 50 mg51.62
Placebo40.65

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Percent Change From Baseline in Log-Transformed Serum 25-Hydroxyvitamin D at Month 24

The 25-hydroxy vitamin D [25(OH)D] test is the most accurate way to measure vitamin D. In the kidney, 25-hydroxy vitamin D is converted into 1,25 di-hydroxyvitamin D, the active vitamin D metabolite. (NCT00885170)
Timeframe: Baseline and Month 24

InterventionPercent Change (Least Squares Mean)
Odanacatib 50 mg-2.57
Placebo0.57

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Percent Change From Baseline in Log-Transformed Serum 1,25 Dihydroxyvitamin D at Month 24

1,25 dihydroxyvitamin D [1,25(OH)2 D] is the active vitamin D metabolite and stimulates calcium absorption in the intestine. (NCT00885170)
Timeframe: Baseline and Month 24

InterventionPercent Change (Least Squares Mean)
Odanacatib 50 mg-5.23
Placebo-6.71

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Percent Change From Baseline in Log-Transformed s-CTx at Month 12

s-CTx is a biochemical marker of bone resorption. (NCT00885170)
Timeframe: Baseline and Month 12

InterventionPercent change (Least Squares Mean)
Odanacatib 50 mg62.27
Placebo68.09

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Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24

BMD at the femoral neck was assessed by dual-energy X-ray absorptiometry (DXA) at baseline and Month 24. (NCT00885170)
Timeframe: Baseline and Month 24

InterventionPercent Change (Least Squares Mean)
Odanacatib 50 mg1.73
Placebo-0.94

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Percent Change From Baseline in Femoral Neck BMD at Month 12

BMD at the femoral neck was assessed by DXA at baseline and Month 12. (NCT00885170)
Timeframe: Baseline and 12 Months

InterventionPercent Change (Least Squares Mean)
Odanacatib 50 mg0.60
Placebo-0.28

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Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 24

BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 24. (NCT00885170)
Timeframe: Baseline and 24 Months

InterventionPercent Change (Least Squares Mean)
Odanacatib 50 mg-0.92
Placebo-1.14

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Serum 25-hydroxyvitamin D Concentrations in Schoolchildren

Baseline and Follow-up 25(OH)D3 by liquid chromatography-tandem mass spectrometry (NCT00886379)
Timeframe: Blood was analyzed at day 0 and day 49

,,,,
Interventionng/ml (Mean)
Blood concentration on Day 0Blood concentration on Day 49
Daily Vitamin D Supplements721
Fortified Mongolian Milk820
Fortified UHT Milk1029
Seasonal Vitamin D Supplements812
Unfortified Mongolain Milk88

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PSA Response

"Difference in the mean change in PSA on vitamin D (9 month period: pre-Vitamin D to 9 months after start of vitamin D) versus on placebo (9 month period: pre-Placebo to 9 months after starting placebo).~Compared using a paired t-test." (NCT00887432)
Timeframe: 9 month period: pre-Vitamin D/pre-placebo to 9 months after start of vitamin D/ placebo, up to 30 days after completion of study treatment

Interventionng/mL (Mean)
Cholecalciferol0.55
Placebo0.31

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Slope of PSA Concentration Over Time

The PSA levels were modeled as a function of treatment, time, their interaction, sequence, and a random subject effect using a linear mixed model. From this model, the subject specific PSA slope was obtained for each subject under each condition (vitamin D versus placebo). The PSA slopes were then compared between treatment conditions using linear mixed model to account for treatment arm and repeated measures. (NCT00887432)
Timeframe: 9 month period: pre-Vitamin D/pre-placebo to 9 months after start of vitamin D/ placebo, up to 30 days after completion of study treatment -Up to 30 days after completion of study treatment

Intervention(ng/mL) / day (Least Squares Mean)
Cholecalciferol0.000434
Placebo0.000245

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Serum 25D Level

(NCT00892099)
Timeframe: 12 weeks

Interventionng/ml (Mean)
High Dose Ergocalciferol49.8
Low Dose Ergocalciferol38.3
Placebo27.3

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Serum Calcium

serum calcium levels (mg/dL) (NCT00892099)
Timeframe: every 4 weeks for 12 weeks

,,
Interventionmg/dl (Mean)
Visit 1Visit 2Visit 3Visit 4
High Dose Ergocalciferol8.89.19.39.1
Low Dose Ergocalciferol8.78.99.19.1
Placebo8.89.09.39.1

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Serum 25-OH Vitamin D

serum 25-OH vitamin D levels (ng/mL) (NCT00892099)
Timeframe: every 4 weeks for 12 weeks

,,
Interventionng/mL (Mean)
Visit 1Visit 2Visit 3Visit 4
High Dose Ergocalciferol21.842.248.949.8
Low Dose Ergocalciferol21.733.635.638.3
Placebo22.327.62727.4

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Serum 1,25(OH)2 Levels

serum 1,25(OH) vitamin D levels (pg/mL) (NCT00892099)
Timeframe: At week 12

Interventionpg/mL (Median)
High Dose Ergocalciferol95
Low Dose Ergocalciferol100
Placebo120

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Parathyroid Hormone

serum PTH levels (pg/mL) (NCT00892099)
Timeframe: every 4 weeks for 12 weeks

,,
Interventionpg/mL (Mean)
Visit 1Visit 2Visit 3Visit 4
High Dose Ergocalciferol281253255245
Low Dose Ergocalciferol214195195216
Placebo243243196215

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Serum Phosphate

serum phosphate levels (mmol/L) (NCT00892099)
Timeframe: every 4 weeks for 12 weeks

,,
Interventionmmol/L (Mean)
Visit 1Visit 2Visit 3Visit 4
High Dose Ergocalciferol4.24.74.94.7
Low Dose Ergocalciferol4.24.75.25.4
Placebo4.14.854.9

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Change in Bone Mineral Density (BMD) at HIP at 3 Months

(NCT00903344)
Timeframe: Change from Baseline to 3 months

Interventiongrams/cm^2 (Mean)
Vitamin D - Experimental-0.017
Multivitamin - Active Comparator-0.016

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Change in Bone Mineral Density (BMD) in HIP at 6 Months

(NCT00903344)
Timeframe: Change from Baseline to 6 months

Interventiongrams/cm^2 (Mean)
Vitamin D - Experimental-0.041
Multivitamin - Active Comparator0.011

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Change in 25-hyroxyvitamin D Levels at 3 Months

Difference in means between visits (NCT00903344)
Timeframe: Change from Baseline to 3 Months

Interventionng/ml (Mean)
Vitamin D - Experimental2.600
Multivitamin - Active Comparator-5.850

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Change in 25-hyroxyvitamin D Levels at 6 Months

(NCT00903344)
Timeframe: Change from Baseline to 6 Months

Interventionng/ml (Mean)
Vitamin D - Experimental1.889
Multivitamin - Active Comparator-3.200

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Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months

difference in mean (NCT00903344)
Timeframe: Change from Baseline to 3 Months

Interventiongrams/cm^2 (Mean)
Vitamin D - Experimental-0.025
Multivitamin - Active Comparator-0.025

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Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months

difference in the mean (NCT00903344)
Timeframe: Change from Baseline to 6 Months

Interventiongrams/cm^2 (Mean)
Vitamin D - Experimental-0.060
Multivitamin - Active Comparator-0.109

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Arteriovenous Fistulae Maturation

Maturation of an AVF is the ability to stick the AVF with two large bore needles at ≥ 6 consecutive dialysis sessions, and achievement of an AVF blood flow >300 ml/min, assessed at six months following AVF creation. (NCT00912782)
Timeframe: 6 months

Interventionpercentage of group (Number)
Placebo50
Cholecalciferol40

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25-hydroxyvitamin D and Serum Calcium

(NCT00912782)
Timeframe: 10 weeks

,
Interventionng/mL (Mean)
Serum 25 (OH) DSerum Calcium
Cholecalciferol53.48.8
Placebo18.49.1

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Change in Blood Level of Vitamin D (25-hydroxyvitamin D)

(NCT00914810)
Timeframe: Baseline and 6 weeks

Interventionng/mL (Mean)
Placebo-1.8
Vitamin D8.7

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Change in Short Physical Performance Battery (SPPB) Score

SPPB measures lower extremity strength using 3 simple office-based tests to assess standing balance, gait speed, and chair stands. The composite SPPB score ranges from 0 (worst performance) to 12 (best performance). The minimal clinically important difference is not fully agreed upon, although a difference of 1.0 point has been used in many studies. (NCT00914810)
Timeframe: Baseline and 6 weeks

Interventionunits on a scale (Mean)
Placebo0.6
Vitamin D0.9

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Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 1 Year Visit.

Child serum 25-hydroxyvitamin D measurement from blood collection at 1 year visit. (NCT00920621)
Timeframe: 1 year visit

Interventionng/mL (Mean)
Vitamin D Treatment29.3
Placebo30.1

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Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 3 Year Visit.

Child serum 25-hydroxyvitamin D measurement from blood collection at 3 year visit. (NCT00920621)
Timeframe: Blood collection at childs' 3 year visit.

Interventionng/mL (Mean)
Vitamin D Treatment21.3
Placebo21.5

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Mass Spec Vitamin D Value From Cord Blood at Delivery

Mass Spec Vitamin D value from cord blood at delivery (NCT00920621)
Timeframe: Blood collection at delivery

Interventionng/mL (Mean)
Vitamin D Treatment28.2
Placebo19.1

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Parental Report of Physician Diagnosis of Lower Respiratory Tract Infection in the Child's First 3 Years of Life.

Parental report of physician diagnosis of lower respiratory tract infection (LRI) in the child's first 3 years of life. LRI defined as physician diagnosed bronchitis, bronchiolitis, croup, or pneumonia ascertained from questionnaires administered every 3 months. (NCT00920621)
Timeframe: Child's first 3 years of life.

InterventionNumber of lower respiratory infections (Number)
Vitamin D Treatment222
Placebo276

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Fecal Microbiome Profile

We extracted DNA and sequenced the bacterial 16S V4 hyper-variable region. The average number of 16S region reads sequenced per participant is provided here. Prior evidence suggests that read counts of at least 1,000 are adequate for 16S fecal microbiome profiling (Reference: Momozawa Y, et cal. Characterization of bacteria in biopsies of colon and stools by high throughput sequencing of the V2 region of bacterial 16S rRNA gene in human. PLoS One. 2011 Feb 10;6(2):e16952.) (NCT00920621)
Timeframe: Mother at 32-38 weeks gestation, Child's first 6 years of life

,
Interventionread counts (Mean)
Mother at 32-38 weeks gestationChild at 3-6 monthsChild at 1 yearChild at 3 yearsChild at 4 yearsChild at 5 yearsChild at 6 years
Placebo10773140241163512407000
Vitamin D Treatment10787134431170912095000

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Sphingolipid Profile

Mass spec measured relative abundance of five metabolites of the sphingolipid metabolism pathway in plasma samples extracted at the year one visit. (NCT00920621)
Timeframe: 1 year

,
Interventionrelative abundance (no units) (Mean)
sphinganine-1-phosphatesphinganinephosphoethanolaminesphingosinesphingosine-1-phosphate
Placebo0.320.310.340.330.32
Vitamin D Treatment0.320.330.330.340.31

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Sphingolipid Profile

Mass spec measured relative abundance of five metabolites of the sphingolipid metabolism pathway in plasma samples extracted at the year three visit. (NCT00920621)
Timeframe: 3 years

,
Interventionrelative abundance (no units) (Mean)
sphinganine-1-phosphatesphinganinephosphoethanolaminesphingosinesphingosine-1-phosphate
Placebo0.320.370.300.370.30
Vitamin D Treatment0.340.390.310.380.31

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Child Positive-specific IgE Tests From Blood Collection at 3 Year Visit.

Child positive-specific IgE tests from blood collection at 3 year visit. (NCT00920621)
Timeframe: 3 years

InterventionPositive-specific IgE tests (Number)
Vitamin D Treatment414
Placebo452

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Bone Mineral Density

Annualized percent change in bone mineral density at spine, hip, femoral neck, and body (NCT00933244)
Timeframe: 1 Year

,,
InterventionPercent Change in Bone Mineral Density (Mean)
Annualized Percent Change in BMD at SpineAnnualized Percent Change in Total Hip BMDAnnualized Percent Change in Femoral Neck BMDAnnualized Percent Change in Total Body BMD
High Dose Vitamin D-0.3-0.2-0.3-0.4
Low Dose Vitamin D0.0-0.5-0.9-0.5
Placebo0.2-0.9-0.8-0.5

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Muscle Function: One Year Change in Timed Up and Go Test, Five Sit-to-Stand Test

We summarized within-arm one-year changes in continuous muscle outcomes using the mean (95% confidence interval). (NCT00933244)
Timeframe: 1 Year

,,
Interventionseconds (Mean)
One Year Change in Timed Up and Go Test (seconds)One Year Change in Five Sit-to-Stand Test (sec)
High Dose Vitamin D-0.38-1.04
Low Dose Vitamin D-0.44-0.98
Placebo-0.35-0.55

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Intestinal Calcium Absorption

Percent of calcium absorbed in the intestinal tract within one day (NCT00933244)
Timeframe: One Year

,,
InterventionTotal Fractional Calcium Absorption (Median)
BaselineOne Year
High Dose Vitamin D0.2000.206
Low Dose Vitamin D0.2170.172
Placebo0.1830.174

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Bone Turnover

C-telopeptide (pg/mL) was measured at baseline, 30 days, 60 days, 120 days, 365 days in the subset of subjects who arrived at all study visit fasting since midnight and had phlebotomy prior to 10 am. Data demonstrated outliers and was summarized using the median (25th, 75th interquartile range). (NCT00933244)
Timeframe: 0, 30, 60, 120, 365 days

,,
Interventionpg/mL (Median)
C-telopeptide (pg/mL) at BaselineC-telopeptide (pg/mL) at 30 daysC-telopeptide (pg/mL) at 60 daysC-telopeptide (pg/mL) at 120 daysC-telopeptide (pg/mL) at 365 days
High Dose Vitamin D812012
Low Dose Vitamin D971-1-10
Placebo980-1-20

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Number of Positive Biopsy Cores (Out of Twelve) Compared to the Corresponding Values Assessed Before Enrollment

Change in the number of positive cores per subject from the pre-study prostate biopsy to the repeat prostate biopsy following study participation. (NCT00953225)
Timeframe: 1 year

Interventioncores per subject (Median)
Vitamin D3-1.00
Placebo0.00

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PSA Slope (Trajectory) or the Change in PSA Level Over Time

Change in PSA (ng/mL) from baseline to 1 year visit, which include the baseline through 1 year follow-up. (NCT00953225)
Timeframe: 1 year (visits # 1-8)

Interventionng/mL (Median)
Vitamin D30.59
Placebo0.27

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Serum Total Calcium

Serum total calcium (mg/dL) at time points 0, 1, 3 and 6 months (NCT00956839)
Timeframe: 0, 1, 3, 6 months post intervention

,,
Interventionmg/dL (Mean)
baseline1 month3 months6 months
IM Vitamin D3 3,00,000 Units9.209.289.409.40
IM Vitamin D3 6,00,000 Units9.569.529.449.40
Oral Vitamin D39.249.289.409.28

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Percentage of Patients With Serum 25 Hydroxy Vitamin D3 > 30 ng/ml

Percentage of patients in each group with serum 25 hydroxy vitamin D >30 ng/ml (NCT00956839)
Timeframe: 6 months post intervention

Interventionpercentage of patients (Number)
IM Vitamin D3 3,00,000 Units85
IM Vitamin D3 6,00,000 Units29
Oral Vitamin D30

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Percentage of Participants With Bone Neoplasms

"Evidence of bone neoplasm(s) was considered an event of interest and was prespecified as a Tier 1 safety event." (NCT00960934)
Timeframe: Baseline through Month 6

InterventionPercentage of participants (Number)
MK-5442 2.5 mg0.0
MK-5442 5 mg0.0
MK-5442 7.5 mg0.0
MK-5442 10 mg0.0
MK-5442 15 mg0.0
Placebo0.0

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Percentage of Participants With Albumin-Corrected Calcium Levels Outside the Pre-defined Limits of Change

"Albumin-Corrected Calcium = ([4 - plasma albumin in g/dL] × 0.8 + serum calcium).~≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with albumin-corrected calcium levels ≥10.6 mg/dL were considered as having a Tier 1 safety event." (NCT00960934)
Timeframe: Baseline through Month 6

InterventionPercentage of participants (Number)
MK-5442 2.5 mg0.0
MK-5442 5 mg9.7
MK-5442 7.5 mg18.8
MK-5442 10 mg37.5
MK-5442 15 mg49.2
Placebo1.6

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LS Mean Percent Change From Baseline to Month 6 in Serum Procollagen Type I N-Terminal Propeptide (P1NP)

Measurement of P1NP appears to be a sensitive marker of bone formation rate in the assessment of osteoporosis. (NCT00960934)
Timeframe: Baseline to Month 6

Interventionpercent change (Least Squares Mean)
MK-5442 2.5 mg-9.97
MK-5442 5 mg-9.76
MK-5442 7.5 mg2.33
MK-5442 10 mg21.30
MK-5442 15 mg38.41
Placebo-18.36

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LS Mean Percent Change From Baseline to Month 6 in Serum Osteocalcin

Serum osteocalcin is a biomarker of bone formation and is measured using units of nanograms (ng) / milliliter (mL). (NCT00960934)
Timeframe: Baseline and Month 6

Interventionpercent change (Least Squares Mean)
MK-5442 2.5 mg-11.61
MK-5442 5 mg-2.75
MK-5442 7.5 mg9.18
MK-5442 10 mg25.79
MK-5442 15 mg37.43
Placebo-15.62

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LS Mean Percent Change From Baseline to Month 6 in Serum C-Terminal Telopeptide Collagen I (s-CTx)

C-Terminal Telopeptide Collagen I is used as a serum-marker of bone resorption in the assessment of osteoporosis. (NCT00960934)
Timeframe: Baseline to Month 6

Interventionpercent change (Least Squares Mean)
MK-5442 2.5 mg-15.39
MK-5442 5 mg-5.87
MK-5442 7.5 mg-4.93
MK-5442 10 mg5.68
MK-5442 15 mg19.37
Placebo-14.89

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Percentage of Participants With Total Serum Calcium Levels Outside the Pre-defined Limits of Change

"Normal serum calcium level is 8-10 mg/dL (2-2.5 mmol/L) with some interlaboratory variation in the reference range, and hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL (>2.5 mmol/L).~Based on these references, ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with calcium levels ≥10.6 mg/dL were considered as having a Tier 1 safety event." (NCT00960934)
Timeframe: Baseline through Month 6

InterventionPercentage of participants (Number)
MK-5442 2.5 mg7.8
MK-5442 5 mg32.3
MK-5442 7.5 mg32.8
MK-5442 10 mg56.3
MK-5442 15 mg73.0
Placebo3.2

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LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Lumbar Spine

Quantitative computed tomography (QCT) technology was used at baseline and periodically through out the study to assess and measure bone mineral content volumetrically (ie, in grams of tissue per centimeter of tissue cubed). (NCT00960934)
Timeframe: Baseline and Month 6

Interventionpercent change (Least Squares Mean)
MK-5442 2.5 mg1.94
MK-5442 5 mg0.94
MK-5442 7.5 mg1.83
MK-5442 10 mg3.35
MK-5442 15 mg1.06
Placebo1.43

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LS Mean Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (s-BSAP)

Bone Specific Alkaline Phosphatase is a biomarker of bone formation and is measured in units of microgram (μg)/liter (L). (NCT00960934)
Timeframe: Baseline and Month 6

Interventionpercent change (Least Squares Mean)
MK-5442 2.5 mg-0.60
MK-5442 5 mg0.26
MK-5442 7.5 mg4.39
MK-5442 10 mg17.33
MK-5442 15 mg13.13
Placebo-6.05

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LS Mean Percent Change From Baseline to Month 6 in Femoral Neck aBMD

"DXA was used to assess and measure aBMD of the femoral neck. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)." (NCT00960934)
Timeframe: Baseline and Month 6

Interventionpercent change (Least Squares Mean)
MK-5442 2.5 mg1.23
MK-5442 5 mg-0.52
MK-5442 7.5 mg0.12
MK-5442 10 mg-0.20
MK-5442 15 mg0.54
Placebo-0.04

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Least Squares (LS) Mean Percent Change From Baseline to Month 6 in Lumbar Spine Areal Bone Mineral Density (aBMD)

"Dual Energy X-ray Absorptiometry (DXA) was used to assess and measure aBMD of the lumbar spine. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)." (NCT00960934)
Timeframe: Baseline (BL) and Month 6

Interventionpercent change (Least Squares Mean)
MK-5442 2.5 mg0.74
MK-5442 5 mg1.50
MK-5442 7.5 mg0.92
MK-5442 10 mg1.69
MK-5442 15 mg1.13
Placebo0.57

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LS Mean Percent Change From Baseline to Month 6 in Trochanter aBMD

"DXA was used to assess and measure aBMD of the trochanter. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)." (NCT00960934)
Timeframe: Baseline and Month 6

Interventionpercent change (Least Squares Mean)
MK-5442 2.5 mg0.41
MK-5442 5 mg0.95
MK-5442 7.5 mg0.54
MK-5442 10 mg0.49
MK-5442 15 mg1.10
Placebo0.49

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LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Hip

Quantitative computed tomography (QCT) technology was used to assess and measure bone mineral content volumetrically (ie, in grams of tissue per centimeter of tissue cubed). (NCT00960934)
Timeframe: Baseline and Month 6

Interventionpercent change (Least Squares Mean)
MK-5442 2.5 mg-0.41
MK-5442 5 mg-0.34
MK-5442 7.5 mg-0.89
MK-5442 10 mg-0.88
MK-5442 15 mg-0.80
Placebo-0.37

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Percentage of Participants With Kidney Stones

"Evidence of kidney stone(s) was considered an event of interest and was prespecified as a Tier 1 safety event." (NCT00960934)
Timeframe: Baseline through Month 6

InterventionPercentage of participants (Number)
MK-5442 2.5 mg1.6
MK-5442 5 mg1.6
MK-5442 7.5 mg0.0
MK-5442 10 mg0.0
MK-5442 15 mg0.0
Placebo0.0

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LS Mean Percent Change From Baseline to Month 6 in Total Hip aBMD

"DXA was used to assess and measure aBMD of the total hip. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)." (NCT00960934)
Timeframe: Baseline and Month 6

Interventionpercent change (Least Squares Mean)
MK-5442 2.5 mg-0.20
MK-5442 5 mg-0.32
MK-5442 7.5 mg0.32
MK-5442 10 mg0.07
MK-5442 15 mg0.33
Placebo0.08

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LS Mean Percent Change From Baseline to Month 6 in Total Body aBMD

"DXA was used to assess and measure aBMD of the total body. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)." (NCT00960934)
Timeframe: Baseline and Month 6

Interventionpercent change (Least Squares Mean)
MK-5442 2.5 mg0.43
MK-5442 5 mg0.28
MK-5442 7.5 mg0.80
MK-5442 10 mg0.21
MK-5442 15 mg0.09
Placebo0.27

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LS Mean Percent Change From Baseline to Month 6 in the Ratio of Urinary N-Telopeptides of Type I Collagen to Creatinine (u-NTx/Cr)

The ratio of u-NTx to Cr is a biomarker for bone resorption. It is measured in the serum in units of nanomoles (nm) of bone collagen equivalents (BCE)/millimoles of creatinine (Cr). (NCT00960934)
Timeframe: Baseline and Month 6

Interventionpercent change (Least Squares Mean)
MK-5442 2.5 mg-12.18
MK-5442 5 mg-9.46
MK-5442 7.5 mg-20.73
MK-5442 10 mg-7.82
MK-5442 15 mg1.87
Placebo-17.90

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Least Squares Mean Percent Change From Baseline to Month 12 in Serum N-Terminal Propeptide (s-P1NP)

s-P1NP is a sensitive marker of bone formation rate in the assessment of osteoporosis and is measured in units of ng/ml. (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo68.61
MK-5442 5 mg127.18
MK-5442 7.5 mg125.69
MK-5442 10 mg163.96
Alendronate 70 mg-5.85

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Least Squares Mean Percent Change From Baseline to Month 12 in Total Body Areal BMD

"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm" (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo-0.17
MK-5442 5 mg-0.54
MK-5442 7.5 mg-0.69
MK-5442 10 mg-1.10
Alendronate 70 mg0.82

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Number of Participants With Trough Serum Calcium Level Exceeding Predefined Limits At Least Once

"Normal serum calcium level is 8-10 mg/dL (2-2.5 mmol/L) with some interlaboratory variation in the reference range, and hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL (>2.5 mmol/L).~Based on these references, ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with at least a one calcium level value ≥10.6 mg/dL were considered as having a Tier 1 adverse event (AE). A Tier 1 AE was an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons." (NCT00996801)
Timeframe: Baseline through Month 12

,,,,,
InterventionParticipants (Number)
≥10.6 ng/mL≥11.1 ng/mL≥12.1 ng/mL
Alendronate 70 mg710
MK-5442 10 mg2771
MK-5442 15 mg39191
MK-5442 5 mg1610
MK-5442 7.5 mg1940
Placebo310

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Number of Participants With Predefined Tier 1 Adverse Events

Osteonecrosis of the jaw (ONJ), kidney stones, and bone neoplasms were predefined Tier-1 AEs in the study (an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons). (NCT00996801)
Timeframe: Baseline through Month 12

,,,,,
InterventionParticipants (Number)
Osteonecrosis of the jawKidney stonesBone neoplasms
Alendronate 70 mg010
MK-5442 10 mg000
MK-5442 15 mg000
MK-5442 5 mg000
MK-5442 7.5 mg000
Placebo030

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Least Squares Mean Percent Change From Baseline to Month 12 in Urinary-N Telopeptides of Type 1 Collagen (u-NTx)

"Urinary, type I collagen, crosslinked N-telopeptide (uNTx) is a biomarker used to measure the rate of bone turnover found in urine.~uNTx was expressed in units of nanomoles (nM) per bone collagen equivalents (BCE) per millimoles of creatinine (Cr) or nM/BCE/mM Cr" (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo63.64
MK-5442 5 mg86.51
MK-5442 7.5 mg83.32
MK-5442 10 mg107.44
Alendronate 70 mg0.18

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Least Squares Mean Percent Change From Baseline to Month 12 in Trochanter Areal BMD

"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm" (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo-0.30
MK-5442 5 mg-1.56
MK-5442 7.5 mg-1.50
MK-5442 10 mg-1.52
Alendronate 70 mg1.68

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Least Squares Mean Percent Change From Baseline to Month 12 in Trabecular Volumetric BMD of the Hip

vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3. (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo-0.02
MK-5442 5 mg0.76
MK-5442 7.5 mg0.81
MK-5442 10 mg0.27
Alendronate 70 mg1.23

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Least Squares Mean Percent Change From Baseline to Month 12 in Serum C-Terminal Propeptide of Type 1 Collagen (s-CTx)

C-Terminal Telopeptide Collagen I is used as a serum-marker of bone resorption in the assessment of osteoporosis and in measured in units of nanograms (n)/milliliter (ml). (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo165.80
MK-5442 5 mg214.09
MK-5442 7.5 mg227.07
MK-5442 10 mg251.08
Alendronate 70 mg26.78

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Least Squares Mean Percent Change From Baseline to Month 12 in Trabecular Volumetric BMD (vBMD) of the Lumbar Spine

vBMD was measured using quantitative computed tomography (QCT) in order to assess bone strength. Quantitative computed tomography is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3. (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo0.18
MK-5442 5 mg-0.25
MK-5442 7.5 mg0.08
MK-5442 10 mg0.16
Alendronate 70 mg1.74

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Least Squares Mean Percent Change From Baseline to Month 12 in 1/3 Distal Forearm Areal BMD

"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm" (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo-0.54
MK-5442 5 mg-1.38
MK-5442 7.5 mg-0.92
MK-5442 10 mg-2.01
Alendronate 70 mg-0.91

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Least Squares Mean Percent Change From Baseline To Month 12 in Lumbar Spine Areal Bone Mineral Density (BMD)

"Areal bone mineral density (BMD) was measured using dual-energy X-ray absorptiometry (DXA) scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm" (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo-0.36
MK-5442 5 mg-0.67
MK-5442 7.5mg-0.52
MK-5442 10 mg-0.53
Alendronate 70 mg1.29

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Least Squares Mean Percent Change From Baseline to Month 12 in Femoral Neck Areal BMD

"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm" (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo-1.26
MK-5442 5 mg-2.12
MK-5442 7.5 mg-1.37
MK-5442 10 mg-1.84
Alendronate 70 mg-0.08

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Least Squares Mean Percent Change From Baseline to Month 12 in Cortical Volumetric BMD of the Lumbar Spine

vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3. (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo-0.67
MK-5442 5 mg-3.41
MK-5442 7.5 mg14.66
MK-5442 10 mg-0.34
Alendronate 70 mg12.80

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Least Squares Mean Percent Change From Baseline to Month 12 in Cortical Volumetric BMD of the Hip

vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3. (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo0.10
MK-5442 5 mg-0.49
MK-5442 7.5 mg-0.15
MK-5442 10 mg-0.16
Alendronate 70 mg0.99

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Least Squares Mean Percent Change From Baseline to Month 12 in Total Hip Areal BMD

"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm" (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo-1.44
MK-5442 5 mg-2.18
MK-5442 7.5 mg-2.16
MK-5442 10 mg-1.66
Alendronate 70 mg0.46

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Number of Participants With Trough Albumin-Corrected Calcium Level Exceeding Predefined Limits At Least Once

"Albumin-Corrected Calcium = ([4 - plasma albumin in g/dL] × 0.8 + serum calcium).~≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with at least one albumin-corrected calcium level value ≥10.6 mg/dL were considered as having a Tier 1 AE (an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons)." (NCT00996801)
Timeframe: Baseline through Month 12

,,,,,
InterventionParticipants (Number)
≥10.6 ng/mL≥11.1 ng/mL≥12.1 ng/mL
Alendronate 70 mg200
MK-5442 10 mg1331
MK-5442 15 mg2890
MK-5442 5 mg300
MK-5442 7.5 mg710
Placebo110

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Least Squares Mean Percent Change From Baseline to Month 12 in Serum Bone-Specific Alkaline Phosphatase (s-BSAP)

Bone Specific Alkaline Phosphatase is a biomarker of bone formation and is measured in units of μg/L. (NCT00996801)
Timeframe: Baseline and Month 12

Interventionpercent change (Least Squares Mean)
Placebo29.51
MK-5442 5 mg50.04
MK-5442 7.5 mg49.98
MK-5442 10 mg51.64
Alendronate 70 mg-3.83

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Mean Level of 25(OH)D

Vitamin D (25(OH)D) level at Month 2. (NCT00996866)
Timeframe: Week 8

Interventionnmol/L (Mean)
Placebo49.9
Vitamin D74.5

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Mean Level of 25(OH)D

Vitamin D (25(OH)D) level at Baseline. (NCT00996866)
Timeframe: Baseline

Interventionnmol/L (Mean)
Placebo51.1
Vitamin D49.2

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Serum Tumor Necrosis Factor-alpha (TNF-α) Concentration

(NCT01005303)
Timeframe: Baseline, and 12 months

,
Interventionpg/mL (Mean)
Baseline12 months
Micronutrient4.14.1
Placebo4.44.6

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Serum N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Concentration

(NCT01005303)
Timeframe: Baseline, and 12 months

,
Interventionng/L (Mean)
Baseline12 months
Micronutrient1293.41763.6
Placebo841.61343.6

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Serum Interleukin-6 (IL-6) Concentration

(NCT01005303)
Timeframe: Baseline, and 12 months

,
Interventionpg/mL (Mean)
Baseline12 months
Micronutrient7.14.2
Placebo5.05.0

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Serum C-reactive Protein (CRP) Concentration

(NCT01005303)
Timeframe: Baseline, and 12 months

,
Interventionmg/L (Mean)
Baseline12 months
Micronutrient6.34.6
Placebo5.64.3

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Urinary 8-iso-prostaglandin F2 Alpha (8-iso-PGF2α) Concentration

(NCT01005303)
Timeframe: Baseline, and 12 months

,
Interventionmol/mmol creatinine (Mean)
Baseline12 months
Micronutrient12.110.5
Placebo11.311.7

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Left Ventricular Ejection Fraction

(NCT01005303)
Timeframe: Baseline, and 12 months

,
Interventionpercentage of LVEF (Mean)
Baseline12 months
Micronutrient38.938.6
Placebo44.744.9

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Quality of Life Questionnaire Score

Minnesota Living With Heart Failure Questionnaire. The questionnaire is comprised of 21 questions around several physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (zero) to 5 (five) scale to indicate the extent to which each itemized adversity of heart failure has prevented the patient from living as they wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses (score range 0-105). Higher scores indicate worse quality of life. (NCT01005303)
Timeframe: Baseline, and 12 months

,
Interventionunits on a scale (Mean)
Baseline12 months
Micronutrient34.033.1
Placebo33.738.2

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Serum Interleukin-10 (IL-10) Concentration

(NCT01005303)
Timeframe: Baseline, and 12 months

,
Interventionpg/mL (Mean)
Baseline12 months
Micronutrient1.21.1
Placebo1.51.5

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Six Minute Walk Test Distance

(NCT01005303)
Timeframe: Baseline, and 12 months

,
InterventionMetres (Mean)
Baseline12 months
Micronutrient417.0412.5
Placebo437.8440.2

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Change in Insulin Requirements

Percentage change from baseline number of units of lantus insulin over 6 months. (NCT01029392)
Timeframe: 6 months

Interventionpercentage change of baseline insulin (Mean)
Vitamin D Supplement2.62
No Vitamin D Supplementation1.80

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Change in Hemoglobin A1c

Change in hemoglobin A1c calculated as a percentage change from baseline measurement (NCT01029392)
Timeframe: 6 months

Interventionpercentage change from baseline (Mean)
Those Requiring Vit D Supplement2.67
No Vitamin D Supplementation1.05

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The Change in the Mean Arterial Blood Pressure in Response to an Infusion of Angiotensin II

(NCT01068418)
Timeframe: baseline and 1 month following vitamin D3 therapy

InterventionmmHg (Mean)
Vitamin D31.97

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The Change in Renal Blood Flow in Response to an Infusion of Angiotensin II

(NCT01068418)
Timeframe: baseline and 1 month following vitamin D3 therapy

InterventionmL/min/1.72m2 (Mean)
Vitamin D3-20.0

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To Achieve Target Vitamin D Level

To determine the ability of achieving the target serum 25-hydroxy vitamin D level of 40 ng/ml within 6 weeks of beginning vitamin D supplements in patients with metastatic colon cancer. A response is defined as achieving serum vitamin D levels ≥40 ng/ml at least once at any point during the first 6 weeks (NCT01074216)
Timeframe: Within 6 weeks of beginning vitamin D

Interventionparticipants (Number)
All Patients41

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Safety

Determined by incidence of elevated serum calcium (above age specific range) associated with elevated serum 25D concentrations (>160ng/ml). (NCT01092338)
Timeframe: 12 weeks

Interventionparticipants (Number)
4000IU/d of Vitamin D30
7000IU/d Vitamin D30

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Efficacy of the Two Doses (4000 and 7000 IU/d)

Daily D3 supplementation will result in 25D >= to 32/ng/ml (NCT01092338)
Timeframe: 12 weeks

Interventionparticipants (Number)
4000IU/d of Vitamin D316
7000IU/d Vitamin D319

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Number of Other Infections

(NCT01102374)
Timeframe: 12 months

Interventionevents (Number)
High Dose Vitamin D33
Standard Dose Vitamin D43

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Number of Acute Respiratory Infections (ARIs)

ARIs defined as upper or lower respiratory infections (NCT01102374)
Timeframe: 12 months

Interventionevents (Number)
High Dose Vitamin D32
Standard Dose Vitamin D48

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Incident Kidney Stones

(NCT01102374)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
High Dose Vitamin D0
Standard Dose Vitamin D0

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Incident Hypercalcemia

(NCT01102374)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
High Dose Vitamin D0
Standard Dose Vitamin D0

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Change in 25-hydroxyvitamin D (25OHD) Level

(NCT01102374)
Timeframe: Baseline and 12 months

Interventionng/mL (Mean)
High Dose Vitamin D8.18
Standard Dose Vitamin D2.71

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Death

(NCT01102374)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
High Dose Vitamin D9
Standard Dose Vitamin D13

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Number of Lower Respiratory Infections

(NCT01102374)
Timeframe: 12 months

Interventionevents (Number)
High Dose Vitamin D11
Standard Dose Vitamin D12

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Number of Upper Respiratory Infections

(NCT01102374)
Timeframe: 12 months

Interventionevents (Number)
High Dose Vitamin D21
Standard Dose Vitamin D36

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Number of Urinary Tract Infections

(NCT01102374)
Timeframe: 12 months

Interventionevents (Number)
High Dose Vitamin D38
Standard Dose Vitamin D22

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Severity of Acute Respiratory Infections

ARIs resulting in emergency department visits or hospitalizations (NCT01102374)
Timeframe: 12 month

Interventionevents (Number)
High Dose Vitamin D3
Standard Dose Vitamin D6

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Time to First ARI

(NCT01102374)
Timeframe: 12 months

InterventionHazard Ratio (Number)
High Dose Vitamin D0.59
Standard Dose Vitamin D1.00

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Falls

(NCT01102374)
Timeframe: 12 months

InterventionEvents (Number)
High Dose Vitamin D70
Standard Dose Vitamin D27

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Fractures

(NCT01102374)
Timeframe: 12 months

Interventionevents (Number)
High Dose Vitamin D5
Standard Dose Vitamin D8

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Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period

Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The DNSS was calculated as the sum of all scores for morning with a range of 0 to 12. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in daytime symptoms. (NCT01103934)
Timeframe: Baseline and 2 weeks

Interventionunits on a scale (Median)
Fluticasone Propionate Plus Vitamin D3-6.9
Fluticasone Propionate Plus Placebo-3.7

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Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period

Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms. (NCT01103934)
Timeframe: Baseline and 2 weeks

Interventionunits on a scale (Median)
Fluticasone Propionate Plus Vitamin D3-11.3
Fluticasone Propionate Plus Placebo-7.6

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Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3)

Sensory organization test (SOT) is a form of posturography. which is designed to assess quantitatively an individual's ability to use visual, proprioceptive and vestibular cues to maintain postural stability in stance. The SOT measures sway during 6 scenarios. In scenarios 1-3 the base is stable and eyes are open, then closed, and then the visual surround moves. SOT 1-3 is an average measurement of equilibrium - the average center of gravity sway for each condition. It generates a score of 0 (fall) up to 100 for each scenario and an overall composite score. Change score is measurement at 16 weeks minus measurement at baseline. (NCT01119131)
Timeframe: Baseline, 16 weeks

Interventionunits on a scale (Mean)
Vitamin D (Open Label)-3.25
Vitamin D2.05
Placebo1.78

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Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration

"This is a test that measures ambulatory balance and mobility. The instrumented timed up and go (iTUG) is an average time (seconds) of three trials that involve the participant arising from a chair, walking 25 feet turning around, walking back to the chair, and sitting down. The turn duration is the average time to turn at the end of the 25 foot walk. Longer duration of time (seconds) indicates more rigidity, a proxy measure for ON time in Parkinson's disease. Change score is measurement at 16 weeks minus measurement at baseline." (NCT01119131)
Timeframe: Baseline and 16 weeks

Interventionseconds (Mean)
Vitamin D (Open Label)0.32
Vitamin D0.09
Placebo-0.07

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Change in Cognition (Trail Making Test B-A)

The Trail Making Test (TMT) consists of two parts (A & B) in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test provides information about visual search speed, scanning, speed of processing, and executive functioning. Part A measures processing speed and part B measures executive functioning. The TMT is time to complete each part of the test in seconds. Higher scores indicate greater impairment. Subtracting part A from part B is theorized to reduce the influence of the working memory and visuospatial demands and, therefore, provides a relatively pure indicator of executive function. Change score is measurement (Part B - Part A) at 16 weeks minus measurement (Part B - Part A) at baseline, negative scores indicate a improvement in executive functioning. (NCT01119131)
Timeframe: Baseline, 16 weeks

Interventionseconds (Mean)
Vitamin D (Open Label)8.00
Vitamin D12.13
Placebo-17.33

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Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6)

Sensory organization test (SOT) is a form of posturography. which is designed to assess quantitatively an individual's ability to use visual, proprioceptive and vestibular cues to maintain postural stability in stance. The SOT measures sway during 6 scenarios. In 4-6 the base moves and the subject has eyes open, then closed, then the visual surround moves. SOT 4-6 is an average measurement of equilibrium - the average center of gravity sway for each condition. It generates a score of 0 (fall) up to 100 for each scenario and an overall composite score. Change score is measurement at 16 weeks minus measurement at baseline. (NCT01119131)
Timeframe: Baseline, 16 weeks

Interventionunits on a scale (Mean)
Vitamin D (Open Label)-1.56
Vitamin D2.272
Placebo-1.89

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Change in Parkinsonism as Measured by the UPDRS

This is the motor subsection of the UPDRS and is a commonly used tool to rate the symptoms of Parkinson's disease. This scale rates from 0 (normal) to 4 (Can barely perform the task) several motor areas including speech, facial expression, tremor, rigidity, hand movements, agility, posture, and gait. A sum score represents motor function with higher values on this scale represent a more severe stage of the disease. Change is measurement at 16 weeks minus baseline measurement, negative scores indicate an improvement in Parkinson's motor symptoms. (NCT01119131)
Timeframe: Baseline, 16 weeks

Interventionunits on a scale (Mean)
Vitamin D (Open Label)0.25
Vitamin D0.48
Placebo-0.18

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Change in Quality of Life as Recorded Using Quality of Life Scales (PDQ39)

"The PDQ39 is a 39 item patient completed survey targeting well-being and functioning in PD. This scale address 8 dimensions (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort). The PDQ39 dimension scores are on a scale of 0 (Never) to 4 (Always/Cannot Do). Scale scores are summed and range from 0 to 100 with 100 being the maximum level of problems. For a single index figure to characterize the impact of Parkinson's disease upon PD patients (PDSI), all 39 items of the PDQ39 can be summed. The PDQ39 and the use of a PDSI have shown adequate reliability and convergent validity. Change score is measurement at 16 weeks minus baseline measurement, negative scores indicate an improvement in quality of life." (NCT01119131)
Timeframe: Baseline, 16 weeks

Interventionunits on a scale (Mean)
Vitamin D (Open Label)-0.16
Vitamin D-0.02
Placebo-0.14

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Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work)

Defined as the total muscular force output for the repetition with the greatest amount of work. The equation for work is: W = F x D. Change score is measurement at 16 weeks minus measurement at baseline. (NCT01119131)
Timeframe: Baseline, 16 weeks

Interventionfoot pounds (Mean)
Vitamin D (Open Label)18.11
Vitamin D23.33
Placebo17.49

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Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work)

Defined as the total muscular force output for the repetition with the greatest amount of work. The equation for work is: W = F x D. Change score is measurement at 16 weeks minus measurement at baseline. (NCT01119131)
Timeframe: Baseline, 16 weeks

Interventionfoot pounds (Mean)
Vitamin D (Open Label)83.07
Vitamin D6.89
Placebo35.19

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Percentage Change From Baseline in Trochanter BMD at Month 24

Trochanter BMD was assessed by DXA at Baseline and at Month 24. (NCT01120600)
Timeframe: Baseline and Month 24

InterventionPercentage change (Least Squares Mean)
Odanacatib 50 mg Once Weekly2.77
Placebo Once Weekly0.66

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Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24

Lumbar spine BMD was assessed by dual energy X-ray absorptiometry (DXA) at Baseline and at Month 24. (NCT01120600)
Timeframe: Baseline and Month 24

InterventionPercentage change (Least Squares Mean)
Odanacatib 50 mg Once Weekly6.86
Placebo Once Weekly1.27

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Percentage Change From Baseline in Femoral Neck BMD at Month 24

Femoral Neck BMD was assessed by DXA at Baseline and at Month 24. (NCT01120600)
Timeframe: Baseline and Month 24

InterventionPercentage change (Least Squares Mean)
Odanacatib 50 mg Once Weekly1.69
Placebo Once Weekly0

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Percentage Change From Baseline in Total Hip BMD at Month 24

Total hip BMD was assessed by DXA at Baseline and at Month 24. (NCT01120600)
Timeframe: Baseline and Month 24

InterventionPercentage change (Least Squares Mean)
Odanacatib 50 mg Once Weekly1.91
Placebo Once Weekly-0.11

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Percentage Change From Baseline in Serum N-Terminal Propeptides of Type I Collagen (s-P1NP) at Month 24

Serum samples were collected to evaluate biochemical markers for s-P1NP, which were measured at Baseline and at Month 24. (NCT01120600)
Timeframe: Baseline and Month 24

InterventionPercentage change (Least Squares Mean)
Odanacatib 50 mg Once Weekly-10.94
Placebo Once Weekly5.06

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Percentage Change From Baseline in Urine Collagen N-Telopeptide/Creatinine Ratio (U-NTx/Cr) at Month 24

Urine samples were collected to evaluate biochemical markers for u-NTx/Cr, which were measured at Baseline and at Month 24. (NCT01120600)
Timeframe: Baseline and Month 24

InterventionPercentage change (Least Squares Mean)
Odanacatib 50 mg Once Weekly-61.43
Placebo Once Weekly6.65

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Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 24

Serum samples were collected to evaluate biochemical markers for s-CTx, which were measured at Baseline and at Month 24. (NCT01120600)
Timeframe: Baseline and Month 24

InterventionPercentage change (Least Squares Mean)
Odanacatib 50 mg Once Weekly-20.07
Placebo Once Weekly56.51

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Number of Participants Who Discontinued Treatment Due to an AE

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. (NCT01120600)
Timeframe: Up to 24 months after first dose of study drug

InterventionParticipants (Number)
Odanacatib 50 mg Once Weekly5
Placebo Once Weekly6

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Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (s-BSAP) at Month 24

Serum samples were collected to evaluate biochemical markers for s-BSAP, which were measured at Baseline and at Month 24. (NCT01120600)
Timeframe: Baseline and Month 24

InterventionPercentage change (Least Squares Mean)
Odanacatib 50 mg Once Weekly-5.28
Placebo Once Weekly2.66

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Number of Participants Who Experienced an Adverse Event (AE)

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. (NCT01120600)
Timeframe: Up to 24 months (plus 14 days) after first dose of study drug

InterventionParticipants (Number)
Odanacatib 50 mg Once Weekly113
Placebo Once Weekly114

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Plasma Renin Activity

Serum for renin will be drawn at baseline, 3, and 6 months, and processed according to lab protocol. (NCT01125436)
Timeframe: change in renin from baseline to 6 months

Interventionng/ml/hr (Mean)
Cholecalciferol + Calcium1.3
Placebo +Calcium-2.5

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Serum Aldosterone

Serum for aldosterone will be drawn at baseline, 3, and 6 months, and processed according to lab protocol. (NCT01125436)
Timeframe: change from baseline to 6 months

Interventionng/dl (Mean)
Cholecalciferol + Calcium3.7
Placebo +Calcium-0.1

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Timed Get Up and Go

stand from chair walk 3 meters, return to chair and sit (NCT01125436)
Timeframe: Change from baseline to 6 months

Interventionseconds (Mean)
Cholecalciferol + Calcium-0.2
Placebo +Calcium-1.0

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Leg Proximal Muscle Strength

Strength of the proximal lower extremity muscles measured by peak torque Nm/kg adjusted for body weight in flexion and extension (NCT01125436)
Timeframe: change from baseline to 6 months

,
Interventionnewton-meters/kg (Mean)
Flexion 60°s-1Extension 60°s-1
Cholecalciferol + Calcium1.65.2
Placebo +Calcium5.13.5

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Peak VO2

Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity (NCT01125436)
Timeframe: change from baseline to 6 months

Interventionml/kg/min (Mean)
Cholecalciferol + Calcium-.17
Placebo +Calcium-.68

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6 Minute Walk Distance

The six-minute walk test is a reliable and valid test of aerobic capacity, predictive of morbidity and mortality outcome, and correlates with Activity of Daily Living (ADL) and Quality of Living (QOL). (NCT01125436)
Timeframe: Change from baseline to 6 months

Interventionmeters (Mean)
Cholecalciferol + Calcium59
Placebo +Calcium36

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Osteocalcin

This secondary outcome measure is change in osteocalcin from baseline to final measure at 6 weeks differences in the 3 arms were compared (NCT01138475)
Timeframe: 6 weeks

Interventionng/mL (Mean)
Paricalcitrol38
Cholecalciferol39
Placebo-controlled42

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Serum 25 OH Vitamin D

This secondary outcome measure is change in serum hydroxy-vitaminD from baseline to final measure at 6 weeks differences in the 3 arms were compared (NCT01138475)
Timeframe: 6 weeks

Interventionng/dL (Mean)
Paricalcitrol27
Cholecalciferol38
Placebo-controlled25

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Serum Calcium

This secondary outcome measure is change in serum calcium from baseline to final measure at 6 weeks differences in the 3 arms were compared (NCT01138475)
Timeframe: 6 weeks

Interventionmg/dL (Mean)
Paricalcitrol9.3
Cholecalciferol9.4
Placebo-controlled9.3

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Serum Phosphorus

This secondary outcome measure is change in serum phosphorus from baseline to final measure at 6 weeks differences in the 3 arms were compared (NCT01138475)
Timeframe: 6 weeks

Interventionmg/dL (Mean)
Paricalcitrol4.0
Cholecalciferol3.4
Placebo-controlled3.7

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The Primary Outcome Measure With iPTH

Change in iPTH was compared in each arm from baseline to final measure at 6 weeks the differences were compared in the 3 arms of the study (NCT01138475)
Timeframe: 6 weeks

Interventionpg/mL (Mean)
Paricalcitol72
Cholecalciferol87
Placebo82

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Alkaline Phosphatase

This secondary outcome measure is change in alkaline phosphatase from baseline to final measure at 6 weeks differences were compared between the 3 arms of the study (NCT01138475)
Timeframe: 6 weeks

InterventionU/L (Mean)
Paricalcitol87
Cholecalciferol94
Placebo101

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Bone Specific Alkaline Phosphatase

This secondary outcome measure is change in bone specific alkaline phosphatase from baseline to final measure at 6 weeks, differences in the 3 arms were compared (NCT01138475)
Timeframe: 6 weeks

Interventionu/L (Mean)
Paricalcitrol15
Cholecalciferol19
Placebo-controlled18

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N-Telopeptide Cross Linked Urine

This secondary outcome measure is change in N-Telopeptide cross linked urine from baseline to final measure at 6 weeks, differences in the 3 arms were compared (NCT01138475)
Timeframe: 6 weeks

Interventionnmol (Mean)
Paricalcitrol74
Cholecalciferol67
Placebo-controlled77

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24 Hour Urine Calcium

This secondary outcome measure is change in 24-hour urine calcium from baseline to final measure at 6 weeks, differences in the 3 arms were compared (NCT01138475)
Timeframe: 6 weeks

Interventionmg/dL (Mean)
Paricalcitrol132
Cholecalciferol101
Placebo-controlled135

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Change in Mammographic Breast Density Over Course of Study

Change in the percent of the breast area that is considered to be at higher density on mammogram. (NCT01166763)
Timeframe: baseline and 6 months

InterventionChange in percent dense breast area (Mean)
High Dose Vitamin D3 (10,000 IU Weekly)-0.5

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Change in Proliferation (as Assessed by Ki-67) Examined in Breast Epithelial Cells.

Change in percent of cells expressing staining for Ki-67 antibody in breast epithelial cell specimens acquird by Random Periareolar Fine Needle Aspiration. (NCT01166763)
Timeframe: baseline and 6 months

Interventionpercentage of cells staining positive (Median)
High Dose Vitamin D3 (10,000 IU Weekly)-0.4

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OH Vitamin D Levels in Serum

Assessment of 25(OH)D levels as a measure of circulating vitamin D. (NCT01166763)
Timeframe: baseline and 6 months

Interventionng/ml (Mean)
High Dose Vitamin D3 (10,000 IU Weekly)55.4

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Number of Participants Who Died From Cardiovascular Causes

Death from cardiovascular causes (NCT01169259)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D152
Vitamin D Placebo138
Active Omega-3 Fatty Acids142
Omega-3 Fatty Acids Placebo148

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Number of Participants Who Died From Coronary Heart Disease

Death from coronary heart disease (NCT01169259)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D48
Vitamin D Placebo38
Active Omega-3 Fatty Acids37
Omega-3 Fatty Acids Placebo49

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Number of Participants Who Died From Invasive Cancer of Any Type

Death from invasive cancer of any type (NCT01169259)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D154
Vitamin D Placebo187
Active Omega-3 Fatty Acids168
Omega-3 Fatty Acids Placebo173

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Number of Participants Who Died From Invasive Cancer of Any Type, Excluding First 2 Years of Follow-up

Death from invasive cancer of any type, excluding first 2 years of follow-up (NCT01169259)
Timeframe: 5 years, excluding first 2 years of follow-up

InterventionParticipants (Count of Participants)
Active Vitamin D112
Vitamin D Placebo149
Active Omega-3 Fatty Acids126
Omega-3 Fatty Acids Placebo135

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Number of Participants Who Died From Myocardial Infarction

Death from myocardial infarction (NCT01169259)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D24
Vitamin D Placebo15
Active Omega-3 Fatty Acids13
Omega-3 Fatty Acids Placebo26

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Number of Participants With Stroke

Stroke (NCT01169259)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D141
Vitamin D Placebo149
Active Omega-3 Fatty Acids148
Omega-3 Fatty Acids Placebo142

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Number of Participants With Total Coronary Heart Disease

Total coronary heart disease = a composite of myocardial infarction, coronary revascularization (percutaneous coronary intervention or coronary-artery bypass grafting), and death from coronary heart disease (NCT01169259)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D332
Vitamin D Placebo346
Active Omega-3 Fatty Acids308
Omega-3 Fatty Acids Placebo370

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Number of Participants With a Major Cardiovascular Event, Excluding First 2 Years of Follow-up

Major cardiovascular event = a composite endpoint of myocardial infarction, stroke, and death from cardiovascular causes; excluding first 2 years of follow-up (NCT01169259)
Timeframe: 5 years, excluding first 2 years of follow-up

InterventionParticipants (Count of Participants)
Active Vitamin D274
Vitamin D Placebo296
Active Omega-3 Fatty Acids269
Omega-3 Fatty Acids Placebo301

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Number of Participants With a Major Cardiovascular Event

Major cardiovascular event = a composite endpoint of myocardial infarction, stroke, and death from cardiovascular causes (NCT01169259)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D396
Vitamin D Placebo409
Active Omega-3 Fatty Acids386
Omega-3 Fatty Acids Placebo419

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Number of Participants With Invasive Cancer of Any Type, Excluding First 2 Years of Follow-up

Invasive cancer of any type, excluding first 2 years of follow-up (NCT01169259)
Timeframe: 5 years, excluding first 2 years of follow-up

InterventionParticipants (Count of Participants)
Active Vitamin D490
Vitamin D Placebo522
Active Omega-3 Fatty Acids536
Omega-3 Fatty Acids Placebo476

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Number of Participants With Ischemic Stroke

Ischemic stroke (NCT01169259)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D117
Vitamin D Placebo110
Active Omega-3 Fatty Acids111
Omega-3 Fatty Acids Placebo116

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Number of Participants With Myocardial Infarction, Excluding First 2 Years of Follow-up

Myocardial infarction, excluding first 2 years of follow-up (NCT01169259)
Timeframe: 5 years, excluding first 2 years of follow-up

InterventionParticipants (Count of Participants)
Active Vitamin D108
VItamin D Placebo117
Active Omega-3 Fatty Acids94
Omega-3 Fatty Acids Placebo131

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Number of Participants With Cardiovascular Event in Expanded Composite Cardiovascular Endpoint

Expanded composite cardiovascular endpoint = a composite endpoint of myocardial infarction, stroke, death from cardiovascular causes, and coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention) (NCT01169259)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D536
Vitamin D Placebo558
Active Omega-3 Fatty Acids527
Omega-3 Fatty Acids Placebo567

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Number of Participants With Percutaneous Coronary Intervention

Percutaneous coronary intervention (NCT01169259)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D182
Vitamin D Placebo188
Active Omega-3 Fatty Acids162
Omega-3 Fatty Acids Placebo208

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Number of Participants With Myocardial Infarction

Myocardial infarction (NCT01169259)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D169
Vitamin D Placebo176
Active Omega-3 Fatty Acids145
Omega-3 Fatty Acids Placebo200

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Number of Participants With Serrated Colorectal Polyps

hyperplastic polyp, traditional serrated adenoma, sessile serrated polyp (NCT01169259)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D172
Vitamin D Placebo169
Active Omega-3 Fatty Acids174
Omega-3 Fatty Acids Placebo167

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Number of Female Participants With Breast Cancer

Breast cancer (in women) (NCT01169259)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D124
Vitamin D Placebo122
Active Omega-3 Fatty Acids117
Omega-3 Fatty Acids Placebo129

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Number of Participants With Colorectal Cancer

Colorectal cancer (NCT01169259)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D51
Vitamin D Placebo47
Active Omega-3 Fatty Acids54
Omega-3 Fatty Acids Placebo44

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Number of Participants With Conventional Colorectal Adenoma

tubular, tubulovillous, villous adenoma; adenoma w/high-grade dysplasia (NCT01169259)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D308
Vitamin D Placebo287
Active Omega-3 Fatty Acids294
Omega-3 Fatty Acids Placebo301

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Number of Male Participants With Prostate Cancer

Prostate cancer (in men) (NCT01169259)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D192
Vitamin D Placebo219
Active Omega-3 Fatty Acids219
Omega-3 Fatty Acids Placebo192

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Number of Participants Who Died From Any Cause

Death from any cause (NCT01169259)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D485
Vitamin D Placebo493
Active Omega-3 Fatty Acids493
Omega-3 Fatty Acids Placebo485

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Number of Participants Who Died From Stroke

Death from stroke (NCT01169259)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D19
Vitamin D Placebo23
Active Omega-3 Fatty Acids22
Omega-3 Fatty Acids Placebo20

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Number of Participants With Coronary-artery Bypass Grafting

Coronary-artery bypass grafting (NCT01169259)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D73
Vitamin D Placebo98
Active Omega-3 Fatty Acids85
Omega-3 Fatty Acids Placebo86

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Number of Participants With Hemorrhagic Stroke

Hemorrhagic stroke (NCT01169259)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D19
Vitamin D Placebo25
Active Omega-3 Fatty Acids25
Omega-3 Fatty Acids Placebo19

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Number of Participants Who Died From Any Cause, Excluding First 2 Years of Follow-up

Death from any cause, excluding first 2 years of follow-up (NCT01169259)
Timeframe: 5 years, excluding first 2 years of follow-up

InterventionParticipants (Count of Participants)
Active Vitamin D368
Vitamin D Placebo384
Active Omega-3 Fatty Acids371
Omega-3 Fatty Acids Placebo381

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Number of Participants With Invasive Cancer of Any Type

Invasive cancer of any type (NCT01169259)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D793
Vitamin D Placebo824
Active Omega-3 Fatty Acids820
Omega-3 Fatty Acids Placebo797

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Subjects Achieving Normal Vitamin D Levels

(NCT01173848)
Timeframe: within 24 weeks

Interventionparticipants (Number)
Vitamin D24
Vitamin D34

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Change in 25OH-Vitamin D Level

Vitamin D deficient study subjects will be randomized to either treatment with 50,000 IU oral 25OH-Vit D weekly or no treatment (standard of care). The primary outcome of change in 25OH-Vit D level will be measured at 6 weeks, 3 months, 6 months, and 12 months. (NCT01175798)
Timeframe: 1 year

Interventionng/dL (Median)
No Treatment (Standard of Care)15.8
Vitamin D Repletion40.9

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Number of Relapse-Free (Documented) Subjects

The relapse-free patients after 2 years of treatment was calculated using Cochran-Mantel-Haenszel test using the site as control variable. (NCT01198132)
Timeframe: 2 years post treatment (IMP) administration

Interventionsubjects (Number)
Cholecalciferol35
Placebo27

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Annualized Relapse Rate

The annualized relapse rate was calculated for each treatment group as follows: the number of relapses observed during the study period divided by the time spent in the study (in years). (NCT01198132)
Timeframe: 2 years post treatment (IMP) administration

InterventionRelapse per year (Mean)
Cholecalciferol0.45
Placebo0.34

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Cumulative Probability of Progression of Disability (Kaplan-Meier Curves)

Disability progression was assessed using Expanded disability status scale (EDSS). EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A one-point increase on the EDSS scale was considered as a progression in disability. The time to disability progression was summarized using Kaplan-Meier survival methods. The cumulative probability of confirmed disease progression at each visit was obtained by applying a Kaplan-Meier method to the time to confirmed disease progression. (NCT01198132)
Timeframe: Baseline up to week 96

Interventionpercentage of subjects (Number)
Cholecalciferol12.7
Placebo9.1

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Mean Number of Relapses Per Subject

Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. Mean and standard deviation were reported. (NCT01198132)
Timeframe: 2 years post treatment (IMP) administration

Interventionrelapses (Mean)
Cholecalciferol0.5
Placebo0.5

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Time to First Documented Relapse

Time to First Documented Relapse was calculated using Kaplan-Meier survival methods. (NCT01198132)
Timeframe: 2 years post treatment (IMP) administration

Interventionweeks (Median)
CholecalciferolNA
Rebif +PlaceboNA

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Change From Baseline in Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L)

The EQ-5D health questionnaire is a generic self-reported health-related quality of life instrument that includes a 100 mm Visual Analog Scale (VAS) to measure the general health state, as well as 5 items corresponding to one dimension each: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. In this study, the VAS scale is not collected and the version 3L of the scale was used: Each dimension had 3 possible levels: 1 = no problem, 2 = some problems and 3 = extreme problems. EQ-5D-3L weighted health state index exists that combines the score of the 5 dimensions and ranges from 0 to 1 (full health). The variables for the 5 dimensions of the EQ-5D descriptive system was named 'mobility','selfcare', 'activity', 'pain', and 'anxiety'. The 5 variables contained the values for the different dimensions in the EQ-5D health profile (i.e. 1, 2, or 3). (NCT01198132)
Timeframe: 2 years post treatment (IMP) administration

,
Interventionunits on a scale (Mean)
Baseline (n=60, 63)Change at Week 96 (n=43, 45)
Cholecalciferol0.7834-0.0051
Placebo0.79370.0043

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Change From Baseline in Measurement and Evaluation of Cognitive Ability by Paced Auditory Serial Addition Task (PASAT) Total Score At Week 96

The Adapted Paced Auditory Serial Addition Task (PASAT) is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. The total score for PASAT is the total number of correct answers (out of 60, for a total possible score ranging from 0-60 with higher score indicates higher auditory processing speed) for each trial. Change from baseline in PASAT total score at Week 96 was summarized. (NCT01198132)
Timeframe: Baseline, Week 96

,
Interventionunits on a scale (Mean)
BaselineChange at Week 96
Cholecalciferol39.96.4
Placebo43.36.0

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Changes From Baseline in Measured Lesion Load (T2)

Baseline defined as last value recorded prior to first intake of study drug. (NCT01198132)
Timeframe: Baseline, Week 96

,
Interventioncubic millimeter (mm^3) (Mean)
Baseline (n=49, 43)Change at Week 96 (n=44, 38)
Cholecalciferol5305.4-315.0
Placebo3520.1596.3

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Number of New or Extended Lesions by T1- and T2-Weighted Magnetic Resonance Imaging (MRI)

(NCT01198132)
Timeframe: 2 years post treatment (IMP) administration

,
Interventionlesions (Mean)
T1-weighted MRIT2-weighted MRI
Cholecalciferol0.40.5
Placebo1.92.0

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Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Abnormal Clinical Laboratory

A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect and TEAE was defined as newly occurring or worsening after first dose. Clinical laboratory abnormalities are expected to be reported as adverse events if they met any criterion for seriousness, led to treatment discontinuation, required a medical intervention or were considered clinically significant by the investigator. (NCT01198132)
Timeframe: Baseline up to end of treatment (week 96)

,
Interventionsubjects (Number)
TEAEsSerious TEAEs
Cholecalciferol4311
Placebo3510

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Glucose Tolerance

The primary endpoint is the change in the area under the glucose curve following an oral glucose tolerance test prior to and after the three month intervention. (NCT01199926)
Timeframe: three months

Interventionmmol/L/120 min (Mean)
Vitamin D-18.0
Placebo-25.7

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Inflammation

The primary endpoint is the change in C reactive protein after the three month intervention (NCT01199926)
Timeframe: three months

Interventionmg/L (Mean)
Vitamin D0.64
Placebo-0.33

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Muscle Function

The primary endpoint is the change in lean mass (kilograms) after the three month resistance exercise intervention. (NCT01199926)
Timeframe: three months

Interventionkilograms (Mean)
Vitamin D1.14
Placebo1.50

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Change in Urinary Albumin:Creatinine Ratio (ACR)

Urinary Albumin:Creatinine Ratio (ACR) is a well-established, sensitive marker of nephropathy progression (urine albumin (mg/dL) to urine creatinine (g/dL) ratio). (NCT01214356)
Timeframe: baseline and 6 months

Interventionratio (Mean)
Vitamin D Supplementation-52.55555556
Usual Care46.44444444

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Monocyte Protein Expression

Flow cytometry analysis of monocyte CD14, ACE, VDR, and Mac-1 expression (NCT01222234)
Timeframe: 8 weeks of therapy

,
Interventionrelative fluorescence units (Mean)
CD14ACEVDRMac-1
Group 1: Cholecalciferol - CKD341101359279914318
Group 2: Calcitriol - CKD385401360346814278.5

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Change in 24,25(OH)2D Levels in CKD vs. Non-CKD Subjects Receiving Cholecalciferol

(NCT01222234)
Timeframe: 8 weeks of therapy

Interventionng/ml (Mean)
Group 1: CKD Cholecalciferol1.59
Group 3: Non-CKD Cholecalciferol3.59

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Number of Participants With Aspergillus Induced IL-13 Responses in CD4+ T-cells

To test the hypothesis that supplementation with Vitamin D in CF patients with ABPA will reduce Aspergillus induced IL-13 responses in peripheral CD4+ T-cells. Response confirmed for each individual patient and recorded as number of participants with response. (NCT01222273)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Cholecalciferol7

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Change in Patient Total IgE Levels

To test the hypothesis that supplementation with Vitamin D in CF patients with ABPA will reduce total IgE levels by the end of the 24-week period (NCT01222273)
Timeframe: 6 months

InterventionIU/mL (Mean)
Cholecalciferol312.6

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Change in Patient Aspergillus Specific IgE Levels

To test the hypothesis that supplementation with Vitamin D in CF patients with ABPA will reduce aspergillus specific IgE levels by the end of the 24-week period (NCT01222273)
Timeframe: 6 months

InterventionkUA/I (Mean)
Cholecalciferol11.73

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Serum Total Cholesterol (Tchol)

(NCT01229891)
Timeframe: 12-week

Interventionmg/dL (Mean)
Plain Yogurt Drink197.3
Vitamin D-fortified Yogurt Drink182.8
Vitamin D-calcium Fortified Yogurt Drink178.5

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Serum Low Density Lipoprotein (LDL)

(NCT01229891)
Timeframe: 12-week

Interventionmg/dL (Mean)
Plain Yogurt Drink93.5
Vitamin D-fortified Yogurt Drink91.1
Vitamin D-calcium Fortified Yogurt Drink96.3

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Serum 25-hydroxyvitamin D

(NCT01229891)
Timeframe: 12-week

Interventionnmol/L (Mean)
Plain Yogurt Drink45.6
Vitamin D-fortified Yogurt Drink76.2
Vitamin D-calcium Fortified Yogurt Drink78.4

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Serum High Density Lipoprotein (HDL)

(NCT01229891)
Timeframe: 12-week

Interventionmg/dL (Mean)
Plain Yogurt Drink51.8
Vitamin D-fortified Yogurt Drink46.1
Vitamin D-calcium Fortified Yogurt Drink48

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Insulin

fasting serum insulin concentration (NCT01229891)
Timeframe: 12-week

InterventionmU/L (Mean)
Plain Yogurt Drink10.8
Vitamin D-fortified Yogurt Drink6.5
Vitamin D-calcium Fortified Yogurt Drink6.4

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Hemoglobin A1c (HbA1c)

(NCT01229891)
Timeframe: 12-week

Interventionpercent (Mean)
Plain Yogurt Drink8.7
Vitamin D-fortified Yogurt Drink7
Vitamin D-calcium Fortified Yogurt Drink7.8

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Serum Triglyceride (TG)

(NCT01229891)
Timeframe: 12-week

Interventionmg/dL (Mean)
Plain Yogurt Drink181.3
Vitamin D-fortified Yogurt Drink155.2
Vitamin D-calcium Fortified Yogurt Drink161.1

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Fasting Serum Glucose (FSG)

(NCT01229891)
Timeframe: 12-week

Interventionmg/dL (Mean)
Plain Yogurt Drink203.3
Vitamin D-fortified Yogurt Drink171.2
Vitamin D-calcium Fortified Yogurt Drink174.3

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Lung Function Change From Baseline

FEV1 (liters) and methacholine PC20 will be evaluated. Changes are measured as 28 weeks minus baseline. (NCT01248065)
Timeframe: Change is measured as value at 28 weeks minus baseline value.

InterventionLiters (Least Squares Mean)
Ciclesonide + Placebo-0.04
Ciclesonide + Vitamin D-0.07

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Treatment Failure

Treatment failure is a well-defined asthma outcome reflecting overall asthma control that has been used previously in multiple clinical trials. Treatment failure as defined in the current proposal and prior trials is consistent with the American Thoracic Society (ATS)/European Respiratory Society(ERS) definition of a moderate exacerbation - a deterioration in symptoms and/or lung function with increased rescue bronchodilator use that lasts 2 days or more. The percentages of participants experiencing a treatment failure are Kaplan-Meier estimates of failure rate. (NCT01248065)
Timeframe: Twenty-eight week intervention period from randomization until end of trial.

InterventionPercentage of participants (Number)
Ciclesonide + Placebo29
Ciclesonide + Vitamin D28

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Exacerbations

Outcome defined as number of exacerbations per person-year. (NCT01248065)
Timeframe: Overall exacerbation rate during 28-week trial

InterventionExacerbations/person-year (Number)
Ciclesonide + Placebo0.40
Ciclesonide + Vitamin D0.26

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Coronary Calcium Score

Bone mineral density assessed by dual-energy X-ray absorptiometry (DXA) of the whole body, lumbar spine and hip was performed using Hologic scanners (QDR 1000W or QDR 2000). The total Agatston coronary calcium score (CCS) was measured as the sum of calcified plaque scores of all the coronary arteries. The amount of calcium present in the coronary arteries is scored according to the Agatson scale, as follows: 0 - no identifiable disease; 1 to 99 - mild disease; 100 to 399 - moderate disease; 400 or higher - severe disease. (NCT01265615)
Timeframe: on day 180

Interventionunits on a scale (Mean)
Paricalcitol Treatment530
Calcitriol Treatment611
Cholecalciferol524
Supplemental990

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GFR (Glomerular Filtration Rate)

Estimated glomerular filtration rate (eGFR) was calculated using the abbreviated form of the Modification of Diet in Renal Disease (MDRD) study equation: eGFR = exp (5.228 - 1.154 × ln (serum creatinine) - 0.203 × ln (age). Concerning of GFR with Tc99m DTPA renography was used for the complex analysis of renal function. Camera based GFR estimated from Tc99m DTPA renography was named Gates GFR. (NCT01265615)
Timeframe: on day 180

Interventionml/min/1.73 m^2 (Mean)
Paricalcitol Treatment84
Calcitriol Treatment81
Cholecalciferol76
Supplemental54

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Heart Failure (HF)

"NYHA (New York Heart Association) functional class verified with veloergometry probe and by NYHA clinical classification NYHA Class Symptoms I No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.~II Mild symptoms and slight limitation during ordinary activity. III Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).~Comfortable only at rest. IV Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients." (NCT01265615)
Timeframe: on day 180 after Tx (transplantation)

InterventionNYHA functional class of HF (Mean)
Paricalcitol Treatment1.8
Calcitriol Treatment1.9
Cholecalciferol1.9
Supplemental2.5

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VDR (Vitamin D Receptor) Expression in Myocardium

VDR content was determined by using an ELISA developed in this laboratory. The protein concentration of the homogenates was determined by the method of Bradford (1976), using BSA as a standard. (NCT01265615)
Timeframe: on day 180

Interventionfmol VDR/ mg protein (Mean)
Paricalcitol Treatment801
Calcitriol Treatment715
Cholecalciferol654
Supplemental389

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VDR (Vitamin D Receptor) Expression in Kidney

VDR content was determined by using an ELISA developed in this laboratory. The protein concentration of the homogenates was determined by the method of Bradford (1976), using BSA as a standard. (NCT01265615)
Timeframe: on day 180

Interventionfmol VDR/ mg protein (Mean)
Paricalcitol Treatment584
Calcitriol Treatment599
Cholecalciferol478
Supplemental333

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Systolic Blood Pressure

SBP measured by routine method (NCT01265615)
Timeframe: on day 180

InterventionmmHg (Mean)
Paricalcitol Treatment143
Calcitriol Treatment141
Cholecalciferol147
Supplemental165

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CAD (Chronic Allograft Dysfunction) Degree

"CAD degree measured by Banff score after routine renal biopsy (revised 2005/2007 criteria). We assessed antibody-mediated rejection, borderline changes, T-cell-mediated rejection, interstitial fibrosis and tubular atropthy, and other changes. Grades:~Grade I. Mild interstitial fibrosis and tubular atrophy (<25% of cortical area) II. Moderate (26-50%) III. Severe (>50%) (may include non-specific vascular and glomerular sclerosis)" (NCT01265615)
Timeframe: on day 90

InterventionScores on a Banff scale (Mean)
Paricalcitol Treatment1.24
Calcitriol Treatment1.22
Cholecalciferol1.43
Supplemental1.68

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CAD (Chronic Allograft Dysfunction) Degree

"Beyond 180 days, chronic allograft dysfunction (CAD) was characterized by mean Banff degree (revised 2005/2007 criteria) with the data of renal biopsy material. Renal tissue was recovered during routined biopsy. We assessed antibody-mediated rejection, borderline changes, T-cell-mediated rejection, interstitial fibrosis and tubular atropthy, and other changes. Grades:~Grade I. Mild interstitial fibrosis and tubular atrophy (<25% of cortical area) II. Moderate (26-50%) III. Severe (>50%) (may include non-specific vascular and glomerular sclerosis)" (NCT01265615)
Timeframe: day 180 after Tx (transplantation)

InterventionScores on a Banff scale (Mean)
Paricalcitol Treatment1.24
Calcitriol Treatment1.22
Cholecalciferol1.43
Supplemental1.68

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Number of Circulating SP (Side Population) Stem-Progenitor Cells

Renal cells and solid tissue were obtained from the normal portion of cortex obtained from surgically removed kidneys or by standart biopsy on day 180. Cytofluorimetric analysis and immunofluorescence were performed as described by Oliver J.A. (2004). Sorting and analysis of different cells was done on a FACS (fluorescent activated cell sorting) and by flow cytometry. Cells were analyzed with EPICS systems (Beckman Coulter). Quantification of mRNA expression was achieved using Assays-on-Demand gene expression kits and the ABI PRISM 7000 Sequence Detection System (Applied Biosystem). (NCT01265615)
Timeframe: on day 180

Interventionper cent of SP cells (Mean)
Paricalcitol Treatment7.6
Calcitriol Treatment6.5
Cholecalciferol5.7
Supplemental4.2

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Serum Creatinine

After an overnight fast, plasma concentrations of hemoglobin, creatinine, cholesterol, glucose, total calcium, and phosphate were measured using an autoanalyzer as described by Adorini L. (2005) (NCT01265615)
Timeframe: on day 180 after Tx

Interventionmg/dL (Mean)
Paricalcitol Treatment2.5
Calcitriol Treatment2.5
Cholecalciferol2.8
Supplemental4.1

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Serum 25-hydroxyvitamin D Concentration

Serum 25-hydroxyvitamin D level was measured at 6 months. (NCT01276587)
Timeframe: Up to 6 months

Interventionng/mL (Mean)
Month 1Month 2Month 3Month 4Month 5Month 6
Single Arm28.536.541.041.7540.7542.5

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CD4+T Cell Count

The change in the CD4+T cell count between the two arms. (NCT01295034)
Timeframe: baseline and 12 months

Interventioncell/μL (Median)
Conventional Vitamin B Dosing26
Tiered/Titrated Vitamin D Dosing40

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25(OH)D Levels

The difference in the percentage of subjects with 25(OH)D levels in the range of 30-60 ng/ml at 12 mo between the two arms. (NCT01295034)
Timeframe: baseline and 12 months

InterventionParticipants (Count of Participants)
Conventional Vitamin D Treatment13
Tiered/Titrated Vitamin D Dosing20

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Trabecular Bone Density at the Forearm

Measured by high resolution peripheral quantitative computed tomography (NCT01306656)
Timeframe: 6 months

Interventionpercentage of change (Mean)
Group 1-1.00345
Group 2-2.59816

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Change in Urinary Calcium Level

This is designed to measure how the study treatment will affect urinary calcium level over time. (NCT01306656)
Timeframe: 1 month, 3 months, 6 months

,
Interventionmg/day (Mean)
1-month3-month6-month
10,000 IU Vitamin D3 + Multivitamin182.67172.67195.17
Placebo + Multivitamin154115.550.5

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Areal Bone Mineral Density of the Lumbar Spine

Measured by dual-energy x-ray absorptiometry (DEXA) scan (NCT01306656)
Timeframe: 6 months

Interventionpercentage of change (Mean)
10,000 IU Vitamin D3 + Multivitamin-.98777
Placebo + Multivitamin1.442861

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Plasma Renin Activity (PRA) [Vitamin D]

PRA is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma PRA was analyzed using a competitive binding radioimmunoassay (RIA) laboratory test. (NCT01320722)
Timeframe: Week 8

Interventionng/mL per hour (Mean)
Vitamin D0.36
Placebo- Vitamin D0.44

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Change in Endothelium-Dependent Vasodilation (EDV)

Endothelial function was assessed by EDV using brachial artery ultrasonography. Measurements of brachial artery diameter were made under basal conditions and reactive hyperemia following ischaemic stimulus. A blood pressure cuff on the forearm was pumped up for 5 minutes then released. Images were taken at baseline and after reactive hyperemia (increased blood flow). The maximum diameter was determined by the investigator. Change in EDV was expressed as a percent of brachial luminal diameter calculated as post-ischaemic brachial artery diameter - pre-ischaemic brachial artery diameter/pre-ischaemic brachial artery diameter * 100. (NCT01320722)
Timeframe: Baseline and Week 8 (pre and post ischaemic stimulus)

,,,,
Interventionpercent of brachial luminal diameter (Mean)
BaselineWeek 8
Allopurinol7.66.2
Placebo- Uric Acid6.57.1
Placebo- Vitamin D7.96.8
Probenecid7.48.3
Vitamin D6.36.1

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Mean 24-Hour Ambulatory Blood Pressure (ABP)

A 24-hour mean ambulatory blood pressure was monitored using a 24 hour ABP device. The ABP device is a small box that is worn on the belt or pant/skirt line with a line that connect under the clothing to the cuff on the upper arm. Blood Pressure was recorded every 30 minutes during the day and every 60 minutes during the night for 24 hours. (NCT01320722)
Timeframe: Baseline and Week 8

,,,,
InterventionmmHg (Mean)
Overall Systolic Blood Pressure (SBP), BaselineOverall Diastolic Blood Pressure (DBP), BaselineAwake SBP, BaselineAsleep SBP, BaselineOverall SBP, Week 8Overall DBP, Week 8Awake SBP, Week 8Asleep SBP, Week 8
Allopurinol124.172.1126.7117.1123.772.0125.1118.6
Placebo- Uric Acid122.471.9125.5113.9122.972.6124.9116.2
Placebo- Vitamin D123.773.7126.4116.5124.774.7127.6117.4
Probenecid126.973.3130.0119.2125.273.8128.1116.2
Vitamin D120.471.6122.4113.9121.672.0124.2114.7

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Mean 24-Hour Ambulatory Blood Pressure (ABP) Nocturnal Dipping

A 24-hour mean ambulatory blood pressure was monitored using a 24 hour ABP device. The ABP device is a small box that is worn on the belt or pant/skirt line with a line that connect under the clothing to the cuff on the upper arm. Blood Pressure was recorded every 30 minutes during the day and every 60 minutes during the night for 24 hours. Nocturnal dipping is the percent change lower between the daytime and nighttime values. (NCT01320722)
Timeframe: Baseline and Week 8

,,,,
Interventionpercent change (Mean)
BaselineWeek 8
Allopurinol7.55.2
Placebo- Uric Acid9.46.9
Placebo- Vitamin D7.88.1
Probenecid8.49.2
Vitamin D7.37.5

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Angiotensin II (ATII) Concentration [Vitamin D]

ATII concentration is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma ATII was analyzed using a double-antibody radioimmunoassay (RIA) laboratory test. (NCT01320722)
Timeframe: Week 8

Interventionpg/mL (Mean)
Vitamin D19.5
Placebo- Vitamin D19.7

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Change in Renal Plasma Flow (RPF) in Response to Captopril in High Sodium Balance [Vitamin D]

Change in RPF in response to captopril is a measure of the vasodilator effect from inhibiting angiotensin II (AngII)- mediated vascular tone and therefore the degree of kidney specific Renin Angiotensin System (RAS) activity. Participants consumed a high sodium diet 3 days prior to the test. Following an 8 hour fast, participants remained in a supine (lying down) position and had an intravenous (IV) catheter inserted in each arm, one for infusion and one for blood collection. An 8 milligrams (mg)/kilogram(kg) loading dose of para-aminohippuric acid (PAH) was given, immediately followed by a continuous PAH infusion at 12 mg/minute. After 60 minutes a single dose of 25 mg of captopril was administered. Three pre-captopril measurements and three post-captopril measurements of RPF were made. RPF was normalized to body surface area of 1.73 meters squared (m^2). The change in RPF was calculated as post-captopril RPF- pre-captopril RPF. (NCT01320722)
Timeframe: Week 8 (pre and post captopril)

InterventionmL/min per 1.73 m^2 (Mean)
Vitamin D35.7
Placebo- Vitamin D35.9

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Plasma Renin Activity (PRA) [Uric Acid]

PRA is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma PRA was analyzed using a competitive binding radioimmunoassay (RIA) laboratory test. (NCT01320722)
Timeframe: Week 8

Interventionng/mL per hour (Median)
Probenecid0.4
Allopurinol0.3
Placebo- Uric Acid0.2

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Change in Renal Plasma Flow (RPF) Response to Captopril in High Sodium Balance [Uric Acid]

RPF in response to captopril iis a measure of the vasodilator effect from inhibiting angiotensin II (AngII)- mediated vascular tone and therefore the degree of kidney specific Renin Angiotensin System (RAS) activity. Participants consumed a high sodium diet 3 days prior to the test. Following an 8 hour fast, participants remained in a supine (lying down) position and had an intravenous (IV) catheter inserted in each arm, one for infusion and one for blood collection. An 8 milligrams (mg)/kilogram(kg) loading dose of para-aminohippuric acid (PAH) was given, immediately followed by a continuous PAH infusion at 12 mg/minute. After 60 minutes a single dose of 25 mg of captopril was administered. Three pre-captopril measurements and three post-captopril measurements of RPF were made. RPF was normalized to body surface area of 1.73 meters squared (m^2). The change in RPF was calculated as post-captopril RPF- pre-captopril RPF. (NCT01320722)
Timeframe: Week 8 (pre and post captopril)

InterventionmL/min per 1.73 m^2 (Median)
Probenecid33
Allopurinol36
Placebo- Uric Acid30

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Angiotensin II (ATII) Concentration [Uric Acid]

ATII concentration is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma ATII was analyzed using a double-antibody radioimmunoassay (RIA) laboratory test. (NCT01320722)
Timeframe: Week 8

Interventionpg/mL (Median)
Probenecid20.3
Allopurinol21.4
Placebo- Uric Acid19.1

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Total IGF-2 in Serum at Baseline and Pre-Surgery

This is measuring the concentration of the Biomarker IGF-2 in blood serum at Baseline and at the end of the study (NCT01325311)
Timeframe: Baseline and Up to Day 35

,
Interventionng/mL (Mean)
BaselinePre-Surgery
Arm I (Cholecalciferol, Genistein)805.9858.8
Arm II (Placebo)770.4605.0

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Total IGF-1 in Serum at Baseline and Pre-Surgery

This is measuring the concentration of the Biomarker IGF-1 in blood serum at Baseline and at the end of the study. (NCT01325311)
Timeframe: Baseline and up to Day 35

,
Interventionng/mL (Mean)
BaselineDay 35
Arm I (Cholecalciferol, Genistein)66.374.6
Arm II (Placebo)64.260.6

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Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms

To identify the amount of Calcitriol that is found in the tissue comparing Placebo and Cholecalciferol/Genistein (NCT01325311)
Timeframe: up to 35 days

,
Interventionparticipants (Number)
UndetectableDetectable
Arm I (Cholecalciferol, Genistein)61
Arm II (Placebo)71

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Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA)

"The Immunohistochemistry measurement for: AR (Nucleus), VDR (Cytoplasm), p21 (Nucleus), PGE2 (Cytoplasm), TUNEL Pos (Nucleus), Caspase 3 (Cytoplasm), PSMA (Cytoplasm), IGF-1 and IGF-2 (Cytoplasm), Akt (Nucleus and Cytoplasm), and pAkt (nucleus and Cytoplasm)~This is to serve as normalized case data to determine expression of protein.~The normalized optical densities were measured as optical density per unit area by densitometric scanning using Vectra imaging system (Perkin Elmer).~This Optical Density is based on fluorescence." (NCT01325311)
Timeframe: Up to day Day 35

,
InterventionNormalized Optical Density (Mean)
AR (Nucleus)VDR (Cytoplasm)p21 (Nucleus)PGE2 (Cytoplasm)TUNEL Pos (Nucleus)Caspase 3 (Cytoplasm)PSMA (Cytoplasm)IGF-1 (Cytoplasm)IGF-2 (Cytoplasm)Akt (Nucleus)pAkt (Nucleus)Akt (Cytoplasm)pAkt (Cytoplasm)
Arm I (Cholecalciferol, Genistein)0.5630.2810.1850.1350.3630.1030.210-0.155-0.4430.3090.2910.3790.365
Arm II (Placebo)-0.563-0.281-0.185-0.135-0.363-0.103-0.2100.1550.443-0.309-0.291-0.379-0.365

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Levels of Calcidiol in the Participants Serum

This is measuring the amount of Calcidiol that was found in the participants blood Serum at baseline and end of study (NCT01325311)
Timeframe: Baseline and up to day 35

,
Interventionng/mL (Mean)
BaselinePre-Surgery
Arm I (Cholecalciferol, Genistein)24.527.3
Arm II (Placebo)20.519.2

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Tissue Levels of Calcitriol Between the Placebo and Cholecalciferol/Genistein Arms

This is a measure of calcitriol in prostate tissue comparing placebo and cholecalciferol/genistein (NCT01325311)
Timeframe: up to Day 35

Interventionng/mL (Mean)
Arm II (Placebo)0.045
Arm I (Cholecalciferol, Genistein)0.057

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PBMC CYP mRNA Expression of CYP24

This is a measure of expression of CYP24 in comparing placebo to Cholecalciferol/genistein. (NCT01325311)
Timeframe: Baseline and Up to Day 35

InterventionRatio to Baseline (Geometric Mean)
Arm II (Placebo)3.054
Arm I (Cholecalciferol, Genistein)2.202

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Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)

(NCT01325311)
Timeframe: up to Day 35

,
Interventionpercentage of participants (Number)
rs2209314- T/Crs2209314- T/Trs2248359- C/Crs2248359- C/Trs2248359- T/Trs2296241- A/Ars2296241- A/Grs2296241- G/Grs2762939- C/Grs2762939- G/Grs927650- C/Crs927650- C/Trs927650- T/Trs703842- A/Ars703842- A/Grs703842- G/G
Arm I (Cholecalciferol, Genistein)42.8657.1442.8657.14014.2971.4314.2928.5771.4371.4314.2914.2914.2971.4314.29
Arm II (Placebo)37.562.537.537.52537.535.52537.562.5050505037.512.5

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Serum Calcium Levels at Baseline and Pre-Surgery

This is a measurement of calcium in the Blood serum at baseline and at the end of the study. (NCT01325311)
Timeframe: Baseline and Day 35

,
Interventionng/mL (absolute change) (Mean)
BaselineDay 35
Arm I (Cholecalciferol, Genistein)11.310.9
Arm II (Placebo)10.510.8

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Levels of Calcitriol in Participants Serum

This is measuring the amount of Calcitriol that was found in the participants blood Serum at baseline and end of study. (NCT01325311)
Timeframe: baseline and Up to Day 35

,
Interventionng/mL (Mean)
BaselinePre-Surgery
Arm I (Cholecalciferol, Genistein)0.50.1
Arm II (Placebo)0.50.5

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Immunohistochemistry Measurements in Benign Prostate Tissue (BPT)

"The Immunohistochemistry measurement for: AR (Nucleus), VDR (Cytoplasm), p21 (Nucleus), PGE2 (Cytoplasm), TUNEL Pos (Nucleus), Caspase 3 (Cytoplasm), PSMA (Cytoplasm), IGF-1 and IGF-2 (Cytoplasm), Akt (Nucleus and Cytoplasm), and pAkt (nucleus and Cytoplasm)~This is to serve as normalized control data to determine expression of protein.~The normalized optical densities were measured as optical density per unit area by densitometric scanning using Vectra imaging system (Perkin Elmer).~This Optical Density is based on fluorescence." (NCT01325311)
Timeframe: Up to Day 35

,
InterventionNormalized Optical Density (Mean)
AR (Nucleus)VDR (Cytoplasm)p21 (Nucleus)PGE2 (Cytoplasm)TUNEL Pos (Nucleus)Caspase 3 (Cytoplasm)PSMA (Cytoplasm)IGF-1 (Cytoplasm)IGF-2 (Cytoplasm)Akt (Nucleus)pAkt (Nucleus)Akt (Cytoplasm)pAkt (Cytoplasm)
Arm I (Cholecalciferol, Genistein)0.4140.5150.0970.1840.1920.352-0.0290.3370.3830.3610.1310.2840.061
Arm II (Placebo)-0.362-0.451-0.085-0.161-0.168-0.3080.025-0.295-0.335-0.316-0.114-0.249-0.053

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Total PTH in Serum at Baseline and Pre-Surgery

This is measuring the concentration of the Biomarker PTH in blood serum at Baseline and at the end of the study (NCT01325311)
Timeframe: Baseline and Up to Day 35

,
Interventionng/mL (Mean)
BaselinePre-Surgery
Arm I (Cholecalciferol, Genistein)144.8136.5
Arm II (Placebo)143.4151.1

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Total PSA in Serum

This is a measure of the concentration of PSA in the blood serum at baseline and at the end of study. (NCT01325311)
Timeframe: at Baseline and up to Day 35

,
Interventionng/mL (Median)
BaselineDay 35
Arm I (Cholecalciferol, Genistein)6.35.8
Arm II (Placebo)8.78.3

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Total IGFBP-3 in Serum at Baseline and Pre-Surgery

This is measuring the concentration of the Biomarker IGFBP-3 in blood serum at Baseline and at the end of the study. (NCT01325311)
Timeframe: Baseline and Up to Day 35

,
Interventionng/mL (Mean)
BaselineDay 35
Arm I (Cholecalciferol, Genistein)2004.51843.4
Arm II (Placebo)1838.91667.5

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PBMC CYP mRNA Expression of CYP27B1

This is a measure of expression of CYP27B1 in comparing placebo to Cholecalciferol/genistein. (NCT01325311)
Timeframe: Up to Day 35

InterventionRatio to Baseline (Geometric Mean)
Arm II (Placebo)1.656
Arm I (Cholecalciferol, Genistein)2.389

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25 (OH)D in Nmol/L Between Baseline and 6 Months

Change in 25 (OH)D level in SCD patients with and without chronic pain between baseline and 6 months. (NCT01331148)
Timeframe: Baseline and after 6 months of study participation

Interventionnmol/L (Mean)
Drug55.2
Placebo50.4

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Change in Post Load Glucose Concentrations

It was performed 2 hours after 75g oral glucose tolerance test (75-OGTT). (NCT01344161)
Timeframe: 3 months minus baseline

Interventionmmol/L (Mean)
Vitamin D-0.29
Placebo-0.3

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Change in Body Fat Mass

Body composition was assessed by Bioelectrical Impedance Analysis (model 4000; Body Stat Quad Scan, Douglas Isle of Man, British Isles).The principle of measuring the flow of current through the body is dependent on the frequency applied. At low frequencies, the current cannot bridge the cellular membrane and will pass predominantly through the extra-cellular space. At higher frequencies penetration of the cell membrane occurs and the current is conducted by both the extra-cellular water (ECW) and intra-cellular water (ICW).FFM can be estimated because FFM is primarily composed of water. (NCT01344161)
Timeframe: 3 months minus baseline

Interventionkg (Mean)
Vitamin D-2.7
Placebo-0.4

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Change in Glucose Concentrations

(NCT01344161)
Timeframe: 3 months minus baseline

Interventionmmol/L (Mean)
Vitamin D-0.28
Placebo-0.65

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Change in Insulin Concentrations

(NCT01344161)
Timeframe: 3 months minus baseline

Interventionpmol/L (Mean)
Vitamin D-24.8
Placebo-19

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Extension Study: Percentage Change From Baseline in s-CTx at Month 12

s-CTx is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. s-CTx was measured at baseline and Month 12. (NCT01350934)
Timeframe: Baseline and Month 12

InterventionPercent change (Least Squares Mean)
Fosamax Plus-76.15
Calcitriol-24.19

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Extension Study: Percentage Change From Baseline in s-P1NP at Month 12

s-P1NP is a biochemical marker of bone turnover that is particularly useful in monitoring bone resorption, a process by which bone is broken down within the body. s-P1NP was measured at baseline and Month 12. (NCT01350934)
Timeframe: Baseline and Month 12

InterventionPercent change (Least Squares Mean)
Fosamax Plus-68.07
Calcitriol-17.00

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Extension Study: Percentage of Participants With Serum 25-Hydroxyvitamin (OH) D <20 ng/mL at Month 12

"The term vitamin D insufficiency is used to describe vitamin D levels that are low enough to cause secondary hyperparathyroidism, bone loss, and increased risk of skeletal fracture. In this study, a threshold for vitamin D insufficiency was a level of serum 25(OH) D <20 ng/mL." (NCT01350934)
Timeframe: Baseline and Month 12

InterventionPercentage of Participants (Number)
Fosamax Plus4.1
Calcitriol47.1

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Base Study: Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 6

BMD at the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) at baseline and Month 6. (NCT01350934)
Timeframe: Baseline and Month 6

InterventionPercent change (Least Squares Mean)
Fosamax Plus3.54
Calcitriol1.59

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Base Study: Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 6

s-CTx is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. s-CTx was measured at baseline and Month 6. (NCT01350934)
Timeframe: Baseline and Month 6

InterventionPercent change (Least Squares Mean)
Fosamax Plus-79.23
Calcitriol-27.20

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Base Study: Percentage Change From Baseline in Serum Procollagen Type 1 N-Terminal Propeptide (s-P1NP) at Month 6

s-P1NP is a biochemical marker of bone turnover that is particularly useful in monitoring bone resorption, a process by which bone is broken down within the body. s-P1NP was measured at baseline and Month 6. (NCT01350934)
Timeframe: Baseline and Month 6

InterventionPercent change (Least Squares Mean)
Fosamax Plus-59.12
Calcitriol-16.75

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Extension Study: Percentage Change From Baseline in Lumbar Spine BMD at Month 12

BMD at the lumbar spine was assessed by DXA at baseline and Month 12. (NCT01350934)
Timeframe: Baseline and Month 12

InterventionPercent change (Least Squares Mean)
Fosamax Plus5.17
Calcitriol2.26

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Incident Autoimmune Diseases

"All participants were followed for the development of new autoimmune diseases, including, but not limited to, rheumatoid arthritis, psoriasis, autoimmune thyroid disease, inflammatory bowel disease and polymyalgia rheumatica. The primary endpoint was all incident autoimmune disease confirmed by extensive medical record review. Participants self-reported all incident autoimmune diseases from baseline through follow-up. We used Cox proportional hazards models to test the effects of vitamin D and n-3 fatty acids upon autoimmune disease incidence.~We compared the separate main effects of vitamin D or n-3 fatty acid supplement assignment on AD incidence using Cox regression models. To account for randomization stratification and study design, we additionally adjusted for age, sex, self-reported race, and randomization to the other supplement. Person-time was counted until diagnosis of a new confirmed AD, death, or the end of the trial. We also test interactions between the two supplements (NCT01351805)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D123
Placebo Vitamin D155
Active n-3 FA130
Placebo n-3 FA148

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Severity of Knee Pain in Subsample With Chronic, Frequent Knee Pain at Baseline- With n-3 FA & Vitamin D

"Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Pain was the primary outcome on a scale of 0-100 with 100= worst pain.~Subsample of VITAL participants with chronic, frequent knee pain at trial baseline were followed with annual WOMAC questionnaires to test for change in severity of chronic knee pain in those taking Omega-3 fish oil (n-3 FA) supplements compared to those taking placebo and for those taking Vitamin D supplements compared to those taking placebo. We tested whether n-3 FA supplements and Vitamin D are associated with reduced levels of WOMAC knee pain at the end of the trial (comparing knee pain outcomes in those receiving supplements to placebo). We will also test whether there were multiplicative interactions between the two supplements for the outcome of knee pain severity by WOMAC-Pain index" (NCT01351805)
Timeframe: Baseline and 5 years

,,,
InterventionWOMAC units on a scale (Mean)
Baseline mean WOMAC PainFollow Up mean WOMAC pain
Active n-3 FA36.533.6
Active Vitamin D35.432.7
Placebo n-3 FA35.433.7
Placebo Vitamin D36.534.6

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Serum Levels of Biomarkers of Systemic Inflammation: C-reactive Protein (CRP)

In a subsample of the randomized trial population across the four arms, blood samples at baseline and in follow-up were collected and analyzed for changes in biomarkers of systemic inflammation: C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-receptor 2 (TNFR2). We tested whether either or both supplements were associated with a decrease in the biomarkers of systemic inflammation (blood biomarker levels among those receiving supplements vs. placebo). We also tested whether there were interactions between the two supplements in their effects on changes in the CRP serum biomarker of systemic inflammation. (NCT01351805)
Timeframe: Baseline and 1 year

,,,
Interventionmg/L (Geometric Mean)
Baseline ln (hsCRP) mg/L, geometric mean (95% Cl)Year 1 ln (hsCRP) mg/L, geometric mean (95% CI)
Active n-3 FA1.571.63
Active Vitamin D1.481.62
Placebo n-3 FA1.431.53
Placebo Vitamin D1.511.54

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Serum Levels of Biomarkers of Systemic Inflammation: Interleukin-6 (IL-6)

In a subsample of the randomized trial population across the four arms, blood samples at baseline and in follow-up were collected and analyzed for changes in biomarkers of systemic inflammation: C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-receptor 2 (TNFR2). We tested whether either or both supplements were associated with a decrease in the biomarkers of systemic inflammation (blood biomarker levels among those receiving supplements vs. placebo). We also tested whether there were interactions between the two supplements in their effects on changes in the IL-6 serum biomarker of systemic inflammation. (NCT01351805)
Timeframe: Baseline and 1 year

,,,
Interventionpg/ml (Geometric Mean)
Baseline ln (IL-6) pg/ml, geometric mean (95% Cl)Year 1 ln (IL-6) pg/mL, geometric mean (95% CI)
Active n-3 FA1.691.70
Active Vitamin D1.711.80
Placebo n-3 FA1.701.72
Placebo Vitamin D1.681.63

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Serum Levels of Biomarkers of Systemic Inflammation: Tumor Necrosis Factor-receptor 2 (TNFR2)

In a subsample of the randomized trial population across the four arms, blood samples at baseline and in follow-up were collected and analyzed for changes in biomarkers of systemic inflammation: C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-receptor 2 (TNFR2). We tested whether either or both supplements were associated with a decrease in the biomarkers of systemic inflammation (blood biomarker levels among those receiving supplements vs. placebo). We also tested whether there were interactions between the two supplements in their effects on changes in the TNFR2 serum biomarker of systemic inflammation. (NCT01351805)
Timeframe: Baseline and 1 year

,,,
Interventionpg/ml (Geometric Mean)
Baseline ln (TNFR2) pg/ml, geometric mean (95% Cl)Year 1 ln (TNFR2) pg/mL, geometric mean (95% CI)
Active n-3 FA2571.32605.3
Active Vitamin D2546.52604.7
Placebo n-3 FA2500.92567.3
Placebo Vitamin D2525.42567.9

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Percent Change in Hepatic Insulin Sensitivity

Endogenous glucose production (EGP) was assessed at each study visit to evaluate hepatic insulin sensitivity. Percent change between the EGP at baseline and second visit (after treatment for up to 3 months with Vitamin D to reach a target level of ≥30 ng/ml), and baseline and third visits (after treatment for up to 6 months with Vitamin D in order to reach a target level of ≥50 ng/ml) will be calculated. (NCT01354964)
Timeframe: 2nd clamp visit (after up to 3 months) and 3rd clamp visit (after up to 6 months)

,
Interventionpercent change (Mean)
Percent change between baseline and 2nd visitPercent change between baseline and 3rd visit
Placebo5.8113.7
Vitamin D-19.2-33.66

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Evaluated Expression of Pro-inflammatory Gene TNF-α

Adipose tissue macrophages will be isolated from subcutaneous abdominal adipose tissue, and will be quantified by fluorescence activated cell sorting (FACS) analysis. TNF-α gene expression will be examined by real-time (rt-PCR) and will provide a measure of macrophage activation at baseline, at 2nd study visit (after treatment with Vitamin D to a goal level of ≥30 ng/ml), and at 3rd study visit (goal Vitamin D level of ≥50 ng/ml). The mRNA copy number is then compared with a reference gene copy number (5 commonly used house keeping genes [HKGs]) as a ratio, which is a measure of relative gene expression. (NCT01354964)
Timeframe: 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)

,
InterventionRatio of mRNA copy numbers (TNF-α/5HKGs) (Mean)
TNF-α (2nd study visit)TNF-α (3rd study visit)
Placebo0.0210.008
Vitamin D0.0230.036

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Percent Change in Peripheral Glucose Uptake

The rate of glucose uptake to determine peripheral insulin sensitivity was measured using the rate of disappearance (Rd) of glucose at each study visit. Percent change between the Rd at baseline and second visit (after treatment with Vitamin D for up to 3 months to target level of ≥30 ng/ml), and baseline and third visits (after treatment with Vitamin D for up to 6 months to target level of ≥50 ng/ml) will be calculated. (NCT01354964)
Timeframe: 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)

,
Interventionpercent change (Mean)
Percent change between baseline and 2nd visitPercent change between baseline and 3rd visit
Placebo-2.541.75
Vitamin D0.48-0.98

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Evaluated Expression of Pro-inflammatory Gene PAI-1

Adipose tissue macrophages will be isolated from subcutaneous abdominal adipose tissue, and will be quantified by fluorescence activated cell sorting (FACS) analysis. PAI-1 gene expression will be examined by real-time (rt-PCR) and will provide a measure of macrophage activation at baseline, at 2nd study visit (after treatment with Vitamin D to a goal level of ≥30 ng/ml), and at 3rd study visit (goal Vitamin D level of ≥50 ng/ml). The mRNA copy number is then compared with a reference gene copy number (5 commonly used house keeping genes [HKGs]) as a ratio, which is a measure of relative gene expression. (NCT01354964)
Timeframe: 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)

,
InterventionRatio of mRNA copy numbers (PAI-1/5HKGs) (Mean)
PAI-1 (2nd study visit)PAI-1 (3rd study visit)
Placebo0.0320.019
Vitamin D0.0200.008

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Evaluated Expression of Pro-inflammatory Gene iNOS

Adipose tissue macrophages will be isolated from subcutaneous abdominal adipose tissue, and will be quantified by fluorescence activated cell sorting (FACS) analysis. iNOS gene expression will be examined by real-time (rt-PCR) and will provide a measure of macrophage activation at baseline, at 2nd study visit (after treatment with Vitamin D to a goal level of ≥30 ng/ml), and at 3rd study visit (goal Vitamin D level of ≥50 ng/ml). The mRNA copy number is then compared with a reference gene copy number (5 commonly used house keeping genes [HKGs]) as a ratio, which is a measure of relative gene expression. (NCT01354964)
Timeframe: 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)

,
InterventionRatio of mRNA copy numbers (iNOS/5HKGs) (Mean)
iNOS (2nd study visit)iNOS (3rd study visit)
Placebo0.0080.005
Vitamin D0.0040.003

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Evaluated Expression of Pro-inflammatory Gene IL-6

Adipose tissue macrophages will be isolated from subcutaneous abdominal adipose tissue, and will be quantified by fluorescence activated cell sorting (FACS) analysis. IL-6 gene expression will be examined by real-time (rt-PCR) and will provide a measure of macrophage activation at baseline, at 2nd study visit (after treatment with Vitamin D to a goal level of ≥30 ng/ml), and at 3rd study visit (goal Vitamin D level of ≥50 ng/ml). The mRNA copy number is then compared with a reference gene copy number (5 commonly used house keeping genes [HKGs]) as a ratio, which is a measure of relative gene expression. (NCT01354964)
Timeframe: 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)

,
InterventionRatio of mRNA copy numbers (IL-6/5HKGs) (Mean)
IL-6 (2nd study visit)IL-6 (3rd study visit)
Placebo0.0470.050
Vitamin D0.0190.022

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Number of Children Who Developed Autism

The child will be screened by an Modified Checklist for Autism in Toddlers (MCHAT) interview at 18 months of age, and by a questionnaire, the Pervasive Developmental Disorder Behavioral Inventory (PDDBI) at 3 years of age to determine whether the child has developed autism or not. (NCT01366885)
Timeframe: Child assessed at 3 years of age

InterventionChildren who developed autism (Number)
Intervention During Pregnancy1

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Number of Mothers Who Developed Side Effects From Vitamin D

Mother will be followed by blood and urine screening for hypercalcemia and hypercalciuria which is the primary side effects of too much vitamin D. (NCT01366885)
Timeframe: During pregnancy and the 3 years of the child's development

Interventionparticipants (Number)
Intervention During Pregnancy0

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Number of Participants With Adverse Events

Unit of Measure is Safety and Tolerability. The number of participants with adverse events will be compared between the groups using the independent sample t-test (assuming the distribution is normal). (NCT01371877)
Timeframe: 3 month study trial

Interventionparticipants (Number)
High Dose Vitamin D0
Low Dose Vitamin D0

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Total Urticaria Severity Score at 3 Months

The Unit of Measure is Efficacy. The Total Urticaria Severity Score (USS) ranges from 0 to 93, higher scores = worse symptoms. This secondary outcome of this study is to determine if high dose vitamin D supplementation improves the urticaria severity score (USS). The change in USS will be compared between the groups using the independent sample t-test (assuming the distribution is normal). Logistic regression and multiple linear regression will be used to adjust for possible confounders. (NCT01371877)
Timeframe: 3 month intervention

,
Interventionunits on a scale (Mean)
Baseline Total Urticaria Score1 week Total Urticaria Score3 month Total Urticaria Score
High Dose Vitamin D41.1425.4815.0
Low Dose Vitamin D40.129.2424.1

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Medication Usage

The Unit of Measure is Efficacy. The primary outcome of this study is to determine if vitamin D supplementation reduces the medication usage in subjects with CUA. Thus, for the outcome of reduction in pills, at 12 weeks, subjects whose pill usage decreases by 2 or more pills per day will be classified as improved. Subjects whose pill consumption did not change or increased will be classified as unchanged. (NCT01371877)
Timeframe: 12 week intervention

,
Interventionnumber of pills/day (Mean)
Baseline medication usage3 month medication usage
High Dose Vitamin D2.82.0
Low Dose Vitamin D4.64.9

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Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 84

The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 84 measurement. (NCT01372995)
Timeframe: Day 84

Interventionparticipants (Number)
Placebo1
250,000 IU of Vitamin D30
500,000 IU of Vitamin D30

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Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 7

The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 7 measurement. (NCT01372995)
Timeframe: Day 7

Interventionparticipants (Number)
Placebo2
250,000 IU of Vitamin D34
500,000 IU of Vitamin D39

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Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 28

The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 28 measurement. (NCT01372995)
Timeframe: Day 28

Interventionparticipants (Number)
Placebo0
250,000 IU of Vitamin D32
500,000 IU of Vitamin D31

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Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 21

The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 21 measurement. (NCT01372995)
Timeframe: Day 21

Interventionparticipants (Number)
Placebo1
250,000 IU of Vitamin D33
500,000 IU of Vitamin D32

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Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 14

The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 14 measurement. (NCT01372995)
Timeframe: Day 14

Interventionparticipants (Number)
Placebo2
250,000 IU of Vitamin D35
500,000 IU of Vitamin D35

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Duration of Time in Hospital

The number of days that each participant spent in the hospital was collected and the average number of days for each study arm is reported. (NCT01372995)
Timeframe: 12 weeks

Interventiondays (Mean)
Placebo36
250,000 IU of Vitamin D325
500,000 IU of Vitamin D318

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Duration of Time in Intensive Care Unit (ICU)

The number of days spent in the intensive care unit (ICU) was collected for each participant and the average number of days for each study arm is reported. (NCT01372995)
Timeframe: 12 weeks

Interventiondays (Mean)
Placebo23
250,000 IU of Vitamin D317
500,000 IU of Vitamin D315

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Day 84 Mortality

The number of participants who died prior to the end of the study (Day 84) was collected. (NCT01372995)
Timeframe: Day 84

Interventionparticipants (Number)
Placebo2
250,000 IU of Vitamin D31
500,000 IU of Vitamin D34

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Change in Sequential Organ Failure Assessment (SOFA) Score

Change in Sequential Organ Failure Assessment (SOFA) score between Baseline and Day 7. The Sequential Organ Failure Assessment (SOFA) score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems (respiratory, nervous, cardiovascular, liver, coagulation, and kidneys). A score ranges from 0-24. 0 (normal) to 4 (high degree of dysfunction) is given for each organ system, with a higher score indicating greater severity. A score of 0-6 is associated with a mortality rate of less than 10% while a score between 16 and 24 is associated with a greater than 90% mortality rate. Scores decreasing between the Baseline and Day 7 measurements are represented as negative values for the change in SOFA score. (NCT01372995)
Timeframe: Baseline, Day 7

Interventionunits on a scale (Mean)
Placebo-2
250,000 IU of Vitamin D3-3
500,000 IU of Vitamin D3-2

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Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Baseline

The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the baseline measurement. (NCT01372995)
Timeframe: Baseline

Interventionparticipants (Number)
Placebo2
250,000 IU of Vitamin D32
500,000 IU of Vitamin D31

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Number of Hospital Mortality Cases

The number of study participants who died while in the hospital was collected. (NCT01372995)
Timeframe: 12 weeks

Interventionparticipants (Number)
Placebo1
250,000 IU of Vitamin D30
500,000 IU of Vitamin D31

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Number of Hospital Acquired Infections

The number of study participants who had a hospital acquired infection. (NCT01372995)
Timeframe: 12 weeks

Interventionparticipants (Number)
Placebo3
250,000 IU of Vitamin D33
500,000 IU of Vitamin D32

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Duration of Time on Ventilator

The number of days spent on mechanical ventilation was collected for all study participants and the average number of days for each study arm is reported. (NCT01372995)
Timeframe: 12 weeks

Interventiondays (Mean)
Placebo20
250,000 IU of Vitamin D312
500,000 IU of Vitamin D314

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Change in Plasma LL-37 Levels

Plasma LL-37 was measured at Baseline, Day 7 and Day 14. (NCT01372995)
Timeframe: Baseline, Day 7, Day 14

,,
Interventionng/mL (Median)
Day 7 Compared to BaselineDay 14 Compared to Baseline
250,000 IU of Vitamin D36.0-12.3
500,000 IU of Vitamin D3-13.5-6.0
Placebo-3.81.1

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Change in Volumetric Bone Mineral Density (vBMD)

To evaluate the change in volumetric BMD (VBMD) at the Tibia (NCT01375010)
Timeframe: Baseline, 12 months

Interventionpercentage of change (Mean)
Group A-0.3
Group B-0.9

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Change in Vitamin D Levels

To evaluate the change in vitamin D levels with supplementation (NCT01375010)
Timeframe: 12 months

Interventionpercentage of change (Mean)
Group A33.7
Group B64.1

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Areal Change in Bone Mineral Density (aBMD)

To evaluate the change in areal BMD (aBMD) at the total hip (TH) (NCT01375010)
Timeframe: Baseline,12 months

Interventionpercentage of change (Mean)
Group A-0.5
Group B-0.8

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Change in Biochemical Markers

To evaluate the effect of vitamin D and calcium supplementation on biochemical markers of bone turnover and markers of inflammation. (PTH) (NCT01375010)
Timeframe: 12 months

Interventionpercentage of change (Mean)
Group A-7.2
Group B-16.8

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Change in Bone Mineral Density (BMD)

Percent change from baseline in BMD at lumbar spine (as measured by Dual-emission X-ray absorptiometry (DXA) scan) at 12 months (NCT01375010)
Timeframe: Baseline, 12 months

Interventionpercentage change (Mean)
Group A0.4
Group B-0.8

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Compare the Effect of Calcitriol and Cholecalciferol Supplementation on Vascular Endothelial Cell Expression of Nf-kB

The effect of calcitriol and cholecalciferol supplementation will be evaluated calculating the mean change in total vascular endothelial cell NFkB expression. NFkB expression is given as arbitrary units and represent ratios of endothelial cell protein expression to human umbilical vein endothelial cell (HUVEC) expression in order to account for any variation in the staining procedure. (NCT01384539)
Timeframe: 6 months

Interventionratio of NFkB to HUVEC expression (Mean)
Cholecalciferol0.03
Calcitriol-0.01

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Compare the Efficacy of Calcitriol and Cholecalciferol Supplementation on Plasma Concentrations of C-reactive Protein

Secondary aims are focused to explore whether vitamin D improves vascular endothelial function through decreases in inflammation (NCT01384539)
Timeframe: 6 months

,
Interventionmg/dL (Median)
BaselineEnd of Study
Calcitriol3.43.9
Cholecalciferol3.03.1

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Compare the Difference Between the Calcitriol and Cholecalciferol Groups in Conduit Artery Endothelium-dependent Dilation (EDD) in Response to Treatment.

EDD will be measured by brachial artery flow-mediated dilation (FMD). The mean change in percent FMD from baseline will be documented. (NCT01384539)
Timeframe: 6 months

Interventionpercent change in FMD (Mean)
Cholecalciferol-0.5
Calcitriol0.3

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Vitamin D Concentrations, Pre Operative and Post Bariatric Surgery Following 12 Weeks of Vitamin D Supplementation

Serum 25(OH)D ng/ml levels at baseline and 12 weeks following bariatric surgery (NCT01385098)
Timeframe: baseline and 12 weeks

Interventionng/mL (Mean)
Preoperative12 weeks
Vitamin D3 and Calcium19.127.2

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Serum 25-hydroxyvitamin D Levels at Baseline and 12 Weeks of Daily Vit D Supplementation Post Roux-en Y OR Sleeve Gastrectomy

We anticipate that vitamin D supplementation of Roux-en Y bariatric surgery patients will be less effective in improving or maintaining vitamin D status. (NCT01385098)
Timeframe: Baseline and 12 weeks

,
Interventionng/mL (Mean)
Preoperative12 Weeks
Roux-Y Gastric Bypass19.628.1
Sleeve Gastrectomy18.526.3

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The Changes From Baseline in P1NP to Weeks 24 and 48

P1NP (marker of bone formation) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively). (NCT01403051)
Timeframe: Weeks 0, 24 and 48

,
Interventionng/mL (Median)
change from baseline to week 24change from baseline to week 48
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF1115
Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF2118

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Number of Participants With Primary Adverse Events

Primary adverse events include all SAEs defined according to ICH guidelines and targeted protocol events, which include all diagnoses of hypercalcemia, hypophoatemia, and nephrolithiasis as well as signs and symptoms grade 2 or higher that may be associated with hypercalcemia and all laboratory toxicities grade 2 or higher defined by the 2004 DAIDS grading table (NCT01403051)
Timeframe: From first study treatment to week 48

Interventionparticipants (Number)
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF50
Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF53

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The Percent Change From Baseline in Bone Mineral Density (BMD) at Spine

The percent change from baseline to week 48 in bone mineral density (BMD) at spine as measured by DXA scan (NCT01403051)
Timeframe: Weeks 0 and 48

Interventionpercentage change (Median)
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF-1.41
Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF-2.91

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The Percent Change From Baseline in Bone Mineral Density (BMD) at Total Hip

The efficacy endpoint is the percent change from baseline to week 48 in bone mineral density (BMD) at total hip (as measured by DXA scan) (NCT01403051)
Timeframe: Weeks 0 and 48

Interventionpercentage change (Median)
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF-1.46
Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF-3.19

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The Changes From Baseline in sCD14 to Weeks 24 and 48

Soluble cluster of differentiation 14 (sCD14) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively). (NCT01403051)
Timeframe: Weeks 0, 24 and 48

,
Interventionlog10 ng/mL (Median)
change from baseline to week 24change from baseline to week 48
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF0.020.07
Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF0.000.02

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The Changes From Baseline in Urinary Phosphate Excretion to Weeks 24 and 48

"Fractional excretion of phosphate changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).~Fractional Excretion of Phosphate (in %) is defined as:~[Urine Phosphate x Serum Creatinine] / [Urine Creatinine x Serum Phosphate] x 100%" (NCT01403051)
Timeframe: Weeks 0, 24 and 48

,
Interventionpercent (Median)
change from baseline to week 24change from baseline to week 48
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF0.70
Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF0.20.9

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The Changes From Baseline in iPTH to Weeks 24 and 48

iPTH (Parathyroid Hormone, intact) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively). (NCT01403051)
Timeframe: Weeks 0, 24 and 48

,
Interventionpg/mL (Median)
change from baseline to week 24change from baseline to week 48
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF0.41.1
Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF4.25.2

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The Changes From Baseline in IL-6 to Weeks 24 and 48

Interleukin 6 (IL-6) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively). (NCT01403051)
Timeframe: Weeks 0, 24 and 48

,
Interventionlog10 pg/mL (Median)
change from baseline to week 24change from baseline to week 48
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF-0.05-0.07
Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF-0.04-0.03

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The Changes From Baseline in HOMA-IR to Weeks 24 and 48

Homeostatic model assessment insulin resistance (HOMA-IR) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively). (NCT01403051)
Timeframe: Weeks 0, 24 and 48

,
InterventionHOMA-IR (Median)
change from baseline to week 24change from baseline to week 48
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF0.170.13
Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF0.390.26

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The Changes From Baseline in Fasting Total Cholesterol to Weeks 24 and 48

Fasting total cholesterol changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively). (NCT01403051)
Timeframe: Weeks 0, 24 and 48

,
Interventionmg/dL (Median)
change from baseline to week 24change from baseline to week 48
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF1113
Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF1814

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The Changes From Baseline in Fasting LDL to Weeks 24 and 48

Fasting LDL cholesterol changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively). (NCT01403051)
Timeframe: Weeks 0, 24 and 48

,
Interventionmg/dL (Median)
change from baseline to week 24change from baseline to week 48
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF02
Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF84

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The Changes From Baseline in CTX to Weeks 24 and 48

CTX (marker of bone resorption) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively). (NCT01403051)
Timeframe: Weeks 0, 24 and 48

,
Interventionng/mL (Median)
change from baseline to week 24change from baseline to week 48
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF0.110.10
Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF0.220.14

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The Changes From Baseline in CD4 to Weeks 4, 12, 24 and 48

Total CD4 count changes from baseline to weeks 4, 12, 24 and 48 [week 4/12/24/48 - baseline]. (NCT01403051)
Timeframe: Weeks 0, 4, 12, 24 and 48

,
Interventioncells/mm^3 (Median)
change from baseline to week 4change from baseline to week 12change from baseline to week 24change from baseline to week 48
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF74103138192
Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF60106136201

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The Change in Total 25-OH Vitamin D Level From Baseline to Weeks 24 and 48

"Changes in total 25-OH vitamin D from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).~Total 25-OH vitamin D is the sum of vitamin 25-OH D2 and D3 levels. All 25-OH vitamin D2 or D3 values below the lower limit of 1.25 ng/mL were imputed to 0 ng/mL" (NCT01403051)
Timeframe: Weeks 0, 24, and 48

,
Interventionng/mL (Median)
change from baseline to week 24change from baseline to week 48
Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF27.524.2
Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF-0.80.6

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Change in 25-hydroxyvitamin D Levels Over 5 Months

Determine the effectiveness of the intervention on improving 25-hydroxyvitamin D levels (change in 25(OH)D from baseline to 5-month follow-up). Measured as 5-month follow-up 25(OH)D level minus baseline 25(OH)D level. (NCT01410084)
Timeframe: 5 months

Interventionng/mL (Mean)
Vitamin D321.7
Vitamin E0

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Number of Participants Who Were Compliant to Intervention

Number of participants who consumed at least 4 out of a possible 5 supplement doses (=>80% compliance) over 5 months. (NCT01410084)
Timeframe: 5 months

InterventionParticipants (Count of Participants)
Vitamin D337
Vitamin E24

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Number of Falls

Determine the effectiveness of the intervention on reducing the number of falls using monthly fall calendars (compare the average number of falls in vitamin D3 group vs. active placebo group over 5 months) (NCT01410084)
Timeframe: 5 months

Interventionfalls/participant (Mean)
Vitamin D30.5
Vitamin E1.1

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Glycemic Control

hemoglobin A1C blood test (NCT01412710)
Timeframe: Baseline

InterventionPercentage of Hemoglobin (Mean)
4000 IU Group8.25
6000 IU Group8.26

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Blood Lipid

Total cholesterol will be used as surrogate measures for cardiovascular disease risk. (NCT01412710)
Timeframe: Baseline

Interventionmg/dl (Mean)
4000 IU Group213.08
6000 IU Group193.88

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Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26

Serum samples for Beta-CrossLaps (β-CTx) will be collected at specific visits during the treatment phase of the study. (NCT01437111)
Timeframe: Baseline and Week 26

InterventionPercent change (Mean)
Fosamax Plus: Recent/Current Osteoporosis Therapy at Baseline-12.65
Fosamax Plus: Other Osteoporosis Therapy at Baseline-49.82
Fosamax Plus: Treatment Naive at Baseline-76.81
Fosamax Plus: All Treated Participants-57.74

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Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26

Serum samples to measure serum 25-hydroxyvitamin D [25(OH)D] will be collected at specific visits during the treatment phase of the study. (NCT01437111)
Timeframe: Week 26

InterventionParticipants (Number)
Fosamax Plus: Recent/Current Osteoporosis Therapy at Baseline1
Fosamax Plus: Other Osteoporosis Therapy at Baseline3
Fosamax Plus: Treatment Naive at Baseline1
Fosamax Plus: All Treated Participants5

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Change in Parameters of the Vitamin D Assay Panel

Secondary outcomes are change in cholecalciferol, 24,25(OH)D3 and free 25(OH)D3. (NCT01465178)
Timeframe: Baseline, 1 and 4 months post supplementation

,
Interventionng/ml (Mean)
Cholecalciferol Month 1Cholecalciferol Month 424,25(OH)D3 Month 124,25(OH)D3 Month 4free 25(OH)D3 Month 1free 25(OH)D3 Month 4
2000 IU Vitamin D36.76.70.31.21.32.4
Placebo-0.6-0.20-0.2-0.1-0.2-0.1

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Change in Serum 25-hydroxy Vitamin D3

Our primary outcome variable is the effect of supplementation on change in serum 25(OH)D3; (NCT01465178)
Timeframe: Baseline, 1 and 4 months post supplementation

,
Interventionng/ml (Mean)
One MonthFour Month
2000 IU Vitamin D36.010.4
Placebo-0.80.3

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HOMA-IR to Adiponectin Ratio (HOMA-IR:Adiponectin) in Blood

The Homeostasis Model of Assessment-Insulin Resistance (HOMA-IR) was used to assess fasting insulin & glucose levels. HOMA-IR & adiponectin were assessed at baseline & after treatment in participants with body mass index ≤25 and >25. By protocol design, the outcome is for non-obese vs obese participants stratified between 400 & 10,000 IU/day. For all serum protein levels, the outcome is reported as the ratio of the baseline to post-treatment values (baseline:post-treatment) of the ratio of the mean serum levels of leptin & adiponectin, (ie, lepton:adiponectin). As a ratio of the ratio of means, the outcome is reported as a number without dispersion. The outcome expresses the treatment effect on HOMA-IR & adiponectin collectively, with <1.00 meaning effect on HOMA-IR levels is reduced relative to the effect on adiponectin levels, & >1.00 meaning the effect is increased relative, with a greater difference meaning greater effect (1.00 represents no measure change). (NCT01472445)
Timeframe: up to 6 weeks

,
Interventionratio baseline:post-treatment (slope) (Number)
Vitamin D 400 IU/dayVitamin D 10,000 IU/day
Non-obese (Body Mass Index ≤ 25)0.961.35
Obese (Body Mass Index > 25)0.520.99

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Expression Level of MKI67 Gene

Ki 67 gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and > 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect. (NCT01472445)
Timeframe: up to 6 weeks

,
Interventionratio baseline:post-treatment (slope) (Mean)
Vitamin D 400 IU/dayVitamin D 10,000 IU/day
Non-obese (Body Mass Index ≤ 25)-0.00958-0.01318
Obese (Body Mass Index > 25)-0.038090.00166

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Expression Level of Insulin-like Growth Factor-binding Protein 3 (IGFBP-3) Gene

"To determine whether dietary vitamin D can reverse the negative effects of obesity and insulin resistance as reflected by changes in breast cancer gene expression patterns in obese and non-obese subjects diagnosed with breast cancer. IGFBP-3 is an endocrine factors.~Insulin-like growth factor-binding protein 3 (IGFBP-3) gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and > 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect." (NCT01472445)
Timeframe: up to 6 weeks

,
Interventionratio baseline:post-treatment (slope) (Mean)
Vitamin D 400 IU/dayVitamin D 10,000 IU/day
Non-obese (Body Mass Index ≤ 25)0.029370.0158
Obese (Body Mass Index > 25)0.009410.01443

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Expression Level of ESR1 Gene

ESR1 gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and > 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect. (NCT01472445)
Timeframe: up to 6 weeks

,
Interventionratio baseline:post-treatment (slope) (Mean)
Vitamin D 400 IU/dayVitamin D 10,000 IU/day
Non-obese (Body Mass Index ≤ 25)0.00526-0.05757
Obese (Body Mass Index > 25)-0.027390.01225

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Expression Level of Cyclin-dependent Kinase Inhibitor 1 (CDKI1; p21) Gene

p21 [aka p21Cip1; p21Waf1, cyclin-dependent kinase inhibitor 1 (CDKI1) or cyclin-dependent kinase (CDK)-interacting protein 1 (CDKIP1)] gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and > 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect. (NCT01472445)
Timeframe: up to 6 weeks

,
Interventionratio baseline:post-treatment (slope) (Mean)
Vitamin D 400 IU/dayVitamin D 10,000 IU/day
Non-obese (Body Mass Index ≤ 25)0.048680.02236
Obese (Body Mass Index > 25)0.034650.01854

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cRP (C-reactive Protein) to Adiponectin Ratio (cRP:Adiponectin) in Blood

Levels in blood of cRP (C-reactive protein) & adiponectin were assessed at baseline & after treatment in participants with body mass index (BMI) ≤25 and >25. By protocol design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day & 10,000 IU/day. For all serum protein levels, the outcome is the ratio of the baseline to post-treatment values (baseline:post-treatment) of the ratio of the mean serum levels of leptin & adiponectin, (ie, lepton:adiponectin). As a ratio of the ratio of means, the outcome is reported as a number without dispersion. The outcome value expresses the treatment effect on cRP and adiponectin collectively, with a value < 1.00 meaning effect on cRP levels was reduced relative to the effect on adiponectin levels, and a value > 1.00 meaning effect on cRP levels was increased relative to the effect on adiponectin levels, with a larger difference from 1.00 indicating a greater effect (1.00 represents no measure change). (NCT01472445)
Timeframe: up to 6 weeks

,
Interventionratio baseline:post-treatment (slope) (Number)
Vitamin D 400 IU/dayVitamin D 10,000 IU/day
Non-obese (Body Mass Index ≤ 25)0.801.33
Obese (Body Mass Index > 25)0.831.00

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Expression Level of Matrix Metalloproteinase-11 (MMP-11) Gene

Matrix metalloproteinase-11 (MMP-11), aka Stromelysin-3 (SL-3), gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and > 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect. (NCT01472445)
Timeframe: up to 6 weeks

,
Interventionratio baseline:post-treatment (slope) (Mean)
Vitamin D 400 IU/dayVitamin D 10,000 IU/day
Non-obese (Body Mass Index ≤ 25)-0.03238-0.00986
Obese (Body Mass Index > 25)-0.00590-0.02139

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Pharmacokinetics of Vitamin D Metabolite Calcitriol

Blood levels (pharmacokinetics) of Vitamin D were evaluated as the blood levels of Vitamin D metabolite calcitriol (also known as 1,25-dihydroxycholecalciferol or 1,25(OH)2D) in participants receiving 400 IU/day Vitamin D. The outcome is reported as the mean calcitriol level pre-treatment and post-treatment, with standard deviation. (NCT01472445)
Timeframe: up to 6 weeks

,
Interventionng/mL (Mean)
Pre-treatment, 400 IU/dayPre-treatment, 10,000 IU/dayPost-treatment, 400 IU/dayPost-treatment, 10,000 IU/day
Non-obese (Body Mass Index ≤ 25)30.4430.7530.8953.75
Obese (Body Mass Index > 25)34.6737.1731.6759.33

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Leptin to Adiponectin Ratio (Leptin:Adiponectin) in Blood

Levels in blood of leptin & adiponectin were assessed at baseline & after treatment in participants with body mass index ≤25 and >25. By protocol design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day and 10,000 IU/day. For all serum protein levels, the outcome is reported as the ratio of the baseline to post-treatment values (baseline:post-treatment) of the ratio of the mean serum levels of leptin and adiponectin, (ie, lepton:adiponectin). As a ratio of the ratio of means, the outcome is reported as a number without dispersion. The outcome value expresses the treatment effect on both leptin and adiponectin collectively, with a value <1.00 meaning that the effect on leptin levels was reduced relative to the effect on adiponectin levels, and a value >1.00 that the effect on leptin levels was increased relative to the effect on adiponectin levels, with a larger difference from 1.00 indicating a greater effect (1.00 means no measure change). (NCT01472445)
Timeframe: up to 6 weeks

,
Interventionratio baseline:post-treatment (slope) (Number)
Vitamin D 400 IU/dVitamin D 10,000 IU/d
Non-obese (Body Mass Index ≤ 25)0.870.95
Obese (Body Mass Index > 25)1.001.00

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Number of Genes That Showed Changes in Expression After Vitamin D Treatment

Normal cells have a complex series of molecular signals that allow communication between cells and to the cell nucleus. These signals work together to control one or more cell functions, such as cell division or cell death. Abnormal signaling activity caused by changes in gene expression can lead to cancer. An understanding of abnormal signaling, both in the tumor and in normal tissues, may lead to new therapies in cancer patients. We wish to identify changes in molecular signaling that occur in the development of melanoma that might be suppressed in benign nevi (moles) in response to vitamin D supplementation. (NCT01477463)
Timeframe: 2 years

Interventionnumber of genes (Number)
All Patients Treated With Vitamin D3270

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Incidence of Hypercalcemia for Vitamin D Toxicity

Calcium levels (NCT01477463)
Timeframe: 2 years

Interventionparticipants (Number)
Arm A: Vitamin D0
Arm B: Placebo0

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Number of Genes Differentialy Regulated in Melanoma That Showed Changes in Expression After Vitamin D Treatment

We utilized a prior gene expression study that compared malignant melanoma cells to benign nevi (moles) and identified over 2300 genes that were differentially regulated in melanoma compared to benign nevi. There were approximately 270 genes in our data set that showed changes in expression after vitamin D treatment. We wish to identify overlap between these two groups. (NCT01477463)
Timeframe: 2 years

Interventionnumber of genes (Number)
All Patients Treated With Vitamin D347

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Vitamin D Toxicity

serum 25(OH)D for (NCT01477463)
Timeframe: 2 years

Interventionng/ml (Mean)
Arm A: Vitamin D47.11
Arm B: Placebo29.83

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Proportion of Participants With Sustained Disability Progression

The Expanded Disability Status Scale (EDSS) is an ordinal clinical rating scale based on a standard neurological examination and is used to measure global neurologic impairment in people with multiple sclerosis (MS). It ranges from a minimum of 0.0 (normal examination) to 10.0 (death due to MS) in half-point increments. A participant will be considered to have had sustained progression of disability if there is an increase in the EDSS score at month 12 by at least 1.0 point that is confirmed on the final examination one year later (month 24). (NCT01490502)
Timeframe: 2 years

Interventionproportion of participants (Number)
Low-dose Vitamin D30.05
High-dose Vitamin D30.08

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Number of Relapses Requiring Treatment

(NCT01490502)
Timeframe: 2 years

Interventionrelapses (Mean)
Low-dose Vitamin D30.15
High-dose Vitamin D30.28

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Number of New or Enlarging T2 Lesions

(NCT01490502)
Timeframe: 2 years

Interventionlesions (Mean)
Low-dose Vitamin D31.95
High-dose Vitamin D32.88

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Development of Nephrolithiasis

(NCT01490502)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Low-dose Vitamin D31
High-dose Vitamin D32

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Proportion of Subjects That Experience a Relapse

Confirmed relapse defined as new or worsening symptoms referable to the central nervous system, lasting at least 24 hours, occurring at least 30 days since the prior attack, accompanied by worsening of the EDSS (>= 0.5 points) or in the Functional Systems (FS) scales (2 points on at least one FS scale or 1 point on >= two FS scales). (NCT01490502)
Timeframe: 2 years

Interventionproportion of participants (Number)
Low-dose Vitamin D30.32
High-dose Vitamin D30.34

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Change in Multiple Sclerosis Functional Composite (MSFC) Score

"The Multiple Sclerosis Functional Composite (MSFC) is a three-part measure of disability for people with multiple sclerosis, including measures of leg function/ambulation, arm/hand function and cognitive function. The three independent measures have different units. We take the reciprocal of the arm/hand function test, and then convert all measures to Z-scores. The average of the Z-scores from each measure yields the MSFC composite Z-score. A Z-score of 0 represents the population mean and positive scores indicate less disability.~The MSFC was measured at baseline and up to 4 more times over 2 years." (NCT01490502)
Timeframe: 2 years

InterventionZ-score (Mean)
Low-dose Vitamin D30.051
High-dose Vitamin D30.025

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Change in Normalized Gray Matter Volume

(NCT01490502)
Timeframe: 2 years

Interventionmicroliters (Mean)
Low-dose Vitamin D3-0.15
High-dose Vitamin D3-0.87

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Development of Hypercalcemia

(NCT01490502)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Low-dose Vitamin D30
High-dose Vitamin D30

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Annualized Relapse Rate

Average relapses per year (NCT01490502)
Timeframe: 2 years

Interventionrelapses per participant per year (Mean)
Low-dose Vitamin D30.20
High-dose Vitamin D30.34

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Change in Brain Parenchymal Volume

(NCT01490502)
Timeframe: 2 years

Interventionmicroliters (Mean)
Low-dose Vitamin D3-0.29
High-dose Vitamin D3-0.81

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Change in Low-contrast Acuity

Low-contrast acuity was measured as binocular vision on a 2.5% Sloan chart at a distance of 2 meters. The chart is used to test the ability to discriminate gradually smaller gray letters with a 2.5% contrast level against a white background. The low-contrast acuity measure is scored as total letters read and ranges from 0 (no letters read) to 60 (all letters read). Low-contrast acuity was measured at baseline and up to 4 more times over 2 years and higher scores indicate better low-contrast acuity. (NCT01490502)
Timeframe: 2 years

Interventionletters (Mean)
Low-dose Vitamin D30.82
High-dose Vitamin D31.09

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Number of Participants With Peripheral Neurotoxic Reactions

NCI CTCAE Version 4.0 (NCT01499940)
Timeframe: Up to 12 months

InterventionParticipants (Count of Participants)
Vitamin D3 2000 IU/Day5

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Change in Steady State Concentrations of Serum Anastrazole and Letrozole

Difference in steady state concentrations in plasma from baseline to 6 months (NCT01509079)
Timeframe: baseline to 6 months

,
Interventionmg/L (Mean)
anastrozoleletrozole
Vitamin D3 4000 IU-1.312.16
Vitamin D3 600 IU2.4-0.83

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Serum Estradiol Concentrations

(NCT01509079)
Timeframe: baseline and 6 months

,
Interventionpg/ml (Geometric Mean)
Baseline6 months
Vitamin D3 4000 IU2.832.94
Vitamin D3 600 IU2.773.0

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Average Percent Adherence to Vitamin D Interventio

adherence measured with pill counts for the vitamin D at predesignated study timepoints: baseline (after run-in), 3 months and 6 months (NCT01509079)
Timeframe: average for all study ppts for: screening to baseline; baseline to 3 months; 3 month to 6 months

Intervention% of adherence for each treatment arm (Number)
Vitamin D3 4000 IU95
Vitamin D3 600 IU95

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Change in Hand Grip Strength

(NCT01509079)
Timeframe: baseline to 6 months

Interventionpounds (Mean)
Vitamin D3 4000 IU1.8
Vitamin D3 600 IU1.0

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Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale

The MS subscale is a self-reported measure on a scale of 0 to 4, with lower score indicating less arthralgia/myalgia (NCT01509079)
Timeframe: baseline to 6 months

Interventionunits on a scale (Mean)
Vitamin D3 4000 IU-0.2
Vitamin D3 600 IU-0.5

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Change in PROMIS Physical Functioning Questionnaire

PROMIS measures physical functioning on the short form and higher scores reflect better physical functioning with 10 questions on daily activities of life on a Likert scale ranging from 5 (no problem performing activity) to 1 (cannot do activity). Range on this measure is from 50 (best)-10 (worst). (NCT01509079)
Timeframe: baseline to 6 months

Interventionunits on a scale (Mean)
Vitamin D3 4000 IU0.6
Vitamin D3 600 IU1.7

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Whole Body Bone Mineral Density

GLM Mean and standard deviation of Whole Body Bone Mineral Density (grams/cm2) of Trial Participants by Treatment Arm after controlling for bisphosphonate use (NCT01509079)
Timeframe: From Baseline and 6 months of D3 supplementation

Interventiongm/cm2 (Geometric Least Squares Mean)
Vitamin D3 4000 IU1.1
Vitamin D3 600 IU1.12

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Changes in Serum 25(OH)D3 Levels

Evaluate the dose-related efficacy of correction of Vitamin D deficiency for 25(OH)D3 levels in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral Vitamin D supplementation: control dose (18,000 IU per month) or supplemented dose (medium 60,000IU per month or high dose 120,000IU/month ) (NCT01523496)
Timeframe: 6 months

Interventionng/mL (Median)
HIV Positive on Vit D Control Dose11
HIV Positive on Vit D Supplementation Dose22
HIV Negative on Vitamin D Control Dose7.5
HIV Negative on Vitamin D Supplementation Dose25

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Changes in Vitamin D Binding Protein (VDBP)

Evaluate the dose-related efficacy of vitamin D binding Protein in levels in the blood in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral vitamin D supplementation. (NCT01523496)
Timeframe: 6 months

Interventionng/mL (Median)
HIV + on Vitamin D Control Dose3.9
HIV + on Vit D Supplementation Dose-8.9
HIV Negative on Vit D Control Dose-11.3
HIV Negative on Vit D Supplementation Dose-11.7

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Change in Serum Hepcidin With Vitamin D Intervention for Children With Chronic Kidney Disease

The null hypothesis to be tested is that Vitamin D supplementation will not be associated with a decrease in serum hepcidin over the study period. Statistical analysis will be performed as intention-to-treat. (NCT01532349)
Timeframe: change from baseline to up to three months

Interventionng/ml (Median)
400 IU Vitamin D48.2
4000 IU Vitamin D75.4

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Total 25-OH Vitamin D3 Level

circulating total 25-OH vitamin D concentration (NCT01554241)
Timeframe: 16 weeks

Interventionng/mL (Mean)
Vitamin D3 800 IU/Day33
2000 IU/Day D334
Vitamin D3 4000 IU/Day43
50,000 IU/Week D361

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Free 25-OH Vitamin D3

circulating free 25-OH vitamin D3 concentration (NCT01554241)
Timeframe: 16 weeks

Interventionpg/mL (Mean)
Vitamin D3 800 IU/Day8.7
2000 IU/Day D39.5
Vitamin D3 4000 IU/Day12.2
50,000 IU/Week D316.8

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25-hydroxyvitamin D Levels at 12 Weeks

(NCT01596842)
Timeframe: 12 weeks

Interventionng/ml (Mean)
Omega-3 Fatty Acid44.4
Olive Oil48.9

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Hemoglobin Levels at 12 Weeks

(NCT01596842)
Timeframe: 12 weeks

Interventiong/dL (Mean)
Omega-3 Fatty Acid10.3
Olive Oil11

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Bone Density

Measured by bone speed of sound (ultrasound) (NCT01601847)
Timeframe: Measured at the 12 month adjusted age visit

Interventionm/s (Median)
Sustained3155
Diet-Limited3149

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Number With Infants With Allergic Sensitization as Measured by the PhadiaTop Infant Assay

Measured using the Phadiatop Infant IgE panel (NCT01601847)
Timeframe: Measured at the 12 month adjusted age visit

InterventionParticipants (Count of Participants)
Sustained7
Diet-Limited3

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Number of Infants With Recurrent Wheezing

Recurrent wheezing was defined as more than 1 episode of wheezing reported during the study period. Separate episodes were defined as occurring at least 2 weeks apart. (NCT01601847)
Timeframe: up to 12 months adjusted age

InterventionParticipants (Count of Participants)
Sustained42
Diet-Limited56

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The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up.

The blood levels of intact parathyroid hormone (iPTH) at the 24th month of following up will be detected. (NCT01633853)
Timeframe: 24 months

Interventionpg/ml (Mean)
Vitamin D296.5
1,25(OH)2 Vitamin D3108.1

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The Blood 25(OH)Vitamin D Level.

The levels of blood 25(OH)Vitamin D at the 24th month of following up. (NCT01633853)
Timeframe: 24 months

Interventionng/ml (Mean)
Vitamin D237.31
1,25(OH)2 Vitamin D318.07

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The Blood Levels of Phosphorus at the 24th Month of Following up.

The blood levels of phosphorus at the 24th month of following up will be detected. (NCT01633853)
Timeframe: 24 months

Interventionmmol/L (Mean)
Vitamin D21.27
1,25(OH)2 Vitamin D31.25

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The Blood Levels of Calcium at the 24th Month of Following up.

The blood levels of calcium at the 24th month of following up will be detected. (NCT01633853)
Timeframe: 24 months

Interventionmmol/L (Mean)
Vitamin D22.31
1,25(OH)2 Vitamin D32.33

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The Incidence Rate of Secondary Hyperparathyroidism.

Patients with the blood iPTH level higher than 300 pg/ml will be regard as sHPT. The incidence of sHPT during following up were recorded and compared between two groups. (NCT01633853)
Timeframe: 24 months

Interventionparticipants (Number)
Vitamin D2 Treatment14
1,25(OH)2 Vitamin D315

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Area Under the Curve From 0 to 6 Hours Post Dose of Parathyroid Hormone (PTH AUC0-6h) in Serum

The area under the curve from 0 to 6 hours post dose of parathyroid hormone (PTH AUC0-6h) in serum, calculated using the linear trapezoidal formula. (NCT01639222)
Timeframe: Day 3 in Period 1 (Reference) and Day 3 in Period 2. Samples were taken at predose, 0.5, 1, 2, 3, 4, and 6 hour post dose.

Interventionh*pg/mL (Mean)
Calcium 500 mg and Vitamin D3 800 IU202.02
Reference Treatment278.86

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Amount of Calcium Excreted in Urine From 0 Hours up to 6 Hours Post Dose (Ca2+ Ae0-6h)

Ca2+ Ae0-6h was calculated as the urine volume of the urine collected from 0 to 6 hours multiplied by the calcium concentration measured in urine. (NCT01639222)
Timeframe: Day 3 of Period 1 (Reference) and Day 3 in Period 2. Samples were taken 0-6 Hours post dose

Interventionmmol (Mean)
Calcium 500 mg and Vitamin D3 800 IU1.07
Reference Treatment0.63

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Amount of Calcium Excreted in Urine From 0 to 6 Hours Post Dose Corected for Creatinine (Ae0-6h/Creatinine)

To account for potential inaccuracies in urine collection, creatinine correction of calcium excretion was also assessed. Ca2+ Ae0-6h/Creatinine was obtained by dividing the urinary concentration of calcium by the urinary creatinine concentration. (NCT01639222)
Timeframe: Day 3 of Period 1 (Baseline) and Day 3 in Period 2. Samples will be taken 0-6 Hours postdose

Interventionliters (Mean)
Calcium 500 mg and Vitamin D3 800 IU1.05
Reference Treatment0.69

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Change in Percentages of T Cell Subsets (IFNγ+ and IL-17+)

Analyzed the mean percentage change in IFNγ+ and IL-17+ cluster of differentiation 4 (CD4) + cells (post- versus pre- supplementation). This represents a change between two time points (90 days versus baseline). (NCT01667796)
Timeframe: Baseline, 90 days

,
Interventionpercentage of cells (Mean)
mean percentage change in IFNγ+ CD4+ cellsmean percentage change in IL-17+ CD4+ cells
Healthy Controls-13.2-0.17
MS Subjects-5.20.21

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Change in Mean Serum Level of 25-hydroxyvitamin D

Generalized estimating equations (GEE) with an autoregressive with lag one correlation matrix were used to compare the serially-measured serum 25(OH)D levels between MS patients and Healthy Controls (HCs) to take into account repeated measures and within-subject correlations. (NCT01667796)
Timeframe: Baseline to 90 days

Interventionnmol/L (Mean)
MS Subjects65.9
Healthy Controls82.4

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Change in Executive Function Score for Cognitive Decline

"The outcome measure is change over time (last assessment score minus the baseline assessment score) in the EXECUTIVE FUNCTION SCORE combining z-scores of 4 tests: category fluency (animal naming), digit span backwards, and Oral Trails Making Test (OTMT)-Part A and OTMT-Part B; for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or decline) over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of +0.006." (NCT01669915)
Timeframe: Change over two assessments (baseline, 2.8 years)

InterventionZ-score (Mean)
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D-0.48
TELEPHONE INTERVIEW ANCILLARY STUDY: Vitamin D Placebo-0.48
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Omega-3 Fatty Acids-0.47
TELEPHONE INTERVIEW ANCILLARY STUDY: Omega-3 Fatty Acids Placebo-0.49

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Change in Episodic Memory Score for Cognitive Decline

"The outcome measure was change over time (last assessment score minus the baseline assessment score) in the EPISODIC MEMORY SCORE combining z-scores of 4 tests: the immediate and delayed recalls of both the East Boston Memory Test (EBMT) and the Telephone Interview of Cognitive Status (TICS) 10-word list; for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or decline) over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.01." (NCT01669915)
Timeframe: Change over two assessments (baseline, 2.8 years)

InterventionZ-score (Mean)
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D0.00
TELEPHONE INTERVIEW ANCILLARY STUDY: Vitamin D Placebo-0.02
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Omega-3 Fatty Acids-0.03
TELEPHONE INTERVIEW ANCILLARY STUDY: Omega-3 Fatty Acids Placebo0.02

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Change in Telephone Interview of Cognitive Status (TICS) for Cognitive Decline.

Change over time (last assessment score minus the baseline assessment score) on the TICS (0-41 points), a measure of general cognition. A higher value on the TICS represents better cognitive performance; for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.05 (NCT01669915)
Timeframe: Change over two assessments (baseline, 2.8 years)

Interventionscore on a scale (Mean)
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D0.12
TELEPHONE INTERVIEW ANCILLARY STUDY: Vitamin D Placebo0.07
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Omega-3 Fatty Acids0.005
TELEPHONE INTERVIEW ANCILLARY STUDY: Omega-3 Fatty Acids Placebo0.18

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Change in Global Composite Score for Cognitive Decline

"We administered by telephone, eight cognitive tests (1.Telephone Interview of Cognitive Status (TICS); 2.Delayed recall of the TICS 10-word list; 3.East Boston Memory Test (EBMT); 4.Delayed recall of the EBMT; 5.Category fluency test (animal naming test); 6.Oral Trail Making Test (OTMT-Part A); 7. OTMT-Part B; 8.Digit span backwards). The primary endpoint was the change over time (last assessment score minus the baseline assessment score) in GLOBAL COMPOSITE SCORE (average of Z-scores of component tests); for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or decline) over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.004." (NCT01669915)
Timeframe: Change over two assessments (baseline, 2.8 years).

InterventionZ-score (Mean)
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D-0.24
TELEPHONE INTERVIEW ANCILLARY STUDY: Vitamin D Placebo-0.25
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Omega-3 Fatty Acids-0.25
TELEPHONE INTERVIEW ANCILLARY STUDY: Omega-3 Fatty Acids Placebo-0.24

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The Change of Bone Mineral Density (BMD) Value

Higher Bone Mineral Density(BMD) value mean a better outcome. (NCT01675297)
Timeframe: baseline and 12 months

,
Interventiong/cm^2 (Mean)
baseline12 monthschange(12months-baseline)
Risedronate0.770.800.03
Risendronate/Cholecalciferol Combination0.770.810.04

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The Change of 25OHD(25-hydroxyvitamin D)

"range of 25OHD: 4.80~52.80 Higher 25OHD scores mean a better outcome.~If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed." (NCT01675297)
Timeframe: baseline, 6months, 12months

,
Interventionng/ml (Mean)
25OHD(baseline)25OHD(6months)25OHD(12months)25OHD change(6months-baseline)25OHD change(12months-baseline)
Risedronate17.8319.4718.351.680.53
Risendronate/Cholecalciferol Combination18.2328.9330.5710.7412.33

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PTH(Parathyroid Hormone Value)

"range of PTH: 13~54 Higher PTH scores mean a worse outcome.~If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed." (NCT01675297)
Timeframe: baseline, 6months, 12months

,
Interventionpg/ml (Mean)
PTH(baseline)PTH(6months)PTH(12months)PTH change(6months-baseline)PTH change(12months-baseline)
Risedronate39.1742.4045.273.396.16
Risendronate/Cholecalciferol Combination40.4837.3439.17-2.78-1.34

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Change in NT-proBNP

Changes in serum concentrations in NT-proBNP (NCT01684722)
Timeframe: baseline to 5 years

Interventionng/l (Geometric Mean)
Vitamin D1.72
Vitamin D Placebo1.38
Fish Oil1.56
Fish Oil Placebo1.54

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Change in Interleukin-6

Changes in serum concentrations in IL-6 (NCT01684722)
Timeframe: baseline to 5 years

Interventionpg/ml (Geometric Mean)
Vitamin D1.04
Vitamin D Placebo1.09
Fish Oil1.10
Fish Oil Placebo1.02

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Change in Estimated Glomerular Filtration Rate

GFR estimated from serum creatinine and cystatin C (NCT01684722)
Timeframe: baseline to 5 years

InterventionmL/min/1.73m2 (Mean)
Vitamin D-12.3
Vitamin D Placebo-13.1
Fish Oil-12.2
Fish Oil Placebo-13.1

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Change in C-reactive Protein

Changes in serum concentrations in CRP (NCT01684722)
Timeframe: baseline to 5 years

Interventionmg/L (Geometric Mean)
Vitamin D0.93
Vitamin D Placebo1.03
Fish Oil0.90
Fish Oil Placebo1.05

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Change in Urine Albumin Excretion

Change in urine albumin-creatinine ratio. (NCT01684722)
Timeframe: baseline to 5 years

Interventiongeometric mean ratio (Geometric Mean)
Vitamin D2.97
Vitamin D Placebo3.02
Fish Oil2.94
Fish Oil Placebo3.05

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Change in LDL Cholesterol Level

(NCT01688102)
Timeframe: baseline and 6 months or last observation carried forward (minimum 2 months)

Interventionmg/dl (Mean)
Oral Vitamin D33.2
Ultraviolet Light1.4

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Change in Parathyroid Hormone (PTH)

(NCT01688102)
Timeframe: baseline vs.6 months

Interventionpg/mL (Mean)
Oral Vitamin D3-5
Ultraviolet Light-9

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Change in Total Cholesterol

Change in Total Cholesterol (NCT01688102)
Timeframe: baseline and 6 months or last observation carried forward (minimum 2 months)

Interventionmg/dL (Mean)
Oral Vitamin D34.1
Ultraviolet Light2.0

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Change in Serum Calcium

(NCT01688102)
Timeframe: baseline vs. 6 months

Interventionmg/dL (Mean)
Oral Vitamin D3.09
Ultraviolet Light.07

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Change in Triglycerides

(NCT01688102)
Timeframe: baseline 6 months or last observation carried forward (minimum 2 months)

Interventionmg/dL (Mean)
Oral Vitamin D32.6
Ultraviolet Light1.7

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Correlation Between Change in LDL Cholesterol and Change in Calcium

The Correlation between change in LDL cholesterol and change in serum calcium (NCT01688102)
Timeframe: 2 months

InterventionPearson correlation coefficient (Number)
Oral Vitamin D30.24
Ultraviolet Light.16

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Correlation Between Change in LDL Cholesterol and Change in PTH

(NCT01688102)
Timeframe: 2 months

InterventionPearson correlation coefficient (Number)
Oral Vitamin D3-.01
Ultraviolet Light.18

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Gene Expression Changes in Peripheral Blood

Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets. (NCT01688102)
Timeframe: baseline vs. 2 months

,
InterventionGSEA Normalized Enrichment Score (Number)
Interferon-alpha responseInterferon-gamma response
Oral Vitamin D34.143.41
Ultraviolet Light-4.05-4.86

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Gene Expression Changes in Skin

Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets. (NCT01688102)
Timeframe: baseline vs. 2 months

,
InterventionGSEA Normalized Enrichment Score (Number)
Interferon-alpha responseInterferon-gamma response
Oral Vitamin D32.082.12
Ultraviolet Light-2.43-2.00

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Change in 25(OH)D

(NCT01688102)
Timeframe: baseline vs. 6 months

Interventionng/ml (Mean)
Oral Vitamin D318.7
Ultraviolet Light15.6

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Change in C Reactive Protein

(NCT01688102)
Timeframe: baseline and 6 months

Interventionmg/L (Mean)
Oral Vitamin D31.88
Ultraviolet Light-.11

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Change in HDL Cholesterol

(NCT01688102)
Timeframe: baseline and 6 months or last observation carried forward (minimum 2 months)

Interventionmg/dL (Mean)
Oral Vitamin D30.2
Ultraviolet Light0.3

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Percent (%) Change in Pre-surgical 25(OH)D 2 Weeks After Surgery

The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of changes in vitamin D status within 10-18 days after surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL-37. (NCT01689779)
Timeframe: Patients will be followed between the day of surgery and an average duration of 14 days after surgery

InterventionPercent change in 25(OH)D (Mean)
Cholecalciferol3
Sugar Pill1

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Percent (%) Change in 25(OH)D 5 Days Following Supplementation With 100,000 IU Cholecalciferol

3-7 days before surgery, patients will receive 100,000 IU of cholecalciferol (vs. placebo) during their pre-op assessment. They will also have their baseline vitamin D status measured during this initial visit. The main study outcome is to determine if 100,000 IU cholecalciferol can be given preoperatively to safely boost vitamin D status. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37 (NCT01689779)
Timeframe: Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days

Interventionpercent change in 25(OH)D (Mean)
Cholecalciferol8
Sugar Pill-2

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Percent (%) Change in Pre-surgical 25(OH)D Within 24 Hours of Surgery

The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of short-term changes in vitamin D status following surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37. (NCT01689779)
Timeframe: Patients will be followed between the day of surgery and 1 day after surgery

InterventionPercent change in 25(OH)D (Mean)
Cholecalciferol-5
Sugar Pill-4

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Percent (%) Change in Pre-surgical LL-37 2 Weeks After Surgery

The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of changes in vitamin D status within 10-18 days after surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL-37. (NCT01689779)
Timeframe: Patients will be followed between the day of surgery and an average duration of 14 days after surgery

InterventionPercent change in LL-37 (Mean)
Cholecalciferol16
Sugar Pill2

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Percent (%) Change in LL-37 5 Days Following Supplementation With 100,000 IU Cholecalciferol

3-7 days before surgery, patients will receive 100,000 IU of cholecalciferol (vs. placebo) during their pre-op assessment. They will also have their baseline vitamin D status measured during this initial visit. The main study outcome is to determine if 100,000 IU cholecalciferol can be given preoperatively to safely boost vitamin D status. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37 (NCT01689779)
Timeframe: Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days

Interventionpercent change in LL-37 (Mean)
Cholecalciferol-10
Sugar Pill-5

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Percent (%) Change in Pre-surgical LL-37 Within 24 Hours of Surgery

The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of short-term changes in vitamin D status following surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37. (NCT01689779)
Timeframe: Patients will be followed between the day of surgery and 1 day after surgery

InterventionPercent change in LL-37 (Mean)
Cholecalciferol-3
Sugar Pill-5

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Number of Participants With an Incident Depression Event

Post-hoc Outcome. Incident Depression is defined as depression cases that occurred among those with no past history of depression as of baseline. Incident depression event was determined by presence of clinical diagnosis, treatment and/or above-threshold symptoms on mood questionnaire (i.e., PHQ-8 >=10 points). (NCT01696435)
Timeframe: From date of randomization until the date of the occurrence of the endpoint, death, or the end of the trial, whichever came first, assessed up to a median of 5.3 years of follow-up

InterventionParticipants (Count of Participants)
Active Vitamin D459
Vitamin D Placebo461
Active Fish Oil493
Fish Oil Placebo427

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Number of Participants With a Depression Event

Depression syndrome will be determined by presence of clinical diagnosis, treatment and/or above-threshold symptoms on mood questionnaire (e.g., PHQ) items. This is an event outcome, where the depression event was defined as a new self-report of physician/clinician-diagnosed depression, treatment (medication and/or counseling) for depression, or presence of clinically relevant depressive symptoms (PHQ-8 total score >=10 points) on the annual study questionnaires that were administered over a median 5.3 years of randomized treatment and follow-up. Participants were followed for the depression event until the occurrence of the endpoint, death, or the end of the trial, whichever came first. The Outcome Measure table shows the counts of depression events in each randomized group by treatment. (NCT01696435)
Timeframe: From date of randomization until the date of the occurrence of the endpoint, death, or the end of the trial, whichever came first, assessed up to a median of 5.3 years of follow-up

InterventionParticipants (Count of Participants)
Active Vitamin D609
Vitamin D Placebo625
Active Fish Oil651
Fish Oil Placebo583

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Number of Participants With a Recurrent Depression Event

Post-hoc Outcome. Recurrent depression is defined as depression cases that occurred among those with past history of depression, but not under treatment or active in the past 2 years as of baseline. Recurrent depression event will be determined by presence of clinical diagnosis, treatment and/or above-threshold symptoms on mood questionnaire (i.e., PHQ-8 >=10 points). (NCT01696435)
Timeframe: From date of randomization until the date of the occurrence of the endpoint, death, or the end of the trial, whichever came first, assessed up to a median of 5.3 years of follow-up

InterventionParticipants (Count of Participants)
Active Vitamin D150
Vitamin D Placebo164
Active Fish Oil158
Fish Oil Placebo156

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Mood Scores

Mood scores are evaluated by the 8-item Patient Health Questionnaire (PHQ-8). The measured outcome was the total PHQ-8 score. The PHQ-8 includes items corresponding to the criteria for major depression. Each of the 8 items can be scored as 0, 1, 2, or 3 points (higher score means worse symptoms). The 8 items are summed to a total PHQ-8 score. The range for the PHQ-8 score is 0-24 points; higher scores denote worse mood or depressive symptoms. The PHQ-8 was measured annually at baseline and at up to 5 follow-up times (for a maximum of 6 time points). Data from all time points was used to determine the mean differences in change in mood scores over all follow-up by randomized treatment. Per protocol, the Statistical Analysis section shows the results for the primary outcome of mean difference in overall change in PHQ-8 scores comparing active and placebo groups (for each agent). (NCT01696435)
Timeframe: Baseline, follow-up year 1, follow-up year 2, follow-up year 3, follow-up year 4, and follow-up year 5

,,,
Interventionscore on a scale (Mean)
Baseline adjusted meanMean change at Year 1Mean change at Year 2Mean change at Year 3Mean change at Year 4Mean change at Year 5
Active Fish Oil1.090.050.070.100.080.18
Active Vitamin D1.080.030.070.090.060.20
Fish Oil Placebo1.110.010.040.060.050.19
Vitamin D Placebo1.130.030.040.070.070.16

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Percentage of Subjects by Treatment Arm Experiencing Any Adverse Event (AE) ≥ Grade 3

Adverse event grading based on National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0 (NCT01709474)
Timeframe: Baseline to 18 Weeks

InterventionPercentage of Participants (Number)
Vitamin D3 6000 IU0
Vitamin D3 400 IU25

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Effect of Vitamin D Supplementation on Blood 25-hydroxyvitaminD Concentration

(NCT01736865)
Timeframe: 12 months

Interventionng/mL (Mean)
Placebo27.5
Cholecalciferol25.8

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Hemoglobin A1c

(NCT01736865)
Timeframe: 12 months

Interventionpercentage (Mean)
Placebo0.2
Cholecalciferol0.2

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Number of Participants With Change in Glycemia

Change in glycemia (categorical variable, composite outcome) defined as [1] a decrease in diabetes medications or [2] a reduction of equal to or more than 0.4 HbA1c units from baseline without increasing medications. (NCT01736865)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Placebo53
Cholecalciferol52

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Disposition Index

Disposition index by the insulin secretion sensitivity index-2 (ISSI-2). This is an calculated value which represents the ability of a person's pancreatic beta cells to lower blood glucose. A higher number means the pancreas is better able to secrete insulin and improve glucose levels. (NCT01736865)
Timeframe: 6 months

Interventionindex (Mean)
Placebo0.023
Cholecalciferol0.149

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Review of the Differences in the Types and Incidence of Toxicities Associated With Vitamin D3 Replacement.

Differences in the types and incidence of toxicities associated with Vitamin D3 replacement, specifically hypercalcemia, with increasing levels of Vitamin D3 along with the effectiveness of Vitamin D3 supplementation on increasing serum levels of Vitamin D (NCT01744821)
Timeframe: Up to 24 months

,,,
Interventionparticipants (Number)
Fatige grade 1Headache grade 1HypercalcemiaLoss of Appetite grade 1Dry Mouth grade 1Constipation grade 1Weakness grade 1
Placebo 2,000 IU Daily0000000
Placebo 50,000 IU Weekly0101100
Vitamin D 2,000 IU Daily0100000
Vitamin D 50,000 IU Weekly1000111

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High Sensitivity C-reactive Protein (Hs-CRP)

A high-sensitivity C-reactive protein (hs-CRP) test may be used to help evaluate an individual for risk of cardiovascular disease (CVD). C-reactive protein (CRP) is a protein that increases in the blood with inflammation. Studies have suggested that a persistent low level of inflammation plays a major role in atherosclerosis, the narrowing of blood vessels due to build-up of cholesterol and other lipids, which is often associated with CVD. The hs-CRP test accurately measures low levels of C-reactive protein to identify low but persistent levels of inflammation and thus helps predict a person's risk of developing CVD. hs-CRP was measured using particle-enhanced immunonephelometry. (NCT01746264)
Timeframe: baseline, 3 months

Interventionnmol/L (Mean)
baseline3 months
Vitamin D347.6240

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Homeostatic Model Assessment of Insulin Resistance Index (HOMA-IR)

This calculation measures insulin resistance, and requires U.S. standard units. The healthy range is 0.5 to 1.4. Less than 1.0 means the subject is insulin-sensitive, which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance. The HOMA-IR was calculated as: HOMA-IR = fasting serum glucose (mmol/L) x fasting insulin (mU/mL)/22.5. (NCT01746264)
Timeframe: baseline, 3 months

Interventionindex of beta cell function (Mean)
baseline3 months
Vitamin D37.117.9

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International Physical Activity Questionnaire (IPAQ) Short Form Score

The IPAQ short form used asked 7 questions about activities in the last 7 days, covering vigorous physical activities, moderate activities, walking, and sitting, asking for days per week, hours per day or minutes per day. The score is reported in metabolic equivalent (MET)-minutes per week. Possible scores could range from 0 (inactive) to greater than 3000 MET-minutes/week (highly active). The definition of high activity was vigorous intensity activity on at least 3 days achieving a minimum total activity of at least 1500 MET-minutes/week OR 7 days of any combination of walking, moderate-intensity or vigorous-intensity activities achieving a minimum total physical activity of at least 3000 MET-minutes/week. Therefore a score of > 3000 MET-minutes/week was possible. (NCT01746264)
Timeframe: baseline, 3 months

InterventionMET-minutes per week (Mean)
baseline3 months
Vitamin D31786.62799.1

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Low-density Lipoprotein Cholesterol (LDL) Cholesterol Levels

The test for low-density lipoprotein cholesterol is used as part of a lipid profile to predict an individual's risk of developing heart disease. A desirable level is <3.36 mmol/L; borderline high is 3.36 - 4.11 mmol/L; high is >/= 4.14 mmol/L. LDL cholesterol was calculated as: LDL = Total cholesterol - HDL cholesterol - Triglycerides/5. (NCT01746264)
Timeframe: baseline, 3 months

Interventionmmol/L (Mean)
baseline3 months
Vitamin D31.952.15

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Reactive Hyperemia Index (RHI)

The cuff of a sphygmomanometer was placed on the forearm and inflated to 50 mm Hg above the participant's systolic blood pressure for a period of 5 min. The increase in resting brachial blood flow was calculated as the maximum flow recorded in the first 15 seconds after cuff deflation and expressed as a percentage increase from baseline reactive. Higher values are considered normal or improved endothelial function. (NCT01746264)
Timeframe: baseline, 3 months

Interventionpercentage increase in blood flow (Mean)
baseline3 months
Vitamin D3449.3513.9

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Serum Parathyroid Hormone (PTH)

A parathyroid hormone (PTH) blood test measures the level of parathyroid hormone in the blood. This test is used to help identify hyperparathyroidism, to find the cause of abnormal calcium levels, or to check the status of chronic kidney disease. PTH controls calcium and phosphorus levels in the blood. PTH was measured by a two-site chemiluminescent immunometric assay. (NCT01746264)
Timeframe: baseline, 3 months

Interventionpmol/L (Mean)
baseline3 months
Vitamin D34.13.3

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Total Cholesterol

Total cholesterol levels were measured by an enzymatic colorimetric assay. (NCT01746264)
Timeframe: baseline, 3 months

Interventionmmol/L (Mean)
baseline3 months
Vitamin D33.694.03

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Triglycerides

Total triglyceride levels were measured by an enzymatic colorimetric assay. (NCT01746264)
Timeframe: baseline, 3 months

Interventionmmol/L (Mean)
Baseline3 months
Vitamin D31.191.58

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Urine Calcium to Creatinine Ratio

Urine calcium/creatinine ratio (unit mg/g) on random urine sample was calculated by dividing calcium in mg by creatinine in g. (NCT01746264)
Timeframe: baseline, 3 months

Interventionmg/g (Mean)
baseline3 months
Vitamin D367.887.7

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High Density Lipoprotein (HDL) Cholesterol Levels

Total HDL cholesterol levels were measured by an enzymatic colorimetric assay. The test for high-density lipoprotein cholesterol (HDL-C) is used along with other lipid tests to screen for unhealthy levels of lipids and to determine the risk of developing heart disease. If a subject has a negative risk factor, a desirable HDL level would be >/= 1.55 mmol/L. (NCT01746264)
Timeframe: baseline, 3 months

Interventionmmol/L (Mean)
baseline3 months
Vitamin D31.21.16

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25-hydroxy Vitamin D (25[OH]D) Levels

25(OH)D was measured using liquid chromatography-tandem mass spectrometry. Total 25(OH)D concentrations of each sample was calculated using internal standard, 25(OH)D_2 and 25(OH)D_3. (NCT01746264)
Timeframe: baseline, 3 months

Interventionnmol/L (Mean)
baseline 25(OH)D3 months 25(OH)D
Vitamin D355.986.9

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Body Mass Index

Body Mass Index (BMI) is a health index for comparing weight to height. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared. The body mass index is an indication if a person is at a suitable weight for his height on an approximation of body fat. A body mass index of under 20 is considered to be underweight, while a body mass index between 20 to 25 is considered healthy. A body mass index in the range of 25 to 30 is regarded as overweight. A body mass index over 30 is regarded as obese. (NCT01746264)
Timeframe: baseline, 3 months

Interventionkg/m^2 (Mean)
baseline3 months
Vitamin D336.136.4

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Calcium Intake Per Day

Calcium intake was measured using the validated Short Calcium Questionnaire (SCQ). This questionnaire is in the form of an spreadsheet, and asks the participant to enter the number of servings per week of various food items and vitamin or mineral supplements. The spreadsheet calculates the daily calcium intake (mg/day) from the data entered. (NCT01746264)
Timeframe: baseline, 3 months

Interventionmg/day (Mean)
baseline3 months
Vitamin D31102.7975.5

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Fasting Glucose

Plasma glucose was measured by hexokinase enzymatic assay. (NCT01746264)
Timeframe: baseline, 3 months

Interventionmmol/L (Mean)
baseline3 months
Vitamin D34.94.97

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Fasting Insulin

Serum insulin was measured using commercial electrochemiluminescence immunoassay kits. (NCT01746264)
Timeframe: baseline, 3 months

Interventionpmol/L (Mean)
baseline3 months
Vitamin D3225.71245.16

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Flow Mediated Dilatation (FMD)

Endothelial function was assessed by FMD, via a high-resolution Doppler ultrasonography examination of the right brachial artery. FMD was calculated as the maximal percentage increase in brachial artery diameter (BAD) from baseline after the release of cuff occlusion. (NCT01746264)
Timeframe: baseline, 3 months

Interventionpercentage increase in BAD (Mean)
Baseline FMD3 months FMD
Vitamin D39.510.4

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Change in Bone Structure

To determine whether vitamin D supplementation results in changes in bone structure. (NCT01747447)
Timeframe: 2 years

,,,
Interventionmg/cm^3 (Mean)
Baseline Total Volumetric Bone Mineral Density at the RadiusYear 2 Total Volumetric Bone Mineral Density at the RadiusBaseline Trabecular Volumetric Bone Mineral Density at the RadiusYear 2 Trabecular Volumetric Bone Mineral Density at the RadiusBaseline Cortical Volumetric Bone Mineral Density at the RadiusYear 2 Cortical Volumetric Bone Mineral Density at the RadiusBaseline Total Volumetric Bone Mineral Density at the TibiaYear 2 Total Volumetric Bone Mineral Density at the TibiaBaseline Trabecular Volumetric Bone Mineral Density at the TibiaYear 2 Trabecular Volumetric Bone Mineral Density at the TibiaBaseline Cortical Volumetric Bone Mineral Density at the TibiaYear 2 Cortical Volumetric Bone Mineral Density at the Tibia
Active Omega-3 Fatty Acids371.28377.60197.50200.121197.871199.88297.55300.91248.45252.111163.591166.61
Active Vitamin D369.68376.24196.45199.561197.751199.41295.29296.76246.63249.301167.391169.98
Omega-3 Fatty Acids Placebo372.29380.98201.78204.691196.851201.16296.96298.90248.31251.151165.811169.90
Vitamin D Placebo373.90382.25202.80205.111196.981201.55299.23303.21250.14254.071162.021166.38

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Body Composition

To determine whether vitamin D supplementation results in changes in body composition as assessed by DXA: total body fat and lean mass, and fat mass index and lean mass index, regional fat and lean mass and derived ratios. (NCT01747447)
Timeframe: 2 years

,,,
Interventionkg/m^2 (Mean)
Body Mass IndexFat Mass IndexLean Mass Index
Active Omega-3 Fatty Acids28.6510.4916.59
Active Vitamin D28.2910.2616.46
Omega-3 Fatty Acids Placebo27.9610.0516.33
Vitamin D Placebo28.3210.2816.46

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Bone Turnover P1NP

To determine whether vitamin D supplementation reduces bone turnover, assessed biomarkers of bone formation (propeptide of type 1 collagen [P1NP]). (NCT01747447)
Timeframe: 2 years

,,,
Interventionug/L (Mean)
Baseline P1NPYear 2 P1NP
Active Omega-3 Fatty Acids50.2548.00
Active Vitamin D49.9948.28
Omega-3 Fatty Acids Placebo48.9949.36
Vitamin D Placebo49.2949.04

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Change in Bone Density

To determine whether vitamin D supplementation produces small increases or reduces bone loss in spine, hip, and total body areal bone density, as assessed by DXA. Reported values are rounded up. (NCT01747447)
Timeframe: 2 years

,,,
Interventiong/cm^2 (Mean)
Baseline Spine Areal Bone Mineral DensityYear 2 Spine Areal Bone Mineral DensityBaseline Femoral Neck Hip Areal Bone Mineral DensityYear 2 Femoral Neck Hip Areal Bone Mineral DensityBaseline Total Hip Areal Bone Mineral DensityYear 2 Total Hip Areal Bone Mineral DensityBaseline Whole Body Areal Bone Mineral DensityYear 2 Whole Body Areal Bone Mineral Density
Active Omega-3 Fatty Acids1.021.030.770.770.940.941.151.15
Active Vitamin D1.021.030.770.770.940.931.151.15
Omega-3 Fatty Acids Placebo1.021.030.760.760.930.931.151.15
Vitamin D Placebo1.021.030.770.770.930.941.151.15

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Bone Turnover Beta Crosslaps

To determine whether vitamin D supplementation reduces bone turnover, assessed biomarkers of bone resorption (beta crosslaps). (NCT01747447)
Timeframe: 2 years

,,,
Interventionpg/mL (Mean)
Baseline beta crosslapsYear 2 beta crosslaps
Active Omega-3 Fatty Acids0.410.40
Active Vitamin D0.400.40
Omega-3 Fatty Acids Placebo0.400.41
Vitamin D Placebo0.410.42

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Change in Estimated GFR From Baseline to Week 48.

To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 48 by randomized study group; (NCT01751646)
Timeframe: Baseline and wk 48

Interventionml/min/1.73m^2 (Median)
Group A: Vitamin D3 50,000 IU-1.91
Group B: Vitamin D3 Placebo0.00

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Change in Estimated GFR From Baseline to Week 24.

To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 24 by randomized study group; (NCT01751646)
Timeframe: Baseline and wk 24

Interventionml/min/1.73m^2 (Median)
Group A: Vitamin D3 50,000 IU0.00
Group B: Vitamin D3 Placebo0.00

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Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Ritonavir Use

Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use (NCT01751646)
Timeframe: Baseline and wk 48

Interventionng/mL (Mean)
Ritonavir Use10.55
No Ritonavir Use10.02

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Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Week 48 by Efavirenz Use

Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use (NCT01751646)
Timeframe: Week 48

Interventionng/mL (Mean)
Efavirenz Use28.24
No Efavirenz Use29.68

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Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Baseline by Efavirenz Use

Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use (NCT01751646)
Timeframe: Baseline

Interventionng/mL (Mean)
Efavirenz Use17.02
No Efavirenz Use19.61

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Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Efavirenz Use

Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use (NCT01751646)
Timeframe: Baseline and wk 48

Interventionng/mL (Mean)
Efavirenz Use10.97
No Efavirenz Use9.79

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Change in URBP/UCr Ratio From Baseline to Week 48

To assess renal tubular function by measuring change in urine retinol binding protein to urine creatinine (URBP/UCr) ratio by randomized study group; (NCT01751646)
Timeframe: Baseline and wk 48

Interventionmcg/g (Median)
Group A: Vitamin D3 50,000 IU-1.06
Group B: Vitamin D3 Placebo-4.72

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Change in UProt/ UCr Ratio From Baseline to Week 48

To assess renal tubular function by measuring change in urinary protein to creatinine ratio by randomized study group; (NCT01751646)
Timeframe: Baseline and wk 48

Interventionratio (Median)
Group A: Vitamin D3 50,000 IU0.00
Group B: Vitamin D3 Placebo0.00

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Change in UGluc From Baseline to Week 48

To assess renal tubular function by measuring change in urine glucose (UGluc) by randomized study group; (NCT01751646)
Timeframe: Baseline and wk 48

Interventionmg/dL (Median)
Group A: Vitamin D3 50,000 IU-0.42
Group B: Vitamin D3 Placebo-0.43

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Change in UB2MG From Baseline to Week 48

To assess renal tubular function by measuring change in urine beta-2 microglobulin (UB2MG) by randomized study group; (NCT01751646)
Timeframe: Baseline and wk 48

Interventionmcg/L (Median)
Group A: Vitamin D3 50,000 IU5.19
Group B: Vitamin D3 Placebo10.75

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Change in Estimated GFR From Baseline to Week 12.

"To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 12 by randomized study group.~eGFR calculated by the CKD-Epi equation for subjects >=18 years of age, and by bedside Schwartz formula for subjects <18 years of age" (NCT01751646)
Timeframe: Baseline and wk 12

Interventionml/min/1.73m^2 (Median)
Group A: Vitamin D3 50,000 IU0.00
Group B: Vitamin D3 Placebo0.00

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Change From Baseline to Week 48 of Total Hip BMD Z-score for the Randomized Study Groups

The Z-score is the standard deviation around mean bone mineral density in the total hip, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults. (NCT01751646)
Timeframe: Baseline and week 48

Interventionz-score (Median)
Group A: Vitamin D3 50,000 IU0.00
Group B: Vitamin D3 Placebo0.00

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Change From Baseline to Week 48 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups

The Z-score is the standard deviation around mean bone mineral density in the lumbar spine, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults. (NCT01751646)
Timeframe: Baseline and week 48

Interventionz-score (Median)
Group A: Vitamin D3 50,000 IU0.00
Group B: Vitamin D3 Placebo-0.10

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Change From Baseline to Week 48 of Femoral Neck BMD Z-score for the Randomized Study Groups

The Z-score is the standard deviation around mean bone mineral density in the femoral neck, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults. (NCT01751646)
Timeframe: Baseline and week 48

Interventionz-score (Median)
Group A: Vitamin D3 50,000 IU0.00
Group B: Vitamin D3 Placebo0.00

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Change From Baseline to Week 48 in UCa/Ucr

(NCT01751646)
Timeframe: Baseline and wk 48

Interventionratio (Median)
Group A: Vitamin D3 50,000 IU0.00
Group B: Vitamin D3 Placebo0.01

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Change From Baseline to Week 48 in SPO4

(NCT01751646)
Timeframe: Baseline and wk 48

Interventionmg/dL (Median)
Group A: Vitamin D3 50,000 IU-0.03
Group B: Vitamin D3 Placebo-0.12

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Change From Baseline to Week 48 in Serum Calcium (SCa)

(NCT01751646)
Timeframe: Baseline and wk 48

Interventionmg/dL (Median)
Group A: Vitamin D3 50,000 IU0.00
Group B: Vitamin D3 Placebo0.04

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Change From Baseline to Week 48 in PTH

(NCT01751646)
Timeframe: Baseline and wk 48

Interventionpg/ML (Median)
Group A: Vitamin D3 50,000 IU-2.21
Group B: Vitamin D3 Placebo-0.96

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Change From Baseline to Week 48 in OC

(NCT01751646)
Timeframe: Baseline and wk 48

Interventionmcg/L (Median)
Group A: Vitamin D3 50,000 IU-0.93
Group B: Vitamin D3 Placebo-0.48

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Change From Baseline to Week 48 in Glucose Homeostasis (Homeostasis Model Assessment of Insulin Resistance (HOMA-IR))

"HOMA-IR is calculated as fasting glucose (mg/dL) X fasting glucose (uIU/mL) / 405. An increase in HOMA-IR means that an individual has become more resistant (less sensitive) to the effects of insulin and thus would be a negative outcome. A reduction in HOMA-IR means that an individual has become more sensitive to the effects of insulin and would be considered a positive outcome.There are no set minimum or maximum scores for HOMA-IR, since it is based on measurements of insulin and glucose, the assays for which may vary. Several studies suggest a cut-off of >2 for any insulin resistance, but normal values appear to vary greatly by population (https://www.mdcalc.com/homa-ir-homeostatic-model-assessment-insulin-resistance)." (NCT01751646)
Timeframe: Baseline and week 48

Interventionunits on a scale (Median)
Group A: Vitamin D3 50,000 IU0.07
Group B: Vitamin D3 Placebo-0.15

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Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Insulin)

(NCT01751646)
Timeframe: Baseline and 48 weeks

InterventionuIU/mL (Median)
Group A: Vitamin D3 50,000 IU0.45
Group B: Vitamin D3 Placebo-0.83

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Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Glucose)

(NCT01751646)
Timeframe: Baseline and week 48

Interventionmg/dL (Median)
Group A: Vitamin D3 50,000 IU0.05
Group B: Vitamin D3 Placebo-0.20

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Percent Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD for the Randomized Study Groups

(NCT01751646)
Timeframe: Baseline and week 24

Interventionpercent change (Median)
Group A: Vitamin D3 50,000 IU0.94
Group B: Vitamin D3 Placebo0.42

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Change From Baseline to Week 48 in FGF23

(NCT01751646)
Timeframe: Baseline and wk 48

Interventionpg/ML (Median)
Group A: Vitamin D3 50,000 IU4.77
Group B: Vitamin D3 Placebo3.15

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Change From Baseline to Week 48 in CTX

(NCT01751646)
Timeframe: Baseline and week 48

Interventionmcg/L (Median)
Group A: Vitamin D3 50,000 IU-0.08
Group B: Vitamin D3 Placebo-0.09

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Change From Baseline to Week 48 in BAP

(NCT01751646)
Timeframe: Baseline and wk 48

InterventionU/L (Median)
Group A: Vitamin D3 50,000 IU-2.71
Group B: Vitamin D3 Placebo-2.19

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Change From Baseline to Week 48 in Actual Free 1,25-OHD

Vitamin D serum concentration (1,25 (OH)DTotal) (pmol/L) multiplied by F times 1,000, where F is defined as F = 1/(1 + Kd * [VDBP] + Ka *[albumin]) where the binding constant for VDBP = Kd = 4.2 x 107 M-1, and for albumin is Ka = 5.4 x 104 M-1 and the concentrations of VDBP and albumin are in moles/L (NCT01751646)
Timeframe: Baseline and wk 48

Interventionfmol/L (Median)
Group A: Vitamin D3 50,000 IU63.73
Group B: Vitamin D3 Placebo25.66

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Change From Baseline to Week 48 in 25-OHD

(NCT01751646)
Timeframe: Baseline and wk 48

Interventionng/ML (Median)
Group A: Vitamin D3 50,000 IU17.80
Group B: Vitamin D3 Placebo2.64

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Change From Baseline to Week 48 in TRP %

(NCT01751646)
Timeframe: Baseline and wk 48

Interventionpercent (Median)
Group A: Vitamin D3 50,000 IU-1.55
Group B: Vitamin D3 Placebo0.62

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Change From Baseline to Week 48 in 1,25-OHD

(NCT01751646)
Timeframe: Baseline and wk 48

Interventionpg/ML (Median)
Group A: Vitamin D3 50,000 IU10.52
Group B: Vitamin D3 Placebo2.74

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Change From Baseline to Week 24 of Total Hip BMD Z-score for the Randomized Study Groups

The Z-score is the standard deviation around mean bone mineral density in the total hip, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults. (NCT01751646)
Timeframe: Baseline and week 24

Interventionz-score (Median)
Group A: Vitamin D3 50,000 IU0.00
Group B: Vitamin D3 Placebo0.00

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Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups

The Z-score is the standard deviation around mean bone mineral density in the lumbar spine, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults. (NCT01751646)
Timeframe: Baseline and week 24

Interventionz-score (Median)
Group A: Vitamin D3 50,000 IU0.00
Group B: Vitamin D3 Placebo0.00

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Change From Baseline to Week 24 of Femoral Neck BMD Z-score for the Randomized Study Groups

The Z-score is the standard deviation around mean bone mineral density in the femoral neck, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults. (NCT01751646)
Timeframe: Baseline and week 24

Interventionz-score (Median)
Group A: Vitamin D3 50,000 IU0.00
Group B: Vitamin D3 Placebo0.00

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Change From Baseline to Week 24 in UCa/Ucr

(NCT01751646)
Timeframe: Baseline and wk 24

Interventionratio (Median)
Group A: Vitamin D3 50,000 IU0.01
Group B: Vitamin D3 Placebo0.01

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Change From Baseline to Week 24 in FGF23

(NCT01751646)
Timeframe: Baseline and wk 24

Interventionpg/ML (Median)
Group A: Vitamin D3 50,000 IU2.93
Group B: Vitamin D3 Placebo3.65

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Change From Baseline to Week 24 in CTX

(NCT01751646)
Timeframe: Baseline and week 24

Interventionmcg/L (Median)
Group A: Vitamin D3 50,000 IU-0.03
Group B: Vitamin D3 Placebo-0.02

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Percent Change From Baseline to Week 24 of Total Hip BMD for the Randomized Study Groups

(NCT01751646)
Timeframe: Baseline and week 24

Interventionpercent change (Median)
Group A: Vitamin D3 50,000 IU-0.27
Group B: Vitamin D3 Placebo0.00

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Change in SCr From Baseline to Week 12.

To assess renal glomerular safety by measuring change in SCr from baseline to week 12 by randomized study group; (NCT01751646)
Timeframe: Baseline and week 12

Interventionmg/dL (Median)
Group A: Vitamin D3 50,000 IU0.03
Group B: Vitamin D3 Placebo0.02

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Change in SCr From Baseline to Week 24.

To assess renal glomerular safety by measuring change in SCr from baseline to week 24 by randomized study group; (NCT01751646)
Timeframe: Baseline and week 24

Interventionmg/dL (Median)
Group A: Vitamin D3 50,000 IU0.02
Group B: Vitamin D3 Placebo0.02

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Change From Baseline to Week 24 in TRP %

(NCT01751646)
Timeframe: Baseline and wk 24

Interventionpercent (Median)
Group A: Vitamin D3 50,000 IU-0.59
Group B: Vitamin D3 Placebo-0.88

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Change From Baseline to Week 24 in SPO4

(NCT01751646)
Timeframe: Baseline and wk 24

Interventionmg/dL (Median)
Group A: Vitamin D3 50,000 IU-0.06
Group B: Vitamin D3 Placebo0.03

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Change From Baseline to Week 24 in Serum Calcium (SCa)

(NCT01751646)
Timeframe: 24 weeks

Interventionmg/dL (Median)
Group A: Vitamin D3 50,000 IU-0.04
Group B: Vitamin D3 Placebo0.08

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Percent Change From Baseline to Week 48 of Total Hip BMD for the Randomized Study Groups

(NCT01751646)
Timeframe: Baseline and week 48

Interventionpercent change (Median)
Group A: Vitamin D3 50,000 IU-0.17
Group B: Vitamin D3 Placebo-0.42

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Percent Change From Baseline to Week 48 of Femoral Neck BMD for the Randomized Study Groups

(NCT01751646)
Timeframe: Baseline and week 48

Interventionpercent change (Median)
Group A: Vitamin D3 50,000 IU-0.30
Group B: Vitamin D3 Placebo-0.11

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Change in SCr From Baseline to Week 48.

To assess renal glomerular safety by measuring change in SCr from baseline to week 48 by randomized study group; (NCT01751646)
Timeframe: Baseline and week 48

Interventionmg/dL (Median)
Group A: Vitamin D3 50,000 IU0.03
Group B: Vitamin D3 Placebo0.01

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Percent Change From Baseline to Week 48 of BMC of Whole Body for the Randomized Study Groups

(NCT01751646)
Timeframe: Baseline and week 48

Interventionpercent change (Median)
Group A: Vitamin D3 50,000 IU0.08
Group B: Vitamin D3 Placebo0.07

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Percent Change From Baseline to Week 48 in Dual Energy X-ray Absorptiometry (DXA)-Measured BMD at the Spine for the Randomized Study Groups

"Percent change from baseline to week (wk) 48 in DXA-measured BMD at the spine for the randomized study groups.~Lumbar spine BMD (L1 - L4) (g/cm2) change from Baseline to wk 48 visit." (NCT01751646)
Timeframe: Baseline and wk 48

Interventionpercent change (Median)
Group A: Vitamin D3 50,000 IU0.19
Group B: Vitamin D3 Placebo0.09

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25-OHD Serum Concentration by Randomized Study Group at Week 12

(NCT01751646)
Timeframe: Week 12

Interventionng/mL (Median)
Group A: Vitamin D3 50,000 IU35.14
Group B: Vitamin D3 Placebo23.97

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Percent Change From Baseline to Week 24 of Femoral Neck BMD for the Randomized Study Groups

(NCT01751646)
Timeframe: Baseline and week 24

Interventionpercent change (Median)
Group A: Vitamin D3 50,000 IU-0.10
Group B: Vitamin D3 Placebo-0.04

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25-OHD Serum Concentration by Randomized Study Group at Week 48

(NCT01751646)
Timeframe: Week 48

Interventionng/mL (Median)
Group A: Vitamin D3 50,000 IU36.89
Group B: Vitamin D3 Placebo20.55

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Percent Change From Baseline to Week 24 of BMC of Whole Body for the Randomized Study Groups

(NCT01751646)
Timeframe: Baseline and week 24

Interventionpercent change (Median)
Group A: Vitamin D3 50,000 IU0.25
Group B: Vitamin D3 Placebo0.07

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Change From Baseline to Week 12 in 1,25-OHD

(NCT01751646)
Timeframe: Baseline and wk 12

Interventionpg/ML (Median)
Group A: Vitamin D3 50,000 IU15.61
Group B: Vitamin D3 Placebo6.06

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Change From Baseline to Week 12 in 25-OHD

(NCT01751646)
Timeframe: Baseline and wk 12

Interventionng/ML (Median)
Group A: Vitamin D3 50,000 IU16.33
Group B: Vitamin D3 Placebo6.91

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Change From Baseline to Week 12 in Actual Free 1,25-OHD

Vitamin D serum concentration (1,25 (OH)DTotal) (pmol/L) multiplied by F times 1,000, where F is defined as F = 1/(1 + Kd * [VDBP] + Ka *[albumin]) where the binding constant for VDBP = Kd = 4.2 x 107 M-1, and for albumin is Ka = 5.4 x 104 M-1 and the concentrations of VDBP and albumin are in moles/L (NCT01751646)
Timeframe: Baseline and wk 12

Interventionfmol/L (Median)
Group A: Vitamin D3 50,000 IU106.50
Group B: Vitamin D3 Placebo53.23

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Change From Baseline to Week 12 in BAP

(NCT01751646)
Timeframe: Baseline and wk 12

InterventionU/L (Median)
Group A: Vitamin D3 50,000 IU-1.05
Group B: Vitamin D3 Placebo-1.74

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Change From Baseline to Week 12 in CTX

(NCT01751646)
Timeframe: Baseline and week 12

Interventionmcg/L (Median)
Group A: Vitamin D3 50,000 IU-0.03
Group B: Vitamin D3 Placebo-0.02

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Change From Baseline to Week 12 in FGF23

(NCT01751646)
Timeframe: Baseline and wk 12

Interventionpg/ML (Median)
Group A: Vitamin D3 50,000 IU3.31
Group B: Vitamin D3 Placebo3.90

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Change From Baseline to Week 12 in OC

(NCT01751646)
Timeframe: Baseline and week 12

Interventionmcg/L (Median)
Group A: Vitamin D3 50,000 IU0.15
Group B: Vitamin D3 Placebo-0.10

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Change From Baseline to Week 12 in PTH

(NCT01751646)
Timeframe: Baseline and wk 12

Interventionpg/ML (Median)
Group A: Vitamin D3 50,000 IU-2.17
Group B: Vitamin D3 Placebo-0.82

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Change From Baseline to Week 12 in Serum Calcium (SCa)

(NCT01751646)
Timeframe: Baseline and wk 12

Interventionmg/dL (Median)
Group A: Vitamin D3 50,000 IU-0.02
Group B: Vitamin D3 Placebo0.08

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Change From Baseline to Week 12 in SPO4

(NCT01751646)
Timeframe: Baseline and wk 12

Interventionmg/dL (Median)
Group A: Vitamin D3 50,000 IU0.00
Group B: Vitamin D3 Placebo0.02

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Change From Baseline to Week 12 in TRP %

(NCT01751646)
Timeframe: Baseline and wk 12

Interventionpercent (Median)
Group A: Vitamin D3 50,000 IU-0.71
Group B: Vitamin D3 Placebo0.04

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Change From Baseline to Week 12 in UCa/Ucr

(NCT01751646)
Timeframe: Baseline and wk 12

Interventionratio (Median)
Group A: Vitamin D3 50,000 IU0.00
Group B: Vitamin D3 Placebo0.00

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Change From Baseline to Week 24 in 1,25-OHD

(NCT01751646)
Timeframe: Baseline and wk 24

Interventionpg/ML (Median)
Group A: Vitamin D3 50,000 IU12.90
Group B: Vitamin D3 Placebo8.58

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Change From Baseline to Week 24 in 25-OHD

(NCT01751646)
Timeframe: Baseline and wk 24

Interventionng/ML (Median)
Group A: Vitamin D3 50,000 IU18.60
Group B: Vitamin D3 Placebo6.78

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Change From Baseline to Week 24 in Actual Free 1,25-OHD

Vitamin D serum concentration (1,25 (OH)DTotal) (pmol/L) multiplied by F times 1,000, where F is defined as F = 1/(1 + Kd * [VDBP] + Ka *[albumin]) where the binding constant for VDBP = Kd = 4.2 x 107 M-1, and for albumin is Ka = 5.4 x 104 M-1 and the concentrations of VDBP and albumin are in moles/L (NCT01751646)
Timeframe: Baseline and wk 24

Interventionfmol/L (Median)
Group A: Vitamin D3 50,000 IU98.61
Group B: Vitamin D3 Placebo59.36

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Change From Baseline to Week 24 in BAP

(NCT01751646)
Timeframe: Baseline and wk 24

InterventionU/L (Median)
Group A: Vitamin D3 50,000 IU-2.54
Group B: Vitamin D3 Placebo-2.03

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Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Week 48 by Ritonavir Use

Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use (NCT01751646)
Timeframe: Week 48

Interventionng/mL (Mean)
Ritonavir Use29.46
No Ritonavir Use28.92

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Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Baseline by Ritonavir Use

Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use (NCT01751646)
Timeframe: Baseline

Interventionng/mL (Mean)
Ritonavir Use18.62
No Ritonavir Use18.69

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25-OHD Serum Concentration by Randomized Study Group at Week 24

(NCT01751646)
Timeframe: Week 24

Interventionng/mL (Median)
Group A: Vitamin D3 50,000 IU37.04
Group B: Vitamin D3 Placebo23.30

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Change From Baseline to Week 24 in PTH

(NCT01751646)
Timeframe: Baseline and wk 24

Interventionpg/ML (Median)
Group A: Vitamin D3 50,000 IU-0.25
Group B: Vitamin D3 Placebo-1.71

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Change From Baseline to Week 24 in OC

(NCT01751646)
Timeframe: Baseline and week 24

Interventionmcg/L (Median)
Group A: Vitamin D3 50,000 IU0.09
Group B: Vitamin D3 Placebo-0.22

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Number of Participants With Incident Visually-Significant AMD

AMD responsible for a reduction in best-corrected visual acuity to 20/30 or worse (NCT01782352)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D73
Vitamin D Placebo61
Active Omega-3 Fatty Acids61
Omega-3 Fatty Acids Placebo73

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Number of Participants With Incident AMD

Incident AMD with or without vision loss to 20/30 or worse; a component of the composite end point of AMD Events (NCT01782352)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D148
Vitamin D Placebo137
Active Omega-3 Fatty Acids137
Omega-3 Fatty Acids Placebo148

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Number of Participants With an AMD Event, Excluding the First Two Years of Follow-up

AMD Event = a composite endpoint of incident AMD plus cases of progression to advanced AMD among participants with AMD at baseline (NCT01782352)
Timeframe: 5 years (excluding the first two years of follow-up)

InterventionParticipants (Count of Participants)
Active Vitamin D84
Vitamin D Placebo91
Active Omega-3 Fatty Acids83
Omega-3 Fatty Acids Placebo92

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Number of Participants With an AMD Event

AMD Event = a composite endpoint of incident AMD plus cases of progression to advanced AMD among participants with AMD at baseline (NCT01782352)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D163
Vitamin D Placebo161
Active Omega-3 Fatty Acids157
Omega-3 Fatty Acids Placebo167

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Number of Participants With Incident Advanced AMD

(NCT01782352)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D51
Vitamin D Placebo42
Active Omega-3 Fatty Acids39
Omega-3 Fatty Acids Placebo54

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Number of Participants With AMD Progression

Progression to advanced AMD among participants with AMD at baseline; a component of the composite end point of AMD Events (NCT01782352)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D15
Vitamin D Placebo24
Active Omega-3 Fatty Acids20
Omega-3 Fatty Acids Placebo19

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Change in 25(OH)D Serum Level After Treatment for Vitamin D Deficiency (Deficiency Defined as 25(OH)D <20 ng/dL)

(NCT01784029)
Timeframe: Baseline to 3 months

Interventionng/mL (Mean)
Low Dose6.2
Weekly High Dose24.9
Daily High Dose21

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Pulse-wave Velocity (PWV)

PWV is a measure of arterial stiffness. Higher values of PWV indicate greater degree of arterial stiffness. (NCT01797302)
Timeframe: 6 months

Interventionmeters/second (Mean)
Vitamin D3 2000 IU4.85
Vitamin D3 1000 IU4.85
Vitamin D3 600 IU4.88

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Systemic Diastolic Blood Pressure

a measure of cardiometabolic health (NCT01797302)
Timeframe: 6 months

InterventionmmHg (Mean)
Vitamin D3 2000 IU67.57
Vitamin D3 1000 IU64.73
Vitamin D3 600 IU67.30

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Systemic Systolic Blood Pressure

a measure of cardiometabolic health (NCT01797302)
Timeframe: 6 months

InterventionmmHg (Mean)
Vitamin D3 2000 IU114.71
Vitamin D3 1000 IU114.88
Vitamin D3 600 IU115.70

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Body Mass Index (BMI)

a surrogate measure of adiposity (NCT01797302)
Timeframe: 6 months

Intervention"kg/m^2" (Mean)
Vitamin D3 2000 IU30.82
Vitamin D3 1000 IU30.99
Vitamin D3 600 IU30.62

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1/Fasting Insulin Ratio

1/fasting insulin ratio is a measure of insulin sensitivity. Increases in 1/fasting insulin ratio indicate improvements in insulin sensitivity. (NCT01797302)
Timeframe: 6 months

Interventionratio (Mean)
Vitamin D3 2000 IU0.08
Vitamin D3 1000 IU0.06
Vitamin D3 600 IU0.06

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Central Diastolic Blood Pressure

a measure of cardiometabolic health (NCT01797302)
Timeframe: 6 months

InterventionmmHg (Mean)
Vitamin D3 2000 IU68.69
Vitamin D3 1000 IU65.33
Vitamin D3 600 IU68.57

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Central Systolic Blood Pressure

a measure of cardiometabolic health (NCT01797302)
Timeframe: 6 months

InterventionmmHg (Mean)
Vitamin D3 2000 IU98.45
Vitamin D3 1000 IU96.05
Vitamin D3 600 IU98.50

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Augmentation Index at Heart Rate of 75 Beats/Min (AIx-75)

"AIx-75 is a measure of arterial stiffness. AIx was measured through radial arterial tonometry using SphygmoCor.~Radial pulse waveform are analyzed through an automatic software function to determine aortic pulse waveform and aortic or central systolic (cSBP) and diastolic blood pressure (cDBP), and these measurements are further analyzed automatically to calculate AIx.~AIx is a composite measure of the magnitude of wave reflection and arterial stiffness in all conduit arteries which affect the timing of the wave reflection. AIx = P2-P1/cSBP-cDBP, where P1 is the height of the incident pressure wave form during systole, P2 is the height of the reflected wave added to the incident wave, cSBP is the aortic systolic BP, and cDBP is the aortic diastolic BP. AIx adjusted to heart rate of 75 beats/min (AIx-75) is a validated index of arterial stiffness, with higher values indicating higher degree of arterial stiffness." (NCT01797302)
Timeframe: 6 months

Interventionratio (Mean)
Vitamin D3 2000 IU3.75
Vitamin D3 1000 IU2.22
Vitamin D3 600 IU1.74

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Fasting Blood Glucose

a measure of cardiometabolic health (NCT01797302)
Timeframe: 6 months

Interventionmg/dL (Mean)
Vitamin D3 2000 IU88.41
Vitamin D3 1000 IU88.48
Vitamin D3 600 IU90.44

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Flow-mediated Dilation (FMD) Percentage

Brachial artery flow-mediated dilation percentage is a measure of endothelial function. FMD percentage calculation is based on baseline brachial artery diameter(brachialADbase) and change in brachial artery diameter (brachialADchange) during post-occlusive reactive hyperemia. FMD% was determined using the formula (brachialADchange/brachialADbase) x 100. (NCT01797302)
Timeframe: 6 months

Interventionpercentage of baseline dilation (Mean)
Vitamin D3 2000 IU7.61
Vitamin D3 1000 IU8.27
Vitamin D3 600 IU7.31

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Blood 25 Hydroxyvitamin D (25OHD) Concentrations

Blood 25OHD will be measured to determine vitamin D deficiency, with a concentration below 50 nmol/L used to define deficiency. A PICU admission blood sample could not be obtained for one patient in the Usual Care Group and one patient in the High Dose Group, thus the total number analyzed differs from the full sample size. (NCT01838447)
Timeframe: 1 day (On admission to the pediatric intensive care unit (PICU) following CHD surgery)

Interventionnmol/L (Mean)
Usual Care Group34.8
High Dose Group52.0

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Post-operative PICU Catecholamine Requirements

Primarily, post-operative catecholamine requirements during the PICU admission will be evaluated as a dichotomous variable (yes/no). If a difference is noted in the primary analysis, inotrope requirements will be determined using the inotrope score, evaluated as the maximum score and in a time to event approach (off all inotropes, score of zero) (NCT01838447)
Timeframe: At any point between PICU admission and discharge, an average length of 5-7 days and not longer than 60 days

InterventionParticipants (Count of Participants)
Usual Care Group15
High Dose Group11

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Number of Participants With Hypercalciuria

Hypercalciuria will be identified using calcium:creatinine ratios defined using age-specific norms and thresholds. (NCT01838447)
Timeframe: Immediately before surgery, on admission to the PICU following CHD surgery, and on the first post-operative day

,
InterventionParticipants (Count of Participants)
EnrolmentIntra-operativePost-Operative Day 1
High Dose Group041
Usual Care Group132

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Change in Montgomery-Åsberg Depression Rating Scale

"Montgomery-Åsberg Depression Rating Scale Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.~The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts~Usual cutoff points are:~0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression." (NCT01884844)
Timeframe: baseline and at 12 week completion

Interventionunits on a scale (Mean)
Vitamin D39.4
Placebo6.4

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Change in Insulin Resistance

Insulin resistance will be measured using the gold standard euglycaemic-hyperinsulinaemic clamp method (note - it is anticipated that a total of 60 volunteers will complete the primary endpoint assessment). (NCT01889810)
Timeframe: Measured at baseline and after 6 months

Interventionμmol/kg/min (Step 2 GIR corrected) (Mean)
Vitamin D3 Supplementation37.4
Placebo36.3

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Change in Immunological Profile 5 Days Following Supplementation With Cholecalciferol

Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. Immunological profile at the onset of a suspected case of sepsis will be compared to the immunological profile between 5-9 days after supplementation with cholecalciferol or placebo. To assess the immunological profile, we will measure serum hsCRP. (NCT01896544)
Timeframe: Patients will be followed between the onset of suspected sepsis and for an average duration of 90 days

,,
Interventionmg/L (Median)
Day 1 hsCRP (mg/L)D 5 hsCRP (mg/L)
Cholecalciferol Dose 120898
Cholecalciferol Dose 211931
Placebo10653

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Change in Immunological Profile 5 Days Following Supplementation With Cholecalciferol

Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. Immunological profile at the onset of a suspected case of sepsis will be compared to the immunological profile between 5-9 days after supplementation with cholecalciferol or placebo. To assess the immunological profile, we will measure serum LL-37. (NCT01896544)
Timeframe: Patients will be followed between the onset of suspected sepsis and for an average duration of 7 days

,,
Interventionng/mL (Median)
Day 1 LL-37 (ng/mL)Day 5 LL 37 (ng/mL)
Cholecalciferol Dose I5254
Cholecalciferol Dose II5167
Placebo5350

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Change in Vitamin D Status 5 Days Following Supplementation With Cholecalciferol

Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. Vitamin D status at the onset of a suspected case of sepsis will be compared to vitamin D status between 5-9 days after supplementation with cholecalciferol or placebo. To assess vitamin D status, we will measure serum and urine: 1) 25-hydroxyvitamin D; 2) 1,25-dihydroxyvitamin D; 3) 24,25-dihydroxyvitamin D; 4) Fibroblast growth factor 23; 5) Vitamin D binding protein; 6) LL-37; 7) Parathyroid hormone; 8) Albumin; 9) Calcium; and 10) Phosphorus levels. (NCT01896544)
Timeframe: Patients will be followed between the onset of suspected sepsis and for an average duration of 7 days

,,
Interventionng/mL (Median)
Day 1Day 5
Cholecalciferol Dose I1522
Cholecalciferol Dose II1729
Placebo1919

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Change in Systolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort

Systolic blood pressure is measured in millimeters of mercury (mmHg). For each participant, her baseline systolic blood pressure is subtracted from her month 6 systolic blood pressure to create a systolic blood pressure change score. (NCT01904032)
Timeframe: Baseline and 6 months

InterventionmmHg (Mean)
Low Dose-2.1579
High Dose-1.6613

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Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort

The Center for Epidemiologic Studies Depression (CES-D) is a self-report questionnaire assessing frequency and severity of depression symptoms. Raw scores range from 0 to 60, where higher scores indicate worse mood. For each participant, her baseline CES-D score is subtracted from her month 6 CES-D score to create a CES-D change score. (NCT01904032)
Timeframe: Baseline and 6 months

Interventionunits on a scale (Mean)
Low Dose-13.2982
High Dose-12.5000

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Change in Diastolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort

Diastolic blood pressure is measured in millimeters of mercury (mmHg). For each participant, her baseline diastolic blood pressure is subtracted from her month 6 diastolic blood pressure to create a diastolic blood pressure change score. (NCT01904032)
Timeframe: Baseline and 6 months

InterventionmmHg (Mean)
Low Dose-0.7544
High Dose0.7581

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Change in Problem Areas in Diabetes (PAIDS) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort

The Problem Areas in Diabetes (PAIDS) score is a self-report questionnaire that assesses diabetes burden and treatment. Scores range from 0 to 100, where higher scores indicate greater distress. For each participant, her baseline PAID score is subtracted from her month 6 PAID score to create a PAID change score. (NCT01904032)
Timeframe: Baseline and 6 months

Interventionscore on a scale (Mean)
Low Dose-13.2237
High Dose-13.2661

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Short Form-12 (SF-12) Physical Composite Scale (PCS)

The SF-12 is a 12-item questionnaire that measures self-reported quality of life through an 8-domain profile of functional health and well-being, physical and mental health summary measures and a preference-based health utility index. Scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. (NCT01908751)
Timeframe: Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery

,,,
Interventionscores on a scale (Mean)
Pre-fracture6 Weeks3 Months6 Months9 Months12 Months
Cancellous Screws53.729.336.743.445.045.0
Sliding Hip Screw50.529.936.236.938.342.2
Vitamin D Placebo50.829.435.738.842.442.6
Vitamin D Supplementation53.529.737.241.441.844.5

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Short Form-12 (SF-12) Mental Health Composite Scale (MCS)

The SF-12 is a 12-item questionnaire that measures self-reported quali... If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome. Scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. (NCT01908751)
Timeframe: Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery

,,,
Interventionscores on a scale (Mean)
Pre-fracture6 Weeks3 Months6 Months9 Months12 Months
Cancellous Screws53.153.954.354.254.053.3
Sliding Hip Screw55.652.050.555.054.052.9
Vitamin D Placebo54.252.950.157.054.353.9
Vitamin D Supplementation54.353.054.452.953.852.4

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Number of Participants With Patient Important Outcomes

"A participant met the primary clinical endpoint if they experienced one or more of the four outcomes:~Re-operation: any unplanned surgery related to the treatment of the femoral neck fracture;~Femoral head osteonecrosis: any evidence of osteonecrosis on any follow-up medical imaging study (i.e., radiographs, magnetic resonance imaging (MRI), or other advanced imaging study);~Severe femoral neck malunion: fracture healing with femoral neck shortening of >10 mm in any plane on follow-up x-rays; or~Nonunion: failure of the fracture to progress towards healing defined as a Radiographic Union Score for Hip (RUSH) score below a pre-determined threshold specific for nonunion at 6 months or greater post-injury." (NCT01908751)
Timeframe: 12 months post-surgery

,,,
InterventionParticipants (Count of Participants)
Primary Clinical EndpointRe-operationFemoral head osteonecrosisSevere femoral neck malunionNonunion
Cancellous Screws136763
Sliding Hip Screw119224
Vitamin D Placebo138433
Vitamin D Supplementation117554

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Hip Outcome Score (HOS) Sports Scale

The HOS measures self-reported functional status through 28 items and two sub-scales that pertain to activities of daily living (ADLs) or higher level activities such as those necessary to participate in sports. Scores for each subscale range from 0 (least function) to 100 (most function). (NCT01908751)
Timeframe: Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery

,,,
Interventionscores on a scale (Mean)
Pre-fracture6 Weeks3 Months6 Months9 Months12 Months
Cancellous Screws86.98.021.445.154.857.3
Sliding Hip Screw78.59.320.833.042.847.5
Vitamin D Placebo76.49.422.241.045.653.1
Vitamin D Supplementation88.68.020.138.152.452.4

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Hip Outcome Score (HOS) Activities of Daily Living Scale

The HOS measures self-reported functional status through 28 items and two sub-scales that pertain to activities of daily living (ADLs) or higher level activities such as those necessary to participate in sports. Scores for each subscale range from 0 (least function) to 100 (most function). (NCT01908751)
Timeframe: Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery

,,,
Interventionscores on a scale (Mean)
Pre-fracture6 Weeks3 Months6 Months9 Months12 Months
Cancellous Screws95.436.159.374.479.679.4
Sliding Hip Screw89.239.156.864.569.073.0
Vitamin D Placebo91.537.159.869.674.776.2
Vitamin D Supplementation93.138.156.769.775.176.6

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Radiographic Fracture Healing

The date of healing will be determined by the Central Adjudication Committee (CAC). They will consider a fracture as healed when there is obliteration of the fracture line by newly formed bone along the cortices and within the trabecular bone on anterior-posterior and lateral radiographs. (NCT01908751)
Timeframe: up to 12 months post-surgery

Interventiondays (Mean)
Sliding Hip Screw224.0
Cancellous Screws236.7
Vitamin D Supplementation210.4
Vitamin D Placebo252.3

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Number of Participants With Non-Operatively-Treated Fracture Healing Complications

Fracture healing complications treated non-operatively are presented in this table and included wound healing problems, infection (superficial and deep), hardware failure, hardware breakage, painful hardware, and peri-prosthetic fracture. (NCT01908751)
Timeframe: 12 months post-surgery

InterventionParticipants (Count of Participants)
Sliding Hip Screw0
Cancellous Screws1
Vitamin D Supplementation0
Vitamin D Placebo0

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Change at Week 16 in % Flow Mediated Dilation in Those Who Did and Did Not Replete Vitamin D

Measures were be performed with a Phillips iU22 Ultrasound system and a L9-3 9 mHz probe in 2D mode by a single operator using EKG gating. Baseline measures of brachial artery diameter will be made after the 10 minutes of rest. The blood pressure cuff, placed on the ipsilateral forearm, was inflated to 50 mmHg above the patient's systolic blood pressure for five minutes and then released. Endothelium-dependent FMD was measured continuously during and for three minutes after cuff release. Subjects rested for 10 minutes. Then, endothelium-independent dilation was measured 3 minutes after administration of 0.4 mg of sublingual nitroglycerine. The outcome (%FMD) was the difference between the average endothelium dependent diameter after cuff deflation and the average baseline diameter. The absolute difference between the % FMD at baseline and 16 week follow up was reported. (NCT01911169)
Timeframe: from zero to sixteen weeks

InterventionAbsolute change in % FMD (Mean)
Repleted Vitamin D1.4
Not Repleted Vitamin D-4.2

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Number of Participants With FEV1 < 80% of Predicted

Forced expiratory volume in 1 second (FEV1) as percent predicted (with reference values used according to the child's age, gender and ethnicity). (NCT01921894)
Timeframe: 8 weeks

Interventionparticipants (Number)
Cholecalciferol 4000 IU0
Cholecalciferol 2000 IU0
Cholecalciferol 200 IU0

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Number of Participants With Elevated Urinary Calcium/Creatinine Ratio

Elevated urinary calcium/creatinine ratio defined as UCa/UCr > 0.37 after either 4 weeks or 8 weeks of supplementation (NCT01921894)
Timeframe: 4 and/or 8 weeks

Interventionparticipants (Number)
Cholecalciferol 4000 IU0
Cholecalciferol 2000 IU0
Cholecalciferol 200 IU0

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Number of Participants With Vitamin D Toxicity

Participants with vitamin D toxicity, hypercalcemia (>10.8mg/dl) and/or an elevated urine Ca/Cr ratio (>0.37) (NCT01921894)
Timeframe: 8 weeks

Interventionparticipants (Number)
Cholecalciferol 4000 IU0
Cholecalciferol 2000 IU0
Cholecalciferol 200 IU0

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Number of Participants With Vitamin D Sufficiency (Vitamin D ≥30 ng/ml) After 4 Weeks of Supplementation

The outcome is defined as the number of participants with a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation (NCT01921894)
Timeframe: 4 weeks

Interventionparticipants (Number)
Cholecalciferol 4000 IU6
Cholecalciferol 2000 IU7
Cholecalciferol 200 IU4

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Number of Participants With Sufficient Vitamin D Levels (≥30 ng/ml) After 8 Weeks of Supplementation

The primary outcome of the proposed trial will be a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation (NCT01921894)
Timeframe: 8 weeks

Interventionparticipants (Number)
Cholecalciferol 4000 IU8
Cholecalciferol 2000 IU6
Cholecalciferol 200 IU4

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Number of Participants With Greater Than 100 Nmol/L 25(OH)D (Converted Vitamin D)

Because the primary endpoint of the study is change in 25(OH)D from baseline to delivery, the primary analysis will be restricted to participants who had greater than 100 nmol/L of 25(OH)D. Recording will be counts of participants in each arm that achieved greater than the 100 nmol/L threshold. (NCT01932788)
Timeframe: 20 weeks

InterventionParticipants (Count of Participants)
Vitamin D 4000 IU110
Placebo Gummy Vitamin22

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Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Pre-diabetes Criteria (Two vs. Three Criteria)

Participants met at least two of three glycemic criteria for prediabetes: fasting plasma glucose level, 100 to 125 mg per deciliter (5.6 to 6.9 mmol per liter); plasma glucose level 2 hours after a 75-g oral glucose load, 140 to 199 mg per deciliter (7.8 to 11.0 mmol per liter) (impaired glucose tolerance); and glycated hemoglobin level, 5.7 to 6.4% (39 to 47 mmol per mole). (NCT01942694)
Timeframe: Approximately 48 months

,
InterventionParticipants (Count of Participants)
Met all three criteriaMet two criteria
Placebo429783
Vitamin D (Cholecalciferol)427784

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Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Waist Circumference

(NCT01942694)
Timeframe: Approximately 48 months

,
InterventionParticipants (Count of Participants)
≥Median of 104.2 cm
Placebo585627
Vitamin D (Cholecalciferol)620591

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Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Age

(NCT01942694)
Timeframe: Approximately 48 months

,
InterventionParticipants (Count of Participants)
25-4445-59≥ 60
Placebo103439670
Vitamin D (Cholecalciferol)106468637

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Time to Development of Diabetes

New-onset diabetes was based on annual glycemic testing of fasting plasma glucose, glycated hemoglobin, and 2-hour post-load plasma glucose and semiannual testing of fasting plasma glucose and glycated hemoglobin. If two or three of the glycemic measures met the 2010 ADA thresholds for diabetes, the participant was considered to have met the diabetes outcome. When only the measure for fasting plasma glucose or glycated hemoglobin met the threshold, confirmatory testing was performed for the positive measure within 8 weeks. If only the measure for 2-hour post-load plasma glucose met the threshold, then a 75-g oral glucose tolerance test to reassess all three glycemic measures was repeated. If the repeat measure was positive or both fasting plasma glucose and glycated hemoglobin were positive (in the case of a repeat oral glucose tolerance test), than the participant was considered to have met the diabetes outcome. (NCT01942694)
Timeframe: Approximately 48 months

InterventionParticipants (Count of Participants)
Placebo323
Vitamin D (Cholecalciferol)293

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Variability of Response to Vitamin D Supplementation by Baseline Characteristic: BMI

(NCT01942694)
Timeframe: Approximately 48 months

,
InterventionParticipants (Count of Participants)
<30≥30
Placebo429783
Vitamin D (Cholecalciferol)435776

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Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Calcium Intake From Supplements

(NCT01942694)
Timeframe: Approximately 48 months

,
InterventionParticipants (Count of Participants)
No intakeAny intake
Placebo793419
Vitamin D (Cholecalciferol)826385

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Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Geographic Location (as a Proxy for Sun Exposure)

(NCT01942694)
Timeframe: Approximately 48 months

,
InterventionParticipants (Count of Participants)
At or above 37° north latitudeBelow 37° north latitude
Placebo898314
Vitamin D (Cholecalciferol)892319

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Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Race (as a Proxy for Skin Pigmentation)

"Race and ethnic group were reporting by the participant. The category other includes American Indian or Alaska Native; Native Hawaiian or other Pacific Islander; and other race. Ethnic group includes any race." (NCT01942694)
Timeframe: Approximately 48 months

,
InterventionParticipants (Count of Participants)
Race: WhiteRace: BlackRace: OtherEthnic Group: HispanicEthnic Group: Non-Hispanic
Placebo806315911051107
Vitamin D (Cholecalciferol)8103011001201091

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Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture.

Total hip bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry (DXA). The DXA image is two dimensional and BMD was expressed as areal density, grams per square centimeter (g/cm^2). The change in BMD between baseline, 6 and 12 months was registered. (NCT01950169)
Timeframe: Baseline, 6 months and 12 months

,,
Interventiong/cm^2 (Mean)
follow up at 6 monthsfollow up at 12 months
B, Bisphosphonate-0.008-0.012
BN/N, Bisphosphonate Along With Nutritional Supplementation0.005-0.004
C, Control-0.017-0.018

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Body Composition, Including Fat Mass at Baseline, 6 and 12 Months After Hip Fracture.

Total body composition, including lean mass composed of muscle, visceral organs and water (LM), fat mass (FM) and bone mineral content (BMC) was measured by dual-energy X-ray absorptiometry (DXA) at baseline and at 6 and 12 months follow up.To normalize for body size, FM was divided by height squared to calculate fat mass index (FMI, kg/m^2). (NCT01950169)
Timeframe: Baseline, 6 and 12 months

,,
Interventionkg/m^2 (Mean)
follow up at 6 monthsfollow up at 12 months
B, Bisphosphonate-0.6-0.3
BN/N, Bisphosphonate Along With Nutritional Supplementation0.10.1
C, Control-0.1-0.1

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Body Composition, Including Lean Mass at Baseline, 6 and 12 Months After Hip Fracture.

Total body composition, including lean mass composed of muscle, visceral organs and water (LM), fat mass (FM) and bone mineral content (BMC) was measured by dual-energy X-ray absorptiometry (DXA) at baseline and at 6 and 12 months follow up. The sum of lean mass (LM) and BMC represents fat-free mass (FFM). To normalize for body size, FFM was divided by height squared to calculate fat-free mass index (FFMI, kg/m^2). (NCT01950169)
Timeframe: Baseline, 6 and 12 months

,,
Interventionkg/m^2 (Mean)
follow up at 6 monthsfollow up at 12 months
B, Bisphosphonate-0.4-0.5
BN/N, Bisphosphonate Along With Nutritional Supplementation-0.9-0.8
C, Control-0.4-0.5

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Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture.

Total body mineral density (BMD) were assessed by dual-energy X-ray absorptiometry (DXA). The DXA image is two dimensional and BMD was expressed as areal density, grams per square centimeter (g/cm^2). The change in BMD between baseline, 6 and 12 months was registered. (NCT01950169)
Timeframe: Baseline, 6 months and 12 months

,,
Interventiong/cm^2 (Mean)
follow-up at 6 monthsfollow-up at 12 months
B, Bisphosphonate-0.005-0.003
BN/N, Bisphosphonate Along With Nutritional Supplementation-0.0060.0006
C, Control-0.012-0.017

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Antimicrobial Activity by Airway Surface Liquid (ASL) as Measured by Relative Light Units (RLU)

We investigated the effect of vitamin D3 supplementation on airway surface liquid antimicrobial activity using a bioluminescent bacterial challenge. We challenged airway surface liquid samples with bioluminescent bacteria and measured live bacteria by relative light units (RLU) after 2 minutes as a surrogate of antimicrobial activity. We interpreted a reduction in live bacteria after challenge in relative light units as increased antimicrobial activity (NCT01967628)
Timeframe: 3 months

InterventionRelative Light Units (RLU) (Mean)
Vitamin D3-581
Sugar Capsule-485

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Change From Baseline in Interleukin-6 at 12 Weeks.

(NCT01974245)
Timeframe: 12 weeks

,
Interventionpg/mL (Mean)
Interleukin-6 baselineInterleukin-6 after intervention
Cholecalciferol8.14.6
Placebo9.09.6

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Compliance With Anti-Cancer Treatment

We checked compliance of aromatase inhibitor therapy during the study by reviewing the patient's use of AI drug. This will be done by counting remaining pills in patient's bottles of AI at 52 weeks. A percentage of the number of pills were actually taken of the number of pills should be taken was calculated. (NCT01988090)
Timeframe: 52 Weeks

Interventionpercentage of pills taken (Mean)
High Dose Vitamin D ARM0.981
800 IU Vitamin D Supplement0.965

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Association Between Vitamin D Levels Changes and Treatment.

Patients' serum 25-hydroxyvitamin D level were tested at baseline and week 12. The changes between baseline and week 12 were calculated. (NCT01988090)
Timeframe: 12 weeks

Interventionng/mL (Mean)
High Dose Vitamin D ARM28.8
800 IU Vitamin D Supplement5.2

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Peak Oxygen Consumption

Peak oxygen consumption( VO2peak) is defined as the highest rate at which oxygen can be taken up and utilized by the body during severe exercise. The participants were encouraged to exercise to exhaustion with progressive 2-minutes increments in the power output during the test. VO2peak was obtained when participants reached volitional exhaustion and met at least one of the following criteria: plateau in oxygen consumption despite increase in workload, rating of perceived exertion >18, Respiratory exchange ratio > 1.10 and peak heart rate within 10 beats of age predicted maximum. . As VO2peak (expressed as liters of oxygen consumed per minute) is also dependent on age, sex, and body size, it was expressed as percentage of the predicted value(VO2peak%). (NCT02030041)
Timeframe: Twelve weeks

Interventionpercentage of predicted value (Mean)
Simvastatin and Placebo43.8
Simvastatin and Vitamin D51.6
Vitamin D and Placebo53.5

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Skeletal Muscle Mitochondrial Content

Skeletal muscle citrate synthase activity is a validated marker of mitochondrial content. Skeletal muscle biopsy was obtained from vastus lateralis muscle of five patients in either groups before and after the intervention. Under aseptic conditions, samples were taken in protease inhibitor cocktail and stored at -80ºC. Mitochondrial citrate synthase activity (the working range of the kit was 1.56-100 µg/mL, with intra and inter assay CV of 4.35-6.55 % and 8.3 % respectively) was measured using ELISA Kit (Abcam, Cambridge, UK) as per manufacturer's instructions.Skeletal muscle citrate synthase activity is a validated marker of mitochondrial content. (NCT02030041)
Timeframe: Twelve weeks

Interventionchange in mOD/min at 412nm (Mean)
Simvastatin and Placebo0.005
Simvastatin and Vitamin D0.005
Vitamin D and Placebo0.0052

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Change in Gait Speed

Gait speed in meters per second (m/s) was obtained from the timed 4-meter, usual-paced walk component of the Short Physical Performance Battery. The change in gait speed was obtained as follow-up measure minus baseline measure. (NCT02166333)
Timeframe: Baseline, 3 months, 12 months and 24 months

,
Interventionm/s (Mean)
Change at 3 monthsChange at 12 monthsChange at 24 months
200 IU/Day-0.01-0.04-0.09
Pooled Higher Doses-0.01-0.04-0.03

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Incidence of First Fall or Death (Whichever Comes First)

Falls were ascertained by a monthly fall calendar completed by each participant, scheduled interviews at 1 month and 3 months after randomization and every 3 months thereafter up to 24 months or trial end. Death was ascertained primarily by reports from family or friends. (NCT02166333)
Timeframe: Randomization to 24 months or end of trial, whichever came first

InterventionFirst fall or death per 100 person-years (Number)
Experience on Best Dose76.9
200 IU/d76.0
Pooled Higher Doses78.0

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Change in HOMA-IR

Change in HOMA-IR from initial visit to end-of-study visit; i.e., the value at the later time point minus the value at the earlier time point. HOMA-IR= Fasting insulin (mIU/ml) x Fasting glucose (mg/dl) / 405. (NCT02168660)
Timeframe: 4-12 mo after randomization (4 months after target 25-hydroxyvitamin D level is reached).

InterventionHOMA-IR score (Median)
Control Group0
Low-Normal Group-1.5
High-Normal Group-1.7

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Change in BMI Z-score

"The change in BMI z-score from baseline to end-of-study visit; i.e., the value at the later time point minus the value at the earlier time point.~The BMI Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched children). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population." (NCT02168660)
Timeframe: 4-12 mo after randomization (4 months after target 25-hydroxyvitamin D level is reached).

Interventionz-score (Median)
Control Group0.03
Low-Normal Group-0.07
High-Normal Group-0.03

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Change in Fatigue

Assessment of fatigue using the Piper Fatigue Scale at weeks 0 and 8. The Piper Fatigue Scale is the average of 22 numeric items, with higher scores indicating greater fatigue [range of scores: 0-10]. Change is calculated as the fatigue score at 8 weeks minus fatigue score at 0 weeks. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time. (NCT02186015)
Timeframe: 0, 8 weeks

Interventionunits on a scale (Median)
Cholecalciferol-0.5

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Change in Muscle Function

Assessment of muscle function using a hand dynamometer at weeks 0 and 8. Change in dominant handgrip strength in kilograms was calculated as 8 weeks minus 0 weeks. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time. (NCT02186015)
Timeframe: 0, 8 weeks

Interventionkilograms (Median)
Cholecalciferol-0.2

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Change in Mood

Assessment of mood using the Patient Health Questionnaire 8 (PHQ-8) at weeks 0 and 8. The PHQ-8 ranges from 0-24 with higher scores indicating more distress. Change was assessed as PHQ-8 score at 8 weeks minus 0 weeks. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time. (NCT02186015)
Timeframe: 0, 8 weeks

Interventionscore on a scale (Median)
Cholecalciferol-1

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Change in Worst Pain Rating From the Beck Pain Scale

Assessment of pain using the Beck Pain Scale at weeks 0 and 8. This is a Likert scale item where a score of 0 corresponds to no pain and a score of 10 corresponds to worst pain. Change is calculated as the worst pain rating at 8 weeks minus the worst pain rating at 0 weeks.Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time. (NCT02186015)
Timeframe: 0, 8 weeks

Interventionscore on a scale (Median)
Cholecalciferol0

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Change in Sleep Quality Assessment

Assessment of sleep using the Pittsburgh Sleep Quality Index (PSQI) at weeks 0 and 8. Scores range from 0-21 with higher scores indicating poorer sleep quality. Change was calculated as week 8 minus week 0 PSQI. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time. (NCT02186015)
Timeframe: 0, 8 weeks

Interventionscore on a scale (Median)
Cholecalciferol-1

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Change in Serum 25(OH)D

Change in laboratory serum value of 25(OH)D at 8 weeks post-supplementation for participants who received weekly supplementation of 50,000 IUs of vitamin D3. Change is expressed as laboratory serum value of 25(OH)D at 8 weeks minus baseline. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time. (NCT02186015)
Timeframe: 0, 8 weeks

Interventionng/ml (Median)
Cholecalciferol32

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Change in Functional Assessment of Cancer Therapy-endocrine

Assessment of quality of life using the functional assessment of cancer therapy- endocrine symptoms at weeks 0 and 8. Scores range from 0-76 with higher scores indicating better quality of life. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time. (NCT02186015)
Timeframe: 0, 8 weeks

Interventionscore on a scale (Median)
Cholecalciferol9

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Change in Functional Assessment of Cancer Therapy-breast

"Assessment of quality of life using the functional assessment of cancer therapy-breast symptoms at weeks 0 and 8. Scores range from 0-40 with higher scores indicating better quality of life.~Change was calculated as week 8 score minus week 0 score. Change was not assessed for participants in the 'no cholecalciferol' arm since they did not receive weekly supplementation and were not followed over time." (NCT02186015)
Timeframe: 0, 8 weeks

Interventionscore on a scale (Median)
Cholecalciferol0

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Change in Bone Strength Index of the Distal Tibia Based on Randomization to Control, Risedronate, or Exercise Group.

"Change in Bone Strength Index (BSI) of the distal tibia based on randomization to Control, Risedronate, or Exercise group.~BSI (mg2/mm4) at the 4% tibial site will be measured using peripheral quantitative computed tomography (pQCT)." (NCT02186600)
Timeframe: Baseline, 6, and 12 months

,,
Interventionmg^2/mm^4 (Mean)
Baseline6 Months12 Months
Control2098.72105.892107.2
Exercise20011987.422009.2
Risedronate1993.31997.322014.2

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Change in Serum Measures of Bone Resorption (Serum NTx) Based on Randomization to Control, Risedronate, or Exercise Group.

Bone turnover is the process of removing old bone (resorption by osteoclasts) and replacing it with new bone (formation by osteoblasts). Menopause results in a brief period (~5 years) of accelerated turnover with resorption far exceeding formation. In this study, resorption will be measured by Serum NTx. (NCT02186600)
Timeframe: Baseline, 6, 12 months

,,
InterventionnanoMolar Bone Collagen Equivalents/L (Mean)
Baseline6 Months12 Months
Control13.9912.1612.36
Exercise15.0313.3613.92
Risedronate14.3110.3011.42

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Change in Bone Mineral Density (BMD) at the Spine (L1-L4) Based on Randomization to Control, Risedronate, or Exercise Group.

Bone mineral density is the gold standard for diagnosis of low bone mass and osteoporosis and will be measured at the spine using Dual Energy X-ray Absorptiometry (DXA). (NCT02186600)
Timeframe: Baseline,6, and 12 months

,,
Interventiong/cm^2 (Mean)
Baseline6 Months12 Months
Control0.889.8870.885
Exercise0.886.8780.885
Risedronate0.892.9070.911

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BMD by DXA at the Lumbar Spine

The mean percent change in bone mineral density (BMD) in the lumbar spine after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams. (NCT02195895)
Timeframe: 12 months

InterventionPercent change (Mean)
Alendronate, Calcium, Vitamin D2.54

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BMD of Total Hip by DXA

The mean percent change in bone mineral density (BMD) of the hip after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams. (NCT02195895)
Timeframe: 12 months

InterventionPercent change (Mean)
Alendronate, Calcium, Vitamin D1.32

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C-terminal Telopeptide (CTX)

The mean percent change in C-terminal telopeptide (CTX) from baseline after 12 months of treatment. CTX is a bone marker found in blood serum and measures the rate of bone breakdown. (NCT02195895)
Timeframe: 12 months

InterventionPercent change (Mean)
Alendronate, Calcium, Vitamin D-61.8

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Bone-specific Alkaline Phosphatase (BSAP)

The mean percent change in bone-specific alkaline phosphatase (BSAP) after 12 months of treatment. BSAP is a bone marker found in blood serum and measures the rate of bone breakdown. (NCT02195895)
Timeframe: 12 months

InterventionPercent change (Mean)
Alendronate, Calcium, Vitamin D-15.5

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Amino-terminal Propeptide of Type 1 Collagen (P1NP)

The mean percent change in amino-terminal of type 1 collagen (P1NP) from baseline after 12 months of treatment. P1NP is a bone marker found in blood serum and provides information about how fast the body is making new bone. (NCT02195895)
Timeframe: 12 months

InterventionPercent change (Mean)
Alendronate, Calcium, Vitamin D-51.5

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Hypercalcemia

Hypercalcemia is presented as number of participants with Calcium >10.8 mg/dl Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. (NCT02208310)
Timeframe: Day 180

InterventionParticipants (Count of Participants)
High Dose Vitamin D0

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Steroid Prescription Given (Dichotomous 0/1)

Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. No steroid prescriptions occurred (NCT02208310)
Timeframe: Day 180

InterventionSteroid prescription occurred (Number)
High Dose Vitamin D0

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Incidence of Nephrolithiasis

Incidence of nephrolithiasis associated with hypercalcemia (>10.8mg/dl) documented by imaging Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. (NCT02208310)
Timeframe: Day 180

InterventionParticipants (Count of Participants)
High Dose Vitamin D0

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Change in Fatigue Measurements

"Change in FACIT-F scale over the year. Scale is 0-160 with 0 being no fatigue and 160 being extreme fatigue. A positive change indicates worsening in symptoms and a negative change indicates an improvement.~Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here." (NCT02208310)
Timeframe: Day 180

Interventionunits on a scale (Number)
High Dose Vitamin D-3

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Change in C-reactive Protein

Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. The delta between first (baseline) and last CRP (Day 180) is reported here. (NCT02208310)
Timeframe: Day 180

Interventionmg/dL (Number)
High Dose Vitamin D0

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Change in Modified Harvey-Bradshaw Index (HBI Without Examination)

"modified Harvey-Bradshaw is a disease assessment scale. 0 is the lowest score and would be considered remission. Scale ranges to over 16 (upper limit is defined by the number of bowel movements in the prior day) with numbers over 16 being severe disease. A positive change (such as that indicated below) therefore references slightly worsening disease while a negative change references improving disease.~Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. 1 subject had an increase of 1 unit on the modified HBI." (NCT02208310)
Timeframe: Day 180

Interventionunits on a scale (0-16) (Number)
High Dose Vitamin D1

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Percent With Escalation of Therapy

Patients who had to have a change in therapy Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. (NCT02208310)
Timeframe: Day 180

InterventionParticipants (Count of Participants)
High Dose Vitamin D0

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Quality of Life Measure Changes

"change in quality of life measures based on Inflammatory bowel disease questionnaire (IBD-Q).~Scale from 0 to 224 with 0 being the poorest quality of life and 224 being the highest quality of life. A positive change indicates improvement while a negative change indicates worsening.~Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here." (NCT02208310)
Timeframe: Day 180

Interventionunits on a scale (Number)
High Dose Vitamin D-7

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Number of Participants With New Heart Failure Hospitalization

We will consider any hospitalization for heart failure among participants enrolled in the parent VITAL trial for this ancillary study. Incident heart failure are initially captured through annual questionnaires with subsequent validation by a team of physicians with expertise in cardiovascular medicine and epidemiology. We excluded 36 participants with prevalent heart failure at the time of randomization for the primary analysis. (NCT02271230)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Active Vitamin D240
Vitamin D Placebo259
Active Omega-3 Fatty Acids244
Omega-3 Fatty Acids Placebo255

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Number of Recurrent Heart Failure Hospitalization

Recurrent heart failure hospitalizations ascertained either by review of medical records and/or use of CMS (Center for Medicare and Medicaid Services) data. (NCT02271230)
Timeframe: 5 years

Interventionhospitalizations for heart failure (Number)
Active Vitamin D341
Vitamin D Placebo364
Active Omega-3 Fatty Acids326
Omega-3 Fatty Acids Placebo379

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Serum Glucose Concentration in Oral Glucose Tolerance Test 1st hr After Treatment

"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction of insulin resistance and improving insulin sensitivity measuring Oral Glucose Tolerance Test 1st hr after the treatment and to compare with same at baseline point within the time frame.~In this measure , Serum Glucose Concentration in Oral Glucose Tolerance test in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms.~One of the clinical signs of improving PCOS prognosis is the improvement in insulin resistance by evaluating the results of Oral Glucose Tolerance Test 1st hr . the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI)." (NCT02328404)
Timeframe: 3 months

Interventionmmol/L (Mean)
Vitamin D3 (Biodal 50,000IU)6.9
Placebo6.4

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Serum Parathyroid Hormone Concentration

"Evaluation of the Safety of the Dose and the Dose Regimen as Per the SmPC by measuring the change in the level of serum Serum Parathyroid Hormone (PTH) Concentration before and after the treatment and/or reporting any adverse events through the trial period.~In this measure , Serum Parathyroid Hormone Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms." (NCT02328404)
Timeframe: 3 months

InterventionPg/ml (Mean)
Vitamin D3 (Biodal 50,000IU)39.1
Placebo52.6

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Serum Calcium Concentration

"Evaluation of the safety of the dose and the dose regimen as per the SmPC by measuring the change in the level of serum Calcium before and after the treatment and/or reporting it as adverse. event through the trial period. as the increase of Serum calcium concentration above the normal level is considered as adverse event for the intervention dose regimen of this study for the purpose of evaluating the safety.~In this measure , Serum Calcium Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms." (NCT02328404)
Timeframe: 3 months

Interventionmmol/L (Mean)
Vitamin D3 (Biodal 50,000IU)2.3
Placebo2.3

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Menstrual Regularity

"Evaluation of the efficacy of the dosing regimen as per the approved SmPC (50,000 IU vitamin D3 once weekly for 3 months) on improvement in PCOS prognosis by assessment of menstrual regularity An improvement in PCOS prognosis by assessment of menstrual regularity is measured through improving progesterone level > 4 ng/mL.~One of the clinical signs of improving PCOS prognosis is menstrual cycle regularity.~In this measure ,the reported results consist of the number of volunteers/patients in each arm either with regular menstrual cycle or irregular menstrual cycle after completing the course of the treatment/ intervention as per the study protocol.~The results will be statistically analyzed using paired student t-test and 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated." (NCT02328404)
Timeframe: 3 months

,
Interventionparticipants (Number)
RegularIrregular
Placebo425
Vitamin D3 (Biodal 50,000IU)272

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Total Testosterone Level

"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS Prognosis by measuring Change in Total Testosterone level before and after the treatment.~In this measure , the Total Testosterone levels in each arm were reported after completing the course of the treatment / intervention as per the study protocol.~One of the clinical signs of improving PCOS prognosis is the change in testosterone level. After which, the means were compared for statistical significance between the two groups / arms.~the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated." (NCT02328404)
Timeframe: 3 months

Interventionnmol/L (Mean)
Vitamin D3 (Biodal 50,000IU)1.6
Placebo1.9

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Sex Hormone Binding Globulin Concentration

"Evaluation of Biodal 50,000 IU on improvement of PCOS Prognosis by comparing the Sex Hormone Binding Globulin concentrations in both groups/arms.~One of the clinical signs of improving PCOS prognosis is the change in the Sex Hormone Binding Globulin Concentration.~In this measure , the Sex Hormone Binding Globulin Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms.~The results will be statistically analyzed using Wilcoxon (Mann-Whiteny) method at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated." (NCT02328404)
Timeframe: 3 months

Interventionnmol/L (Mean)
Vitamin D3 (Biodal 50,000IU)85.9
Placebo100.6

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Serum Progesterone Level

"The results below show the Serum Progesterone level after treatment in each arm after completing the course of the treatment / intervention as per the study protocol.after which, the means were compared for statistical significance between the two groups / arms. After which, the means were compared for statistical significance between the two groups / arms.~The evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS Prognosis by measuring Change in Serum Progesterone level.~One of the clinical signs of improving PCOS prognosis is the change in progesterone level. the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated." (NCT02328404)
Timeframe: 3 months

Interventionnmol/L (Mean)
Vitamin D3 (Biodal 50,000IU)5.8
Placebo7.3

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Serum Phosphorous Concentration

"Evaluation of the safety of the dose and the dose regimen as per the SmPC by measuring the change in the level of serum PO4 Concentration before and after the treatment and/or reporting as adverse event through the trial period.as the increase of Serum phosphoruse concentration above the normal level is considered as adverse event for the intervention dose regimen of this study for the purpose of evaluating the safety.~In this measure , Serum Phosphorous Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms." (NCT02328404)
Timeframe: 3 months

Interventionmmol/L (Mean)
Vitamin D3 (Biodal 50,000IU)1.2
Placebo1.2

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Serum Chromium Concentration

"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on improving serum chromium level to be > 0.05 and < 0.5 ppm. which will be assessed by measuring serum chromium level before and after supplementation of Vitamin D3.~In this measure , Serum chromium Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms.~One of the clinical signs of improving PCOS prognosis is the improvement in serum chromium level . the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated." (NCT02328404)
Timeframe: 3 months

Interventionppm (Mean)
Vitamin D3 (Biodal 50,000IU)0.27
Placebo0.27

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Body Mass Index

"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction of body mass index to be <25-30 kg/m^2.~Evaluation of the Effectiveness of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction in Body Mass Index before and after the treatment. After which, the means were compared for statistical significance between the two groups / arms.~In this measure , Body Mass Index in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months)." (NCT02328404)
Timeframe: 3 months

Interventionkg/m^2 (Mean)
Vitamin D3 (Biodal 50,000IU)25.6
Placebo26.5

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Free Androgen Index

"Free Androgen Index is calculated as the ratio of total testosterone to sex hormone binding globulin (SHBG).~In this measure , the Free Androgen Index in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms.~Improvement assessment of PCOS Prognosis by evaluating the change in Free Androgen Index.~One of the clinical signs of improving PCOS prognosis is the change in FAI. the results will be statistically analyzed using Wilcoxon (Mann- Whitney) method at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated." (NCT02328404)
Timeframe: 3 months

InterventionRatio (Mean)
Vitamin D3 (Biodal 50,000IU)4.5
Placebo4.4

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Hirsutism Score

"The scale ranges between 0 and 36, where A score of 8 or higher was considered as androgen excess (Ferriman and Gallwey, 1961).Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS prognosis by evaluating Hirsutism Score.Hirsutism score was assessed using self-administrated Ferriman-Gallwey scoring system (Ferriman and Gallwey, 1961). Each participant answered the hirsutism test with the help of a trained nurse who was working in the same clinic. The score of each body site may range between 0 (no excessive terminal hair growth) to 4 (extensive terminal hair growth).~In this measure , the hirsutism score were reported in each are after completing the course of treatment/ intervention as per the study protocol. after which, the means were compared for statistical significance between the two groups / arms." (NCT02328404)
Timeframe: 3 months

Interventionunits on a scale (Mean)
Vitamin D3 (Biodal 50,000IU)11.5
Placebo16.7

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Serum 25-Hydroxy Vitamin D3 Level

"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on increase the level of serum 25(OH)D > 20 ng/ml by measuring of the serum 25(OH)D levels on 104 of the study period after 3 months treatment .~In this measure , Serum 25-Hydroxy Vitamin D3 leveln in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms." (NCT02328404)
Timeframe: 3 months

Interventionng/ml (Mean)
Vitamin D3 (Biodal 50,000IU)48.2
Placebo11.8

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Serum C-Reactive Protien Concentration

"Evaluation of the Efficacy of the Dose (50,000IU) and the Dose Regimen on inflammation by measuring reduction of the serum concentration of C-Reactive Protein before and after the treatment.~In this measure , Serum C-Reactive Protien Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms." (NCT02328404)
Timeframe: 3 months

Interventionmg/L (Mean)
Vitamin D3 (Biodal 50,000IU)5.4
Placebo3.9

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Ultrasound Examination of Number of Follicles and Ovarian Volume

"Evaluation of the efficacy of the dosing regimen as per the approved Summery of Product Characteristics (SmPC) (50,000 IU vitamin D3 once weekly for 3 months) on improvement in PCOS prognosis clinically using ultrasound examination.~In this measure the reported results were the finding of the ultrasound examination after the course of the treatment /intervention as per the study protocol and reporting the numbers of patients with normal ovaries, One normal ovary and the other is polycystic or both ovaries are poly-cystic.~An improvement in PCOS prognosis clinically by ultrasound examination is defined by:~decreasing the number of follicles to < 12 follicles measuring 2-9 mm in diameter~decreasing ovarian volume to < 10 cm3" (NCT02328404)
Timeframe: 3 months

,
Interventionparticipants (Number)
Both NormalLeft or Right NormalBoth Polycystic
Placebo01118
Vitamin D3 (Biodal 50,000IU)7517

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Change From Baseline in GADA Month 12

Change from baseline to month 12 in GADA titers (NCT02387164)
Timeframe: Month 12

InterventionU/mL (Mean)
Alum-GAD, Vitamin D37916.9
Placebo, Vitamin D3-120.0

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Change From Baseline in GADA Month 1

Change from baseline to month 1 in GADA (Glutamic Acid Decarboxylase Antibodies) titers (NCT02387164)
Timeframe: Month 1

InterventionU/mL (Mean)
Alum-GAD, Vitamin D31619.1
Placebo, Vitamin D3-51.9

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Change From Baseline in GADA Month 24

Change from baseline to month 24 in GADA titers (NCT02387164)
Timeframe: Month 24

InterventionU/mL (Mean)
Alum-GAD, Vitamin D33216.6
Placebo, Vitamin D31062.7

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Injection Site Reactions Month 1

Number of patients experiencing injection site reactions at month 1 (NCT02387164)
Timeframe: Month 1

,
Interventionparticipants (Number)
ErythemaHaematomaItchingOedemaPainTenderness
Alum-GAD, Vitamin D3110200
Placebo, Vitamin D3000000

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Injection Site Reactions Day 1

Number of patients experiencing injection site reactions at day 1 (NCT02387164)
Timeframe: Day 1

,
Interventionparticipants (Number)
ErythemaHaematomaItchingOedemaPainTenderness
Alum-GAD, Vitamin D3000000
Placebo, Vitamin D3000000

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Number of Patients With Proteinuria as Measured by Urine Dipstick

Proteinuria at last antenatal visit (usually 36-40 weeks' gestation), measured by 1+ Standard Diagnostics UroColor 10 10 (Kyonggi-do, South Korea) reagent strips (NCT02395081)
Timeframe: 36-40 weeks gestation/delivery

InterventionParticipants (Count of Participants)
600 IU2
2000 IU2
4000 IU0

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Assisted Vaginal Delivery as Measured by Medical Record Abstraction

Assisted vaginal delivery with forceps delivery was abstracted from the labor and delivery chart. (NCT02395081)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
600 IU0
2000 IU0
4000 IU0

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Casarean Section as Measured by Medical Record Abstraction

Cesarean section was abstracted from the labor and delivery chart. (NCT02395081)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
600 IU22
2000 IU27
4000 IU26

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Average Monthly Blood Pressure

Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) were measured in mm Hg at each antenatal care visit by the Study Coordinator, using the Omron- Elite 7300 (Omron Healthcare, Bannockburn, Illinois, USA) automated blood pressure monitor. Three blood pressure readings were taken after at least five minutes seated rest. For the analysis of mean blood pressures at each antenatal visit, the three readings were averaged for each participant. (NCT02395081)
Timeframe: During pregnancy

,,
InterventionmmHg (Mean)
SBP wk 16-20SBP wk 20-24SBP wk 24-28SBP wk 28-32SBP wk 36-40DBP wk 16-20DBP wk 20-24DBP wk 24-28DBP wk 28-32DBP wk 32-36DBP wk 36-40
2000 IU104.5103.6103.3103.9110.663.763.162.663.666.571.0
4000 IU105.5105.4104.0105.4111.165.263.863.565.167.171.7
600 IU104.5105.1104.9104.5110.863.863.264.264.467.270.4

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Number of Large for Gestational Age (LGA) Neonates as Measured by Medical Record Abstraction

LGA defined by the highest 10th percentiles of sex-specific birthweight for gestational age charts of the INTERGROWTH-21st study (NCT02395081)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
600 IU25
2000 IU26
4000 IU33

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Total Serum 25(OH)D Concentration

Circulating vitamin D at the end of the study as measured by VIDAS® enzyme linked fluorescent assay (ELFA) (NCT02395081)
Timeframe: 36 weeks gestation or delivery, if delivery occurred before 36 weeks

Interventionnmol/l (Mean)
600 IU46
2000 IU70
4000 IU81

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Number of Small for Gestational Age (SGA) Neonates as Measured by Medical Record Abstraction

SGA defined by the lowest 10th percentiles of sex-specific birthweight for gestational age charts of the INTERGROWTH-21st study (NCT02395081)
Timeframe: Delivery

InterventionParticipants (Count of Participants)
600 IU1
2000 IU2
4000 IU2

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Mean Calcemia as Measured by Serum Calcium Test (2mo)

Measured on a semi-automated photometer (Humalyzer 3500, Human Diagnostics, Magdeburg, Germany) (NCT02395081)
Timeframe: 2 months after randomization

Interventionmmol/L (Mean)
600 IU2.2
2000 IU2.2
4000 IU2.2

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Mean Calcemia as Measured by Serum Calcium Test (36-40 Weeks)

Measured on a semi-automated photometer (Humalyzer 3500, Human Diagnostics, Magdeburg, Germany) (NCT02395081)
Timeframe: 36-40 weeks of pregnancy/delivery

Interventionmmol/L (Mean)
600 IU2.3
2000 IU2.3
4000 IU2.3

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Number of Patients With Preterm Delivery as Measured by Clinical Diagnosis

Gestational age was determined clinically by last menstrual period and by routine first trimester ultrasound which was universal; where these differed by more than 10 days, the ultrasound date was used. Gestational age at delivery was recorded by clinicians and rounded to the nearest week. Preterm delivery was defined as delivery before the 37th week of gestation. (NCT02395081)
Timeframe: During pregnancy

InterventionParticipants (Count of Participants)
600 IU9
2000 IU8
4000 IU5

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Number of Patients With Hypertensive Disorders of Pregnancy as Measured by Clinical Diagnosis

In Mongolia, clinician-diagnosed preeclampsia may include a blood pressure increases >30 mm Hg above early pregnancy, with or without documented hypertension, proteinuria, or symptoms such as headache and edema (NCT02395081)
Timeframe: During pregnancy

InterventionParticipants (Count of Participants)
600 IU4
2000 IU3
4000 IU3

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Number of Patients With Bacterial Vaginosis as Measured by Potassium Hydroxide (KOH) Wet Mount

Bacterial vaginosis was routinely screened by potassium hydroxide wet mount at the first antenatal visit, at 28 weeks' and 32 weeks' gestation. It was also diagnosed by whiff test. We included both wet mount and whiff test positive in the bacterial vaginosis endpoint (NCT02395081)
Timeframe: During pregnancy

InterventionParticipants (Count of Participants)
600 IU17
2000 IU19
4000 IU18

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The Number of Participants With Preeclampsia

Preeclampsia as measured by new onset hypertension after 20 weeks gestation and proteinuria. (NCT02395081)
Timeframe: After 20 weeks gestation

InterventionParticipants (Count of Participants)
600 IU1
2000 IU0
4000 IU0

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Trail Making Test Part B

The Trail Making Test Part B is a measure of executive functioning. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by WPS Publishers (https://www.wpspublish.com/). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance. (NCT02416193)
Timeframe: 13 Weeks

Interventionunits on a scale (Mean)
Low Dose0.01
High Dose-0.10

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Controlled Oral Word Association Test

The Controlled Oral Word Association Test is a measure of verbal fluency. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by Tombaugh and Kozak (1996). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance. (NCT02416193)
Timeframe: 13 Weeks

Interventionunits on a scale (Mean)
Low Dose-0.35
High Dose-0.37

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Hopkins Verbal Learning Total Recall Test

The Hopkins Verbal Learning Total Recall Test is an assessment of memory. Scores are standardized as T-scores (μ = 50, SD = 10) using age adjusted normative data provided by PAR Incorporated (https://www.parinc.com/). A T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean. T-scores below 50 indicate performance is lower than average, and T-scores above 50 indicate performance is higher than average. Higher T-scores indicate better performance. (NCT02416193)
Timeframe: 13 weeks

Interventionunits on a scale (Mean)
Low Dose38.07
High Dose39.57

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Stroop Interference Test

The Stroop Interference Test is a measure of executive functioning. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by PAR Incorporated (https://www.parinc.com/). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance. (NCT02416193)
Timeframe: 13 Weeks

Interventionunits on a scale (Mean)
Low Dose-0.15
High Dose-0.30

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Letter-Number Sequencing

The the Letter-Number Sequencing Test (from the Wechsler Adult Intelligence Scale-III assessment) is an assessment of working memory. Scores on the assessment are standardized as scaled scores with a mean of 10 and standard deviation of 3 (μ = 10, SD = 3) using age adjusted normative data provided by Pearson assessments (https://www.pearsonassessments.com/). A scaled score indicates the number of standard deviations away from the mean. A scaled score of 10 is equal to the mean. Scaled scores below 10 indicate performance is lower than average, and scaled scores higher than 10 indicate performance is higher than average. Higher scaled scores indicate better performance. (NCT02416193)
Timeframe: 13 weeks

Interventionunits on a scale (Mean)
Low Dose9.13
High Dose9.00

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Semantic Fluency Test

The Semantic Fluency Test is a measure of verbal fluency. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by Tombaugh and Kozak (1996). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance. (NCT02416193)
Timeframe: 13 Weeks

Interventionunits on a scale (Mean)
Low Dose0.41
High Dose-0.36

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Symbol-Digit Modality Test

The Symbol-Digit Modality Test is a measure of executive functioning. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by WPS Publishers (https://www.wpspublish.com/). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance. (NCT02416193)
Timeframe: 13 Weeks

Interventionunits on a scale (Mean)
Low Dose0.12
High Dose0.05

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Vitamin D Axis Function - Calcium

Improved signalling through the vitamin D axis will be evaluated through an evaluation of blood calcium levels (i.e. calcium metabolism). Calcium levels will be reported as median plus interquartile range and will be compared between the 2 study groups. (NCT02452762)
Timeframe: On day 0, 3, 7, hospital discharge (expected average of 2 weeks)

,
Interventionmmol/mmol (Median)
Day 0 - LowestDay 0 - HighestDay 3 - Lowest ionized calcium concentrationDay 3 - Highest ionized calcium concentrationDay 7 - Lowest ionized calcium concentrationDay 7 - Highest ionized calcium concentrationHospital discharge - Lowest ionized calcium concentrationHospital discharge - Highest ionized calcium concentration
Enteral Loading Arm1.171.221.161.211.171.221.241.26
Placebo Arm1.181.211.121.271.171.181.201.24

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Vitamin D Status

The percentage of critically ill children who achieve a blood 25OHD concentration above 75 nmol/L by day 7 (NCT02452762)
Timeframe: 7 days

InterventionPercentage of participants in study arm (Number)
Enteral Loading Arm81.6
Placebo Arm5.6

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Patient Accrual Rate

The investigators will determine the feasibility of a subsequent multicentre phase III interventional study through an evaluation of patient accrual rate. The expected patient accrual rate is 88 patients over a 2-year period (2-5 patients per month per centre; low estimate 60 patients (0-2 per month per centre). The study will be considered feasible if the patient accrual rate is achieved (NCT02452762)
Timeframe: 2 years

InterventionNumber of patients enrolled per month (Number)
Overall Cohort3.35

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The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS

Ferriman-Gallwey score is a method used to assess and quantify hirsutism in women. A total score < 8 is considered normal whereas a score of 8 to 15 indicates mild hirsutism. A score >15 indicates moderate or severe hirsutism. (NCT02460380)
Timeframe: Baseline (pre-treatment) and 4 months later (two months after the completion of treatment)

,
InterventionScores on a scale (Mean)
Ferriman-Gallwey score before treatmentFerriman-Gallwey score after treatment
Placebo8.17.6
Vitamin D39.88.1

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The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS

Blood pressure (NCT02460380)
Timeframe: Baseline (pre-treatment) and 4 months later (two months after the completion of treatment)

,
InterventionmmHG (Mean)
Systolic blood pressure before treatmentSystolic blood pressure after treatmentDiastolic blood pressure before treatmentDiastolic blood pressure after treatmentMean arterial pressure before treatmentMean arterial pressure after treatment
Placebo11310969678481
Vitamin D311210868.467.98381

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Effect of Vitamin D on Angiogenic Factors

Serum VEGF level (NCT02460380)
Timeframe: Baseline (pre-treatment) and 8 weeks later (post-treatment)

,
Interventionpg/mL (Mean)
Serum VEGF level before treatmentSerum VEGF level after treatment
Placebo893.1866
Vitamin D31106.4965.3

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Effect of Vitamin D on Angiogenic Factors

Serum TGF-β1/sENG ratio as a measure of TGF-β1 bioavailability (NCT02460380)
Timeframe: Baseline (pre-treatment) and 8 weeks later (post-treatment)

,
Interventionratio (Mean)
Serum TGF-β1/sENG before treatmentSerum TGF-β1/sENG after treatment
Placebo5.65.5
Vitamin D36.75.9

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The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS

The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance. Insulin resistance is a condition in which cells fail to respond to the normal actions of the hormone insulin. The HOMA index was calculated as the product of fasting plasma blood glucose and insulin divided by 22.5. (NCT02460380)
Timeframe: Baseline (pre-treatment) and 8 weeks later (post-treatment)

,
InterventionHOMA IR score (Mean)
Insulin resistance (HOMA-IR)before treatmentInsulin resistance (HOMA-IR) after treatment
Placebo1.581.52
Vitamin D3 Group Before Treatment2.072.03

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The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS

Lipid profile (NCT02460380)
Timeframe: Baseline (pre-treatment) and 8 weeks later (post-treatment)

,
Interventionmg/dL (Mean)
HDL before treatmentHDL after treatmentLDH before treatmentLDL after treatmentTotal cholesterol before treatmentTotal cholesterol after treatmentTriglycerides before treatmentTriglycerides after treatment
Placebo475010310117917711398
Vitamin D34648106100183166138117

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The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS

Interval between periods as a measure ovulatory dysfunction (NCT02460380)
Timeframe: Baseline (pre-treatment) and 4 months later (two months after the completion of treatment)

,
InterventionDays (Mean)
Interval between periods before treatmentInterval between periods after treatment
Placebo7975
Vitamin D380.260

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The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS

Free testosterone (NCT02460380)
Timeframe: Baseline (pre-treatment) and 8 weeks later (post-treatment)

,
Interventionng/dL (Mean)
Free testosterone before treatmentFree testosterone after treatment
Placebo0.610.68
Vitamin D30.590.68

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Spontaneous IL-17a Secretion

Spontaneous IL-17a secretion at baseline, 6 months, 9 months, 15 months and 30 months (NCT02464033)
Timeframe: Baseline, 6 months, 9 months, 15 months and 30 months

Interventionpg/ml (Median)
IL-17a, BaselineIL-17a, 6 monthsIL-17a, 9 monthsIL-17a,15 monthsIL-17a, 30 months
GAD-Alum+Vitamin D+Etanercept3.166.077.066.544.75

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Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability

Number of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse (NCT02464033)
Timeframe: 2 months

InterventionParticipants (Count of Participants)
GAD-Alum+Vitamin D+Etanercept5

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Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability

Number of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse (NCT02464033)
Timeframe: 1 months

InterventionParticipants (Count of Participants)
GAD-Alum+Vitamin D+Etanercept3

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Number of Patients With Clinically Significant Laboratory Findings

Number of patients with clinically significant laboratory findings, laboratory measurements as an assessment of the tolerability (NCT02464033)
Timeframe: Month 1, 2, 3, 6, 9, 15 and 30

InterventionParticipants (Count of Participants)
GAD-Alum+Vitamin D+Etanercept0

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Number of Patients With Any Abnormal Findings From Physical Examinations After Baseline

Number of patients with any abnormal findings from physical examinations after baseline, including neurological assessments as an assessment of tolerability. (NCT02464033)
Timeframe: Month 1, 2, 3, 6, 9, 15 and 30

InterventionParticipants (Count of Participants)
GAD-Alum+Vitamin D+Etanercept6

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Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L

Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 6 months (NCT02464033)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
GAD-Alum+Vitamin D+Etanercept17

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Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L

Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 30 months (NCT02464033)
Timeframe: 30 months

InterventionParticipants (Count of Participants)
GAD-Alum+Vitamin D+Etanercept8

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Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L

Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 15 months (NCT02464033)
Timeframe: 15 months

InterventionParticipants (Count of Participants)
GAD-Alum+Vitamin D+Etanercept14

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Hemoglobin A1c (HbA1c), Change From Baseline

Hemoglobin A1c (HbA1c), change from baseline to 6 months (NCT02464033)
Timeframe: Baseline and 6 months

Interventionmmol/mol (Mean)
GAD-Alum+Vitamin D+Etanercept0.80

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Hemoglobin A1c (HbA1c), Change From Baseline

Hemoglobin A1c (HbA1c), change from baseline to 30 months (NCT02464033)
Timeframe: Baseline and 30 months

Interventionmmol/mol (Mean)
GAD-Alum+Vitamin D+Etanercept7.55

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GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)

GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000 (NCT02464033)
Timeframe: 6 months

InterventionU/mL (Mean)
GAD-Alum+Vitamin D+Etanercept2509.41

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Hemoglobin A1c (HbA1c), Change From Baseline

Hemoglobin A1c (HbA1c), change from baseline to 15 months (NCT02464033)
Timeframe: Baseline and 15 months

Interventionmmol/mol (Mean)
GAD-Alum+Vitamin D+Etanercept6.15

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GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)

GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000 (NCT02464033)
Timeframe: 30 months

InterventionU/mL (Mean)
GAD-Alum+Vitamin D+Etanercept347.01

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GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)

GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000 (NCT02464033)
Timeframe: 15 months

InterventionU/mL (Mean)
GAD-Alum+Vitamin D+Etanercept1036.19

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Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline

Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline (NCT02464033)
Timeframe: Baseline and 6 months

InterventionIU (Mean)
GAD-Alum+Vitamin D+Etanercept0.01

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Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline

Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline (NCT02464033)
Timeframe: Baseline and 30 months

InterventionIU (Mean)
GAD-Alum+Vitamin D+Etanercept0.42

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Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline

Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline (NCT02464033)
Timeframe: Baseline and 15 months

InterventionIU (Mean)
GAD-Alum+Vitamin D+Etanercept0.25

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C-peptide: Stimulated, 90 Minute Value, Change From Baseline

C-peptide: Stimulated, 90 minute value, change from baseline to 6 months (NCT02464033)
Timeframe: Baseline and 6 months

Interventionnmol/L (Mean)
GAD-Alum+Vitamin D+Etanercept-0.09

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C-peptide: Stimulated, 90 Minute Value, Change From Baseline

C-peptide: Stimulated, 90 minute value, change from baseline to 30 months (NCT02464033)
Timeframe: Baseline and 30 months

Interventionnmol/L (Mean)
GAD-Alum+Vitamin D+Etanercept-0.49

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C-peptide: Stimulated, 90 Minute Value, Change From Baseline

C-peptide: Stimulated, 90 minute value, change from baseline to 15 months (NCT02464033)
Timeframe: Baseline and 15 months

Interventionnmol/L (Mean)
GAD-Alum+Vitamin D+Etanercept-0.35

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C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline

Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 6 months. MMTT=Mixed Meal Tolerance Test (NCT02464033)
Timeframe: Baseline and 6 months at 0, 30, 60, 90 and 120 minutes post-dose

Interventionnmol/L*min (Mean)
GAD-Alum+Vitamin D+Etanercept-0.09

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C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline

Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 30 months (NCT02464033)
Timeframe: Baseline and 30 months at 0, 30, 60, 90 and 120 minutes post-dose

Interventionnmol/L*min (Mean)
GAD-Alum+Vitamin D+Etanercept-0.40

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C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline

Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 15 months (NCT02464033)
Timeframe: Baseline and 15 months at 0, 30, 60, 90 and 120 minutes post-dose

Interventionnmol/L*min (Mean)
GAD-Alum+Vitamin D+Etanercept-0.30

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C-peptide Fasting Concentration, Change From Baseline

C-peptide: Fasting, concentration, change from baseline to 30 months (NCT02464033)
Timeframe: Baseline and 30 months

Interventionnmol/L (Mean)
GAD-Alum+Vitamin D+Etanercept-0.15

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C-peptide Fasting Concentration, Change From Baseline

C-peptide: Fasting, concentration, change from baseline to 15 months (NCT02464033)
Timeframe: Baseline and 15 months

Interventionnmol/L (Mean)
GAD-Alum+Vitamin D+Etanercept-0.10

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C-peptide Fasting Concentration, Change From Baseline

C-peptide: Fasting concentration, change from baseline to 6 months (NCT02464033)
Timeframe: Baseline and 6 months

Interventionnmol/L (Mean)
GAD-Alum+Vitamin D+Etanercept-0.02

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GAD65-induced TNF-alpha Secretion

GAD65-induced TNF-alpha secretion at baseline, 6 months, 9 months, 15 months, 30 months (NCT02464033)
Timeframe: Baseline, 6 months, 9 months, 15 months, 30 months

Interventionpg/ml (Median)
TNF-alpha, baselineTNF-alpha, 6 monthsTNF-alpha, 9 monthsTNF-alpha, 15 monthsTNF-alpha, 30 months
GAD-Alum+Vitamin D+Etanercept0.010.010.010.010.01

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GAD65-induced GM-CSF Secretion

GAD65-induced GM-CSF secretion baseline, 6 months, 9 months, 15 months, 30 months (NCT02464033)
Timeframe: Baseline, 6 months, 9 months, 15 months, 30 months

Interventionpg/ml (Median)
GM-CSF, baselineGM-CSF, 6 monthsGM-CSF, 9 monthsGM-CSF, 15 monthsGM-CSF, 30 months
GAD-Alum+Vitamin D+Etanercept0.010.011.520.010.01

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GAD65-induced IFN-gamma Secretion

GAD65-induced IFN-gamma secretion at baseline, 6 months, 9 months, 15 months, 30 months (NCT02464033)
Timeframe: Baseline, 6 months, 9 months, 15 months, 30 months

Interventionpg/ml (Median)
IFN-gamma, baselineIFN-gamma, 6 monthsIFN-gamma, 9 monthsIFN-gamma, 15 monthsIFN-gamma, 30 months
GAD-Alum+Vitamin D+Etanercept4.3911.4422.770.010.01

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GAD65-induced IL-13 Secretion

GAD65-induced IL-13 secretion at baseline, 6 months, 9 months, 15 months, 30 months (NCT02464033)
Timeframe: Baseline, 6 months, 9 months, 15 months, 30 months

Interventionpg/ml (Median)
IL-13, BaselineIL-13, 6 monthsIL-13, 9 monthsIL-13, 15 monthsIL-13, 30 months
GAD-Alum+Vitamin D+Etanercept0.011.675.120.010.01

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GAD65-induced IL-4 Secretion

GAD65-induced IL-4 secretion at baseline, 6 months, 9 months, 15 months, 30 months (NCT02464033)
Timeframe: Baseline, 6 months, 9 months, 15 months, 30 months

Interventionpg/ml (Median)
IL-4, baselineIL-4, 6 monthsIL-4, 9 monthsIL-4, 15 monthsIL-4, 30 months
GAD-Alum+Vitamin D+Etanercept0.010.010.010.010.01

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GAD65-induced MCP-1 Secretion

GAD65-induced MCP-1 secretion at baseline, 6 months, 9 months, 15 months, 30 months (NCT02464033)
Timeframe: Baseline, 6 months, 9 months, 15 months, 30 months

Interventionpg/ml (Median)
MCP-1, baselineMCP-1, 6 monthsMCP-1, 9 monthsMCP-1, 15 monthsMCP-1, 30 months
GAD-Alum+Vitamin D+Etanercept0.0138.540.0124.4237.50

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GAD65-induced MIP-1b Secretion

GAD65-induced MIP-1b secretion at baseline, 6 months, 9 months, 15 months, 30 months (NCT02464033)
Timeframe: Baseline, 6 months, 9 months, 15 months, 30 months

Interventionpg/ml (Median)
MIP-1b, baselineMIP-1b, 6 monthsMIP-1b, 9 monthsMIP-1b, 15 monthsMIP-1b, 30 months
GAD-Alum+Vitamin D+Etanercept0.010.010.0130.6414.61

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Change From Baseline in Lung Cathelicidin Level at 8 Weeks

Change from baseline to 8 weeks in bronchoscopic lavage lung cathelicidin levels after vitamin D supplementation (comparison between pre- and post-supplementation cathelicidin levels using paired t-tests for repeated measures) (NCT02464059)
Timeframe: Baseline and 8 weeks

Interventionpg/mL (Mean)
Vitamin D3-65.5

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Change From Baseline in Blood Cathelicidin at 8 Weeks

Change from baseline to 8 weeks in blood cathelicidin levels after vitamin D supplementation (comparison between pre- and post-supplementation cathelicidin levels using paired t-tests for repeated measures) (NCT02464059)
Timeframe: Baseline and 8 weeks

Interventionng/ml (Mean)
Vitamin D3-0.55

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Effectiveness of Vitamin d Supplementation on Improving Endothelial Function

Changes of endothelial function at baseline and following 10 weeks of vitamin D supplementation as measured by pulse amplitude tonometry (PAT) fingertip plethysmography. Endothelial dysfunction was classified as a Reactive Hyperemic Index (RHI) of < 1.67 . RHI scale typical ranges from 1.0 to 3.0. (NCT02513823)
Timeframe: Baseline and 10 weeks

Interventionunits on a scale (Mean)
Reactive Hyperemia Index BaselineReactive Hyperemia Index 10 Weeks
Intervention2.12.0

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Effectiveness of Vitamin D Supplementation on Reducing Blood Pressure

Changes in systolic and diastolic blood pressure will be measured at baseline and following vitamin D supplementation for 10 weeks in African American healthy pre-menopausal women (NCT02513823)
Timeframe: Baseline and 10 weeks

InterventionmmHg (Mean)
SPB at BaselineSBP at 10 WeeksDBP at baselineDBP at 10 weeks
Intervention1241257981

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Proportion of Participants in Whom Fluticasone Dose Was Halved at Visit 6

"In the absence of moderate or severe asthma exacerbations, participants may have their dose of inhaled corticosteroids (ICS) reduced by 50% if the following criteria are met at visit 6 (halfway through the Trial Phase):~Asthma Control Test (ACT) score greater than 19~Both pre-bronchodilator FEV1 and FEV1/FVC ≥80% of predicted~Use of ≤4 puffs of a rescue inhaler per week~≤1 day per month with asthma symptoms preventing full participation in usual daily activities~Clinician's judgment regarding adequate asthma control" (NCT02687815)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
Vitamin D328
Placebo29

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Days to a Severe Asthma Exacerbation

A severe asthma exacerbation is defined as an exacerbation that meets either of these criteria: 1) Use of systemic corticosteroids (tablets, suspension, or injection), or an increase from a stable maintenance dose, for at least 3 days OR 2) A hospitalization or ER visit because of asthma, requiring systemic corticosteroids. (NCT02687815)
Timeframe: 48 weeks

InterventionDays (Mean)
Vitamin D3240
Placebo253

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Average Cumulative Prescribed Dose of ICS at the End of the Trial

The average cumulative dose of inhaled corticosteroids (ICS) during the study period (NCT02687815)
Timeframe: 48 weeks

Interventionmg (Mean)
Vitamin D359.6
Placebo55.2

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Days to Viral-induced Severe Exacerbation

A severe viral asthma exacerbation is defined as a severe asthma exacerbation [defined as an exacerbation that meets either of these criteria: 1) Use of systemic corticosteroids (tablets, suspension, or injection), or an increase from a stable maintenance dose, for at least 3 days OR 2) A hospitalization or ER visit because of asthma, requiring systemic corticosteroids] along with a positive respiratory viral panel from a nasal blow collected within 72 hours of the exacerbation. (NCT02687815)
Timeframe: 48 weeks

InterventionDays (Mean)
Vitamin D3272
Placebo281

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Number of Gene Transcripts Identified Regulated by Vitamin D Supplementation in Both AA and European American Participants

"The intent of this outcome measure was to identify the number of gene transcripts found to be differentially expressed (where a difference or change has occurred) in both AA and EA subjects upon vitamin D supplementation. The transcripts differentially expressed were compared to the transcripts in the Placebo Arm/Group." (NCT02726113)
Timeframe: up to 8 months post prostatectomy

Interventiondifferentially expressed transcripts (Number)
All Study Participants346

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Changes in Serum Levels of Vitamin D [25(OH)D3] in Subjects in the Supplementation Group and Those in the Control Group (Placebo).

Baseline vitamin D3 levels will be obtained at enrollment and approximately two months later during the surgical procedure (prostatectomy). These D3 levels will be evaluated for the 27 participants who had genomic analysis and compared by race (Caucasian and AA). (NCT02726113)
Timeframe: approximately two months from baseline to date of prostatectomy (exit)

,
Interventionng/ml (Mean)
Baseline CaucasianExit CaucasianBaseline AAExit AA
Control34.829.626.0624.88
Intervention29.846.9421.6648.84

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"Changes in Serum Levels of Tartrate-resistant Acid Phosphatase 5b Isoenzyme (TRAcP5b) Over Time, i.e. Baseline, 3 Months, 6 Months."

"Tartrate-resistant acid phosphatase 5b isoenzyme (TRAcP5b) is a specific product of osteoclasts; it is considered as a marker of bone resorption. The concentration of TRAcP5B (U/L) will be measured at T0, T3, and T6 on serum samples (fasting morning samples) using commercially available reagents and following the manufacturer's protocol. At the end of the study, the results will be aggregated as mean ± standard of the mean, median and min-max range. Data will be statistically analyzed in order to compare the activity of Potassium Citrate versus Placebo (unpaired analysis) and to evaluate the effect of Potassium Citrate and Placebo over time (paired analysis).~Differences will be considered to be statistically significant for p-value <0.05." (NCT02731820)
Timeframe: Baseline (T0), 3 months (T3) 6 months (T6)

,
InterventionU/L (Mean)
Baseline (T0)3 months (T3)6 months (T6)
Control Group, Placebo2.642.852.25
Treatment Group, Potassium Citrate2.352.792.69

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"Changes in Serum Levels of N-terminal Propeptide of Type I Procollagen (P1NP) Over Time, i.e. Baseline, 3 Months, 6 Months."

"N-terminal propeptide of type I procollagen (P1NP) is a product of the conversion of procollagen to collagen; it is considered as a marker of bone formation. The concentration of P1NP (pg/L) will be measured at T0, T3, and T6 on serum samples (fasting morning samples) using commercially available reagents and following the manufacturer's protocol. At the end of the study, the results will be aggregated as mean ± standard of the mean, median and min-max range. Data will be statistically analyzed in order to compare the activity of Potassium citrate versus Placebo (unpaired analysis) and to evaluate the effect of Potassium Citrate and Placebo over time (paired analysis).~Differences will be considered to be statistically significant for p-value <0.05." (NCT02731820)
Timeframe: Baseline (T0), 3 months (T3) 6 months (T6)

,
Interventionpg/L (Mean)
Baseline (T0)3 months (T3)6 months (T6)
Control Group, Placebo18.8218.3916.77
Treatment Group, Potassium Citrate17.4516.2414.97

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Changes in Serum Level of Carboxyterminal Cross-linked Telopeptide of Type I Collagen (CTX); Over Time, i.e. Baseline, 3 Months, 6 Months.

"Carboxyterminal cross-linked telopeptide of type I collagen (CTX) is a degradation product of the type I collagen; it is considered as a marker of bone resorption. The concentration of CTX (µg/L) will be measured at T0, T3, and T6 on serum samples (fasting morning samples) using commercially available reagents and following the manufacturer's protocol.~At the end of the study, the results will be aggregated as mean ± standard of the mean, median and min-max range. Data will be statistically analyzed in order to compare the activity of Potassium citrate versus Placebo (unpaired analysis) and to evaluate the effect of Potassium Citrate and Placebo over time (paired analysis).~Differences will be considered to be statistically significant for p-value <0.05." (NCT02731820)
Timeframe: Baseline (T0), 3 months (T3) 6 months (T6)

,
Interventionµg/L (Mean)
Baseline (T0)3 months (T3)6 months (T6)
Control Group, Placebo0.640.560.54
Treatment Group, Potassium Citrate0.640.630.53

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"Changes in Serum Levels of Bone-specific Alkaline Phosphatase (BAP) Over Time, i.e. Baseline, 3 Months, 6 Months."

"Bone-specific alkaline phosphatase (BAP) is a specific product of osteoblasts; it is considered as a marker of bone formation. The concentration of BAP (µg/L) will be measured at T0, T3, and T6 on serum samples (fasting morning samples) using commercially available reagents and following the manufacturer's protocol. At the end of the study, the results will be aggregated as mean ± standard of the mean, median and min-max range. Data will be statistically analyzed in order to compare the activity of Potassium citrate versus Placebo (unpaired analysis) and to evaluate the effect of Potassium Citrate and Placebo over time (paired analysis).~Differences will be considered to be statistically significant for p-value <0.05." (NCT02731820)
Timeframe: Baseline (T0), 3 months (T3) 6 months (T6)

,
Interventionµg/L (Mean)
Baseline (T0)3 months (T3)6 months (T6)
Control Group, Placebo20.3618.2715.79
Treatment Group, Potassium Citrate21.8919.8116.83

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Level of Serum 25 OHD Level Pre-treatment and Post Treatment

Patients had analysis of serum 25 OHD level pre and post treatment, to check if treatment with Topical Vitamin D made any difference. (NCT02735200)
Timeframe: baseline and 5 months

,
Interventionng/mL (Mean)
pre treatmentpost treatment
Application of Aloe Vera Gel10.3610.51
Topical Application of Vitamin D312.0337.17

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Number of Participants With Adverse Events (AE)

A count of the participants who experienced adverse events will measure participant safety (NCT02786498)
Timeframe: Up to 12 months post-injury

InterventionParticipants (Count of Participants)
High Loading Dose9
High Daily Dose10
Low Daily Dose11
Control Group14

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Serum Levels of Calcium

Will measure participant safety (NCT02786498)
Timeframe: Up to 3 months post-injury

,,,
Interventionmg/dL (Mean)
baselineWeek 6Month 3
Control Group9.09.69.6
High Daily Dose8.89.69.6
High Loading Dose9.19.69.5
Low Daily Dose8.39.69.7

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Serum Levels of Parathyroid Hormone

Helps the body to maintain stable levels of calcium in the blood (NCT02786498)
Timeframe: Up to 3 months post-injury

,,,
Interventionpg/mL (Mean)
BaselineWeek 6Month 3
Control Group60.343.674.6
High Daily Dose64.728.871.0
High Loading Dose69.641.942.4
Low Daily Dose67.868.063.1

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Count of Participants Who Completed Radiographic Imaging Measures

Count of participants who completed radiographic imaging measures to determine participant protocol adherence and assists with identifying healing status (NCT02786498)
Timeframe: up to 12 months

,,,
InterventionParticipants (Count of Participants)
BaselineWeek 6Month 3Month 6Month 9Month 12
Control Group2719161355
High Daily Dose2422171143
High Loading Dose2724211646
Low Daily Dose2417201364

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Count of Participants Who Completed Blood Measures

Will measure participants adherence to the blood measures of the protocol. (NCT02786498)
Timeframe: Up to 3 months post-injury

,,,
InterventionParticipants (Count of Participants)
baselineWeek 6Month 3
Control Group262215
High Daily Dose242011
High Loading Dose262119
Low Daily Dose241517

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Serum Level of 25(OH)D

Correlations will be assessed between participants' 25(OH)D levels at enrolment, changes in 25(OH)D levels from enrolment to 3 months, and 25(OH)D levels at 3 months and fracture healing (NCT02786498)
Timeframe: Up to 3 months post-injury

,,,
Interventionng/mL (Mean)
BaselineWeek 6Month 3
Control Group17.326.123.1
High Daily Dose20.738.428.2
High Loading Dose18.839.339.9
Low Daily Dose19.735.538.1

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Fracture Healing Will be Assessed Radiographically Using Radiographic Union Score for Tibial Fractures (RUST)

Radiographic fracture healing was measured using the Radiographic Union Score for Tibial fractures (RUST), which assesses the presence of bridging callus or a persistent fracture line on each of four cortices. This method evaluates two orthogonal radiographic views; each cortex is attributed points ranging from 1 to 3. A fracture in the immediate postoperative period will receive the minimum score, 4, (1 point for each of the four cortices) and a fully consolidated or healed fracture will be assigned the maximum score, 12 (3 points on each of the four cortices). (NCT02786498)
Timeframe: 3 months post-injury

InterventionScore on a scale 4-12 (Mean)
High Loading Dose11.0
High Daily Dose11.3
Low Daily Dose11.0
Control Group10.4

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Fracture Healing Will be Assessed Clinically Using Function IndeX for Trauma (FIX-IT)

FIX-IT is a standardized measure of weight-bearing and pain in patients with lower extremity fractures, specifically tibia and femur fractures. The FIX-IT score ranges from 0 to 12 points in 2 domains: the ability to bear weight (maximum 6 points) and pain at the fracture site (maximum 6 points) The ability to bear weight is assessed through the single-leg stand and ambulation procedures. Pain is assessed through palpation and stress procedures. The scores in both domains, which are weighted equally, are summed to obtain the final total score; the maximum score of 12 indicates the highest level of function. (NCT02786498)
Timeframe: 3 months post-injury

Interventionscores on a scale (Mean)
High Loading Dose10.1
High Daily Dose9.7
Low Daily Dose9.3
Control Group9.0

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Fracture Healing Will be Assessed Biochemically Using Serum Levels of the Bone Turnover Marker N-terminal Propeptide of Type I Procollagen (P1NP)

P1NP is a bone-formation marker and prior research has found that it is highest at 12 weeks after fractures of the tibial shaft and proximal femur. (NCT02786498)
Timeframe: 3 months post-injury

Interventionng/mL (Mean)
High Loading Dose160.9
High Daily Dose187.8
Low Daily Dose166.7
Control Group140.7

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Fracture Healing Will be Assessed Biochemically Using Serum Levels of the Bone Turnover Marker (BTM) C-terminal Telopeptide of Type I Collagen (CTX)

The BTM C-terminal telopeptide of type I collagen (CTX). CTX is a marker of bone resorption. Clinically important changes in the CTX markers are unknown; however, in a previous study of tibia fracture healing, Veitch et al observed concentrations of both bone turnover markers approximately 100% greater than baseline values.43 Given the large changes observed in these bone turnover markers, the same criteria will be applied for identifying a potentially clinically beneficial regimen and remain powered to detect a mean difference of 20% (SD 30%). (NCT02786498)
Timeframe: 3 months post-injury

Interventionng/mL (Mean)
High Loading Dose0.59
High Daily Dose0.79
Low Daily Dose0.67
Control Group0.78

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Number of Participants With Adherence With Vitamin D Supplementation

Will measure adherence with vitamin D supplementation based on participants self report at the 6 week and 3 month visits. (NCT02786498)
Timeframe: Up to 3 months post-injury

,,,
InterventionParticipants (Count of Participants)
6 Weeks3 Months
Control Group2220
High Daily Dose2019
High Loading Dose1921
Low Daily Dose1819

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Vitamin D3 Level

(NCT02802449)
Timeframe: Baseline and Week 6

,
Interventionng/ml (Mean)
BaselineWeek 6
25 Hydroxy-Vitamin D3 or [25 (OH) D3]16.5532.73
Placebo17.0216.64

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Oxidative Stress Markers: Isoprostane

(NCT02802449)
Timeframe: Baseline and Week 6

,
Interventionpg/ml (Mean)
Isoprostane (Baseline)Isoprostane (Week 6)
25 Hydroxy-Vitamin D3 or [25 (OH) D3]11914.99979.7
Placebo8298.6687.1

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Plasma PTH Level

Building upon our hypothesis above, this aim exploits the fact that the nuclear Vit-D Receptor (VDR) regulates parathyroid hormone (PTH) gene transcription. Therefore the plasma PTH level serves as a sensitive biomarker of the Vit-D nutri-genomic response. This aim will define the multivariate determinants (covariates such as age, BMI, baseline Vit-D level and dietary calcium) of the Vit-D-PTH level relationship (the primary outcome variable) in African-Americans. It is anticipated that the Vit-D supplementation trial will document a wide variance of Vit-D-PTH level relationships that will identify patients at the upper and lower quartiles of the distribution that are either 'nutrient-responsive' or 'nutrient-resistant'. These studies should help identify the 'clinical' characteristics of the sub-set of African-Americans that exhibit the poorest response to Vit-D supplementation. (NCT02802449)
Timeframe: Baseline and Week 6

,
Interventionpg/ml (Mean)
BaselineWeek 6
25 Hydroxy-Vitamin D3 or [25 (OH) D3]60.7354.05
Placebo58.2957.88

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Oxidative Stress Markers: Homocysteine

(NCT02802449)
Timeframe: Baseline and Week 6

,
Interventionumol/L (Mean)
Homocysteine (Baseline)Homocysteine (Week 6)
25 Hydroxy-Vitamin D3 or [25 (OH) D3]11.911.8
Placebo11.511.0

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Oxidative Stress Markers: Cysteine

(NCT02802449)
Timeframe: Baseline and Week 6

,
Interventionumol/L (Mean)
Cysteine (Baseline)Cysteine (Week 6)
25 Hydroxy-Vitamin D3 or [25 (OH) D3]252.4241.2
Placebo253.5249.0

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Oxidative Stress Markers: GSH

(NCT02802449)
Timeframe: Baseline and Week 6

,
Interventionumol/L (Mean)
GSH (Baseline)GSH (Week 6)
25 Hydroxy-Vitamin D3 or [25 (OH) D3]4.13.5
Placebo4.13.6

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As-treated Hospital Length of Stay

Two-sided t-test evaluated comparing length of stay in vitamin D3 vs. placebo treated patients utilizing patients after randomization, factoring excluded patients (e.g., as-treated) using a p<0.05 as significant. (NCT02881957)
Timeframe: Until discharge

Interventiondays (Mean)
Vitamin D310.4
Placebo9.1

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As-treated ICU Length of Stay

Two-sided t-test evaluated comparing length of stay within the ICU specifically in vitamin D3 vs. placebo treated patients utilizing patients after randomization but excluding patients who did not receive treatment (e.g., as-treated) using a p<0.05 as significant. (NCT02881957)
Timeframe: Until discharge

Interventiondays (Mean)
Vitamin D35.8
Placebo5.4

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Number of Participants With Pneumonia

Pneumonia diagnosis (NCT02881957)
Timeframe: Until discharge

InterventionParticipants (Count of Participants)
Vitamin D316
Placebo14

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Intent-to-treat Hospital Length-of-stay

Intent-to-treat hospital length-of-stay (NCT02881957)
Timeframe: Until discharge

Interventiondays (Mean)
Vitamin D310.9
Placebo9.1

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Intent-to-treat ICU Length of Stay

Two-sided t-test evaluated comparing length of stay within the ICU specifically in vitamin D3 vs. placebo treated patients utilizing patients after randomization (e.g., intent-to-treat) using a p<0.05 as significant. (NCT02881957)
Timeframe: Until discharge

Interventiondays (Mean)
Vitamin D36.4
Placebo5.4

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Number of Participants With Urinary Tract Infection

Urinary tract infection diagnosis (NCT02881957)
Timeframe: Until discharge

InterventionParticipants (Count of Participants)
Vitamin D39
Placebo6

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Number of Participants With Sepsis

Diagnosis of sepsis (NCT02881957)
Timeframe: Until discharge

InterventionParticipants (Count of Participants)
Vitamin D32
Placebo3

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In-hospital Mortality

In-hospital mortality (NCT02881957)
Timeframe: Until discharge

InterventionParticipants (Count of Participants)
Vitamin D311
Placebo13

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Number of Participants With Deep Vein Thrombosis

Deep vein thrombosis diagnosis (NCT02881957)
Timeframe: Until discharge

InterventionParticipants (Count of Participants)
Vitamin D38
Placebo3

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Change in Serum PTH Concentration

(NCT02925195)
Timeframe: 16 weeks

Interventionpg/mL (Mean)
Active Treatment-3
Placebo2

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Change in Serum Calcium Concentrations

(NCT02925195)
Timeframe: 16 weeks

Interventionmg/dL (Mean)
Active Treatment0
Placebo0

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Change in Serum 1,25(OH)2D Concentration

(NCT02925195)
Timeframe: 16 weeks

Interventionpg/mL (Mean)
Active Treatment2
Placebo-1

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Change in Urine Calcium Excretion

Urine calcium excretion estimated as spot urine calcium-creatinine ratio (NCT02925195)
Timeframe: 16 weeks

Interventionmg per g of creatinine (Mean)
Active Treatment8
Placebo1

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Change in Systolic Blood Pressure

(NCT02925195)
Timeframe: 16 weeks

InterventionmmHg (Mean)
Active Treatment-3
Placebo-4

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Change in Intact Parathyroid Hormone Levels From Baseline to 12 Weeks

Intact parathyroid hormone levels will be measured with the use of the Elecsys Parathyroid Hormone Immunoassay (NCT03070483)
Timeframe: Change in PTH levels from baseline and at 12 weeks after initiation of intervention

Interventionpg/ml (Median)
Vitamin D27.5

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Change in Mean Blood Pressure From Baseline to 12 Weeks

Seated blood pressure is measured at baseline and at 6 and 12 week follow-up visits in the clinic using an appropriate sized cuff after a rest period using an automated device (Omron). Blood pressure will be measured three times in one minute intervals at each time point and the average of these three recordings will be recorded as the mean blood pressure at each time point. Arm circumference will be measured to ensure the correct cuff size is used for all blood pressure measurements including home monitoring of blood pressure. Due to small number of participants, the change in mean blood pressure was analyzed as difference in mean blood pressure (2 x average diastolic blood pressure + average systolic blood pressure)/3 between baseline and at 12 weeks. (NCT03070483)
Timeframe: Difference in BP from baseline and 12 weeks after initiation of intervention

InterventionmmHg (Mean)
Vitamin D Arm4.3

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Change in Total 25-hydroxyvitamin D From Baseline to 12 Weeks

Total 25-hydroxyvitamin D will be measured with the use of liquid chromatography-tandem mass spectrometry (NCT03070483)
Timeframe: Change in total 25-hydroxyvitamin D level from baseline to 12 weeks after initiation of intervention

Interventionng/ml (Mean)
Vitamin D Arm21.7

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Change in 24-hour Urine Calcium Excretion From Baseline to 12 Weeks

A 24-hour urine will be collected and calcium will be measured by Quest diagnostics (NCT03070483)
Timeframe: Change in 24 hour urine calcium excretion from baseline and at 12 weeks after initiation of intervention

Interventionmg/day (Median)
Vitamin D336.2

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Highest Ionized Calcium to Day 14

Clinically available serum or ionized calcium levels through day 14 were collected for all randomized participants. This time frame was selected to align with the 25OHD half life of two weeks. (NCT03096314)
Timeframe: up to 14 days after randomization

Interventionmg/dL (Mean)
High Dose Vitamin D Formulation4.7
Placebo4.6

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Number of Participants Who Developed (New) ARDS to Day 7

Presence of ARDS determined using the PaO2/FiO2 ratio or SpO2/FiO2 ratio (i.e., imputed P/F ratio) and chest x-ray confirmation. PaO2 = partial pressure of arterial oxygen; FiO2 = percentage of inspired oxygen; SpO2 = peripheral capillary oxygen saturation, an estimate of the amount of oxygen in the blood. For participants with P/F <300 or imputed P/F <300, FiO2 ≥40%, and PEEP ≥5 cm H2O, we determined if hypoxemia was valid, acute, and not fully explained by congestive heart failure (CHF) or fluid overload. PEEP = positive end expiatory pressure. (NCT03096314)
Timeframe: Up to 7 days after randomization

InterventionParticipants (Count of Participants)
High Dose Vitamin D Formulation20
Placebo17

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Highest Total Calcium to Day 14

Clinically available serum or ionized Ca levels were obtained through day 14 for all randomized patients. This time frame was selected to align with the 25OHD half life of two weeks. (NCT03096314)
Timeframe: 14 days after randomization

Interventionmg/dL (Mean)
High Dose Vitamin D Formulation8.9
Placebo8.8

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Hospital Length of Stay to Day 90

Number of days from enrollment to the day of study hospital discharge up to day 90. Only calculated for patients that survived through day 90. (NCT03096314)
Timeframe: 90 days after randomization

Interventiondays (Mean)
High Dose Vitamin D Formulation9.1
Placebo10.4

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Hospital Mortality to Day 90

Analysis of the number of participants who died prior to hospital discharge up to study day 90. (NCT03096314)
Timeframe: Up to 90 days after randomization

Interventionparticipants (Number)
High Dose Vitamin D Formulation92
Placebo72

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Hypercalcemia to Day 14

As the half-life of 25OHD is approximately 2 weeks, clinically available serum or ionized calcium levels through study day 14 were collected. The number of participants with hypercalcemia was reported. (NCT03096314)
Timeframe: up to 14 days after randomization

InterventionParticipants (Count of Participants)
High Dose Vitamin D Formulation14
Placebo11

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Kidney Stones to Day 90

Incident of kidney stones determined by chart review at the end of hospitalization and by self-report at day 90 phone call in those discharged from the hospital prior to day 90. (NCT03096314)
Timeframe: 90 days after randomization

InterventionParticipants (Count of Participants)
High Dose Vitamin D Formulation0
Placebo3

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New Renal Replacement Therapy (RRT)

Participants who were on chronic dialysis at baseline were excluded from the analysis. Participants who started renal replacement therapy on a study day after day 0 and inclusive of day 7 were considered as having new renal replacement therapy. Those who have never started renal replacement therapy over days 0-7 were considered as not having new renal replacement therapy. (NCT03096314)
Timeframe: Up to 7 days after randomization

InterventionParticipants (Count of Participants)
High Dose Vitamin D Formulation20
Placebo18

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New Vasopressor Use to Day 7

The number of subjects in each arm that are started on a vasopressor after randomization up to study day 7. (NCT03096314)
Timeframe: Up to 7 days after randomization

InterventionParticipants (Count of Participants)
High Dose Vitamin D Formulation43
Placebo42

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Ventilator-free Days (VFDs) to Day 28

In participants who survive 28 days, ventilator free days (VFDs) is defined as 28 minus duration of ventilation. Duration of ventilation is counted from the first study day of assisted breathing through the last day of assisted breathing provided the last day is prior to day 28. Or it is counted from the first study day of assisted breathing through day 28. For participants discharged with assisted ventilation prior to day 28, a phone call will be required to assess ventilator status at day 28. Participants discharged prior to day 28 (but not to home) on unassisted breathing will be assumed to remain on unassisted breathing through day 28. Isolated periods of ventilation briefer than 24 hours for surgical procedures and ventilation solely for sleep disordered breathing do not count towards duration of ventilation. In participants who never require assisted breathing, duration of ventilation is zero. Participants who do not survive 28 days will be assigned zero VFD. (NCT03096314)
Timeframe: 28 days after randomization

Interventiondays (Mean)
High Dose Vitamin D Formulation21.3
Placebo22.1

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Severity of Acute Respiratory Distress Syndrome (ARDS)

Severity of ARDS is determined using the PaO2/FiO2 ratio or SpO2/FiO2 ratio and confirmation of ARDS through chest x-ray reviews. The breakout of mild to severe was categorized as P/F or imputed P/F ratio of 201-300 (mild), 100-200 (moderate), or less than 100 (severe). This physiologic outcome is one of three key organ systems (respiratory, renal, and cardiovascular) used to assess change in organ failure severity from randomization up to study day 7. (NCT03096314)
Timeframe: 7 days after randomization

,
InterventionParticipants (Count of Participants)
MildModerateSevere
High Dose Vitamin D Formulation695
Placebo4121

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Highest Creatinine Levels

The highest recorded creatinine values is taken from available levels reported across the 7 study days for each patient. (NCT03096314)
Timeframe: Up to 7 days after randomization

Interventionmg/dL (Mean)
High Dose Vitamin D Formulation2.2
Placebo2.1

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25OHD Levels at Day 3

Baseline levels will be measured using LC/MS/MS methods (all randomized participants) and at day 3 (the first 300 randomized participants only). (NCT03096314)
Timeframe: 3 days after randomization

Interventionng/mL (Mean)
High Dose Vitamin D Formulation46.9
Placebo11.4

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Alive and Home (Prior Level of Care) at Day 90

This endpoint is the count of participants who have survived and are present at home, defined as pre-hospitalization level of care, at day 90. (NCT03096314)
Timeframe: 90 days post randomization

InterventionParticipants (Count of Participants)
High Dose Vitamin D Formulation348
Placebo345

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All-cause, All Location Mortality to Day 28

This variable was calculated in participants who were reported alive at day 28. Vital status of the patient at day 28 was determined using any of the following methods: medical record review, phone calls to patient, proxy or healthcare facility, or review of obituaries. (NCT03096314)
Timeframe: Up to 28 days after randomization

Interventionparticipants (Number)
High Dose Vitamin D Formulation92
Placebo69

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All-cause, All-location Mortality to Day 90

Vital status of the patient at day 90 was determined using any of the following methods: medical record review, phone calls to patient, proxy or healthcare facility, review of obituaries, or information from the Centers for Disease Control and Prevention's National Death Index (NDI). (NCT03096314)
Timeframe: 90 days after randomization

InterventionParticipants (Count of Participants)
High Dose Vitamin D Formulation125
Placebo109

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Falls to Day 90

We assessed for incidence of falls by chart review at the end of hospitalization and by self-report at the 90 day phone call. Most data suggest that high dose vitamin D in healthy outpatients may improve muscle function, balance, and bone mineral density, and thus decrease fall-related fractures, but other data suggest that high dose vitamin D supplementation may actually increase the incidence of falls/fractures. (NCT03096314)
Timeframe: 90 days post randomization

InterventionParticipants (Count of Participants)
High Dose Vitamin D Formulation36
Placebo27

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Healthcare Facility Length of Stay to Day 90

Healthcare facility length of stay is the time spent in another hospital or healthcare facility (e.g. long-term acute care [LTAC] hospitals or acute rehabilitation/skilled nursing facility), for the subgroup of participants that were discharged to another healthcare facility after the initial hospitalization. This measure is defined as the number of days from initial hospital discharge to the first facility discharge to home (pre-hospitalization level of care) up to day 90. Healthcare facility LOS is zero for patients discharged to home (pre-hospitalization level of care) from the study hospital. This endpoint will be analyzed only in survivors using SACE methods because healthcare facility length of stay in those who die during the follow-up period is non-informative for this endpoint. (NCT03096314)
Timeframe: 90 days after randomization

Interventiondays (Mean)
High Dose Vitamin D Formulation6.0
Placebo8.1

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Number of Participants With Pre-eclampsia in Both Arms

Occurrence of pre-eclampsia or not in all patients irrespective of Vitamin D dose. (NCT03101150)
Timeframe: From 20 weeks of pregnancy till event of pre-eclampsia seen, whichever came first, assessed up to 32 weeks.

InterventionParticipants (Count of Participants)
400 IU6
4000 IU1

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Number of Patients With Intrauterine Growth Retardation

Patients having fetus with retardation of growth in both arms. (NCT03101150)
Timeframe: At delivery

InterventionParticipants (Count of Participants)
400 IU18
4000 IU8

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Change in Vitamin D Level

Level of Improvement in Vitamin D status in both arms (NCT03101150)
Timeframe: At 36th week of pregnancy

Interventionnmol/L (Mean)
400 IU35.3
4000 IU72.3

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Rate of Patient Recruitment to a Randomised Chemoprevention Study in Men Enrolled on an Active Surveillance Programme for Prostate Cancer. Number Accrued Per Month.

The proportion of eligible patients that join the trial over the 12-month trial recruitment period. (NCT03103152)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
High Dose Aspirin & Vitamin D17
High Dose Aspirin, Vitamin D Placebo16
Low Dose Aspirin , Vitamin D19
Low Dose Aspirin, Vitamin D Placebo18
Aspirin Placebo, Vitamin D16
Aspirin Placebo, Vitamin D Placebo18

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Number of Participants With Histological Disease Progression

"Histological disease progression will be defined as an increase in Gleason scores from: Gleason 3+3 to Gleason score 7 or higher Gleason 3+4 (score 7) to 4+3 (score 7) or Gleason 4+3 to a higher score~Or a 50% increase in maximum cancer core length (MCCL)" (NCT03103152)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
High Dose Aspirin & Vitamin D2
High Dose Aspirin, Vitamin D Placebo7
Low Dose Aspirin , Vitamin D5
Low Dose Aspirin, Vitamin D Placebo2
Aspirin Placebo, Vitamin D3
Aspirin Placebo, Vitamin D Placebo6

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Sex Differences in Treatment Response Based on Pain Scores

Examines existence of gender-based treatment response differences in pain severity measured by a 0-10 numeric rating scale where 0 is no pain and 10 is the most severe pain. Higher scores reflect greater pain (poor outcome). (NCT03313076)
Timeframe: 6 weeks following burn injury

,,,
Interventionunits on a scale (Mean)
MaleFemale
No Omega 3 Treatment1.801.00
No Vitamin D Treatment2.831.33
Omega-31.432.00
Vitamin D0.332

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General Mental Health as Measured by the Short Form (SF)-12 General Mental Health Component Scores

Assessment of mental health will be determined by the short form (SF)-12 mental component score. The short form SF-12 Health Survey is a 12-item participant completed questionnaire to measure general health. It includes a mental component score (MCS): ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good mental health. (NCT03313076)
Timeframe: 6 weeks following burn injury

Interventionscore on a scale (Mean)
Omega-349.98
No Omega 3 Treatment48.29
Vitamin D52.80
No Vitamin D Treatment46.16

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General Physical Health by Treatment Group Measured by the SF-12 General Physical Health Component Scores

Assessment of physical health will be determined by the SF-12 physical component score. The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health. It includes a physical component score (PCS): ranging from 0 to 100 points. Low values represent a poor physical health and high values represent a good physical health. (NCT03313076)
Timeframe: 6 weeks following burn injury

Interventionscore on a scale (Mean)
Omega-340.84
No Omega 3 Treatment40.12
Vitamin D40.83
No Vitamin D Treatment40.29

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Pain Interference by Treatment Group Measured by the Brief Pain Inventory

The degree to which pain interferes with important life function will be determined by the Brief Pain Inventory. This is a validated, self-reported scale that measures the severity of pain based on the average pain experienced and assesses impact of pain across 7 domains of life function (e.g., enjoyment of life, relationships, normal work). The total severity scores range from 0 (no interference) to 70 (maximum interference). Higher scores reflect greater pain interference. (NCT03313076)
Timeframe: 6 weeks following burn injury

Interventionscore on a scale (Mean)
Omega-311.60
No Omega 3 Treatment13.71
Vitamin D5.5
No Vitamin D Treatment18.67

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Percent of Participants Who Are Compliant With Follow-up (Feasibility)

The primary objective of this pilot study is to ensure that the investigators are able to make follow-up assessments on a majority of participants. The percent of participants who are compliant with follow-up will be determined 6 weeks following major thermal burn injury. Feasibility is defined as >80% of enrolled participants at 6 weeks following Major Thermal Burn Injury (MThBI). (NCT03313076)
Timeframe: 6 weeks following burn injury

Interventionpercentage of participants (Number)
n-3 PUFA (O3FA) + Vitamin D3100
n-3 PUFA (O3FA) Placebo + Vitamin D350
n-3 PUFAs (O3FA) + Vitamin D3 Placebo83.3
n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo80

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By Group Efficacy Estimates Over Year Following Thermal Burn Injury

Estimates of efficacy will be obtained via repeated measures analysis of pain severity over the 1 year following injury using mixed effects models. Pain will be assessed using a 0-10 numeric rating scale with 0 indicating no pain and 10 indicating pain as severe as you can imagine. Higher scores represent worse outcome. These values (collected in identical fashion over 1 year following burn injury) will be entered into a linear mixed model, and overall effect estimates (beta coefficients) among groups will be determined. Final model was a piece-wise linear mixed model, with a cut-point at 6 weeks. Mixed models were adjusted for age, sex, race, initial pain severity. Every 1 unit change in beta coefficient represents a 1 unit change in pain severity on the 0-10 numeric rating scale. (NCT03313076)
Timeframe: Over 1 year following MThBI

,,,
Interventionscore on a scale (Mean)
Baseline (Day 1)Week 1Week 2Week 3Week 4Week 5Week 6Month 3Month 6Month 12
No Omega 3 Treatment7.575.503.82.82.331.431.570.330.330.5
No Vitamin D Treatment7.656.094.912.902.41.562.331.00.861.25
Omega-37.195.74.52.01.731.221.60.671.141.2
Vitamin D7.0153.221.91.610.750.250.670.6

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Change in Insulin Consumption

Change in daily exogenous insulin consumption (IU) (NCT03345004)
Timeframe: Baseline and 15 months

InterventionIU/kg/24h (Mean)
Active Arm0.183
Placebo Arm0.094
Active (HLA DR3-DQ2)0.143
Placebo (HLA DR3-DQ2)0.153

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Change in Maximum C-peptide

Change in maximum C-peptide during MMTT (nmol/L) (NCT03345004)
Timeframe: Baseline and 15 months

Interventionnmol/L (Mean)
Active Arm-0.350
Placebo Arm-0.300
Active (HLA DR3-DQ2)-0.257
Placebo (HLA DR3-DQ2)-0.277

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Number of Clinically Significant Abnormal Results in Vital Signs

Vital signs (blood pressure) (mmHg) (NCT03345004)
Timeframe: 15 months

,
InterventionClinically significant abnormal results (Number)
Systolic blood pressureDiastolic blood pressure
Active Arm00
Placebo Arm00

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Change in Stimulated C-peptide During a MMTT

Change in C-peptide between Baseline and 15 Months. C-peptide was measured by Area Under the Curve [AUC] at 0-120 min during a Mixed Meal Tolerance Test (MMTT) and divided by 120 min. The results are given as the ratio (back-transformed from log-scale) between 15 Months and Baseline as predicted by the MMRM (Mixed Model Repeated Measures) model. (NCT03345004)
Timeframe: Baseline and 15 months

InterventionUnitless back-transformed from log-scale (Mean)
Active Arm0.551
Placebo Arm0.506
Active (HLA DR3-DQ2)0.663
Placebo (HLA DR3-DQ2)0.425

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Change in HbA1c

Change in HbA1c (mmol/mol) (NCT03345004)
Timeframe: Baseline and 15 months

Interventionmmol/mol (Mean)
Active Arm0.53
Placebo Arm1.04
Active (HLA DR3-DQ2)0.87
Placebo (HLA DR3-DQ2)-0.98

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Number of Hypoglycemias

Number of self-reported episodes of severe hypoglycemia (Severe hypoglycemia defined as needing help from others and/or seizures and/or unconscious) (counts) (NCT03345004)
Timeframe: Baseline and 15 months

InterventionEpisodes (Number)
Active Arm0
Placebo Arm6
Active (HLA DR3-DQ2)0
Placebo (HLA DR3-DQ2)0

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Number of Patients Having at Least 1 Severe Hypoglycemic Event

Number of patients having at least 1 severe hypoglycemic event (counts) (NCT03345004)
Timeframe: Baseline and 15 months

InterventionParticipants (Count of Participants)
Active Arm0
Placebo Arm1
Active (HLA DR3-DQ2)0
Placebo (HLA DR3-DQ2)0

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Stimulated C-peptide Above 0.2 Nmol/L at 90 Min

Percentage of patients with a stimulated 90min C-peptide level above 0.2 nmol/L (0.6 ng/ml) (NCT03345004)
Timeframe: 15 months

InterventionPercent of patients (Number)
Active Arm87.3
Placebo Arm71.4
Active (HLA DR3-DQ2)96.6
Placebo (HLA DR3-DQ2)64.7

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Stimulated Maximum C-peptide Above 0.2 Nmol/L

Percentage of patients with a stimulated maximum C-peptide level above 0.2 nmol/L (0.6 ng/ml) (NCT03345004)
Timeframe: 15 months

InterventionPercent of patients (Number)
Active Arm92.7
Placebo Arm75.7
Active (HLA DR3-DQ2)96.6
Placebo (HLA DR3-DQ2)70.6

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C-peptide Levels During a MMTT

C-peptide measured at 30, 60, 90, and 120 minutes during MMTT (nmol/L) at 15 months (NCT03345004)
Timeframe: 15 months

,,,
Interventionnmol/L (Mean)
30 min60 min90 min120 min
Active (HLA DR3-DQ2)0.6590.9111.0161.065
Active Arm0.3760.5360.6450.691
Placebo (HLA DR3-DQ2)0.5800.7150.7170.728
Placebo Arm0.3740.4950.5620.590

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Change in Glycemic Variability/Fluctuations

Change in glycemic variability/fluctuations (evaluated from data from continuous glucose monitoring FreeStyle LibrePro, FGM) over 14 day period. (NCT03345004)
Timeframe: Screening and 15 months

,,,
Interventionglycemic variability/fluctuation per day (Mean)
70-180 mg/dL (hours)50-70 mg/dL (hours)<50 mg/dL (minutes)
Active (HLA DR3-DQ2)-1.7240.03416.7
Active Arm-2.479-0.03515.7
Placebo (HLA DR3-DQ2)-3.9200.58148.1
Placebo Arm-2.4510.1979.0

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Number of Clinically Significant Abnormal Results From Physical and Neurological Examinations

"Physical examination (general appearance including skin, mouth, throat, cardiovascular, abdomen, lymphatic glands, and neurological/musculoskeletal [including reflexes]).~Standardised clinical neurological examination including extremity reflexes, Romberg, Walk on a line, 2 meters, Standing on 1 leg, left and right, 15 seconds per leg, Finger-nose, Mimic, Babinski reflex.~The outcome of the assessments was recored as normal or abnormal" (NCT03345004)
Timeframe: 15 months

,
InterventionClinically significant abnormal results (Number)
Physical examinationNeurological examination
Active Arm154
Placebo Arm90

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Change in Body Mass Index (BMI)

Change in BMI (kg/m2) (NCT03345004)
Timeframe: Baseline and 15 months

Interventionkg/m2 (Mean)
Active Arm0.8
Placebo Arm1.3

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Change in Body Weight

Change in body weight (kg) (NCT03345004)
Timeframe: Baseline and 15 months

InterventionKg (Mean)
Active Arm4.3
Placebo Arm5.6

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Change in Fasting C-peptide

Change in Fasting C-peptide (nmol/L) (NCT03345004)
Timeframe: Baseline and 15 months

Interventionnmol/L (Mean)
Active Arm-0.115
Placebo Arm-0.106
Active (HLA DR3-DQ2)-0.081
Placebo (HLA DR3-DQ2)-0.095

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Change in IDAA1c

Change in insulin-dose-adjusted HbA1c (IDAA1c) (NCT03345004)
Timeframe: Baseline and 15 months

InterventionPercent of glycated hemoglobin (Mean)
Active Arm0.757
Placebo Arm0.377
Active (HLA DR3-DQ2)0.663
Placebo (HLA DR3-DQ2)0.667

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Number of Clinically Significant Abnormal Results From Laboratory Measurements (Haematology and Clinical Chemistry) and Urinalysis.

Number of clinically significant abnormal results from laboratory measurements (haematology and clinical chemistry) and urinalysis. (counts) (NCT03345004)
Timeframe: 15 months

Interventionnumber of significant abnormal results (Number)
Active Arm11
Placebo Arm3

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Percentage of Patients With IDAA1c ≤ 9

Percentage of patients with IDAA1c ≤ 9 (NCT03345004)
Timeframe: 15 months

InterventionPercent of patients (Number)
Active Arm62.7
Placebo Arm61.4
Active (HLA DR3-DQ2)78.6
Placebo (HLA DR3-DQ2)40.0

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Change in Quality of Life (QoL)

Change in QoL as measured by the standardised measure of health questionnaire EQ-5D-5L between baseline and Month 15. The EQ-5D-5L is based on 5 questions rated at 5 levels indicating from no problem (level 1) to extreme problems (level 5) regarding current state of mobility, self-care, activity, pain and anxiety. The outcome is presented as a weighted index value, where 1 is the best possible health and 0 represents being dead. (NCT03345004)
Timeframe: Baseline and 15 months

,
InterventionIndex value (Median)
BaselineMonth 15
Active Arm1.0001.000
Placebo Arm1.0001.000

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GAD65A Titer

GAD65A titer (IU/ml) (NCT03345004)
Timeframe: Baseline and 15 months

,
InterventionIU/mL (Mean)
BaselineMonth 15
Active Arm731.319941.2
Placebo Arm627.3476.7

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Injection Site Reactions

Injection site reactions (NCT03345004)
Timeframe: 15 months

Interventionnumber of episodes (Number)
Active Arm10
Placebo Arm3

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Changes From Baseline Week in Vitamin D 25-hydroxy Levels at Week 12.

"Vitamin D, 25-hydroxy blood serum assays will be tested at Quest Diagnostics. Changes in values from baseline week to week 12 will be calculated.~Reference ranges:~optimal 30-100 ng/mL Insufficient 20-29 ng/mL deficient <20ng/mL" (NCT03380091)
Timeframe: Baseline week & week 12

Interventionmg/dL (Mean)
Vitamin D (Cholecalciferol)11
Metformin-5

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Changes From Baseline Week in Insulin Resistance Score at Week 12.

Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) will be used to calculate Insulin Resistance based on fasting glucose (mg/dL) and fasting insulin (μIU/mL) blood serum assays tested at Quest Diagnostics. HOMA-IR = Fasting Insulin (uIU/mL) x Fasting Glucose (mg/dL). Healthy range is between 0.5-1.4. Values below 1.0 indicate insulin sensitivity and are optimal. Values greater than 1.9 indicate clinically significant insulin resistance. (NCT03380091)
Timeframe: Baseline week & week 12

Interventionunits on a scale (Mean)
Vitamin D (Cholecalciferol)0.81
Metformin-1.2

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Change From Baseline in State-Trait Anxiety Inventory Score (STAI-S) at 12 Weeks

STAI-S is a validated self-reported instrument of 20 questions. Range of scores for the State Anxiety (STAI-S) subtest is 20-80, the higher score indicating greater anxiety. A threshold point score of 39-40 has been suggested by recent literature to detect clinically significant symptoms. Change = Week 12 total score - Baseline week score (NCT03380091)
Timeframe: Baseline week & Week 12

Interventionscore on a scale (Mean)
Metformin0
Vitamin D (Cholecalciferol)10

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Change From Baseline in Depression Score on the Beck Depression Inventory (BDI-II) at 12 Weeks

BDI-II is a validated self-reported instrument of 21 questions which are each scored 0-3. Total scores range from 0-63, with higher score totals indicating more severe depression symptoms. {0-9: indicates minimal depression; 0-18: indicates mild depression; 19-29: indicates moderate depression; 30-63: indicates severe depression}. Change = Week 12 total score - Baseline week score (NCT03380091)
Timeframe: Baseline & 12 weeks

Interventionscore on a scale (Mean)
Vitamin D (Cholecalciferol)-8
Metformin7

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Change From Baseline of Femoral Neck Bone Density Measured by DXA

Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA). (NCT03424239)
Timeframe: Baseline and 6 months

Interventiong/cm^2 (Mean)
Drug: Zoledronic Acid, Calcium+Vitamin D-0.038

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Change From Baseline of Spine Bone Density Measured by DXA

Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA). (NCT03424239)
Timeframe: Baseline and 6 months

Interventiong/cm^2 (Mean)
Drug: Zoledronic Acid, Calcium+Vitamin D0.003

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Change in Serum CTX

The primary aim of this study is to determine the postoperative changes in serum markers of bone turnover after a preoperative infusion of zoledronic acid. Serum C-terminal telopeptide of type 1 collagen (CTX) is marker of bone resorption. (NCT03424239)
Timeframe: Baseline and 6 months

Interventionng/ml (Mean)
Drug: Zoledronic Acid, Calcium+Vitamin D0.228

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Change in Total Hip Bone Mineral Density by DXA

Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA). (NCT03424239)
Timeframe: Baseline and 6 months

Interventiong/cm^2 (Mean)
Drug: Zoledronic Acid, Calcium+Vitamin D-0.039

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Change in Trabecular Spine Bone Mineral Density by QCT

Early changes in volumetric bone mineral density will be measured at the spine by Quantitative Computed Tomography (QCT). (NCT03424239)
Timeframe: Baseline and 6 months

Interventionmg/cm^3 (Mean)
Drug: Zoledronic Acid, Calcium+Vitamin D4.9

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Incidence and Severity of Treatment-Emergent Adverse Events (TEAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

This study is descriptive and no primary or secondary efficacy endpoints are defined. (NCT03588884)
Timeframe: 5 months

,,,
Interventionnumber of TEAE count (Number)
Grade 1 MildGrade 2 ModerateGrade 3 SevereGrade Potentially Life ThreateningGrade 5 Fatal
Cholecalciferol138000
CTAP101391200
Immediate-release (IR) Calcifediol123300
Paricalcitol105100

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AMH Levels in Women With PCOS

AMH measured by serum analysis (NCT03644212)
Timeframe: 8 weeks after completing vitamin D treatment

Interventionng/mL (Mean)
Vitamin D Treatment1.4
Non Treated0

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Part 1: Optimal Dosing Level to Use in Part 2

Determine the best vitamin D supplementation level based on PK analysis of participants enrolled in Part 1. The PK of 25(OH)D after vitamin D supplementation in children will be characterized using a 2-compartment population PK model (popPK) with linear absorption and elimination kinetics. (NCT03686150)
Timeframe: 20 weeks

InterventionIU (Number)
Daily Dose (IU)Single Loading Dose (IU)
Vitamin D3 Oral Regimen800050000

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Part 2: Proportion of Participants With Vitamin D Levels >= 40 ng/ml

Proportion of participants in part 2 who achieve vitamin levels >= 40 ng/ml (NCT03686150)
Timeframe: 16 weeks

Interventionproportion of participants (Number)
Part 2, Cohort A Vitamin D3 Oral Regimen0.786
Part 2, Cohort B Vitamin D Oral Regimen0

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Number of Participants With a Physical Disability After Stroke as Measured by the Modified Katz Activities of Daily Living (ADL) Scale

The modified Katz ADL scale ask participants to self-report if they need needing help with any of the following items: bathing; dressing; eating; getting in and out of a chair; and walking 50 yards. Individuals who report needing help with any of those items will be considered to have a physical disability after stroke. (NCT04070833)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Active Vitamin D6
Vitamin D Placebo6
Active Omega-3 Fatty Acids3
Omega-3 Fatty Acids Placebo9

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Number of Participants With a Physical Disability After Stroke as Measured by the Rosow-Breslau Functional Health Scale

The Rosow-Breslau Functional Health Scale asks participants to self-report if they need help with any of the following tasks: walking 0.5 mile; walking up and down stairs to the second floor; and doing heavy work around the house. Individuals who report needing help with any of those tasks will be considered to have a physical disability after stroke. (NCT04070833)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Active Vitamin D45
Vitamin D Placebo53
Active Omega-3 Fatty Acids42
Omega-3 Fatty Acids Placebo56

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Number of Participants With at Least One Functional Limitation After Stroke According to the Scale Adapted From Nagi

Functional limitations will be assessed through self-report using the physical performance scale adapted from Nagi. The adapted Nagi scale asks respondents if they experience any limitations in each of the following items: pulling or pushing large objects; stooping, crouching, or kneeling; reaching or extending arms above shoulder level; reaching or extending arms below shoulder level; writing or handling or fingering small objects; standing in one place for long periods; and sitting for an hour. Participants reporting a limitation in any of these items will be considered to have at least one functional limitation after stroke. (NCT04070833)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Active Vitamin D24
Vitamin D Placebo27
Active Omega-3 Fatty Acids20
Omega-3 Fatty Acids Placebo31

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Number of Participants With Social Disability After Stroke as Measured by FHS Social Disability Scale

"Social disability was assessed through a self-administered questionnaire which asked questions about social functioning developed in the Framingham Heart Study. The scale covers five social areas (housekeeping, transportation, social interaction, food preparation, and grocery shopping). Respondents are grouped into four categories (need met, no apparent problem (best outcome); need met, potential problem; uncertain need met, potential problem; need unmet, current problem (worst outcome)) for each social area using a previously published algorithm.~We created summary indices for the total number of unmet needs across all areas and for the total number of unmet needs or uncertain needs met, potential problem. These indices range from 0 to 5, but to avoid problems with model convergence due to sparse data, we will a priori categorize them as 0 (best outcome), 1, or ≥2 (worst outcome)." (NCT04070833)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Unmet need72055558Unmet need72055559Unmet need72055560Unmet need72055561Uncertain need met or unmet need72055559Uncertain need met or unmet need72055561Uncertain need met or unmet need72055560Uncertain need met or unmet need72055558
012
Active Vitamin D81
Vitamin D Placebo98
Active Omega-3 Fatty Acids92
Omega-3 Fatty Acids Placebo87
Active Vitamin D10
Vitamin D Placebo5
Active Omega-3 Fatty Acids5
Omega-3 Fatty Acids Placebo10
Active Vitamin D3
Vitamin D Placebo2
Active Omega-3 Fatty Acids2
Omega-3 Fatty Acids Placebo3
Active Vitamin D59
Vitamin D Placebo79
Active Omega-3 Fatty Acids74
Omega-3 Fatty Acids Placebo64
Active Vitamin D19
Vitamin D Placebo16
Active Omega-3 Fatty Acids13
Omega-3 Fatty Acids Placebo22
Active Vitamin D16
Vitamin D Placebo10
Active Omega-3 Fatty Acids12
Omega-3 Fatty Acids Placebo14

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Clinical PDT Response as Measured by Percent Change in AK Lesions From Baseline to 3 Months

"Clinical PDT response as measured by the percent change of AK lesions 3 months after treatment~Baseline vitamin D (calcidiol) level will be taken for each patient." (NCT04140292)
Timeframe: 3 months after treatment

InterventionPercent change of AK lesions (Mean)
Vitamin D3 + Photodynamic Therapy (PDT)59.1
Photodynamic Therapy (PDT)72.5

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Number of Participants Reporting 1 or Higher on the Pain Scale

"Pain scale recorded on a 0-to-10 visual/analog scale, with higher scores mean more pain; 0 is no pain, 10 is the worst pain imaginable. Number of participants receiving treatment that reported a pain level greater than 1." (NCT04140292)
Timeframe: During treatment (at the 5 min mark), and again immediately afterwards.

InterventionParticipants (Count of Participants)
Vitamin D3 + Photodynamic Therapy (PDT)0
Photodynamic Therapy (PDT)0

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Tolerability as Measured by Participants' Symptom Score Sheets

"Participants are asked to recall the symptoms they experienced during the week following PDT. The study physician asks them whether they had experienced each of the following 13 symptoms (YES/NO), and positive (YES) answers were summed to create a Side Effects Score (SES). The maximum and minimum possible values are 13 and 0 respectively, with a higher score correlating to poorer participant outcomes.~The 13 possible side effects were: pain, erythema, scabbing, blistering, erosions, edema, warmth, exfoliation, discharge, hemorrhage, tightness, hyperpigmentation, hypopigmentation." (NCT04140292)
Timeframe: 1 week after treatment

Interventionscore on a scale (Mean)
Vitamin D3 + Photodynamic Therapy (PDT)3.7
Photodynamic Therapy (PDT)3.7

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Change in Composite Asthma Severity Index (CASI)

"CASI was measured by questionnaire and is a severity score of symptom burden, exacerbations, healthcare utilization, lung function and dose of inhaled corticosteroids. The change in CASI score was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months).~[The CASI score has a minimum value = 0, maximum value = 20, a higher score indicates greater asthma severity]" (NCT04179461)
Timeframe: Baseline to 12 months

Interventionscore on a scale (Median)
V1V2V3
Personalized Treatment555

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Asthma Control Test (ACT)

"ACT was measured by questionnaire, assessing frequency of reported asthma symptoms, rescue medication use, the effect of asthma on daily functioning, and overall asthma control. The change in ACT score was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months).~[The ACT score has a minimum value = 5, maximum value = 25, a score 19 indicates well-controlled asthma]" (NCT04179461)
Timeframe: Baseline to 12 months

Interventionscore on a scale (Median)
V1V2V3
Personalized Treatment23.021.722.5

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Adherence of Asthma Controller Medication

Adherence was measured using the Propeller Health Inhaler monitor and web-based software management platform that tracks adherence of asthma medications. The change in adherence was calculated between V1 (baseline) to V3 (12 Months). (NCT04179461)
Timeframe: Baseline to 12 months

Interventionpercentage of medication taken (Median)
V1V3
Personalized Treatment4236

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Pulmonary Function Measured by Spirometry: Forced Expiratory Volume in 1 Second (FEV1) / Forced Vital Capacity (FVC)

"FEV1 is air volume exhaled in 1 second during spirometry. Forced vital capacity is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. The change in FEV1/FVC was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months). This will be used as a measurement in asthma severity.~[A lower FEV1/FVC ratio indicates more severe asthma]" (NCT04179461)
Timeframe: Baseline to 12 months

InterventionRatio (Median)
V1V2V3
Personalized Treatment0.810.80.8

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Death

Number of study participants who died with 21 day of randomization (NCT04400890)
Timeframe: Within 21 days from randomization

InterventionParticipants (Count of Participants)
Resveratrol With Vitamin D30
Placebo With Vitamin D30

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Pneumonia

Number of study participants are diagnosed with pneumonia with 21 day of randomization (NCT04400890)
Timeframe: 21 days from randomization

InterventionParticipants (Count of Participants)
Resveratrol With Vitamin D34
Placebo With Vitamin D38

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Hospitalization Rates for COVID-19

Number of study participants admitted to the hospital within 21 days of randomization (NCT04400890)
Timeframe: 21 days from study randomization

InterventionParticipants (Count of Participants)
Resveratrol With Vitamin D31
Placebo With Vitamin D33

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ICU Admission Rates

Number of study participants admitted within 21 who subsequently get admitted to the ICU (NCT04400890)
Timeframe: 21 days from randomization

InterventionParticipants (Count of Participants)
Resveratrol With Vitamin D30
Placebo With Vitamin D30

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Invasive Ventilation Rates

Number of study participants who get admitted with 21 day of randomization who receiving invasive ventilation. (NCT04400890)
Timeframe: 21 days from randomization

InterventionParticipants (Count of Participants)
Resveratrol With Vitamin D30
Placebo With Vitamin D30

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Pulmonary Embolism

Number of study participants are diagnosed with pulmonary embolism with 21 day of randomization (NCT04400890)
Timeframe: 21 days from start of randomization.

InterventionParticipants (Count of Participants)
Resveratrol With Vitamin D31
Placebo With Vitamin D31

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Number of Mothers With Elevated Calcium Concentrations at 1 Month

Number of mothers with serum calcium > 10.5 mg/dL (NCT04629534)
Timeframe: 1 month post enrollment

InterventionParticipants (Count of Participants)
Group A0
Group B0

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Number of Mothers With Elevated Calcium Concentrations at Month 2

Number of mothers with serum calcium > 10.5 mg/dL (NCT04629534)
Timeframe: 2 months post enrollment

InterventionParticipants (Count of Participants)
Group A0
Group B0

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Number of Infants With Elevated Calcium Concentration at Month 1

Number of infants with serum calcium > 11.0 mg/dL (NCT04629534)
Timeframe: 1 month post enrollment

InterventionParticipants (Count of Participants)
Group A0
Group B0

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Number of Mothers With Sufficient 25(OH)D Stores at 3 Months

Number of mothers with 25(OH)D levels >20 ng/mL (NCT04629534)
Timeframe: 3 months post enrollment

InterventionParticipants (Count of Participants)
Group A1
Group B1

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Number of Mothers With Elevated Calcium Concentrations at Month 3

Number of mothers with serum calcium > 10.5 mg/dL (NCT04629534)
Timeframe: 3 months post enrollment

InterventionParticipants (Count of Participants)
Group A0
Group B0

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Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 1

Number of mothers with serum calcium > 1.0 mmol/mmol (NCT04629534)
Timeframe: 1 month post enrollment

InterventionParticipants (Count of Participants)
Group A0
Group B0

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Number of Infants With Elevated Calcium Concentration at Month 2

Number of infants with serum calcium > 11.0 mg/dL (NCT04629534)
Timeframe: 2 months post enrollment

InterventionParticipants (Count of Participants)
Group A0
Group B0

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Number of Infants With Elevated Calcium Concentration at Month 3

Number of infants with serum calcium > 11.0 mg/dL (NCT04629534)
Timeframe: 3 months post enrollment

InterventionParticipants (Count of Participants)
Group A0
Group B0

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Number of Infants With Sufficient 25(OH)D Stores at 3 Months

Number of infants with 25(OH)D levels > 20 ng/mL (NCT04629534)
Timeframe: 3 months post enrollment

InterventionParticipants (Count of Participants)
Group A1
Group B1

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Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 2

Number of mothers with urine calcium/creatinine ratio > 1.0 mmol/mmol (NCT04629534)
Timeframe: 2 months post enrollment

InterventionParticipants (Count of Participants)
Group A0
Group B0

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Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 3

Number of mothers with urine calcium/creatinine ratio > 1.0 mmol/mmol (NCT04629534)
Timeframe: 3 months post enrollment

InterventionParticipants (Count of Participants)
Group A0
Group B0

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