Page last updated: 2024-11-12

tocotrienols

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Occurs in Manufacturing Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

tocotrienol : A tocol in which the hydrocarbon chain at position 2 contains three double bonds. [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 CID9929901
CHEMBL ID120643
CHEBI ID197268
SCHEMBL ID1448780
SCHEMBL ID1081622
MeSH IDM0370452

Synonyms (23)

Synonym
tocotrienol
ccris 7711
tocotrienols ,
CHEMBL120643
(r)-3,4-dihydro-2-methyl-2-(4,8,12-trimethyl-3,7,11-tridecatrienyl)-2h-1-benzopyran-6-ol
CHEBI:197268
2-methyl-2-[(3e,7e)-4,8,12-trimethyltrideca-3,7,11-trienyl]-3,4-dihydrochromen-6-ol
NCGC00186586-01
SCHEMBL1448780
unii-0867i0n41v
0867i0n41v ,
6829-55-6
SCHEMBL1081622
2h-1-benzopyran-6-ol, 3,4-dihydro-2-methyl-2-(4,8,12-trimethyl-3,7,11-tridecatrienyl)-
2-methyl-2-[(3e,7e)-4,8,12-trimethyltrideca-3,7,11-trien-1-yl]-3,4-dihydro-2h-1-benzopyran-6-ol
DB12647
GJJVAFUKOBZPCB-ZGRPYONQSA-N
Q27236375
97530-73-9
3,4-dihydro-2-methyl-2-[(3e,7e)-4,8,12-trimethyl-3,7,11-tridecatrien-1-yl]-2h-1-benzopyran-6-ol
DTXSID601336446
2-methyl-2-(4,8,12-trimethyltrideca-3,7,11-trien-1-yl)chroman-6-ol
2-methyl-2-((3e,7e)-4,8,12-trimethyltrideca-3,7,11-trien-1-yl)chroman-6-ol

Research Excerpts

Overview

Tocotrienols are a class of vitamin E reported to be potent antioxidants, besides having the ability to inhibit the HMG-CoA reductase enzyme. They have shown to be a potent antioxidant, anti-inflammatory, and antifibrotic agent.

ExcerptReferenceRelevance
"Tocotrienols are a unique form of vitamin E with strong antioxidant and anti-inflammatory properties that can be exploited as a preventive agent for pre-eclampsia."( Tocotrienol in Pre-Eclampsia Prevention: A Mechanistic Analysis in Relation to the Pathophysiological Framework.
Abdul Rahman, R; Chin, KY; Kalok, A; Mahdy, ZA; Nik-Ahmad-Zuky, NL, 2022
)
1.44
"Tocotrienols have shown to be a potent antioxidant, anti-inflammatory, and antifibrotic agent in animal and clinical studies."( A Phase IIb Randomized Controlled Trial Investigating the Effects of Tocotrienol-Rich Vitamin E on Diabetic Kidney Disease.
Abdul Kadir, K; Ahmad, B; Chuar, PF; Ho, JI; Ho, LS; Koay, YY; Phang, SCW; Tan, GCJ, 2021
)
1.34
"Tocotrienols are a subclass of vitamin E compounds that display potent anticancer activity. "( Role of GTP-binding proteins in reversing the antiproliferative effects of tocotrienols in preneoplastic mammary epithelial cells.
Briski, KP; Nachnani, A; Shah, S; Sylvester, PW, 2002
)
1.99
"Tocotrienols is an isoform of tocopherols. "( [Progression of tocotrienols].
Dong, F; Sun, W; Yan, Y, 2004
)
2.11
"Tocotrienols are a class of vitamin E reported to be potent antioxidants, besides having the ability to inhibit the HMG-CoA reductase enzyme. "( Dose dependent elevation of plasma tocotrienol levels and its effect on arterial compliance, plasma total antioxidant status, and lipid profile in healthy humans supplemented with tocotrienol rich vitamin E.
Rahman, AR; Rasool, AH; Wong, AR; Yuen, KH; Yusoff, K, 2006
)
1.78
"Tocotrienols are a group of natural vitamin E compounds with patent antitumoral effects, mostly based on their ability to induce apoptosis in cancer cells. "( Tocotrienols: balancing the mitochondrial crosstalk between apoptosis and autophagy.
Molero, X; Rickmann, M; Vaquero, EC,
)
3.02
"Tocotrienols are a form of vitamin E, having an unsaturated isoprenoid side-chain rather than the saturated side-chain of tocopherols. "( Inhibition of proliferation of estrogen receptor-negative MDA-MB-435 and -positive MCF-7 human breast cancer cells by palm oil tocotrienols and tamoxifen, alone and in combination.
Carroll, KK; Chambers, AF; Gapor, A; Guthrie, N, 1997
)
1.95

Effects

Tocotrienols have been shown to inhibit the 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase activity. They have been reported to exert anticancer, anti-inflammatory, antioxidant, cardio-protective and boneprotective effects through modulation of NFκB signalling pathway.

ExcerptReferenceRelevance
"Tocotrienols have been reported to exert anticancer, anti-inflammatory, antioxidant, cardio-protective and boneprotective effects through modulation of NFκB signalling pathway. "( Modulation of NFκB signalling pathway by tocotrienol: A systematic review.
Agarwal, R; Nasir, NAA; Sadikan, MZ, 2021
)
2.06
"Tocotrienols (T3s) have been hypothesized to have greater antioxidant capacity than tocopherols (Ts) due to differences in biokinetics that affect their absorption and function. "( Antioxidant status following postprandial challenge of two different doses of tocopherols and tocotrienols.
Cheng, HM; Fairus, S; Sundram, K, 2020
)
2.22
"Tocotrienols have shown to be a potent antioxidant, anti-inflammatory, and antifibrotic agent in animal and clinical studies."( A Phase IIb Randomized Controlled Trial Investigating the Effects of Tocotrienol-Rich Vitamin E on Diabetic Kidney Disease.
Abdul Kadir, K; Ahmad, B; Chuar, PF; Ho, JI; Ho, LS; Koay, YY; Phang, SCW; Tan, GCJ, 2021
)
1.34
"Tocotrienols have shown bone-protective effect in animals. "( Tocotrienol supplementation suppressed bone resorption and oxidative stress in postmenopausal osteopenic women: a 12-week randomized double-blinded placebo-controlled trial.
Felton, CK; Mo, H; Romero, AW; Shen, CL; Tomison, MD; Yang, S, 2018
)
1.92
"Tocotrienols (TT) have been shown to benefit bone health in ovariectomized animals, a model of postmenopausal women. "( Tocotrienol supplementation suppressed bone resorption and oxidative stress in postmenopausal osteopenic women: a 12-week randomized double-blinded placebo-controlled trial.
Felton, CK; Mo, H; Romero, AW; Shen, CL; Tomison, MD; Yang, S, 2018
)
1.92
"Tocotrienols have been reported to possess anticancer effects other than anti-inflammatory and antioxidant activities. "( Alkaloid extracts of Ficus species and palm oil-derived tocotrienols synergistically inhibit proliferation of human cancer cells.
Abubakar, IB; Lim, KH; Loh, HS, 2015
)
2.11
"Tocotrienols have been shown many biologic functions such as antioxidant, anti-cancer, maintaining fertility and regulating the immune system and so on. "( Tocotrienol-rich fraction (TRF) suppresses the growth of human colon cancer xenografts in Balb/C nude mice by the Wnt pathway.
Guan, T; He, N; Li, M; Li, Q; Liu, JR; Liu, YH; Zhang, J; Zhang, JS; Zhang, SJ; Zhou, PH, 2015
)
1.86
"Tocotrienols have been known for their antioxidant properties besides their roles in cellular signalling, gene expression, immune response and apoptosis. "( Targeting genes in insulin-associated signalling pathway, DNA damage, cell proliferation and cell differentiation pathways by tocotrienol-rich fraction in preventing cellular senescence of human diploid fibroblasts.
Durani, LW; Jaafar, F; Makpol, S; Mohd Yusof, YA; Tajul Arifin, K; Tan, JK; Wan Ngah, WZ,
)
1.57
"Tocotrienols have been reported as antitumor agents and widely commercialized as an antioxidant dietary supplement. "( Chemoprevention of tocotrienols: the mechanism of antiproliferative effects.
Wada, S, 2009
)
2.12
"Tocotrienols of palm oil have been shown to possess potent neuroprotective, antioxidative, anticancer, and cholesterol-lowering activities. "( Tocotrienols inhibited growth and induced apoptosis in human HeLa cells through the cell cycle signaling pathway.
Ng, LT; Wu, SJ, 2010
)
3.25
"Tocotrienols have been shown to possess antioxidant, antitumor, cardioprotective, and antiproliferative effects. "( Role of immunoregulatory transcription factors in differential immunomodulatory effects of tocotrienols.
Checker, R; Devasagayam, TP; Khan, NM; Patil, A; Patwardhan, R; Sandur, SK; Sharma, D; Wilankar, C, 2011
)
2.03
"Tocotrienols have been shown to lower the atherogenic apolipoprotein B and lipoprotein plasma levels."( Cellular protection and therapeutic potential of tocotrienols.
Batirel, S; Catalgol, B; Ozer, NK, 2011
)
1.34
"Tocotrienols have been shown to have molecular targets including: apoptotic regulators, cytokines, adhesion molecules, enzymes, kinases, receptors, transcription factors, and growth factors."( Tocotrienols: the lesser known form of natural vitamin E.
Khanna, S; Patel, V; Rink, C; Sen, CK, 2011
)
2.53
"Tocotrienols have been reported to improve lipid profiles, reduce atherosclerotic lesions, decrease blood glucose and glycated haemoglobin concentrations, normalise blood pressure in vivo and inhibit adipogenesis in vitro, yet their role in the metabolic syndrome has not been investigated. "( Tocotrienols reverse cardiovascular, metabolic and liver changes in high carbohydrate, high fat diet-fed rats.
Brown, L; Poudyal, H; Ward, LC; Wong, WY, 2012
)
3.26
"Tocotrienols have been reported to lower LDL-cholesterol and fasting glucose concentrations and to have potent antioxidant effects, but the results are contradictory."( Supplementation with 3 compositionally different tocotrienol supplements does not improve cardiovascular disease risk factors in men and women with hypercholesterolemia.
DeMichele, SJ; Edens, NK; Mustad, VA; Ruey, PP; Smith, CA, 2002
)
1.76
"Tocotrienols have been reported to have higher biological activities than tocopherols. "( Tumor suppressive effects of tocotrienol in vivo and in vitro.
Murakoshi, M; Nishino, H; Noguchi, N; Satomi, Y; Wada, S; Yoshikawa, T, 2005
)
1.77
"Tocotrienols has been shown to inhibit the 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase activity; however, the published animal and human studies yield conflicting results. "( Effect of either gamma-tocotrienol or a tocotrienol mixture on the plasma lipid profile in hamsters.
Aebischer, C; Elste, V; Raederstorff, D; Weber, P, 2002
)
1.76

Actions

Tocotrienols can suppress the growth of different malignancies, including those of breast, lung, ovary, prostate, liver, brain, colon, myeloma, and pancreas. Tocotrianols also inhibit vascularization-reducing proliferation, migration and tube formation.

ExcerptReferenceRelevance
"Tocotrienols can suppress the growth of different malignancies, including those of breast, lung, ovary, prostate, liver, brain, colon, myeloma, and pancreas."( Molecular Mechanisms of Action of Tocotrienols in Cancer: Recent Trends and Advancements.
Aggarwal, V; Chaudhary, A; Garg, VK; Jain, A; Kashyap, D; Sak, K; Sethi, G; Tuli, HS; Yerer, MB, 2019
)
1.51
"Tocotrienols also inhibit vascularization-reducing proliferation, migration and tube formation."( Chemoprevention of tocotrienols: the mechanism of antiproliferative effects.
Wada, S, 2009
)
1.4

Treatment

Tocotrienols treatment induced increases in α-tocopherol levels of 4-fold and 6-fold in plasma and platelets, respectively. Treatment with tocotrienols may protect neurite function through its neuroprotective function.

ExcerptReferenceRelevance
"α-Tocotrienols treatment induced increases in α-tocopherol levels of 4-fold and 6-fold in plasma and platelets, respectively."( Tocotrienols-induced inhibition of platelet thrombus formation and platelet aggregation in stenosed canine coronary arteries.
Folts, JD; Karpen, CW; Morrison, DC; Papasian, CJ; Qureshi, AA; Qureshi, N, 2011
)
2.37
"Pretreatment with tocotrienols prevented radiation-induced changes at 2 weeks."( Effects of radiation on the epidermal growth factor receptor pathway in the heart.
Boerma, M; Corry, PM; Guha, C; Hauer-Jensen, M; Lieblong, BJ; Moros, EG; Sharma, SK; Sridharan, V; Tripathi, P, 2013
)
0.71
"Treatment with tocotrienols may protect neurite function through its neuroprotective function."( Hydrogen peroxide induces neurite degeneration: Prevention by tocotrienols.
Fukui, K; Koike, T; Takatsu, H; Urano, S, 2011
)
0.95
"Treatment with tocotrienols (TRF) also increased levels of tocopherols and tocotrienols in post- vs pre-treatment samples (tocopherols, 68 vs 20 μg/mL in plasma and 31.4 vs 7.9 μg/mL in platelets; tocotrienols, 8.6 vs 1.7 μg/mL in plasma and 3.8 vs 3.9 μg/mL in platelets)."( Tocotrienols-induced inhibition of platelet thrombus formation and platelet aggregation in stenosed canine coronary arteries.
Folts, JD; Karpen, CW; Morrison, DC; Papasian, CJ; Qureshi, AA; Qureshi, N, 2011
)
2.15

Toxicity

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 14 tocopherols and tocotrienols. The panel concluded these ingredients are safe as used in cosmetics.

ExcerptReferenceRelevance
" No adverse event due to treatments was reported by the participants."( A 12-week evaluation of annatto tocotrienol supplementation for postmenopausal women: safety, quality of life, body composition, physical activity, and nutrient intake.
Abbasi, M; Felton, CK; Hao, L; Khan, MS; Mo, H; Romero, AW; Scott, S; Shen, CL; Tomison, MD; Wang, S; Yang, S, 2018
)
0.48
"Annatto-derived tocotrienol up to 600 mg per day for 12 weeks appeared to be safe in postmenopausal osteopenic women, particularly in terms of liver and kidney functions."( A 12-week evaluation of annatto tocotrienol supplementation for postmenopausal women: safety, quality of life, body composition, physical activity, and nutrient intake.
Abbasi, M; Felton, CK; Hao, L; Khan, MS; Mo, H; Romero, AW; Scott, S; Shen, CL; Tomison, MD; Wang, S; Yang, S, 2018
)
0.48
"The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 14 tocopherols and tocotrienols and concluded these ingredients are safe as used in cosmetics."( Safety Assessment of Tocopherols and Tocotrienols as Used in Cosmetics.
Andersen, FA; Belsito, DV; Bergfeld, WF; Fiume, MM; Heldreth, B; Hill, RA; Klaassen, CD; Liebler, DC; Marks, JG; Shank, RC; Slaga, TJ; Snyder, PW,
)
0.62
" Inhibition is time and dose-dependent, therefore tocotrienols' homologs show very high toxic or no effects."( Studies on the growth inhibiting and non-cytotoxic effects of tocotrienols on selected cancer cell lines.
Nogala-Kalucka, M; Szulczewska-Remi, A,
)
0.62
" Thirteen serious adverse events occurred."( Randomised single centre double-blind placebo controlled phase II trial of Tocovid SupraBio in combination with pentoxifylline in patients suffering long-term gastrointestinal adverse effects of radiotherapy for pelvic cancer: The PPALM study.
Abdi, BA; Abraham, D; Adams, C; Anbalagan, S; Andreyev, HJN; Bliss, J; Boyle, S; Gothard, L; Hauer-Jensen, M; Lucy, C; Matthews, J; Musallam, A; Taylor, A; Tovey, H; Yarnold, J, 2022
)
0.72
" No adverse reaction was observed."( Open-label, single-arm, single-center clinical study on the effectiveness and safety of a moisturizer containing tocotrienol-rich composition in children with mild to moderate atopic dermatitis.
Chang, HW; How, KN; Lai, OM, 2023
)
0.91
"The results suggested that tocotrienol-rich moisturizer is safe and effective in the management of AD in young children."( Open-label, single-arm, single-center clinical study on the effectiveness and safety of a moisturizer containing tocotrienol-rich composition in children with mild to moderate atopic dermatitis.
Chang, HW; How, KN; Lai, OM, 2023
)
0.91

Pharmacokinetics

ExcerptReferenceRelevance
"To evaluate and compare the pharmacokinetic parameters, especially bioavailability, of annatto-based tocotrienol with palm tocotrienol-rich fraction in healthy human volunteers for better therapeutic outcome."( Pharmacokinetics and bioavailability of tocotrienols in healthy human volunteers: a systematic review.
Farhat, K; Khan, DA; Khan, MA; Noor, M; Rafique, S; Sharif, M, 2023
)
1.18
" Pharmacokinetic parameters of annatto-based tocotrienol were better than palm-derived tocotrienol."( Pharmacokinetics and bioavailability of tocotrienols in healthy human volunteers: a systematic review.
Farhat, K; Khan, DA; Khan, MA; Noor, M; Rafique, S; Sharif, M, 2023
)
1.18

Compound-Compound Interactions

ExcerptReferenceRelevance
"The present study was performed to investigate the effect of astaxanthin in combination with other antioxidants against oxidative damage in streptozotocin (STZ)-induced diabetic Osteogenic Disorder Shionogi (ODS) rats."( Effect of astaxanthin in combination with alpha-tocopherol or ascorbic acid against oxidative damage in diabetic ODS rats.
Nakano, M; Nguyen, VC; Onodera, A; Saito, E; Takahashi, J; Tanabe, M; Yajima, K, 2008
)
0.35
"We conducted a double-blinded, placebo-controlled pilot trial to test the effectiveness of adjuvant tocotrienol therapy in combination with tamoxifen for five years in women with early breast cancer."( Effectiveness of tocotrienol-rich fraction combined with tamoxifen in the management of women with early breast cancer: a pilot clinical trial.
Abdul Razak, G; Gomez, PA; Nesaretnam, K; Selvaduray, KR; Veerasenan, SD, 2010
)
0.36

Bioavailability

Tocotrienols, however, have poor oral bioavailability and were therefore entrapped into parenteral nanoemulsions. The effect of nanoencapsulation on the oral bio availability and tissue distribution of tocotrienols were investigated.

ExcerptReferenceRelevance
" Although the antioxidant activity of tocotrienols is higher than that of tocopherols, tocotrienols have a lower bioavailability after oral ingestion."( Molecular aspects of alpha-tocotrienol antioxidant action and cell signalling.
Packer, L; Rimbach, G; Weber, SU, 2001
)
0.58
"We have investigated the pharmacokinetics and bioavailability of alpha-, gamma- and delta-tocotrienols under fed and fasted conditions in eight healthy volunteers."( Pharmacokinetics and bioavailability of alpha-, gamma- and delta-tocotrienols under different food status.
Wong, JW; Yap, SP; Yuen, KH, 2001
)
0.77
" It is important to characterize the active components in garlic and their bioavailability after ingestion."( Effects on the human serum lipoprotein profile of beta-glucan, soy protein and isoflavones, plant sterols and stanols, garlic and tocotrienols.
Brouns, F; Hornstra, G; Kerckhoffs, DA; Mensink, RP, 2002
)
0.52
"A study was conducted to evaluate the bioavailability of alpha-, gamma- and delta-tocotrienols administered via oral, intravenous, intramuscular and intraperitoneal routes in rats."( Influence of route of administration on the absorption and disposition of alpha-, gamma- and delta-tocotrienols in rats.
Lim, AB; Yap, SP; Yuen, KH, 2003
)
0.76
"A single dose comparative bioavailability study was conducted to evaluate the bioavailability of tocotrienols from two self-emulsifying formulations, one of which produced an emulsion that readily lipolysed under in vitro condition (SES-A), while the other produced a finer dispersion with negligible lipolysis (SES-B) in comparison with that of a non-self-emulsifying formulation in soya oil."( Influence of lipolysis and droplet size on tocotrienol absorption from self-emulsifying formulations.
Yap, SP; Yuen, KH, 2004
)
0.54
" The report that the affinity of TTP to bind (alpha-TCT is an order of magnitude lower than that for alpha-TCP questions the bioavailability of orally taken TCT to tissues."( Natural vitamin E alpha-tocotrienol: retention in vital organs in response to long-term oral supplementation and withdrawal.
Ezziddin, O; Khanna, S; Patel, V; Roy, S; Sen, CK, 2006
)
0.33
"The study showed a good bioavailability of these vitamins and increment due to supplementation."( Plasma vitamin C and tocotrienols changes in response to dietary supplementation among young male adults.
Das, S; Fatimah, IS; Khairul, O; Lee, CC; Mohamad, J; Poh, BK; Zahara, AM, 2010
)
0.68
"To determine the bioavailability of tocotrienol complex with gamma-cyclodextrin, the effects of tocotrienol/gamma-cyclodextrin complex on tocotrienol concentration in rat plasma and tissues were studied."( Complexation of tocotrienol with gamma-cyclodextrin enhances intestinal absorption of tocotrienol in rats.
Ichikawa, T; Ikeda, S; Nakata, D; Terao, K; Uchida, T; Uekaji, Y; Watanabe, T; Yano, T, 2010
)
0.36
" To circumvent these limitations in oral absorption of tocotrienols, investigators have developed novel prodrug derivatives and nanoparticle delivery systems that greatly enhance tocotrienol bioavailability and therapeutic responsiveness."( The value of tocotrienols in the prevention and treatment of cancer.
El Sayed, KA; Kaddoumi, A; Nazzal, S; Sylvester, PW, 2010
)
0.98
" The low bioavailability and rapid excretion of T(3) represents a major hurdle in their preventive use."( Do tocotrienols have potential as neuroprotective dietary factors?
Chin, XW; Eckert, GP; Frank, J; Rimbach, G; Schrader, C, 2012
)
1
" However recent studies tried to increase the bioavailability with esterification and combination use."( Cellular protection and therapeutic potential of tocotrienols.
Batirel, S; Catalgol, B; Ozer, NK, 2011
)
0.62
" Low-phytate (LP) grain is distinguished by containing not only a reduced level of phytate P but also an increased level of inorganic P, resulting in greater bioavailability of P and mineral cations in animal diets."( Compositional equivalence of barleys differing only in low- and normal-phytate levels.
Bregitzer, P; Hicks, KB; Liu, K; Moreau, RA, 2012
)
0.38
" However, its potential in cancer therapy is limited by its poor bioavailability and its inability to specifically reach tumors at therapeutic concentrations after intravenous administration."( Delivery of the vitamin E compound tocotrienol to cancer cells.
Dufès, C, 2011
)
0.37
" The purpose of the current study was to evaluate the in vivo oral bioavailability of vitamin E isoforms, δ-tocotrienol (δ-T3) and γ-tocotrienol (γ-T3) administered as SEDDS, as compared to commercially available UNIQUE E® Tocotrienols capsules."( Nonlinear absorption kinetics of self-emulsifying drug delivery systems (SEDDS) containing tocotrienols as lipophilic molecules: in vivo and in vitro studies.
Alayoubi, A; Alqahtani, S; Kaddoumi, A; Nazzal, S; Sylvester, PW, 2013
)
0.8
" The reason behind this discrepancy might be due to the safety and bioavailability of the currently used oral statins."( A review on the use of statins and tocotrienols, individually or in combination for the treatment of osteoporosis.
Abdul-Majeed, S; Mohamed, N; Soelaiman, IN, 2013
)
0.67
" Its clinical use, however, is limited by poor oral bioavailability and short half-life."( Effect of PEG surface conformation on anticancer activity and blood circulation of nanoemulsions loaded with tocotrienol-rich fraction of palm oil.
Alayoubi, A; Alqahtani, S; Kaddoumi, A; Nazzal, S, 2013
)
0.39
" Tocotrienols, however, have poor oral bioavailability and were therefore entrapped into parenteral nanoemulsions for parenteral administration."( Entrapment into nanoemulsions potentiates the anticancer activity of tocotrienols against the highly malignant (+SA) mouse mammary epithelial cells.
Alayoubi, A; Ayoub, NM; Malaviya, A; Nazzal, S; Sylvester, PW, 2014
)
1.55
" This single-dose, randomized, crossover study aimed to compare the safety and bioavailability of a new formulation of Gamma Delta Tocotrienol (GDT) in comparison with the existing Tocotrienol-rich Fraction (TRF) in terms of gamma and delta isomers in healthy volunteers."( A new formulation of Gamma Delta Tocotrienol has superior bioavailability compared to existing Tocotrienol-Rich Fraction in healthy human subjects.
Bhoo-Pathy, N; Chik, Z; Choudhury, RB; Fuang, HG; Jabir, RS; Meganathan, P; Nesaretnam, K; Taib, NA, 2015
)
0.42
" Tocotrienol-containing plant foods and tocotrienol derivatives and formulations with enhanced bioavailability may offer a novel approach in AD prevention and treatment."( Potential of tocotrienols in the prevention and therapy of Alzheimer's disease.
Mo, H; Xia, W, 2016
)
0.8
" Owing to a difference in the affinity of T3 and Toc for the α-tocopherol transfer protein, the bioavailability of orally ingested T3 is lower than that of Toc."( Synergistic Anticancer Effect of Tocotrienol Combined with Chemotherapeutic Agents or Dietary Components: A Review.
Eitsuka, T; Miyazawa, T; Nakagawa, K; Nishida, H; Tatewaki, N, 2016
)
0.43
"CC-60 and TRF-80 supplementation increased bioavailability of palm-based carotenes and tocotrienols but had no effects, superior or detrimental, on vascular function or CVD risk factors."( Short term effects of palm-tocotrienol and palm-carotenes on vascular function and cardiovascular disease risk: A randomised controlled trial.
Abeywardena, MY; Brinkworth, GD; Stonehouse, W; Thompson, CH, 2016
)
0.66
" Compared to tocopherols, less research has been conducted on these compounds because of their low bioavailability and distribution in plant tissues."( Advances in Genetic Improvement for Tocotrienol Production: A Review.
Abdullah, SNA; Babura, SR; Khaza Ai, H, 2017
)
0.46
" Thus, SIRT1 may regulate vitamin E transportation and bioavailability at cellular level."( Cellular Uptake and Bioavailability of Tocotrienol-Rich Fraction in SIRT1-Inhibited Human Diploid Fibroblasts.
Abdullah, A; Jaafar, F; Makpol, S, 2018
)
0.48
" The increased bioavailability of VE by antibiotics is probably due to increased absorption of VE or its decreased degradation by gut microbes."( Effects of antibiotics on degradation and bioavailability of different vitamin E forms in mice.
Lee, MJ; Lin, Y; Liu, AB; Ran, L; Xie, P; Yang, CS, 2019
)
0.51
" However, the bioavailability of these metabolites has not been well characterized."( Tocopherols and Tocotrienols Are Bioavailable in Rats and Primarily Excreted in Feces as the Intact Forms and 13'-Carboxychromanol Metabolites.
Jiang, Q; Liu, KY, 2020
)
0.9
" The cellular levels of vitamin E were quantified to determine bioavailability at cellular levels."( Analysis of expression of vitamin E-binding proteins in H2O2 induced SK-N-SH neuronal cells supplemented with α-tocopherol and tocotrienol-rich fraction.
Abd Hamid, R; Chang, SK; Chiroma, AA; Khaza'ai, H; Zainal, Z; Zakaria, ZA, 2020
)
0.56
"Tocotrienol has been shown to prevent bone loss in animal models of postmenopausal osteoporosis, but the low oral bioavailability might limit its use."( Therapeutic potential of annatto tocotrienol with self-emulsifying drug delivery system in a rat model of postmenopausal bone loss.
Chin, KY; Ima-Nirwana, S; Mohamad, NV, 2021
)
0.62
" Recent studies have focused on targeted drug delivery by enhancing the bioavailability through carriers, self-sustained emulsions, nanoparticles, and ethosomes."( Revisiting the therapeutic potential of tocotrienol.
Mathai, M; Ranasinghe, R; Zulli, A, 2022
)
0.72
" Delta isomer of annatto-based tocotrienol had the highest bioavailability amongst all isomers of tocotrienol."( Pharmacokinetics and bioavailability of tocotrienols in healthy human volunteers: a systematic review.
Farhat, K; Khan, DA; Khan, MA; Noor, M; Rafique, S; Sharif, M, 2023
)
1.18

Dosage Studied

Tocotrienols have very short plasma half-lives. They require dosing at very high levels to achieve necessary therapeutic benefits. The antiproliferative and cytotoxic effects of tocotrienols are mediated through different mechanisms.

ExcerptRelevanceReference
" The in vitro cholesterol-biosynthesis-inhibitory and HMGR-suppressive activities in HepG2 cells of an expanded series of benzopyran and tetrahydronaphthalene isosteres and the hypocholesterolemic activity of selected compounds assessed in orally dosed chickens are presented."( Inhibitors of cholesterol biosynthesis. 2. Hypocholesterolemic and antioxidant activities of benzopyran and tetrahydronaphthalene analogues of the tocotrienols.
Deason, ME; Dischino, DD; Gillespie, E; Parker, RA; Pearce, BC; Qureshi, AA; Volk, K; Wright, JJ, 1994
)
0.49
" The tocotrienol-rich fraction (TRF) of palm oil inhibited growth of MCF7 cells in both the presence and absence of estradiol with a nonlinear dose-response but such that complete suppression of growth was achieved at 8 microg/mL."( Tocotrienols inhibit the growth of human breast cancer cells irrespective of estrogen receptor status.
Darbre, P; Dils, R; Nesaretnam, K; Stephen, R, 1998
)
1.74
" In Experiment 2, we examined whether sesaminol caused enhanced absorption of alpha-tocopherol and alpha-tocotrienol in a dosage regimen supplying T-mix and sesaminol on alternating days and observed significantly higher levels of alpha-tocopherol and alpha-tocotrienol in rats fed sesaminol, even without simultaneous intake, compared to those in rats without sesaminol."( Effect of sesaminol on plasma and tissue alpha-tocopherol and alpha-tocotrienol concentrations in rats fed a vitamin E concentrate rich in tocotrienols.
Iizuka, Y; Ikeda, I; Ikeda, S; Yamashita, K, 2002
)
0.52
" Furthermore, dose-response studies show that growth inhibitory doses of tocotrienols are 5-6 times lower than their corresponding lethal doses, suggesting that the antiproliferative and cytotoxic effects of tocotrienols are mediated through different mechanisms."( Mechanisms mediating the antiproliferative and apoptotic effects of vitamin E in mammary cancer cells.
Shah, SJ; Sylvester, PW, 2005
)
0.56
" Adult Beagle dogs (n 8) were administered a single oral dosage of a TCT-rich fraction (TRF; 40 mg/kg body weight) containing 32 % α-TCT, 2 % β-TCT, 27 % γ-TCT, 14 % δ-TCT and 25 % α-tocopherol (α-TCP)."( Increased antioxidant capacity in the plasma of dogs after a single oral dosage of tocotrienols.
Abraham, G; Raila, J; Rohn, S; Schweigert, FJ, 2011
)
0.59
" Feed nutrients resulted in a dose-response relationship of these compounds in the egg yolk."( Supplementation of laying-hen feed with palm tocos and algae astaxanthin for egg yolk nutrient enrichment.
Dolde, D; Walker, LA; Wang, T; Xin, H, 2012
)
0.38
" When evaluating the efficacy of vitamin E prophylactic or therapeutic use in previous and future studies, it is critical to consider dosage to be administered, form of vitamin E and source (such as whether from synthetic or purified from natural sources)."( Vitamin E: a dark horse at the crossroad of cancer management.
Cardenas, E; Ghosh, R, 2013
)
0.39
" Unfortunately, despite their very significant radioprotectant activity, tocotrienols have very short plasma half-lives and require dosing at very high levels to achieve necessary therapeutic benefits."( Molecular dynamics guided design of tocoflexol: a new radioprotectant tocotrienol with enhanced bioavailability.
Boerma, M; Breen, PJ; Compadre, CM; Ghosh, S; Hauer-Jensen, M; Kiaei, M; Singh, A; Thakkar, S; Varughese, KI; Zheng, G, 2014
)
0.63
" Its potential should be evaluated further by varying the dosage and treatment duration."( Effects of annatto-derived tocotrienol supplementation on osteoporosis induced by testosterone deficiency in rats.
Chin, KY; Ima-Nirwana, S, 2014
)
0.4
" Recent expansive development of diverse nanoemulsion (NE) vehicles emphasized their vast potential to improve the effective dosing of different clinical and experimental drugs of lipophilic nature, such as T3."( Enhanced effectiveness of tocotrienol-based nano-emulsified system for topical delivery against skin carcinomas.
Elbayoumi, T; Hoang, C; Nayel, A; Pham, J, 2016
)
0.43
" In conclusion, the concentrations of vitamin E congeners and the expression of genes related to vitamin E status follow characteristic time-related changes during the transition from late gestation to early lactation but are unaffected by CLA supplementation at the dosage used."( Tocopherols and tocotrienols in serum and liver of dairy cows receiving conjugated linoleic acids or a control fat supplement during early lactation.
Dänicke, S; Frank, J; Meyer, U; Rehage, J; Sadri, H; Sauerwein, H, 2015
)
0.76
" Tocotrienols were measured in heart, liver and adipose tissue showing that chronic oral dosage delivered tocotrienols to these organs despite low or no detection of tocotrienols in plasma."( Anti-inflammatory γ- and δ-tocotrienols improve cardiovascular, liver and metabolic function in diet-induced obese rats.
Brown, L; Fong, CW; Ward, LC; Wong, WY; Yap, WN, 2017
)
1.66
" The present trial compares the antioxidant effectiveness following postprandial challenge of two different doses of α-T or palm T3-rich fraction (TRF) treatments and evaluates their dose-response effects on antioxidant status."( Antioxidant status following postprandial challenge of two different doses of tocopherols and tocotrienols.
Cheng, HM; Fairus, S; Sundram, K, 2020
)
0.78
" However, a significant dose-response effect was observed for plasma MDA throughout the 8-hour postprandial period."( Antioxidant status following postprandial challenge of two different doses of tocopherols and tocotrienols.
Cheng, HM; Fairus, S; Sundram, K, 2020
)
0.78
" The meta-analysis revealed that TRF supplementation at a dosage of 250-400 mg significantly decreased HbA1c (-0."( Effects of Tocotrienol-Rich Fraction Supplementation in Patients with Type 2 Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Abdul Kadir, K; Ahmad, B; M Palanisamy, UD; Phang, SCW, 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 (5 Items)

ItemProcessFrequency
Snackscore-ingredient2
Chocolate candiescore-ingredient1
Confectioneriescore-ingredient1
Cocoa and its productscore-ingredient1
Sweet snackscore-ingredient1

Drug Classes (1)

ClassDescription
diterpenoidAny terpenoid derived from a diterpene. The term includes compounds in which the C20 skeleton of the parent diterpene has been rearranged or modified by the removal of one or more skeletal atoms (generally methyl groups).
[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]

Protein Targets (1)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
TDP1 proteinHomo sapiens (human)Potency17.90080.000811.382244.6684AID686978; AID686979
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Bioassays (12)

Assay IDTitleYearJournalArticle
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID51435Hypocholesterolemic activity in 6-week old male mormocholesterolemic chickens using experiment 21994Journal of medicinal chemistry, Feb-18, Volume: 37, Issue:4
Inhibitors of cholesterol biosynthesis. 2. Hypocholesterolemic and antioxidant activities of benzopyran and tetrahydronaphthalene analogues of the tocotrienols.
AID86700Compound evaluated for percent inhibition of cholesterol synthesis from HMG-CoA Reductase in HepG2 cell1992Journal of medicinal chemistry, Oct-02, Volume: 35, Issue:20
Hypocholesterolemic activity of synthetic and natural tocotrienols.
AID102346LDL oxidation assay as spectrophotometric determination of TBARS1994Journal of medicinal chemistry, Feb-18, Volume: 37, Issue:4
Inhibitors of cholesterol biosynthesis. 2. Hypocholesterolemic and antioxidant activities of benzopyran and tetrahydronaphthalene analogues of the tocotrienols.
AID51439Hypocholesterolemic activity in 6-week old male mormocholesterolemic chickens using experiment 21994Journal of medicinal chemistry, Feb-18, Volume: 37, Issue:4
Inhibitors of cholesterol biosynthesis. 2. Hypocholesterolemic and antioxidant activities of benzopyran and tetrahydronaphthalene analogues of the tocotrienols.
AID226925Compound oxidation potential using cyclic voltametry1994Journal of medicinal chemistry, Feb-18, Volume: 37, Issue:4
Inhibitors of cholesterol biosynthesis. 2. Hypocholesterolemic and antioxidant activities of benzopyran and tetrahydronaphthalene analogues of the tocotrienols.
AID232598Ratio of HDL/total cholesterol value1994Journal of medicinal chemistry, Feb-18, Volume: 37, Issue:4
Inhibitors of cholesterol biosynthesis. 2. Hypocholesterolemic and antioxidant activities of benzopyran and tetrahydronaphthalene analogues of the tocotrienols.
AID86701Compound evaluated for percent inhibition of cholesterol synthesis from [14C]acetate in HepG2 cell1992Journal of medicinal chemistry, Oct-02, Volume: 35, Issue:20
Hypocholesterolemic activity of synthetic and natural tocotrienols.
AID83297In vitro suppression of HMG-CoA reductase (HMGR) in Hep G2 cells1994Journal of medicinal chemistry, Feb-18, Volume: 37, Issue:4
Inhibitors of cholesterol biosynthesis. 2. Hypocholesterolemic and antioxidant activities of benzopyran and tetrahydronaphthalene analogues of the tocotrienols.
AID86398In vitro inhibition of cholesterol biosynthesis in Hep G2 cells1994Journal of medicinal chemistry, Feb-18, Volume: 37, Issue:4
Inhibitors of cholesterol biosynthesis. 2. Hypocholesterolemic and antioxidant activities of benzopyran and tetrahydronaphthalene analogues of the tocotrienols.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (815)

TimeframeStudies, This Drug (%)All Drugs %
pre-19902 (0.25)18.7374
1990's22 (2.70)18.2507
2000's227 (27.85)29.6817
2010's426 (52.27)24.3611
2020's138 (16.93)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 46.24

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 strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index46.24 (24.57)
Research Supply Index6.79 (2.92)
Research Growth Index6.09 (4.65)
Search Engine Demand Index142.47 (26.88)
Search Engine Supply Index3.91 (0.95)

This Compound (46.24)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials51 (6.10%)5.53%
Reviews133 (15.91%)6.00%
Case Studies1 (0.12%)4.05%
Observational0 (0.00%)0.25%
Other651 (77.87%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (121)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase II Randomized, Double Blinded, Placebo-controlled Study of Gamma Tocopherol-enriched Supplement on Lower Airway Responses to Inhaled Wood Smoke in Healthy Adults [NCT03444298]Phase 223 participants (Actual)Interventional2018-06-08Completed
Efficacy of Vitamin C, Vitamin E and Their Combination for Treatment of Restless Legs Syndrome in Hemodialysis Patients: a Randomized Double-blind, Placebo-controlled Trial [NCT01125033]Phase 2/Phase 360 participants (Actual)Interventional2008-03-31Completed
Malaysian Tocotrienol Rich Fraction: Immunomodulatory Effect in Women With Breast Cancer [NCT03855423]12 participants (Anticipated)Interventional2019-02-18Recruiting
Effects of Supplementation With Tocotrienol on Inflammation, Oxidative Stress and Microbiota of Chronic Kidney Disease Patients [NCT04900532]61 participants (Actual)Interventional2019-05-01Active, not recruiting
Effect of Gamma Tocopherol Enriched Supplementation on Response to Inhaled O3 Exposure [NCT02911688]Phase 218 participants (Actual)Interventional2016-09-30Completed
A 4-month, Randomized, Placebo-controlled, Double-blind Intervention of Antioxidant Supplementation in Overweight Children Enrolled in an Outpatient Weight-loss Program: Effects on Oxidative and Inflammatory Markers, Hepcidin, Iron Status, and Components [NCT01316081]45 participants (Actual)Interventional2011-03-31Completed
Effectiveness of Tocotrienol-rich Fraction Combined With Tamoxifen in the Management of Women With Early Breast Cancer: A Pilot Clinical Trial [NCT01157026]240 participants (Actual)Interventional2001-11-30Completed
A Randomized Double-Blind Placebo-Controlled Study Of Oral Coenzyme Q10 To Relieve Self-Reported Cancer Treatment Related Fatigue In Breast Cancer Patients [NCT00096356]Phase 1236 participants (Actual)Interventional2004-08-27Completed
Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer: A Marker Based Phase II Trial [NCT04175470]Phase 260 participants (Anticipated)Interventional2019-10-29Recruiting
Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer [NCT00006392]Phase 335,533 participants (Actual)Interventional2001-07-31Completed
Preoperative Use of Tocotrienol Associated With Personalized Nutritional and Psychoeducational Support in Women With Primary Breast Cancer. [NCT04496492]Phase 250 participants (Actual)Interventional2016-02-09Completed
Cardioprotective Synergy of Smoking Cessation and γ-Tocopherol in Restoring Vascular Endothelial Function [NCT01314443]Phase 1/Phase 267 participants (Actual)Interventional2011-01-31Completed
Phase III, Single Centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Trial to Evaluate the Efficacy and Safety of Oral Vitamin E (Mixed Tocotrienol) for 6 Months in Patients With Moderate Acute Ischemic Stroke [NCT02263924]Phase 3150 participants (Anticipated)Interventional2015-07-31Recruiting
Antioxidant Micronutrients in Malaria:a Randomised Clinical Trial [NCT01152931]Phase 310 participants (Actual)Interventional2010-08-31Completed
The Effect of Alpha-tocopherol in Hemolysis and Oxidative Stress Marker on the Red Cell [NCT03948737]40 participants (Actual)Interventional2016-12-30Completed
Mechanism of Absorption and Distribution of Tocotrienols Under Different Food Status [NCT01185769]10 participants (Actual)Interventional2009-09-30Completed
A Double Blind Placebo Controlled Study On The Neuroprotective And Anti-Atherogenic Effects Of Palm TocotrienolRich Fraction(Palm Vitamin E) [NCT00753532]Phase 2241 participants (Actual)Interventional2007-11-30Completed
Randomized Clinical Trial Evaluating Combined Pentoxifylline-tocopherol-clodronate vs Placebo in Radiation-induced Brachial Plexopathy: the PENTOCLO Trial [NCT01291433]Phase 359 participants (Actual)Interventional2011-03-31Completed
Effect of the Application of Vitamin E Ointment, Over Staple Lines and Anastomosis in Roux-en-Y Gastric Bypass, on Postoperative Pain [NCT03765827]Phase 3140 participants (Actual)Interventional2018-12-05Completed
NAFLD in T2DM: Prevalence in Hispanics and Role of Treatment [NCT01002547]Phase 4105 participants (Actual)Interventional2010-06-24Completed
Effect of Subcutaneous Sterile Vitamin E Ointment on Incisional Surgical-site Infection Following Elective Laparoscopic Colorectal Cancer Surgery [NCT02820948]Phase 3108 participants (Actual)Interventional2015-01-31Completed
Effects of a Tocotrienol-Enriched Fraction of Palm Oil and Chinese Red Yeast Rice on Serum Lipids in Hypercholesterolemic Subjects [NCT02142569]Phase 2/Phase 30 participants (Actual)Interventional2013-10-30Withdrawn(stopped due to We were unable to procure the supplement for this study.)
Phase 1b to Assess Safety, Tolerability, Pharmacokinetic Profile, and Antimalarial Activity of Single Doses of Co-administered OZ439and PQP Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Adult Volunteers [NCT03542149]Phase 124 participants (Actual)Interventional2018-04-23Completed
A Phase II, Randomised Controlled Trial to Evaluate the Efficacy and Safety of Moisturising Creams With or Without Palm-oil-derived Vitamin E Concentrate in Addition to Urea-based Cream or Urea-based Cream Alone in Capecitabine-associated Palmar-Plantar E [NCT05939726]90 participants (Anticipated)Interventional2023-05-16Recruiting
Anti-Inflammatory Effect of Tocotrienol Supplementation in Subjects With Moderately Elevated Inflammation [NCT03532763]180 participants (Anticipated)Interventional2018-04-19Recruiting
Effect of Gamma Tocopherol Supplementation on Neutrophil Response to 20,000 EU of Clinical Center Reference Endotoxin in Normal Adults [NCT00631085]Phase 118 participants (Actual)Interventional2008-05-31Completed
Interventional Strategy in Tackling Emerging Non-alcoholic Fatty Liver Disease in Childhood Obesity [NCT05905185]Phase 429 participants (Actual)Interventional2020-01-01Completed
A Randomized Investigation of Side Effects to FOLFOXIRI in Combination With Tocotrienol or Placebo as First Line Treatment of Metastatic Colorectal Cancer [NCT02705300]Phase 270 participants (Actual)Interventional2016-05-06Active, not recruiting
"The Effect of KB-120 Small Molecular Nutrient in Women With Decreased Ovarian Reserve" [NCT06081257]80 participants (Anticipated)Interventional2023-10-15Not yet recruiting
A Phase I Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Vitamin E δ-Tocotrienol Administered to Subjects With Resectable Pancreatic Exocrine Neoplasia [NCT00985777]Phase 126 participants (Actual)Interventional2009-09-30Completed
Efficacy of Alpha Tocopherol and New Biomarker (Urine NGAL) for Prevention and Early Diagnosis of Contrast-induced Nephropathy in CKD Patients Undergoing Elective Coronary Procedures [NCT01061320]Phase 3200 participants (Anticipated)Interventional2010-01-31Enrolling by invitation
PentoxIfylline and Tocopherol for the Treatment of Post-radiotherapy Fibrosis in Head and Neck Cancer Patients: a Feasibility Study [NCT03723291]Phase 150 participants (Anticipated)Interventional2019-09-01Recruiting
Osteoradionecrosis and PENTOCLO Protocol: Retrospective Study. [NCT04097847]96 participants (Actual)Observational2017-06-02Completed
Effects of Coenzyme Q10 in Parkinson Disease - Phase III [NCT00740714]Phase 3600 participants (Actual)Interventional2008-12-31Terminated(stopped due to The investigational drug is unlikely to demonstrate efficacy over placebo for this indication. However, no safety issues were discovered.)
In Vitro Basophil Responsiveness to Allergen Challenge After Gamma-tocopherol Supplementation in Allergic Asthmatics [NCT00836368]Phase 125 participants (Actual)Interventional2008-12-31Completed
Evaluation of a Short Course of Gamma Tocopherol Supplementation in Adult Subjects [NCT02610829]10 participants (Actual)Interventional2015-11-30Completed
A Randomized Controlled Project to Study the Efficacy of Combined Pentoxiphylline and Vitamin E Versus Vitamin E in Patients With Non- Alcoholic Steatohepatitis [NCT01384578]Phase 30 participants (Actual)Interventional2011-07-31Withdrawn(stopped due to Lack of funds)
The PENTO Protocol in Medication-related Osteonecrosis of the Jaw [NCT05795647]Phase 217 participants (Anticipated)Interventional2023-11-20Not yet recruiting
Tocotrienol Against the Progression of End Stage Liver Disease [NCT02581085]Phase 270 participants (Anticipated)Interventional2019-11-01Recruiting
Single-site, Open-label, Dose-ranging, Efficacy, and Safety Study of EGCG/Tocotrienol in 18 Patients With Splicing-mutation-mediated CF [NCT00889434]7 participants (Actual)Interventional2011-11-01Completed
The Effect of Supplemental Adjuvants for Intracellular Nutrition and Treatment on Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration [NCT00893724]60 participants (Anticipated)Interventional2009-06-30Active, not recruiting
CSP #546 - A Randomized, Clinical Trial of Vitamin E and Memantine in Alzheimer's Disease (TEAM-AD) [NCT00235716]Phase 3613 participants (Actual)Interventional2007-08-31Completed
The Effect of Vitamin E and Docosahexaenoic Acid Ethyl Ester on Non-Alcoholic Fatty Liver Disease (NAFLD) - Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial (PUVENAFLD) [NCT04198805]Phase 2205 participants (Actual)Interventional2020-01-03Completed
Exploratory, Double-blind, Randomized, Placebo Controlled Study of AMP-886 in the Elderly [NCT01953172]12 participants (Actual)Interventional2013-10-31Terminated(stopped due to Recruitment problems)
A Phase 2A Clinical Trial of EPI-743 (Vincerinone™) on Visual Function in Friedreich's Ataxia Patients With Point Mutations [NCT01962363]Phase 24 participants (Actual)Interventional2013-10-31Completed
A Clinical Study on the Neuroprotection by Tocotrienols in Type 1 and Type 2 Diabetes Mellitus [NCT01973400]Phase 3300 participants (Actual)Interventional2011-06-30Completed
[NCT02011906]Phase 420 participants (Anticipated)Interventional2013-10-31Enrolling by invitation
Actions of Dietary Tocotrienols on Obesity [NCT03705845]Phase 1/Phase 260 participants (Anticipated)Interventional2019-03-15Recruiting
Tocotrienol as a Nutritional Supplement in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) [NCT02644252]Phase 379 participants (Actual)Interventional2016-01-31Terminated(stopped due to The trial was ended prematurely because of a poor accrual rate)
Vitamin E Supplementation in Burn Patients [NCT01413620]Phase 10 participants (Actual)Interventional2011-08-31Withdrawn
Effects of a High-dose Concentrate of n-3 Fatty Acids or Corn Oil Introduced Early After an Acute Myocardial Infarction on Serum Triacylglycerol and High-density Lipoprotein (HDL)- Cholesterol [NCT01422317]Phase 3300 participants (Actual)Interventional1995-09-30Completed
Evaluation of the Clinical Benefit of a Spa Care on the Evolution of Late Fibrosis After Postoperative Radiotherapy for Breast Cancer in Remission [NCT02898376]Phase 3142 participants (Anticipated)Interventional2018-12-31Not yet recruiting
Phase III Study Analyzing the Effectiveness of Dalteparin Therapy as Intervention in Recurrent Pregnancy Loss [NCT00400387]Phase 3449 participants (Actual)Interventional2006-11-30Completed
A Phase II Study of the Use of Pentoxifylline and a-Tocopherol in the Treatment of Chronic Breast Pain Associated With Breast Radiotherapy [NCT00188669]Phase 248 participants (Anticipated)Interventional2002-07-31Terminated(stopped due to date: August 2006. No annual renewal)
Tocotrienols Supplementation in School Going Children With Attention Deficit/Hyperactivity Disorder(ADHD) - A Randomized Controlled Trial [NCT01855984]Phase 2/Phase 3160 participants (Anticipated)Interventional2012-02-29Completed
Human Blood Outcomes Following Tocotrienol Supplementation - Nutrition Phase IIB NUTRITION PHASE IIB [NCT01858311]300 participants (Actual)Observational2013-03-31Completed
Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer [NCT02909751]Phase 280 participants (Actual)Interventional2016-09-14Completed
To Investigate the Effectiveness of Adjuvant Supplements Prior to in Vitro Fertilization Cycles [NCT05471453]90 participants (Anticipated)Interventional2022-03-02Recruiting
Mechanisms for Vascular Dysfunction and Exercise Tolerance in CF [NCT02690064]13 participants (Actual)Interventional2015-04-30Active, not recruiting
Pentoxifylline, Atorvastatin, and Vitamin E (PAVE) as Treatment for Radiation-Induced Erectile Dysfunction [NCT03830164]Phase 214 participants (Actual)Interventional2019-11-20Completed
Effects of a Tocotrienol-Enriched Fraction of Palm Oil on Serum Lipids in Hypercholesterolemic Subjects [NCT02634606]Phase 313 participants (Actual)Interventional2011-03-22Terminated(stopped due to Unable to obtain supplement for this study. Unable to recruit.)
ASSESSMENT OF INTERMEDIATE ENDPOINT BIOMARKERS TO 13-CIS RETINOIC ACID WITH OR WITHOUT ALPHA TOCOPHEROL OR OBSERVATION [NCT00002586]Phase 296 participants (Actual)Interventional1993-01-31Completed
Comparison of Gamma-tocopherol Supplementation in Allergic Asthmatics and Normal Volunteers [NCT00386178]Phase 116 participants (Actual)Interventional2006-10-31Completed
Vitamin E Versus Vitamin E Plus Pentoxiphyllin in Patients With Nonalcoholic Steatohepatitis: A Prospective Randomized Clinical Trial [NCT01279434]0 participants (Actual)Interventional2012-01-31Withdrawn
Trace Element Replenishment Study in Hemodialysis Patients [NCT01473914]Phase 3150 participants (Actual)Interventional2012-11-30Completed
Advances in the Management of Mandibular Osteoradionecrosis: Pentoxifylline and Tocopherol as Medical Treatment [NCT02368457]Phase 424 participants (Actual)Interventional2016-02-29Completed
Tocopherols and Alpha Lipoic Acid Treatment Chronic Kidney Disease (TALAT) [NCT00308971]Phase 262 participants (Actual)Interventional2006-03-31Completed
A Multicentre, Placebo-controlled Trial of Eicosapentaenoic Acid (EPA) and Antioxidant Supplementation in the Treatment of Schizophrenia and Related Disorders [NCT00419146]Phase 2/Phase 399 participants (Actual)Interventional2001-09-30Completed
VEAPS: Vitamin E Atherosclerosis Prevention Study [NCT00114387]Phase 2/Phase 3353 participants Interventional1996-07-31Completed
Tocotrienols Supplementation for Postmenopausal Women With Low Muscle Strength [NCT03708354]Phase 1/Phase 20 participants (Actual)Interventional2019-04-15Withdrawn(stopped due to Difficulties in Recruiting)
Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol [NCT00678834]Early Phase 180 participants (Actual)Interventional2006-03-31Completed
A Phase II Study of the Use of Pentoxifylline and Vitamin E in the Treatment of Late Radiation Related Injuries [NCT00188552]Phase 250 participants (Anticipated)Interventional2002-07-31Terminated(stopped due to May 2007: No annual renewal)
Effect of House Dust Mite Allergen Challenge in Persons Using 1200 mg Gamma Tocopherol Supplements [NCT00466596]Phase 18 participants (Actual)Interventional2007-03-31Completed
Impact of Oral Versatile Antioxidants on Glaucoma Progression:Comparative Early Results [NCT01544192]Phase 360 participants (Actual)Interventional2008-04-30Completed
Efficacy and Safety of the Association With Pentoxyphilline and Tocopherol on the Fibrosis in Patients With Chronic Hepatitis C [NCT00119119]Phase 3100 participants Interventional2002-02-28Terminated
Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE) [NCT00040378]4,246 participants (Actual)Observational2002-05-31Completed
The Respiratory Ancillary Study (RAS) to SELECT [NCT00063453]Phase 32,920 participants (Actual)Interventional2003-08-31Completed
A Parallel, Evaluator-Blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Two Marketed Topical Skin Protectants Containing Zinc Oxide in Children With Diaper Rash [NCT00219466]Phase 4112 participants (Actual)Interventional2005-06-30Completed
A Randomized Double Blind Placebo Controlled Clinical Trial Aim to Assess the Efficacy of Vitamin E Formulation (Tocopherol) in the Treatment of Chemotherapy Induced Stomatitis in Patients Undergoing Stem Cell Transplantation [NCT00162526]Phase 230 participants (Anticipated)Interventional2005-12-31Withdrawn(stopped due to the PI is no longer work at Hadassah)
Study of the Effect of Oral Supplementation With Vitamin E on Circulating Oxidative Markers, Hemodialysis Vascular Access Occlusion, and Clinical Events in Patients With End Stage Renal Failure Treated by Hemodialysis [NCT00410449]35 participants Observational2001-05-31Completed
S0000D: A Study of the Effect of Vitamin E and/or Selenium on Adenomatous Colorectal Polyps (ACP) in Participants Enrolled in SELECT [NCT00706121]Phase 38,094 participants (Actual)Interventional2008-06-30Completed
S0000B: Prevention of Cataract and Age-Related Macular Degeneration With Vitamin E and Selenium - SELECT Eye Endpoints (SEE) [NCT00784225]Phase 313,475 participants (Actual)Interventional2004-07-31Completed
Effect of Tocotrienols on Bone Health: A Pilot Study [NCT02058420]Phase 1/Phase 278 participants (Actual)Interventional2014-02-28Completed
DBPCR Clinical Trial for Treatment of Rhinitis With Intranasal Vitamin E [NCT00281307]10 participants (Actual)Interventional2005-12-07Terminated(stopped due to Due to a substantial response to placebo an interim analysis indicated the need for a larger than expected study population to achieve the level of significance)
Effects of Tocotrienols Supplementation on Platelet Aggregation in Subjects With Metabolic Syndrome [NCT01631838]32 participants (Actual)Interventional2012-05-31Completed
A Randomized Placebo-controlled Double-blind Pilot / Phase II Study to Assess the Efficacy and Safety of HOV-12020 in Patients With Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy (CADASIL) [NCT04658823]Phase 250 participants (Anticipated)Interventional2020-12-21Active, not recruiting
Enhancing Treatment of Iron Deficiency and Iron Deficiency Anemia With an Antioxidant, Vitamin E [NCT01700426]Phase 144 participants (Actual)Interventional2011-06-30Completed
Vitamin E Supplementation in Burned Patients [NCT01749371]Phase 2/Phase 331 participants (Actual)Interventional2013-02-28Completed
Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen [NCT01822405]Phase 242 participants (Anticipated)Interventional2010-07-31Recruiting
Effects of Inclusion of Sunflower Oil, Vitamin E and Selenium in the Diet of Dairy Cows on Milk Composition and Its Influence on Nutrition and Health of Elderly [NCT02980094]132 participants (Actual)Interventional2011-08-31Completed
A Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of Vitamin E δ-Tocotrienol Following Single Dose Administration in Healthy Subjects [NCT01446952]Phase 118 participants (Actual)Interventional2011-09-30Completed
A Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of Vitamin E δ-Tocotrienol Following Multiple Dose Administration in Healthy Subjects [NCT01450046]Phase 118 participants (Actual)Interventional2011-10-31Completed
Study of the Absorption of Vitamin E Water-soluble Form (Pegylated) in the Familial Hypocholesterolemia With Chylomicron Retention [NCT01457690]Phase 314 participants (Actual)Interventional2011-10-31Completed
A Phase III Biomarker Study of Neoadjuvant Vitamin E in Patients With Locally Treatable Prostate Cancer Prior to Prostatectomy or Brachytherapy [NCT00809458]Phase 315 participants (Actual)Interventional2008-09-30Terminated(stopped due to Low rate of accrual.)
A Randomized, Double-Blind, Placebo-Controlled Study, to Assess the Efficacy and Safety of Tocovid Suprabio 200mg in Non-alcoholic Fatty Liver (NAFL) [NCT04704063]Phase 2170 participants (Anticipated)Interventional2021-01-01Active, not recruiting
Pentoxifylline and Tocopherol (PENTO) in the Treatment of Medication-related Osteonecrosis of the Jaw (MRONJ): A Prospective, Randomized Controlled Trial to Evaluate a Novel Non-operative Treatment [NCT03040778]Phase 3100 participants (Anticipated)Interventional2018-04-01Enrolling by invitation
Palm Tocotrienols in Chronic Hemodialysis (PATCH Study) [NCT02358967]280 participants (Actual)Interventional2017-06-15Completed
Prospective, Randomized, Single-blind, Multinational, Long-term Study for the Evaluation of the Clinical Outcome, Oxidation Profile and Wear Analysis of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty [NCT04618016]560 participants (Anticipated)Observational2021-03-08Recruiting
Phase 1a: A Randomized, 2-period Cross-over Study to Compare the Bioavailability of Gamma-Delta Tocotrienol (GDT) With That of Tocotrienol Rich Fraction (TRF) in Twelve Healthy Subjects [NCT01571921]Phase 112 participants (Actual)Interventional2013-01-31Completed
Effect of Stellate Ganglion Block on Meniere's Disease [NCT01574313]Phase 420 participants (Actual)Interventional2010-04-30Completed
Human Blood Outcomes Following Tocotrienol Supplementation - NUTRITION Phase I and Phase IIA [NCT01578629]Phase 1/Phase 2210 participants (Actual)Interventional2012-03-31Completed
Efficacy Of Tocotrienol a Natural Vitamin E In Biopsy Wound. [NCT01579227]101 participants (Anticipated)Observational2012-01-31Active, not recruiting
[NCT01594346]Phase 3349 participants (Actual)Interventional2000-09-30Completed
Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E Patients [NCT01597765]60 participants (Actual)Interventional2009-06-30Completed
A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating The Safety And Efficacy Of An Oral Supplement Containing Astaxanthin (2 mg) + Lycopene (1.8 mg) + D-Alpha-Tocopherol (10 IU) For The Treatment Of Skin Aging [NCT03460860]100 participants (Actual)Interventional2018-03-05Completed
A Randomised Double-blinded Placebo Controlled Study on the Effect of Topical Palm Tocotrienol on Skin Biophysical Properties [NCT05787743]41 participants (Actual)Interventional2023-07-17Terminated(stopped due to Sponsor withdrawal)
Therapeutic Effect of Semaglutide on Nonalcoholic Fatty Liver Disease in Obesity and/or Type 2 Diabetes Mellitus [NCT05813249]Phase 4180 participants (Anticipated)Interventional2023-02-15Recruiting
The Efficacy and Safety of Vitamin E Mixed Tocotrienols In Patients With Amyotrophic Lateral Sclerosis (ALS) : A Pilot Exploratory Study [NCT04140136]Phase 220 participants (Anticipated)Interventional2019-06-17Recruiting
Provision of Antioxidant Therapy in Hemodialysis (PATH) Study [NCT00237718]Phase 2385 participants (Actual)Interventional2006-04-30Completed
Lipid Peroxidation and Options Antioxidant Therapy for Secondary Lymphedema of the Lower Extremities [NCT04360889]Phase 4120 participants (Actual)Interventional2019-09-01Completed
Effects of Vitamin E (Alfa-Tocoferol) Supplementation on Isoprostane and Lipid Profile of Obese Adolescent in Jakarta, Indonesia [NCT03358524]Phase 469 participants (Actual)Interventional2017-09-28Completed
Treatment for Non-Alcoholic Fatty Liver With Different Doses of Vitamin E [NCT01792115]Phase 222 participants (Actual)Interventional2013-05-01Completed
Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing [NCT02473302]24 participants (Actual)Interventional2014-04-30Completed
Effect of Antioxidant Vitamins on Coagulopathy and Nosocomial Pneumonia After Severe Trauma [NCT01897792]Phase 211 participants (Actual)Interventional2013-05-31Terminated(stopped due to Inability to recruit patients that meet inclusion criteria.)
Vitamin E Pharmacokinetics and Biomarkers in Normal and Obese Women [NCT00862433]Phase 150 participants (Actual)Interventional2014-10-10Completed
An Examination Into the Effects of a Nutraceutical Supplement on Cognition, Stress, and Eye and Skin Health in Adults With Self-reported Cognitive Complaints: a Randomised, Double-blind, Placebo-controlled Trial [NCT05941949]110 participants (Anticipated)Interventional2023-07-05Recruiting
Faecal Microbiome as Determinant of the Effect of Diet on Colorectal-cancer Risk: Comparison of Meat Based Versus Pesco-vegetarian Diets (MeaTIc) [NCT03416777]103 participants (Actual)Interventional2019-06-01Completed
Efficacy of Natural Vitamin E Tocotrienol on the Treatment of Surgical Scars [NCT00700791]Early Phase 1168 participants (Anticipated)Interventional2008-07-31Terminated(stopped due to The PI moved to another Institution)
Safety of Tocotrienols in Atrial Fibrillation After Coronary Artery Bypass Grafting Surgery: A Randomized Controlled Exploratory Trial [NCT03807037]Phase 2/Phase 3250 participants (Actual)Interventional2018-12-17Completed
Effect of Gamma Tocopherol Enriched Supplementation on Response to Inhaled LPS [NCT02104505]Phase 1/Phase 223 participants (Actual)Interventional2015-11-30Completed
Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer. A Randomized Phase II Marker Trial [NCT04245865]Phase 274 participants (Anticipated)Interventional2020-06-26Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00006392 (6) [back to overview]Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival
NCT00006392 (6) [back to overview]Number of Participants With Colorectal Cancer
NCT00006392 (6) [back to overview]Number of Participants With Any Diagnosis of Cancer
NCT00006392 (6) [back to overview]Number of Participants With Lung Cancer
NCT00006392 (6) [back to overview]Number of Participants With Prostate Cancer
NCT00006392 (6) [back to overview]Number of Participants With Serious Cardiovascular Events
NCT00096356 (3) [back to overview]Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization
NCT00096356 (3) [back to overview]Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization
NCT00096356 (3) [back to overview]Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization
NCT00235716 (7) [back to overview]Caregiver Activity Survey Change From Baseline
NCT00235716 (7) [back to overview]All-cause Mortality
NCT00235716 (7) [back to overview]Mini-Mental State Examination Change From Baseline
NCT00235716 (7) [back to overview]Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline
NCT00235716 (7) [back to overview]Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline
NCT00235716 (7) [back to overview]Dependence Scale: Time to Event Analysis (Increase of of One Dependence Level)
NCT00235716 (7) [back to overview]Neuropsychiatric Inventory Change From Baseline
NCT00237718 (2) [back to overview]F2-isoprostane (F2-iso)
NCT00237718 (2) [back to overview]Interleukin-6 (IL-6)
NCT00678834 (1) [back to overview]"The Levels of TCT in the Tissues of Non-healthy Subjects and in the Tissue of Healthy Subjects Following Oral Supplementation (200 mg x 2 Per Day for 4-24 Weeks)"
NCT00706121 (9) [back to overview]Effect Modification of Vitamin E by Body Mass Index on CRA Occurence, Analyzed by Active Vitamin e vs. Vitamin e Placebo
NCT00706121 (9) [back to overview]Effect Modification of Vitamin E by Aspirin on CRA Occurrence, Analyzed by Active Vitamin e vs. Vitamin e Placebo
NCT00706121 (9) [back to overview]Effect Modification of Selenium by Body Mass Index on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
NCT00706121 (9) [back to overview]Effect Modification of Selenium by Aspirin on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
NCT00706121 (9) [back to overview]Effect of Vitamin E on CRA Occurrence, Analyzed by Active Vitamin E vs. Vitamin E Placebo
NCT00706121 (9) [back to overview]Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
NCT00706121 (9) [back to overview]Effect of Selenium on Occurrences of Multiple (>2) Adenomas
NCT00706121 (9) [back to overview]Effect of Selenium and/or Vitamin E on Colorectal Cancer (CRC) Incidence
NCT00706121 (9) [back to overview]Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo
NCT00740714 (23) [back to overview]Change in Modified Schwab & England Independence Scale From Baseline to 16 Months
NCT00740714 (23) [back to overview]Change in PD Quality of Life Scale From Baseline to 16 Months
NCT00740714 (23) [back to overview]Change in Symbol Digit Modalities Test From Baseline to 16 Months
NCT00740714 (23) [back to overview]Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Total Score (Sum of Parts I, II and III Ranges From 0 to 176))
NCT00740714 (23) [back to overview]CoQ10 Levels in Plasma
NCT00740714 (23) [back to overview]Change in Modified Rankin Scale From Baseline to 16 Months
NCT00740714 (23) [back to overview]Change in Hoehn & Yahr Score From Baseline to 16 Months
NCT00740714 (23) [back to overview]Adverse Experiences: Urinary Tract Infection
NCT00740714 (23) [back to overview]Adverse Experiences: Tremor
NCT00740714 (23) [back to overview]Adverse Experiences: Nausea
NCT00740714 (23) [back to overview]Adverse Experiences: Anxiety
NCT00740714 (23) [back to overview]Adverse Experiences: Back Pain
NCT00740714 (23) [back to overview]Adverse Experiences: Back Pain: Moderate/Severe
NCT00740714 (23) [back to overview]Adverse Experiences: Constipation
NCT00740714 (23) [back to overview]Adverse Experiences: Constipation: Moderate/Severe
NCT00740714 (23) [back to overview]Adverse Experiences: Depression
NCT00740714 (23) [back to overview]Adverse Experiences: Anxiety: Moderate/Severe
NCT00740714 (23) [back to overview]Adverse Experiences: Headache
NCT00740714 (23) [back to overview]Adverse Experiences: Hypertension
NCT00740714 (23) [back to overview]Adverse Experiences: Insomnia
NCT00740714 (23) [back to overview]Adverse Experiences: Insomnia: Moderate/Severe
NCT00740714 (23) [back to overview]Adverse Experiences: Nasopharyngitis
NCT00740714 (23) [back to overview]Adverse Experiences: Diarrhoea
NCT01002547 (17) [back to overview]Fasting Plasma Insulin
NCT01002547 (17) [back to overview]HDL-cholesterol
NCT01002547 (17) [back to overview]LDL-cholesterol
NCT01002547 (17) [back to overview]Liver Fat by Magnetic Resonance Imaging and Spectroscopy (MRS).
NCT01002547 (17) [back to overview]Liver Histology (Kleiner's et al Criteria, Hepatology 2005)
NCT01002547 (17) [back to overview]Matsuda Index
NCT01002547 (17) [back to overview]Number of Participants With Resolution of NASH Without Worsening of Fibrosis
NCT01002547 (17) [back to overview]Plasma ALT
NCT01002547 (17) [back to overview]Plasma AST
NCT01002547 (17) [back to overview]Total Body Fat by DEXA
NCT01002547 (17) [back to overview]Triglycerides
NCT01002547 (17) [back to overview]Weight
NCT01002547 (17) [back to overview]Individual Histological Scores
NCT01002547 (17) [back to overview]Mean Individual Histological Scores
NCT01002547 (17) [back to overview]Total Cholesterol
NCT01002547 (17) [back to overview]Body Mass Index
NCT01002547 (17) [back to overview]Fasting Plasma Glucose
NCT01314443 (3) [back to overview]Absolute Change in Brachial Artery Flow-mediated Dilation at Day 7 From Day 0
NCT01314443 (3) [back to overview]Absolute Change From Baseline in Plasma Malondialdehyde at Day 7 From Day 0.
NCT01314443 (3) [back to overview]Absolute Change From Baseline in Plasma Gamma-tocopherol (Vitamin E) at Day 7 From Day 0.
NCT01792115 (8) [back to overview]Physiological: Absolute Change in Liver Fat
NCT01792115 (8) [back to overview]Percent Change in Liver Fat
NCT01792115 (8) [back to overview]Percent Change in AST
NCT01792115 (8) [back to overview]Percent Change in ALT
NCT01792115 (8) [back to overview]Biochemical: Number of Patients With Normal Transaminases at End of Treatment.
NCT01792115 (8) [back to overview]Absolute Change in GGT
NCT01792115 (8) [back to overview]Absolute Change in AST
NCT01792115 (8) [back to overview]Absolute Change in ALT
NCT01897792 (10) [back to overview]Number of Subjects With 60-day Survival
NCT01897792 (10) [back to overview]Number of Total Blood Product Transfusions
NCT01897792 (10) [back to overview]Number of Subjects With Ventilator-associated Pneumonia.
NCT01897792 (10) [back to overview]Number of Subjects With Organ Injury
NCT01897792 (10) [back to overview]Number of Subjects Surviving to Day 28
NCT01897792 (10) [back to overview]Number of Protocol Violations Per Arm.
NCT01897792 (10) [back to overview]Number of Participants With Coagulation Abnormalities
NCT01897792 (10) [back to overview]Mean Number of Ventilator-free Days for Subjects
NCT01897792 (10) [back to overview]Mean Number of Hospital Stay Days.
NCT01897792 (10) [back to overview]Mean Number of Days in ICU.
NCT02104505 (4) [back to overview]Mucociliary Clearance as Affected by Gamma Tocopherol
NCT02104505 (4) [back to overview]Mucociliary Clearance (MCC) Associated With CCRE Challenge as Affected by Gamma Tocopherol
NCT02104505 (4) [back to overview]Comparison of Change in Sputum Percent Neutrophils (PMN)s Following Inhaled Clinical Center Reference Endotoxin (CCRE) Challenge as Affected by Gamma Tocopherol
NCT02104505 (4) [back to overview]Chronic Eosinophilic Airway Inflammation as Affected by Gamma Tocopherol
NCT02368457 (2) [back to overview]Clinical Symptoms Evaluation, Measured Using the LENT-SOMA Scale
NCT02368457 (2) [back to overview]Bone and/or Tissue Healing as Measured With the Classification of ORN Stages, Area of Bone Exposed (mm2) and Radiological Findings (OPG).
NCT02911688 (8) [back to overview]Change in Sputum IL-8 From Baseline Following Ozone Exposure
NCT02911688 (8) [back to overview]Change in Sputum IL-6 From Baseline Following Ozone Exposure
NCT02911688 (8) [back to overview]Change in Central Lung Clearance of Technetium Sulfur Colloid Particles (0-30 Minutes) From Baseline Following Ozone Exposure
NCT02911688 (8) [back to overview]Change in Whole Lung Clearance of Technetium Sulfur Colloid Particles (0-120 Minutes) From Baseline Following Ozone Exposure
NCT02911688 (8) [back to overview]Change From Baseline in Sputum Percent Neutrophils (%PMN) Following Ozone Exposure
NCT02911688 (8) [back to overview]Change in Sputum Tumor Necrosis Factor (TNF)-Alpha From Baseline Following Ozone Exposure
NCT02911688 (8) [back to overview]Change in Sputum Percent Eosinophils From Baseline Following Ozone Exposure
NCT02911688 (8) [back to overview]Change in Sputum Interleukin (IL)-1b From Baseline Following Ozone Exposure
NCT03830164 (3) [back to overview]Choosing Other Erectile Dysfunction (ED) Treatments After Pentoxifylline, Atorvastatin and Vitamin E (PAVE)
NCT03830164 (3) [back to overview]Number of Participants With Incidence of Adverse Events (AEs)
NCT03830164 (3) [back to overview]Change in International Index of Erectile Function (IIEF) Scores
NCT04198805 (24) [back to overview]Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Body Mass Index (BMI)
NCT04198805 (24) [back to overview]Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Waist Circumference.
NCT04198805 (24) [back to overview]Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Waist-to-hip Ratio .
NCT04198805 (24) [back to overview]Change After 6 Months of DHA EE and /or Vitamin E Intervention in the Anthropometric Measure, Bodyweight.
NCT04198805 (24) [back to overview]Change in Health Related Quality of Life Score (Short Form (SF-36))
NCT04198805 (24) [back to overview]Change in Dietary Intake Levels of Long-chain Polyunsaturated Fatty Acids (LC-PUFA ) (i.e. DHA and EPA) as Measured by the Food Frequency Questionnaire (FFQ)
NCT04198805 (24) [back to overview]Liver Enzymes Alkaline Phosphatase in the DHA EE and /or Vitamin E Intervention Over a 6 Month Period.
NCT04198805 (24) [back to overview]Change in Plasma Vitamin E Concentration
NCT04198805 (24) [back to overview]Change in Plasma DHA EE Concentration
NCT04198805 (24) [back to overview]Change in Liver Enzymes Bilirubin in the DHA EE and /or Vitamin E Intervention Over a 6 Month Period.
NCT04198805 (24) [back to overview]Change in Liver Enzymes (AST) in the DHA EE and /or Vitamin E Intervention Over a 6 Month Period.
NCT04198805 (24) [back to overview]Change in Liver Enzymes (ALT) in the DHA EE and /or Vitamin E Intervention Over a 6 Month Period.
NCT04198805 (24) [back to overview]Change in Lipid Profile (Triglycerides)
NCT04198805 (24) [back to overview]Change in Lipid Profile (Oxidized LDL)
NCT04198805 (24) [back to overview]Change in Lipid Profile (Low Density Lipoprotein (LDL-C))
NCT04198805 (24) [back to overview]Change in Lipid Profile (HDL-C)
NCT04198805 (24) [back to overview]Change in Inflammatory Markers (Cytokeratin 18 (CK-18))
NCT04198805 (24) [back to overview]Change in Insulin Levels to Determine Insulin Resistance
NCT04198805 (24) [back to overview]Change in Inflammatory Markers (TNFα)
NCT04198805 (24) [back to overview]Change in Inflammatory Markers (IL-1β)
NCT04198805 (24) [back to overview]Change in Hepatic Fat Fraction [%] Between Vitamin E vs Placebo Arm
NCT04198805 (24) [back to overview]Change in Hepatic Fat Fraction [%] Between of Vitamin E and DHA EE vs Placebo
NCT04198805 (24) [back to overview]Change in Hepatic Fat Fraction [%] Between DHA EE vs Placebo Arm
NCT04198805 (24) [back to overview]Change in Fibrosis-4 (FIB-4) Score

Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival

Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation. Other cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized. (NCT00006392)
Timeframe: Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.

,,,
Interventionparticipants (Number)
All deathsAll cancer deathsProstate cancer deathsLung cancer deathsColorectal cancer deaths
Combination35911703915
Placebo38212504110
Selenium37812814510
Vitamin E35810603813

[back to top]

Number of Participants With Colorectal Cancer

Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized. (NCT00006392)
Timeframe: Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.

Interventionparticipants (Number)
Vitamin E66
Selenium63
Combination77
Placebo60

[back to top]

Number of Participants With Any Diagnosis of Cancer

Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized. (NCT00006392)
Timeframe: Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.

Interventionparticipants (Number)
Vitamin E856
Selenium837
Combination846
Placebo824

[back to top]

Number of Participants With Lung Cancer

Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized. (NCT00006392)
Timeframe: Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.

Interventionparticipants (Number)
Vitamin E67
Selenium75
Combination78
Placebo67

[back to top]

Number of Participants With Prostate Cancer

Participants are seen at the study site every six month for an update of medical events. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation. (NCT00006392)
Timeframe: Every six months for 7 to 12 years depending on when the participant was randomized.

Interventionparticipants (Number)
Vitamin E473
Selenium432
Combination437
Placebo416

[back to top]

Number of Participants With Serious Cardiovascular Events

Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Cardiovascular events are based on self-report and are not confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized. (NCT00006392)
Timeframe: Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.

Interventionparticipants (Number)
Vitamin E1034
Selenium1080
Combination1041
Placebo1050

[back to top]

Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization

CES-D is the Center for Epidemiologic Studies Depression Form. It consists of 20 questions. The total score ranges from 0 to 60. Higher scores indicate greater depression. (NCT00096356)
Timeframe: 24 weeks

Interventionunits on a scale (Least Squares Mean)
Arm 1- CoQ10 & Vitamin E11.7
Arm 2 - Placebo & Vitamin E12.4

[back to top]

Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization

POMS-F is the Profile of Mood States - fatigue scale. It ranges from 0 to 28; higher values indicate greater fatigue. (NCT00096356)
Timeframe: 24 weeks

Interventionunits on a scale (Least Squares Mean)
Arm 1 - CoQ10 & Vitamin E6.96
Arm 2 - Placebo & Vitamin E8.33

[back to top]

Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization

FACT-B stands for Functional Assessment of Cancer Therapy - Breast. It measures quality of life. It is the total of the FACT subscales (emotional, social, functional, and physical) and the Breast subscale. Scores range from 0 to 144; higher scores reflect better overall quality of life. (NCT00096356)
Timeframe: 24 weeks

Interventionunits on a scale (Least Squares Mean)
Arm 1 - CoQ10 & Vitamin E111.8
Arm 2 - Placebo & Vitamin E109.8

[back to top]

Caregiver Activity Survey Change From Baseline

The Caregiver Activity Survey (CAS) was developed to measure the time caregivers spend aiding Alzheimer patients with their day-to-day activities. The CAS consists of six items that ask for an estimate in hours and minutes of the time that the caregiver spent during the previous 24 hours performing these particular activities. The six CAS items are as follows: 1) communication with the person, 2) using transportation, 3) dressing, 4) eating, 5) looking after one's appearance, and 6) supervising the person. The more caregiving hours the worse the patient's functioning level. Outcome analysis is average least square means change from baseline. (NCT00235716)
Timeframe: 6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline

,,,
Interventionhours per day (Least Squares Mean)
6 months minus baseline12 months minus baseline18 months minus baseline24 months minus baseline30 months minus baseline36 months minus baseline42 months minus baseline48 months minus baselineAverage change from baseline
Memantine0.992.723.773.065.225.729.469.275.52
Placebo1.201.893.163.454.3610.6810.6212.175.14
Vitamin E-0.93-0.182.121.604.147.694.9510.173.35
Vitamin E + Memantine1.081.392.692.823.414.905.4813.805.00

[back to top]

All-cause Mortality

Survival analysis of death from any cause. (NCT00235716)
Timeframe: up to 4 years

Interventionparticipants (Number)
Vitamin E26
Memantine39
Vitamin E + Memantine32
Placebo31

[back to top]

Mini-Mental State Examination Change From Baseline

The Mini-Mental State Examination (MMSE) briefly and objectively assess cognitive status in psychiatric patients with cognitive impairment. The MMSE questions are grouped into seven categories, each representing a different cognitive domain. The MMSE yields a total score that ranges from 0 for a patient who gives no correct response to a score of 30 for a patient who makes no errors. Outcome analysis is average least square means change from baseline. (NCT00235716)
Timeframe: 6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline

,,,
Interventionunits on a scale (Least Squares Mean)
6 months minus baseline12 months minus baseline18 months minus baseline24 months minus baseline30 months minus baseline36 months minus baseline42 months minus baseline48 months minus baselineAverage change from baseline
Memantine-0.24-1.09-2.62-3.44-3.79-4.26-4.59-5.98-3.05
Placebo-0.34-1.39-2.21-2.90-3.26-3.87-4.68-5.42-3.16
Vitamin E-0.35-0.95-2.00-2.62-3.67-4.97-4.84-5.26-2.97
Vitamin E + Memantine-0.20-0.65-1.22-2.29-3.16-3.69-3.80-5.70-2.80

[back to top]

Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline

The primary outcome of the study was the Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory. The ADCS/ADL Inventory is designed to assess functional abilities to perform activities of daily living in Alzheimer patients with a broad range of dementia severity. The total score ranges from 0 to 78 with higher scores indicating greater abilities. Outcome analysis is average least square means change from baseline. (NCT00235716)
Timeframe: 6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline

,,,
Interventionunits on a scale (Least Squares Mean)
6 months minus baseline12 months minus baseline18 months minus baseline24 months minus baseline30 months minus baseline36 months minus baseline42 months minus baseline48 months minus baselineAverage change from baseline
Memantine-2.40-6.99-9.32-14.06-18.30-18.78-23.48-24.60-14.98
Placebo-4.52-8.11-10.21-16.18-19.67-24.82-28.13-27.55-16.96
Vitamin E-1.72-4.29-8.01-11.88-15.84-19.71-25.30-26.55-13.81
Vitamin E + Memantine-2.78-6.60-7.98-12.82-15.66-18.89-23.44-29.25-15.20

[back to top]

Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline

The Alzheimer's Disease Assessment Scale (ADAS) is a 21-item scale designed to assess the severity of cognitive and non-cognitive behavioral impairments in patients with Alzheimer's disease. The cognitive portion of the scale (ADAS-cog) consists of 11 items to assess memory, language, and praxis functions. The ADAS-cog total score ranges from 0 (no errors) to 70 (severe cognitive impairment). Outcome analysis is average least square means change from baseline. (NCT00235716)
Timeframe: 6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline

,,,
Interventionunits on a scale (Least Squares Mean)
6 months minus baseline12 months minus baseline18 months minus baseline24 months minus baseline30 months minus baseline36 months minus baseline42 months minus baseline48 months minus baselineAverage change from baseline
Memantine1.113.325.696.737.648.318.2411.746.38
Placebo3.044.266.046.718.9010.7710.6110.857.78
Vitamin E1.382.404.344.327.879.0010.3510.735.97
Vitamin E + Memantine1.532.483.465.765.858.267.979.706.13

[back to top]

Dependence Scale: Time to Event Analysis (Increase of of One Dependence Level)

The Dependence Scale assesses the level of assistance needed by patients with Alzheimer's disease for activities of daily living. The scale yields six levels of dependence: no assistance required (Level 0); requires occasional reminders (Level 1); requires frequent reminders and/or help with household chores (Level 2); needs daily supervision (Level 3); needs to be dressed, toileted or fed (Level 4); needs to be transferred, diapered or tube fed (Level 5). (NCT00235716)
Timeframe: Every 6 months to a maximum of 4 years

Interventionparticipants (Number)
Vitamin E80
Memantine87
Vitamin E + Memantine87
Placebo79

[back to top]

Neuropsychiatric Inventory Change From Baseline

The Neuropsychiatric Inventory (NPI) assesses psychological and behavioral problems in patients with dementia. For each of twelve domains, there are four scores: frequency, severity, total frequency x severity, and caregiver distress. The frequency x severity total scores from each domain are summed for an overall total score that ranges from 0 to 144. The total caregiver distress scores are also summed for an overall total caregiver distress score that ranges from 0 to 60. The secondary endpoint for the trial will be the overall frequency times severity total score. Outcome analysis is average least square means change from baseline. (NCT00235716)
Timeframe: 6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline

,,,
Interventionunits on a scale (Least Squares Mean)
6 months minus baseline12 months minus baseline18 months minus baseline24 months minus baseline30 months minus baseline36 months minus baseline42 months minus baseline48 months minus baselineAverage change from baseline
Memantine-0.200.311.184.292.623.243.632.791.87
Placebo0.461.084.063.591.660.603.640.302.26
Vitamin E-1.24-1.040.932.163.212.150.81-0.600.79
Vitamin E + Memantine-0.47-0.170.411.982.162.791.855.141.79

[back to top]

F2-isoprostane (F2-iso)

F2-iso is a sensitive laboratory assay for serum levels of F2-isoprostane, which is a biomarker of oxidative stress. (NCT00237718)
Timeframe: month 6

Interventionng/ml (Mean)
ALA and Vitamin E0.077
Placebo0.073

[back to top]

Interleukin-6 (IL-6)

IL-6 is a sensitive laboratory assay for serum levels of interleukin-6, which is a pro-inflammatory cytokine used to evaluate the inflammatory response. (NCT00237718)
Timeframe: month 6

Interventionpg/ml (Mean)
ALA and Vitamin E19
Placebo20

[back to top]

"The Levels of TCT in the Tissues of Non-healthy Subjects and in the Tissue of Healthy Subjects Following Oral Supplementation (200 mg x 2 Per Day for 4-24 Weeks)"

(NCT00678834)
Timeframe: After at least 1 month of supplementation

Interventionnmol/g (Mean)
Arm 1: Surgical, Adipose9.94
Arm 1: Surgical, Brain1.29
Arm 1: Surgical, Heart5.37
Arm 1: Surgical, Liver0.42
Arm 2: Surgical, Adipose28.6
Arm 2: Surgical, Brain50.5
Arm 2: Surgical, Heart31.9
Arm 2: Surgical, Liver64.3
Arm 3: Healthy, Blood, Week 00.01
Arm 3: Healthy, Blood, Week 61.9
Arm 3: Healthy, Skin, Week 121.5
Arm 3: Healthy, Skin, Week 02.5
Arm 3: Healthy, Blood, Week 120.03

[back to top]

Effect Modification of Vitamin E by Body Mass Index on CRA Occurence, Analyzed by Active Vitamin e vs. Vitamin e Placebo

(NCT00706121)
Timeframe: From 1 year post randomization through study completion

,
Interventionercentage of participants in subgroup (Number)
NormalOverweightObese
Active Vitamin E30.236.836.5
Vitamin E Placebo31.434.935.7

[back to top]

Effect Modification of Vitamin E by Aspirin on CRA Occurrence, Analyzed by Active Vitamin e vs. Vitamin e Placebo

(NCT00706121)
Timeframe: From 1 year post randomization through study completion

,
Interventionercentage of participants in subgroup (Number)
UsersNon-users
Active Vitamin E34.536.5
Vitamin E Placebo35.333.3

[back to top]

Effect Modification of Selenium by Body Mass Index on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo

(NCT00706121)
Timeframe: From 1 year post randomization through study completion

,
Interventionpercentage of participants (Number)
NormalOverweightObese
Active Selenium30.235.235.2
Selenium Placebo31.436.537.0

[back to top]

Effect Modification of Selenium by Aspirin on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo

(NCT00706121)
Timeframe: From 1 year post randomization through study completion

,
Interventionercentage of participants in subgroup (Number)
UsersNon-users
Active Selenium33.534.9
Selenium Placebo36.434.9

[back to top]

Effect of Vitamin E on CRA Occurrence, Analyzed by Active Vitamin E vs. Vitamin E Placebo

(NCT00706121)
Timeframe: From 1 year post randomization through study completion

InterventionParticipants (Count of Participants)
Active Vitamin E1159
Vitamin E Placebo1127

[back to top]

Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo

(NCT00706121)
Timeframe: From 1 year post randomization through study completion

InterventionParticipants (Count of Participants)
Active Selenium1136
Selenium Placebo1150

[back to top]

Effect of Selenium on Occurrences of Multiple (>2) Adenomas

(NCT00706121)
Timeframe: From 1 year post randomization through study completion

InterventionParticipants (Count of Participants)
Active Selenium258
Selenium Placebo276

[back to top]

Effect of Selenium and/or Vitamin E on Colorectal Cancer (CRC) Incidence

(NCT00706121)
Timeframe: From 1 year post randomization through study completion

InterventionParticipants (Count of Participants)
Vitamin E10
Selenium11
Combination9
Placebo6

[back to top]

Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo

Adenomas with diameter >=1cm or any adenoma with villous features or high-grade dysplasia (NCT00706121)
Timeframe: From 1 year post randomization through study completion

InterventionParticipants (Count of Participants)
Active Selenium269
Selenium Placebo282

[back to top]

Change in Modified Schwab & England Independence Scale From Baseline to 16 Months

This scale measures activities of daily living. This is an investigator and subject assessment of the subject's level of independence at all scheduled visits. The subject is scored on a percentage scale reflective of his/her ability to perform acts of daily living in relation to pre-Parkinson disease ability. Scores range in increments of 10%: 100% for normal (subject is completely independent; essentially normal) to 0% (vegetative functions such as swallowing, bladder and bowel functions are not functioning; bedridden). (NCT00740714)
Timeframe: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

Interventionunits on a scale (Least Squares Mean)
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day-4.94
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day-4.29
C. Placebo With Vitamin E 1200 IU/Day-4.07

[back to top]

Change in PD Quality of Life Scale From Baseline to 16 Months

The subject will complete a questionnaire that will evaluate how Parkinson disease has affected their health and overall quality of life at each visit. The total quality of life scale measures a total of 33 aspects of quality of life. Each aspect is rated on scale of 0 (best outcome) to 4 (worst outcome). Total score range is 0-132. A higher score or increased score compared to a previous visit indicates a lowered quality of life. (NCT00740714)
Timeframe: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

Interventionunits on a scale (Least Squares Mean)
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day5.06
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day6.12
C. Placebo With Vitamin E 1200 IU/Day5.57

[back to top]

Change in Symbol Digit Modalities Test From Baseline to 16 Months

The Symbol Digit Modalities Test screens cognitive impairment by using a simple substitution tasks that individuals with normal functioning can easily perform. The test score range is from 0(worst outcome) to 110 (best outcome). (NCT00740714)
Timeframe: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

Interventionunits on a scale (Least Squares Mean)
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day-3.36
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day-0.49
C. Placebo With Vitamin E 1200 IU/Day-3.02

[back to top]

Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Total Score (Sum of Parts I, II and III Ranges From 0 to 176))

Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline visit and month 16 or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first. The UPDRS score has three components, each consisting of questions answered on a 0-4 point scale. Part I assesses mentation, behavior and mood; Part II assesses activities of daily living in the week prior to the designated visit; and Part III assesses motor abilities at the time of the visit. A total of 31 items are included in Parts I, II and III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total score ranges from 0-176. (NCT00740714)
Timeframe: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

Interventionunits on a scale (Least Squares Mean)
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day8.01
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day7.50
C. Placebo With Vitamin E 1200 IU/Day6.92

[back to top]

CoQ10 Levels in Plasma

Based on samples analyzed to date (NCT00740714)
Timeframe: Baseline, 1, 8 and 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

,,
Interventionug/ml (Mean)
1 month visit8 month visit16 month visit
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day3.553.322.88
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day2.572.672.17
C. Placebo With Vitamin E 1200 IU/Day.751.07.63

[back to top]

Change in Modified Rankin Scale From Baseline to 16 Months

The Modified Rankin Scale is a global functional health index with a strong accent on physical disability. Subjects are scored on a scale of 0 (no symptoms at all) to 5 (severe disability: bedridden incontinent, and requiring constant nursing care and attention. (NCT00740714)
Timeframe: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

Interventionunits on a scale (Least Squares Mean)
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day.38
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day.31
C. Placebo With Vitamin E 1200 IU/Day.40

[back to top]

Change in Hoehn & Yahr Score From Baseline to 16 Months

The Modified Hoehn and Yahr Scale is an 8-level Parkinson disease staging instrument. The investigator will assess disease stage at each level. The disease stages range from the best outcome of 0 (no signs of disease) to the worst outcome of 5 (wheelchair bound or bedridden unless aided). (NCT00740714)
Timeframe: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

Interventionunits on a scale (Least Squares Mean)
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day.21
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day.20
C. Placebo With Vitamin E 1200 IU/Day.16

[back to top]

Adverse Experiences: Urinary Tract Infection

Number of patients with urinary tract infections (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Interventionparticipants (Number)
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day6
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day8
C. Placebo With Vitamin E 1200 IU/Day3

[back to top]

Adverse Experiences: Tremor

Number of participants with tremor (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Interventionparticipants (Number)
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day10
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day13
C. Placebo With Vitamin E 1200 IU/Day8

[back to top]

Adverse Experiences: Nausea

Number of participants with nausea (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Interventionparticipants (Number)
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day7
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day7
C. Placebo With Vitamin E 1200 IU/Day10

[back to top]

Adverse Experiences: Anxiety

Number of participants with anxiety (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Interventionparticipants (Number)
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day12
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day13
C. Placebo With Vitamin E 1200 IU/Day14

[back to top]

Adverse Experiences: Back Pain

Number of participants with back pain (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Interventionparticipants (Number)
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day9
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day13
C. Placebo With Vitamin E 1200 IU/Day9

[back to top]

Adverse Experiences: Back Pain: Moderate/Severe

Number of participants with moderate/severe back pain (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Interventionparticipants (Number)
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day7
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day9
C. Placebo With Vitamin E 1200 IU/Day7

[back to top]

Adverse Experiences: Constipation

Number of participants with constipation (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Interventionparticipants (Number)
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day7
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day13
C. Placebo With Vitamin E 1200 IU/Day7

[back to top]

Adverse Experiences: Constipation: Moderate/Severe

Number of participants with moderate/severe constipation (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Interventionparticipants (Number)
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day3
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day10
C. Placebo With Vitamin E 1200 IU/Day3

[back to top]

Adverse Experiences: Depression

Number of participants with depression (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Interventionparticipants (Number)
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day9
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day6
C. Placebo With Vitamin E 1200 IU/Day14

[back to top]

Adverse Experiences: Anxiety: Moderate/Severe

Number of participants with moderate/severe anxiety (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Interventionparticipants (Number)
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day9
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day9
C. Placebo With Vitamin E 1200 IU/Day7

[back to top]

Adverse Experiences: Headache

Number of participants with headache (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Interventionparticipants (Number)
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day9
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day8
C. Placebo With Vitamin E 1200 IU/Day11

[back to top]

Adverse Experiences: Hypertension

Number of participants with hypertension (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Interventionparticipants (Number)
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day5
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day7
C. Placebo With Vitamin E 1200 IU/Day0

[back to top]

Adverse Experiences: Insomnia

Number of participants with insomnia (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Interventionparticipants (Number)
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day6
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day13
C. Placebo With Vitamin E 1200 IU/Day6

[back to top]

Adverse Experiences: Insomnia: Moderate/Severe

Number of participants with moderate/severe insomnia (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Interventionparticipants (Number)
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day2
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day9
C. Placebo With Vitamin E 1200 IU/Day0

[back to top]

Adverse Experiences: Nasopharyngitis

Number of participants with nasopharyngitis (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Interventionparticipants (Number)
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day7
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day9
C. Placebo With Vitamin E 1200 IU/Day3

[back to top]

Adverse Experiences: Diarrhoea

Number of participants with diarrhoea (NCT00740714)
Timeframe: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Interventionparticipants (Number)
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day6
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day9
C. Placebo With Vitamin E 1200 IU/Day11

[back to top]

Fasting Plasma Insulin

Change from baseline after 18 months of therapy (NCT01002547)
Timeframe: Month 18

InterventionuU/ml (Mean)
Placebo3
Vitamin E-3
Pioglitazone + Vitamin E-3

[back to top]

HDL-cholesterol

Change from baseline in plasma HDL-cholesterol after 18 months of therapy (NCT01002547)
Timeframe: Month 18

Interventionmg/dl (Mean)
Placebo-1
Vitamin E1
Pioglitazone + Vitamin E3

[back to top]

LDL-cholesterol

Change from baseline in plasma LDL-cholesterol after 18 months of therapy (NCT01002547)
Timeframe: Month 18

Interventionmg/dl (Mean)
Placebo-12
Vitamin E0
Pioglitazone + Vitamin E-4

[back to top]

Liver Fat by Magnetic Resonance Imaging and Spectroscopy (MRS).

Change from baseline in intrahepatic triglyceride content after 18 months of therapy (NCT01002547)
Timeframe: Month 18

Interventionpercentage (Mean)
Placebo1
Vitamin E-6
Pioglitazone + Vitamin E-10

[back to top]

Liver Histology (Kleiner's et al Criteria, Hepatology 2005)

"Number of patients with reduction of at least 2 points in the nonalcoholic fatty liver disease activity score (NAS) (with reduction in at least 2 different histological categories) without worsening of fibrosis. NAS is the sum of the separate scores for steatosis (0-3), hepatocellular ballooning (0-2) and lobular inflammation (0-3), and ranges from 0-8 .~The scoring system is based on the following grading:~Steatosis: 0 = <5%; 1 = 5-33%; 2 = >33-66%; 3 = >66%. Lobular Inflammation: 0 = No foci 1 = <2 foci/200x; 2 = 2-4 foci/200x, 3 = >4 foci/200x. Hepatocyte Ballooning: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning. Fibrosis: 0 = None; 1 = Perisinusoidal or periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis." (NCT01002547)
Timeframe: 18 months

InterventionParticipants (Count of Participants)
Placebo7
Vitamin E13
Pioglitazone + Vitamin E24

[back to top]

Matsuda Index

This is a method for assessing insulin resistance (IR) based on measurements of glucose and insulin during the oral glucose tolerance test. The formula used is = (10000/(SQRT(fasting plasma glucose * fasting plasma insulin * ((fasting plasma glucose * 15 + glucose at minute 30 * 30 + glucose at minute 60 * 30 + glucose at minute 90 * 30 + glucose at minute 120 * 15)/120)*((fasting plasma insulin * 15 + insulin at minute 30 * 30 + insulin at minute 60 * 30 + insulin at minute 90 * 30 + insulin at minute 120 * 15)/120))), with a lower value representing worse insulin resistance. (NCT01002547)
Timeframe: Month 18

Interventionunits on a scale (Mean)
Placebo2.53
Vitamin E2.31
Pioglitazone + Vitamin E4.02

[back to top]

Number of Participants With Resolution of NASH Without Worsening of Fibrosis

Resolution of NASH was defined as absence of NASH after 18 months of therapy in patients with definite NASH (presence of zone 3 accentuation of macrovesicular steatosis of any grade, hepatocellular ballooning of any degree, and lobular inflammatory infiltrates of any amount) at baseline. (NCT01002547)
Timeframe: Month 18

InterventionParticipants (Count of Participants)
Placebo5
Vitamin E14
Pioglitazone + Vitamin E20

[back to top]

Plasma ALT

Change from baseline in plasma ALT after 18 months of therapy (NCT01002547)
Timeframe: Month 18

InterventionU/L (Mean)
Placebo-6
Vitamin E-24
Pioglitazone + Vitamin E-18

[back to top]

Plasma AST

Change from baseline in plasma AST after 18 months of therapy (NCT01002547)
Timeframe: Month 18

InterventionU/L (Mean)
Placebo-8
Vitamin E-15
Pioglitazone + Vitamin E-10

[back to top]

Total Body Fat by DEXA

Change from baseline in total body fat by DEX after 18 months of therapy (NCT01002547)
Timeframe: Month 18

Interventionpercentage (Mean)
Placebo0
Vitamin E0
Pioglitazone + Vitamin E2

[back to top]

Triglycerides

Change from baseline in plasma triglycerides after 18 months of therapy (NCT01002547)
Timeframe: Month 18

Interventionmg/dl (Median)
Placebo13
Vitamin E14
Pioglitazone + Vitamin E-2

[back to top]

Weight

Change from baseline in weight (NCT01002547)
Timeframe: Month 18

Interventionkg (Mean)
Placebo-0.8
Vitamin E0.5
Pioglitazone + Vitamin E5.7

[back to top]

Individual Histological Scores

"Number of patients with improvement of at least 1 grade in each of the histological parameters.~Steatosis: 0 = <5%; 1 = 5-33%; 2 = >33-66%; 3 = >66%. Lobular Inflammation: 0 = No foci 1 = <2 foci/200x; 2 = 2-4 foci/200x, 3 = >4 foci/200x.~Hepatocyte Ballooning: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning.~Fibrosis: 0 = None; 1 = Perisinusoidal or periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis." (NCT01002547)
Timeframe: Month 18

,,
InterventionParticipants (Count of Participants)
SteatosisInflammationBallooningFibrosis
Pioglitazone + Vitamin E32252319
Placebo15141110
Vitamin E24131819

[back to top]

Mean Individual Histological Scores

"Mean change in individual scores compared to baseline. Steatosis range 0-3, where: 0 = <5% fat; 1 = 5-33% fat; 2 = >33-66% fat; 3 = >66% fat.~Lobular Inflammation, range 0-3, where: 0 = No foci 1 = <2 foci/200x; 2 = 2-4 foci/200x, 3 = >4 foci/200x.~Hepatocyte Ballooning, range 0-2, where: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning.~Fibrosis stage, range 0-4, where: 0 = None; 1 = Perisinusoidal or periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis." (NCT01002547)
Timeframe: Month 18

,,
Interventionunits on a scale (Mean)
SteatosisInflammationBallooningFibrosis
Pioglitazone + Vitamin E-1.3-0.6-0.6-0.6
Placebo-0.4-0.2-0.1-0.3
Vitamin E-1.0-0.4-0.5-0.6

[back to top]

Total Cholesterol

Change from baseline in plasma total cholesterol after 18 months of therapy (NCT01002547)
Timeframe: Month 18

Interventionmg/dl (Mean)
Placebo-11
Vitamin E5
Pioglitazone + Vitamin E1

[back to top]

Body Mass Index

Weight (in kg) / (Height [in m] x Height [in m]) (NCT01002547)
Timeframe: Month 18

Interventionkg/m2 (Mean)
Placebo-0.6
Vitamin E0.1
Pioglitazone + Vitamin E1.4

[back to top]

Fasting Plasma Glucose

Change from baseline after 18 months of therapy (NCT01002547)
Timeframe: Month 18

Interventionmg/dl (Mean)
Placebo6
Vitamin E-3
Pioglitazone + Vitamin E-16

[back to top]

Absolute Change in Brachial Artery Flow-mediated Dilation at Day 7 From Day 0

Flow-mediated dilation (FMD) of the brachial artery is measured to assess vascular endothelial function. FMD is obtained by monitoring change in vessel diameter before and after brachial artery occlusion with a blood pressure cuff. The unit of FMD is % and is calculated using the following equation: FMD = [(peak dilation at post occlusion - vessel diameter at preocclusion)/vessel diameter at preocclusion]*100. (NCT01314443)
Timeframe: Day 0 and 7 of intervention

Intervention% of preocclusion diameter (Mean)
Dietary Supplement + Smoking Cessation4.08
Placebo + Smoking Cessation2.77
Dietary Supplement + Nicotine Replacement Therapy2.97
Placebo + Nicotine Replacement Therapy2.66

[back to top]

Absolute Change From Baseline in Plasma Malondialdehyde at Day 7 From Day 0.

Plasma measurements of malondialdehyde, a marker of lipid peroxidation was assessed in response to smoking cessation and in combination with gamma-tocopherol (vitamin E) supplementation (NCT01314443)
Timeframe: Day 0 and 7 of intervention

InterventionmicroM (Mean)
Dietary Supplement + Smoking Cessation-0.08
Placebo + Smoking Cessation-0.06
Dietary Supplement + Nicotine Replacement Therapy-0.04
Placebo + Nicotine Replacement Therapy-0.07

[back to top]

Absolute Change From Baseline in Plasma Gamma-tocopherol (Vitamin E) at Day 7 From Day 0.

Plasma measurements of gamma-tocopherol was assessed in response to smoking cessation and in combination with gamma-tocopherol (vitamin E) supplementation. (NCT01314443)
Timeframe: Day 0 and 7 of intervention

InterventionmicroM (Mean)
Dietary Supplement + Smoking Cessation7.30
Placebo + Smoking Cessation-0.10
Dietary Supplement + Nicotine Replacement Therapy7.28
Placebo + Nicotine Replacement Therapy-0.24

[back to top]

Physiological: Absolute Change in Liver Fat

Physiological response defined as absolute change in liver fat measured by 1H-MRS (NCT01792115)
Timeframe: Baseline and 24 weeks

Interventionpercent liver fat (Mean)
Vit E 200 IU/d-1.9
Vitamin E 400-7.6
Vitamin E 800-0.6

[back to top]

Percent Change in Liver Fat

Percent change in liver fat by week 24 (NCT01792115)
Timeframe: Baseline and 24 weeks

Interventionpercent of percent liver fat (Mean)
Vit E 200 IU/d0.33
Vitamin E 400-0.42
Vitamin E 800-0.10

[back to top]

Percent Change in AST

Percent change in AST by week 24 (NCT01792115)
Timeframe: Baseline and 24 weeks

Interventionpercent (Mean)
Vit E 200 IU/d-0.15
Vitamin E 400-0.07
Vitamin E 800-0.24

[back to top]

Percent Change in ALT

Percent change in ALT by week 24 (NCT01792115)
Timeframe: Baseline and 24 weeks

Interventionpercent (Mean)
Vit E 200 IU/d-0.17
Vitamin E 400-0.19
Vitamin E 800-0.35

[back to top]

Biochemical: Number of Patients With Normal Transaminases at End of Treatment.

Biochemical response defined as number of patients with normal transaminases AST <=32 or ALT <=35 U/L at end of treatment. (NCT01792115)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
Vit E 200 IU/d6
Vitamin E 4006
Vitamin E 8006

[back to top]

Absolute Change in GGT

Change in GGT by week 24 (U/L) (NCT01792115)
Timeframe: Baseline and 24 weeks

Interventionu/l (Mean)
Vit E 200 IU/d-6.1
Vitamin E 400-22.8
Vitamin E 800-11

[back to top]

Absolute Change in AST

Absolute Change in AST [u/l] by week 24 (NCT01792115)
Timeframe: Baseline and 24 weeks

Interventionu/l (Mean)
Vit E 200 IU/d-5.6
Vitamin E 400-1.8
Vitamin E 800-10.6

[back to top]

Absolute Change in ALT

Absolute Change in ALT [u/l] by week 24 (NCT01792115)
Timeframe: Baseline and 24 weeks

Interventionu/l (Mean)
Vit E 200 IU/d-8
Vitamin E 400-8.3
Vitamin E 800-22

[back to top]

Number of Subjects With 60-day Survival

Number of subjects in each arm that survived to day 60 (NCT01897792)
Timeframe: from enrollment up to 60 days post enrollment

Interventionparticipants (Number)
Vitamins C and E6
0.9% Saline and Sugar Pill5

[back to top]

Number of Total Blood Product Transfusions

the number of blood product transfusions for all subjects in each group over the course of 3 days. (NCT01897792)
Timeframe: From enrollment to 3 days

Interventionblood transfusions (Number)
Vitamins C and E11
0.9% Saline and Sugar Pill5

[back to top]

Number of Subjects With Ventilator-associated Pneumonia.

Number of subjects diagnosed with pneumonia and requiring ventilator support. (NCT01897792)
Timeframe: From enrollment to 3 days

Interventionparticipants (Number)
Vitamins C and E4
0.9% Saline and Sugar Pill2

[back to top]

Number of Subjects With Organ Injury

Any injury to internal organs (thoracic, abdominal or cranial cavity) (NCT01897792)
Timeframe: From enrollment to 3 days

Interventionparticipants (Number)
Vitamins C and E0
0.9% Saline and Sugar Pill0

[back to top]

Number of Subjects Surviving to Day 28

Number of subjects that survived to day 28 after enrollment (NCT01897792)
Timeframe: from enrollment up to 28 days post enrollment

Interventionparticipants (Number)
Vitamins C and E6
0.9% Saline and Sugar Pill5

[back to top]

Number of Protocol Violations Per Arm.

The number of times that there was a deviation or violation from how the protocol was to be implemented. (NCT01897792)
Timeframe: from enrollment up to 60 days post enrollment

Interventionprotocol deviations (Number)
Vitamin C and E Participants -1
0.9% Saline and Sugar Pill Participants - Protocol Violations0

[back to top]

Number of Participants With Coagulation Abnormalities

Coagulation parameters are evaluated using standard functional tests (prothrombin time (PT), partial thromboplastin time (PTT), fibrinogen and platelet count)and point of care functional analysis using thromboelastogram (TEG-ROTEM). A blood sample is collected upon arrival in the emergency department at 0 hours only and analyzed for markers of activation of coagulation, inflammation, and levels of vitamin C/E. (NCT01897792)
Timeframe: From enrollment up to 3 days

Interventionparticipants (Number)
Vitamins C and E2
0.9% Saline and Sugar Pill1

[back to top]

Mean Number of Ventilator-free Days for Subjects

The mean number of ventilator free days (not on ventilator) for subjects in each arm (NCT01897792)
Timeframe: from enrollment up to 60 days post enrollment

Interventiondays (Mean)
Vitamins C and E12
0.9% Saline and Sugar Pill6.2

[back to top]

Mean Number of Hospital Stay Days.

The mean number of days subjects were in the hospital in each arm of the study (NCT01897792)
Timeframe: from enrollment up to 60 days post enrollment

Interventiondays (Mean)
Vitamins C and E18.3
0.9% Saline and Sugar Pill18.2

[back to top]

Mean Number of Days in ICU.

the mean number of days each subject was in the ICU in each arm (NCT01897792)
Timeframe: from enrollment up to 60 days post enrollment

Interventiondays (Mean)
Vitamins C and E15
0.9% Saline and Sugar Pill11

[back to top]

Mucociliary Clearance as Affected by Gamma Tocopherol

On day 11 of treatment (approximately 6 hours after the daily dose) with placebo or gamma tocopherol, a whole lung region of interest (ROI) bordering the right lung was used to estimate (by computer analysis) whole lung retention of inhaled radiolabeled particles. This was performed by measuring the labeled particle counts over a 2 hour period and determining the fraction of initial particle counts remaining. From this data, we determined the percentage of labeled particles cleared from the lung during the 2 hour observation period. (NCT02104505)
Timeframe: after 11 days of gamma tocopherol or placebo treatment

Intervention% of labeled particles cleared from lung (Mean)
Gamma Tocopherol21.4
Placebo21.4

[back to top]

Mucociliary Clearance (MCC) Associated With CCRE Challenge as Affected by Gamma Tocopherol

On day 14 of treatment (approximately 6 hours after the final dose) with placebo or gamma tocopherol, a whole lung region of interest (ROI) bordering the right lung was used to estimate (by computer analysis) whole lung retention of inhaled radiolabeled particles. This was performed by measuring the labeled particle counts over a 2 hour period and determining the fraction of initial particle counts remaining. From this data, we determined the percentage of labeled particles cleared from the lung during the 2 hour observation period. (NCT02104505)
Timeframe: after 14 days of gamma tocopherol or placebo treatment

Intervention% of labeled particles cleared from lung (Mean)
Gamma Tocopherol20.2
Placebo16.3

[back to top]

Comparison of Change in Sputum Percent Neutrophils (PMN)s Following Inhaled Clinical Center Reference Endotoxin (CCRE) Challenge as Affected by Gamma Tocopherol

In asthmatic individuals, exposure to CCRE is expected to increase PMNs in the sputum. The sputum PMNs were measured at baseline (immediately prior to dosing) and again on day 14 of treatment (approximately 8 hours after the final dose) with placebo or gamma tocopherol. The outcome is to compare the change in PMNs from baseline to post treatment after exposure to CCRE (NCT02104505)
Timeframe: after 14 days of gamma tocopherol or placebo treatment

Interventionchange in percentage of PMNs in sputum (Mean)
Gamma Tocopherol11.7
Placebo20.1

[back to top]

Chronic Eosinophilic Airway Inflammation as Affected by Gamma Tocopherol

The sputum eosinophils were measured at baseline (immediately prior to dosing) and again after 14 days of treatment (approximately 8 hours after the final dose) with placebo or gamma tocopherol. The outcome is to compare sputum eosinophils per mg before and after gamma tocopherol treatment. (NCT02104505)
Timeframe: after 14 days of gamma tocopherol or placebo treatment

Interventioneosinophils per mg sputum (Mean)
Gamma Tocopherol2.6
Placebo9.5

[back to top]

Clinical Symptoms Evaluation, Measured Using the LENT-SOMA Scale

"Evaluation of symptoms improvement using the LENT-SOMA scale (Late Effect Normal Tissue Task Force / Subjective, Objective, Management, Analytic scale).~To examine the LENT/SOMA scale prospectively using interviews and questionnaires~Assessments were made from baseline to 1, 3, 6 and 9 months of starting treatments. The acceptability and feasibility of using the scales was examined using compliance in completion of the questionnaires.~Maximum score: 36 Minimum score: 0~Questionnaires have been completed for 24 patients after treatment. Higher values represents worse outcome.~Scale categories:~Subjective: pain, nutritional problems, difficulty in mouth openning. Objective: bone exposure, trismus, Management: analgesic treatment, oral treatment, nutrition. Analytic: radiological findings." (NCT02368457)
Timeframe: From baseline to 1,3, 6, 9 months of starting treatment

,
Interventionunits on a scale (Mean)
1 month of starting treatment3 month of starting treatment6 month of starting treatment9 month of starting treatment
CONTROL15.515.515.515.5
Pentoxifylline and Tocopherol14.5141413.3

[back to top]

Bone and/or Tissue Healing as Measured With the Classification of ORN Stages, Area of Bone Exposed (mm2) and Radiological Findings (OPG).

"Clinical healing assessment as measured with the classification of ORN stages, area of bone exposed (mm2) and radiological findings (OPG).~Intraoral bone exposure is measured in mm2." (NCT02368457)
Timeframe: From baseline to 1, 3, 6, and 9 months of starting treatment

,
Interventionmm2 (Mean)
1 month of starting treatment3 month of starting treatment6 month of starting treatment9 month of starting treatment
Control Group15151515
Pentoxifylline and Tocopherol141311.510

[back to top]

Change in Sputum IL-8 From Baseline Following Ozone Exposure

Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of inflammatory cytokines. The analysis will determine if gamma tocopherol pre-treatment reduces ozone-induced sputum inflammatory cytokine production compared to placebo pre-treatment. (NCT02911688)
Timeframe: baseline and 6 hours post ozone exposure

Interventionpicograms per milliliter (Mean)
Gamma Tocopherol-341.1
Placebo406.8

[back to top]

Change in Sputum IL-6 From Baseline Following Ozone Exposure

Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of inflammatory cytokines. The analysis will determine if gamma tocopherol pre-treatment reduces ozone-induced sputum inflammatory cytokine production compared to placebo pre-treatment. (NCT02911688)
Timeframe: baseline and 6 hours post ozone exposure

Interventionpicograms per milliliter (Mean)
Gamma Tocopherol58.0
Placebo44.3

[back to top]

Change in Central Lung Clearance of Technetium Sulfur Colloid Particles (0-30 Minutes) From Baseline Following Ozone Exposure

Central lung clearance (0-30 minutes) was measured using gamma scintigraphy and represented as mean average 30 minute clearance of inhaled technetium (99mTc) sulfur colloid particles from the large bronchial airways. (NCT02911688)
Timeframe: baseline and 1 hour after exiting ozone chamber

Intervention% clearance (Mean)
Gamma Tocopherol-0.2
Placebo-4.3

[back to top]

Change in Whole Lung Clearance of Technetium Sulfur Colloid Particles (0-120 Minutes) From Baseline Following Ozone Exposure

Whole lung clearance was measured using gamma scintigraphy and represented as mean average 120 minute clearance of inhaled technetium (99mTc) sulfur colloid particles in order to estimate the rate of airway mucociliary clearance. (NCT02911688)
Timeframe: baseline and 1 hour after exiting ozone chamber

Intervention% clearance (Mean)
Gamma Tocopherol2
Placebo0

[back to top]

Change From Baseline in Sputum Percent Neutrophils (%PMN) Following Ozone Exposure

Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of inflammatory cells. The analysis will determine if gamma tocopherol pre-treatment reduces ozone-induced sputum percent neutrophils compared to placebo pre-treatment. (NCT02911688)
Timeframe: baseline and 6 hours post-ozone exposure

Interventionpercent neutrophils (Mean)
Gamma Tocopherol (N=7)34.1
Placebo (N=7)36.5

[back to top]

Change in Sputum Tumor Necrosis Factor (TNF)-Alpha From Baseline Following Ozone Exposure

Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of inflammatory cytokines. The analysis will determine if gamma tocopherol pre-treatment reduces ozone-induced sputum inflammatory cytokine production compared to placebo pre-treatment. (NCT02911688)
Timeframe: baseline and 6 hours post ozone exposure

Interventionpicograms per milliliter (Mean)
Gamma Tocopherol-61.1
Placebo-301.4

[back to top]

Change in Sputum Percent Eosinophils From Baseline Following Ozone Exposure

The investigators assessed induced sputum cellularity at baseline and 6 hours after ozone exposure to determine if treatment with gamma tocopherol/placebo impacts ozone-induced sputum eosinophilia. (NCT02911688)
Timeframe: baseline and 6 hours post-ozone exposure

Interventionpercent eosinophils (Mean)
Gamma Tocopherol (N=7)0.8
Placebo (N=7)-1.1

[back to top]

Change in Sputum Interleukin (IL)-1b From Baseline Following Ozone Exposure

Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of inflammatory cytokines. The analysis will determine if gamma tocopherol pre-treatment reduces ozone-induced sputum inflammatory cytokine production compared to placebo pre-treatment. (NCT02911688)
Timeframe: baseline and 6 hours post ozone exposure

Interventionpicograms per milliliter (Mean)
Gamma Tocopherol-9.7
Placebo176

[back to top]

Choosing Other Erectile Dysfunction (ED) Treatments After Pentoxifylline, Atorvastatin and Vitamin E (PAVE)

To report the rate of choosing other ED treatments after PAVE. (NCT03830164)
Timeframe: Up to 12 months

InterventionParticipants (Count of Participants)
Cohort 11
Cohort 20
Cohort 30

[back to top]

Number of Participants With Incidence of Adverse Events (AEs)

The safety profile of the pentoxifylline, atorvastatin and vitamin E (PAVE) combination will be reported for each cohort, with adverse events summarized by grade and time to onset to first grade 3 adverse event. (NCT03830164)
Timeframe: Up to 12 months

,,
InterventionParticipants (Count of Participants)
Serious Adverse EventAdverse Event
Cohort 100
Cohort 202
Cohort 300

[back to top]

Change in International Index of Erectile Function (IIEF) Scores

To estimate the proportion of participants who achieve a clinically significant improvement in erectile dysfunction (ED) when treated with a combination of Atorvastatin or participant's currently prescribed statin, Vitamin E, and Pentoxifylline (PAVE) (NCT03830164)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Cohort 10
Cohort 20
Cohort 30

[back to top]

Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Body Mass Index (BMI)

Evaluation of baseline and 6-month measurements of body mass index (BMI) in the DHA EE and /or Vitamin E intervention over a 6 month period. (NCT04198805)
Timeframe: Baseline to 6 months

Interventionkg/m^2 (Mean)
DHA EE (1.89 g) and Vitamin E (1000 mg)0.1
Vitamin E (1000 mg)0.2
DHA EE (1.89 g)-0.0
Placebo-0.0

[back to top]

Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Waist Circumference.

Evaluation of baseline and 6 month measurements of waist circumference in the DHA EE and /or Vitamin E intervention over a 6 month period. (NCT04198805)
Timeframe: Baseline to 6 months

Interventioncentimeters (cm) (Mean)
DHA EE (1.89 g) and Vitamin E (1000 mg)0.8
Vitamin E (1000 mg)-0.5
DHA EE (1.89 g)-0.2
Placebo0.8

[back to top]

Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Waist-to-hip Ratio .

Evaluation of baseline and 6-month measurements of waist-to-hip ratio (the circumference of the waist divided by the circumference of the hips) in the DHA EE and /or Vitamin E intervention over a 6 month period. (NCT04198805)
Timeframe: Baseline to 6 months

Interventionratio (Mean)
DHA EE (1.89 g) and Vitamin E (1000 mg)0.0
Vitamin E (1000 mg)-0.0
DHA EE (1.89 g)0.0
Placebo-0.0

[back to top]

Change After 6 Months of DHA EE and /or Vitamin E Intervention in the Anthropometric Measure, Bodyweight.

Evaluation of baseline and 6-month measurements of body weight in the DHA EE and /or Vitamin E intervention over a 6 month period. (NCT04198805)
Timeframe: Baseline to 6 months

Interventionkilogram (kg) (Mean)
DHA EE (1.89 g) and Vitamin E (1000 mg)0.4
Vitamin E (1000 mg)0.5
DHA EE (1.89 g)0.0
Placebo-0.0

[back to top] [back to top]

Change in Dietary Intake Levels of Long-chain Polyunsaturated Fatty Acids (LC-PUFA ) (i.e. DHA and EPA) as Measured by the Food Frequency Questionnaire (FFQ)

Evaluation of baseline and 6-month dietary intake levels of LC-PUFA (i.e. DHA and EPA) as measured by the Food Frequency Questionnaire (FFQ)in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline). (NCT04198805)
Timeframe: Baseline to 6 months

,,,
Interventionmg per day (Mean)
FFQ DHAFFQ EPA
DHA EE (1.89 g)-0.7-0.6
DHA EE (1.89 g) and Vitamin E (1000 mg)2.30.7
Placebo-1.6-0.8
Vitamin E (1000 mg)4.42.4

[back to top]

Liver Enzymes Alkaline Phosphatase in the DHA EE and /or Vitamin E Intervention Over a 6 Month Period.

Evaluation of baseline and 6-month liver enzymes: Alkaline Phosphatase in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline). (NCT04198805)
Timeframe: Baseline to 6 months

InterventionU/L (Mean)
DHA EE (1.89 g) and Vitamin E (1000 mg)-4.1
Vitamin E (1000 mg)-0.4
DHA EE (1.89 g)1.1
Placebo2.5

[back to top]

Change in Plasma Vitamin E Concentration

Evaluation of baseline and 6-month plasma Vitamin E concentration in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline). (NCT04198805)
Timeframe: Baseline to 6 months

Interventionng/mL (Mean)
DHA EE (1.89 g) and Vitamin E (1000 mg)6972
Vitamin E (1000 mg)9949
DHA EE (1.89 g)480.9
Placebo148.0

[back to top]

Change in Plasma DHA EE Concentration

Evaluation of baseline and 6-month plasma DHA EE concentration in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline). (NCT04198805)
Timeframe: Baseline to 6 months

Interventionug/mL (Mean)
DHA EE (1.89 g) and Vitamin E (1000 mg)41.6
Vitamin E (1000 mg)0.6
DHA EE (1.89 g)52.8
Placebo-2.6

[back to top]

Change in Liver Enzymes Bilirubin in the DHA EE and /or Vitamin E Intervention Over a 6 Month Period.

Evaluation of baseline and 6-month liver enzymes: Bilirubin in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline). (NCT04198805)
Timeframe: Baseline to 6 months

Interventionmg/dL (Mean)
DHA EE (1.89 g) and Vitamin E (1000 mg)0.1
Vitamin E (1000 mg)-0.0
DHA EE (1.89 g)-0.0
Placebo0.1

[back to top]

Change in Liver Enzymes (AST) in the DHA EE and /or Vitamin E Intervention Over a 6 Month Period.

Evaluation of baseline and 6-month liver enzymes: aspartate aminotransferase (AST) in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline). (NCT04198805)
Timeframe: Baseline to 6 months

InterventionU/L (Mean)
DHA EE (1.89 g) and Vitamin E (1000 mg)-1.4
Vitamin E (1000 mg)-6.4
DHA EE (1.89 g)2.9
Placebo-2.8

[back to top]

Change in Liver Enzymes (ALT) in the DHA EE and /or Vitamin E Intervention Over a 6 Month Period.

Evaluation of baseline and 6-month liver enzymes: alanine transaminase (ALT) in the DHA EE and /or Vitamin E intervention over a 6 month period value at (6 months minus value at baseline). (NCT04198805)
Timeframe: Baseline to 6 months

InterventionU/L (Mean)
DHA EE (1.89 g) and Vitamin E (1000 mg)-4.6
Vitamin E (1000 mg)-16.7
DHA EE (1.89 g)7.0
Placebo-6.8

[back to top]

Change in Lipid Profile (Triglycerides)

Evaluation of baseline and 6-month lipid profile (TGs)in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline). (NCT04198805)
Timeframe: Baseline to 6 months

Interventionmg/dL (Mean)
DHA EE (1.89 g) and Vitamin E (1000 mg)-23.1
Vitamin E (1000 mg)2.0
DHA EE (1.89 g)-6.6
Placebo-21.4

[back to top]

Change in Lipid Profile (Oxidized LDL)

Evaluation of baseline and 6-month lipid profile (oxidized LDL) in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline). (NCT04198805)
Timeframe: Baseline to 6 months

InterventionU/L (Mean)
DHA EE (1.89 g) and Vitamin E (1000 mg)4.1
Vitamin E (1000 mg)5.3
DHA EE (1.89 g)4.6
Placebo0.5

[back to top]

Change in Lipid Profile (Low Density Lipoprotein (LDL-C))

Evaluation of baseline and 6-month lipid profile (low density lipoprotein (LDL-C))in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline). (NCT04198805)
Timeframe: Baseline to 6 months

Interventionmg/dL (Mean)
DHA EE (1.89 g) and Vitamin E (1000 mg)9.9
Vitamin E (1000 mg)2.1
DHA EE (1.89 g)19.4
Placebo5.1

[back to top]

Change in Lipid Profile (HDL-C)

Evaluation of baseline and 6-month lipid profile (HDL-C) in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline). (NCT04198805)
Timeframe: Baseline to 6 months

Interventionmg/dL (Mean)
DHA EE (1.89 g) and Vitamin E (1000 mg)1.7
Vitamin E (1000 mg)0.0
DHA EE (1.89 g)2.4
Placebo0.5

[back to top]

Change in Inflammatory Markers (Cytokeratin 18 (CK-18))

Evaluation of baseline and 6-month inflammatory markers (cytokeratin 18) in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline). (NCT04198805)
Timeframe: Baseline to 6 months

InterventionU/L (Mean)
DHA EE (1.89 g) and Vitamin E (1000 mg)-17.7
Vitamin E (1000 mg)-26.8
DHA EE (1.89 g)37.3
Placebo61

[back to top]

Change in Insulin Levels to Determine Insulin Resistance

(NCT04198805)
Timeframe: Baseline to 6 months

InterventionulU/mL (Mean)
DHA EE (1.89 g) and Vitamin E (1000 mg)4.7
Vitamin E (1000 mg)-5.7
DHA EE (1.89 g)9.9
Placebo4.3

[back to top]

Change in Inflammatory Markers (TNFα)

Evaluation of baseline and 6-month inflammatory markers (TNFα) in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline). (NCT04198805)
Timeframe: Baseline to 6 months

Interventionpg/mL (Mean)
DHA EE (1.89 g) and Vitamin E (1000 mg)-1.3
Vitamin E (1000 mg)-0.2
DHA EE (1.89 g)-0.3
Placebo-0.5

[back to top]

Change in Inflammatory Markers (IL-1β)

Evaluation of baseline and 6-month inflammatory markers (IL-1β) in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline). (NCT04198805)
Timeframe: Baseline to 6 months

Interventionpg/mL (Mean)
DHA EE (1.89 g) and Vitamin E (1000 mg)0.0
Vitamin E (1000 mg)-0.1
DHA EE (1.89 g)0.2
Placebo-0.4

[back to top]

Change in Hepatic Fat Fraction [%] Between Vitamin E vs Placebo Arm

Change in liver fat content relative to baseline between Vitamin E vs placebo arm. This will be measured by MRI-PDFF at baseline and after 6 months of intervention (value at 6 months minus value at baseline). (NCT04198805)
Timeframe: Baseline to 6 months

InterventionPercentage of liver fat (Mean)
Vitamin E (1000 mg)-10.4
Placebo-8.2

[back to top]

Change in Hepatic Fat Fraction [%] Between of Vitamin E and DHA EE vs Placebo

A change in liver fat content relative to baseline between Vitamin E and DHA EE vs placebo. This will be measured by MRI-PDFF at baseline and after 6 months of intervention (value at 6 months minus value at baseline). (NCT04198805)
Timeframe: Baseline to 6 months

InterventionPercentage of liver fat (Mean)
DHA EE (1.89 g) and Vitamin E (1000 mg)-6.8
Placebo-8.2

[back to top]

Change in Hepatic Fat Fraction [%] Between DHA EE vs Placebo Arm

Change in liver fat content relative to baseline between DHA EE vs placebo arm. This will be measured by MRI-PDFF at baseline and after 6 months of intervention (value at 6 months minus value at baseline). (NCT04198805)
Timeframe: Baseline to 6 months

InterventionPercentage of liver fat (Mean)
DHA EE (1.89 g)2.2
Placebo-8.2

[back to top]

Change in Fibrosis-4 (FIB-4) Score

The formula for FIB-4 is: Age ([yr] x AST [U/L]) / ((PLT [10(9)/L]) x (ALT [U/L])(1/2)). A value of FIB-4 below 1.30 is considered as low risk for advanced fibrosis; a value of FIB-4 over 2.67 is considered as high risk for advanced fibrosis (NCT04198805)
Timeframe: Baseline to 6 months

Interventionunits on a scale (Mean)
DHA EE (1.89 g) and Vitamin E (1000 mg)-0.1
Vitamin E (1000 mg)-0.2
DHA EE (1.89 g)-0.1
Placebo-0.0

[back to top]