Page last updated: 2024-11-11

ferrous fumarate

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Description

ferrous fumarate: used in treatment of iron deficiency anemia; RN given refers to Fe(+2)[1:1] salt [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID6433164
CHEBI ID31607
SCHEMBL ID24284
SCHEMBL ID24286
MeSH IDM0099196

Synonyms (93)

Synonym
2-butenedioic acid (2e)-, iron(2+) salt
ferrofumarate
einecs 231-731-5
2-butenedioic acid (2e)-, iron(2+) salt (1:?)
7705-12-6
hemoton
galfer
2-butenedioic acid (2e)-, iron(2+) salt (1:1)
tolifer
2-butenedioic acid, (e)-, iron(2+) salt
ferrofume
feostat
fersamal
tolferain
2-butenedioic acid (e)-, iron(2+) salt (1:1)
ferrotemp
feroton
ercoferro
fumafer
fumaric acid, iron(2+) salt (1:1)
fumiron
iron(2+) fumarate
iron(ii) fumarate
erco-fer
einecs 205-447-7
firon
ferrone
fumar
cpiron
ferronat
palafer
toleron
fumar-f
one-iron
ircon
ccris 6896
feostat (tn)
ferrum (tn)
D01194
141-01-5
ferrous fumarate (jan/usp)
ferrous fumarate
fumaric acid, iron(2+) salt
orgasal
ferrosi fumaras
iron (as ferrous fumarate)
iron (as fumarate)
heferol
AKOS015918237
ferretts
ferrocite
ferrous fumarate [usp:jan]
unii-r5l488ry0q
r5l488ry0q ,
ferrosi fumaras [who-ip latin]
ferrous fumarate [orange book]
minastrin 24 fe component ferrous fumarate
ferrous fumarate [usp monograph]
ferrous fumarate [ep monograph]
ferrous fumarate [fcc]
ferrous fumarate [ii]
ferrous fumarate [vandf]
ferrous fumarate [mi]
lo minastrin fe component ferrous fumarate
ferrous fumarate [who-ip]
ferrous fumarate [inci]
norquest fe component ferrous fumarate
ferrous fumarate [jan]
ferrous fumarate component of norquest fe
ferrous fumarate [mart.]
iron (as ferrous fumarate) [vandf]
meterfer
ferrous fumarate [who-dd]
SCHEMBL24284
SCHEMBL24286
DTXSID7047148 ,
PMVSDNDAUGGCCE-TYYBGVCCSA-L
J-521364
J-007445
CHEBI:31607
Q416370
DB14491
(e)-but-2-enedioate;iron(2+)
HY-B1651
CS-0013603
AMY8976
ferrousfumarate
ferrous fumarate (usp:jan)
ferrous fumarate (ep monograph)
ferrous fumarate (usp monograph)
ferrous fumarate (ii)
dtxcid5027148
ferrous fumarate (mart.)

Research Excerpts

Toxicity

ExcerptReferenceRelevance
"Treatment of iron deficiency anaemia with conventional oral preparations is handicapped by unpredictable haematological response in addition to potential for irritating gastrointestinal adverse events."( Evaluation of efficacy and safety of iron polymaltose complex and folic acid (Mumfer) vs iron formulation (ferrous fumarate) in female patients with anaemia.
Adsul, BB; Desai, A; Gandewar, K; Korde, KM; Reddy, PS, 2001
)
0.31
" Both the formulations were equally well-tolerated and adverse events were mainly gastrointestinal in nature."( Comparative assessment of the bioavailability, efficacy and safety of a modified-release (MR) carbonyl iron tablet and oral conventional iron preparation in adult Indian patients with nutritional iron deficiency anaemia.
Adsul, BB; Baliga, V; Desai, A; Gawde, A, 2005
)
0.33
" However, large randomized trials have revealed that provision of iron to young children caused serious adverse effects because iron powerfully promotes microbial growth."( Efficacy and safety of hepcidin-based screen-and-treat approaches using two different doses versus a standard universal approach of iron supplementation in young children in rural Gambia: a double-blind randomised controlled trial.
Bah, A; Cerami, C; Goheen, MM; Kendall, L; Moretti, D; Mulwa, S; Prentice, AM; Wegmüller, R, 2016
)
0.43
"A MNP containing a low dose of highly bioavailable iron reduces anaemia, and the addition of GOS mitigates most of the adverse effects of iron on the gut microbiome and morbidity in African infants."( Prebiotic galacto-oligosaccharides mitigate the adverse effects of iron fortification on the gut microbiome: a randomised controlled study in Kenyan infants.
Barth-Jaeggi, T; Boekhorst, J; Cercamondi, CI; Karanja, S; Kortman, GAM; Lacroix, C; Moretti, D; Paganini, D; Schwab, C; Timmerman, HM; Uyoga, MA; Zimmermann, MB, 2017
)
0.46

Pharmacokinetics

ExcerptReferenceRelevance
" Plasma dolutegravir AUC(0-∞), Cmax , and C24 were reduced by 39%, 37%, and 39%, respectively, when co-administered with calcium carbonate while fasting and were reduced by 54%, 57%, and 56%, respectively, when co-administered with ferrous fumarate while fasting."( Pharmacokinetics of dolutegravir when administered with mineral supplements in healthy adult subjects.
Arya, N; Borland, J; Piscitelli, S; Song, I; Wynne, B, 2015
)
0.42

Bioavailability

Ferrous fumarate is as well absorbed as ferrous sulfate in non-anemic, iron sufficient infants and young children.

ExcerptReferenceRelevance
" One possible explanation for this observation is that iron from multivitamins is more poorly absorbed than iron from iron tablets."( Iron absorption from chewable vitamins with iron versus iron tablets: implications for toxicity.
Lacouture, PG; Linakis, JG; Woolf, A, 1992
)
0.28
"The effect of ferrous fumarate on the relative bioavailability of ciprofloxacin after a single 500 mg oral dose of ciprofloxacin was studied in eight healthy males."( Decreased ciprofloxacin absorption with concomitant administration of ferrous fumarate.
Brouwers, JR; Proost, JH; Sijtsma, J; Van der Kam, HJ, 1990
)
0.28
"Hemoglobin-repletion tests in rats, organoleptic studies, and iron-absorption studies in humans were used to search for Fe sources with high bioavailability that could be added to infant cereals as alternatives to the Fe compounds currently used for fortification."( Iron fortification of infant cereals: a proposal for the use of ferrous fumarate or ferrous succinate.
Burri, J; Cook, JD; Furniss, DE; Hurrell, RF; Lynch, SR; Whittaker, P, 1989
)
0.28
" In the first study, bioavailability of iron from ferrous sulfate and the complex was defined at physiologic doses of 5 mg (Group 1: n = 14) and therapeutic doses of 50 mg (Group 2: n = 13)."( Oral iron therapy in human subjects, comparative absorption between ferrous salts and iron polymaltose.
Jacobs, P; Johnson, G; Wood, L, 1984
)
0.27
"Our objective was to compare iron bioavailability from ferric pyrophosphate with an alternative iron source that is soluble in dilute acid, ferrous fumarate, and to evaluate the influence of ascorbic acid on iron bioavailability from ferrous fumarate in infants."( Iron bioavailability in infants from an infant cereal fortified with ferric pyrophosphate or ferrous fumarate.
Barclay, D; Davidsson, L; Hurrell, RF; Kastenmayer, P; Szajewska, H, 2000
)
0.31
"Geometric mean iron bioavailability was significantly higher from [57Fe]ferrous fumarate than from [57Fe]ferric pyrophosphate [4."( Iron bioavailability in infants from an infant cereal fortified with ferric pyrophosphate or ferrous fumarate.
Barclay, D; Davidsson, L; Hurrell, RF; Kastenmayer, P; Szajewska, H, 2000
)
0.31
"Iron bioavailability from iron-fortified infant cereals can be improved by using an iron compound with high relative bioavailability and by ensuring adequate ascorbic acid content of the product."( Iron bioavailability in infants from an infant cereal fortified with ferric pyrophosphate or ferrous fumarate.
Barclay, D; Davidsson, L; Hurrell, RF; Kastenmayer, P; Szajewska, H, 2000
)
0.31
"The goal was to evaluate the bioavailability of iron from meals based on corn tortillas and black bean paste that were fortified with ferrous fumarate, ferrous sulfate, or NaFeEDTA and to investigate the potential of Na(2)EDTA to increase the bioavailability of iron from ferrous fumarate."( Iron bioavailability from iron-fortified Guatemalan meals based on corn tortillas and black bean paste.
Boy, E; Davidsson, L; Dimitriou, T; Hurrell, RF; Walczyk, T, 2002
)
0.31
"With use of a crossover study design, iron bioavailability was measured in Guatemalan girls aged 12-13 y by a stable-isotope technique based on erythrocyte incorporation 14 d after intake."( Iron bioavailability from iron-fortified Guatemalan meals based on corn tortillas and black bean paste.
Boy, E; Davidsson, L; Dimitriou, T; Hurrell, RF; Walczyk, T, 2002
)
0.31
"The bioavailability of iron from ferrous fumarate was not improved by the addition of Na(2)EDTA, contrary to what was previously shown for ferrous sulfate in other cereal-based meals."( Iron bioavailability from iron-fortified Guatemalan meals based on corn tortillas and black bean paste.
Boy, E; Davidsson, L; Dimitriou, T; Hurrell, RF; Walczyk, T, 2002
)
0.31
" Due to high concentrations of inhibitors of iron absorption, the bioavailability from this matrix is unknown."( Iron bioavailability in corn-masa tortillas is improved by the addition of disodium EDTA.
Olivares, M; Pizarro, F; Walter, T, 2003
)
0.32
" However, the effect of encapsulation per se on Fe bioavailability is a concern."( The potential of encapsulated iron compounds in food fortification: a review.
Zimmermann, MB, 2004
)
0.32
" The effect of therapy on haematological parameters and iron status and estimation of bioavailability were the main efficacy outcomes."( Comparative assessment of the bioavailability, efficacy and safety of a modified-release (MR) carbonyl iron tablet and oral conventional iron preparation in adult Indian patients with nutritional iron deficiency anaemia.
Adsul, BB; Baliga, V; Desai, A; Gawde, A, 2005
)
0.33
" Iron bioavailability from cocoa powder enriched with ferric pyrophosphate encapsulated in liposomes or ferrous fumarate was assessed in rats."( A comparative study of iron bioavailability from cocoa supplemented with ferric pyrophosphate or ferrous fumarate in rats.
Izquierdo-Pulido, M; Navas-Carretero, S; Pérez-Granados, AM; Sarriá, B; Schoppen, S; Vaquero, MP, 2007
)
0.34
"The choice of iron fortificant usually represents a balance between bioavailability of the compound and its tendency to cause organoleptic problems."( Fortifying brown bread with sodium iron EDTA, ferrous fumarate, or electrolytic iron does not affect iron status in South African schoolchildren.
Dhansay, MA; Lombard, CJ; Smuts, CM; van Stuijvenberg, ME, 2008
)
0.35
"Non-water-soluble iron compounds have been reported to be less well absorbed than ferrous sulfate in young children, and concern has been raised about their usefulness as food fortificants."( Regular consumption of a complementary food fortified with ascorbic acid and ferrous fumarate or ferric pyrophosphate is as useful as ferrous sulfate in maintaining hemoglobin concentrations >105 g/L in young Bangladeshi children.
Davidsson, L; Hurrell, R; Jamil, KA; Sarker, SA; Sultana, S, 2009
)
0.35
"In the first study, young women (n = 98) with an iron status varying from iron deficiency anemia to iron sufficiency (women with serum ferritin concentrations 25-40 microg/L were not included) were given stable isotope-labeled test meals (n = 196) containing ferrous sulfate, ferrous fumarate, or ferric pyrophosphate, after which plasma hepcidin and iron bioavailability were measured."( Plasma hepcidin is a modest predictor of dietary iron bioavailability in humans, whereas oral iron loading, measured by stable-isotope appearance curves, increases plasma hepcidin.
Biebinger, R; Egli, I; Hurrell, RF; Troesch, B; Zeder, C; Zimmermann, MB, 2009
)
0.35
" Plasma hepcidin significantly, but modestly, predicted iron bioavailability from ferrous sulfate and ferrous fumarate (r = -0."( Plasma hepcidin is a modest predictor of dietary iron bioavailability in humans, whereas oral iron loading, measured by stable-isotope appearance curves, increases plasma hepcidin.
Biebinger, R; Egli, I; Hurrell, RF; Troesch, B; Zeder, C; Zimmermann, MB, 2009
)
0.35
"Plasma hepcidin is only a modest predictor of dietary iron bioavailability in humans."( Plasma hepcidin is a modest predictor of dietary iron bioavailability in humans, whereas oral iron loading, measured by stable-isotope appearance curves, increases plasma hepcidin.
Biebinger, R; Egli, I; Hurrell, RF; Troesch, B; Zeder, C; Zimmermann, MB, 2009
)
0.35
" We measured the bioavailability of Fe and Zn from Thriposha formula at two different molar ratios of Zn:Fe in order to determine the effect on Fe and Zn absorption."( Changing the zinc:iron ratio in a cereal-based nutritional supplement has no effect on percent absorption of iron and zinc in Sri Lankan children.
Abrams, SA; Griffin, I; Hettiarachchi, M; Hilmers, D; Liyanage, C, 2010
)
0.36
"The bioavailability of iron is critical for the usefulness of double-fortified salt."( Iron in vitro bioavailability and iodine storage stability in double-fortified salt.
Diosady, LL; Li, YO; Wesley, AS, 2009
)
0.35
" Iron in vivo tests in rats have confirmed that the ferrous fumarate microencapsulated in a lipid is highly bioavailable, with a bioavailability of 95% relative to ferrous sulfate."( Iron in vitro bioavailability and iodine storage stability in double-fortified salt.
Diosady, LL; Li, YO; Wesley, AS, 2009
)
0.35
" This recommendation is based on the compound's good sensory properties and on results from isotope studies in adults that reported similar iron absorption values for ferrous fumarate and ferrous sulphate (relative bioavailability [RBV] of ferrous fumarate, 100)."( Use of ferrous fumarate to fortify foods for infants and young children.
Hurrell, R, 2010
)
0.36
" Two recent studies in young children have reported that it is only 30% as well absorbed as ferrous sulfate."( A comparison of the bioavailability of ferrous fumarate and ferrous sulfate in non-anemic Mexican women and children consuming a sweetened maize and milk drink.
Harrington, M; Hotz, C; Hurrell, RF; Polvo, GO; Rivera, JA; Villalpando, S; Walczyk, T; Zeder, C; Zimmermann, MB, 2011
)
0.37
"Ferrous fumarate is as well absorbed as ferrous sulfate in non-anemic, iron sufficient infants and young children, and can be recommended as a useful fortification compound for complementary foods designed to prevent iron deficiency."( A comparison of the bioavailability of ferrous fumarate and ferrous sulfate in non-anemic Mexican women and children consuming a sweetened maize and milk drink.
Harrington, M; Hotz, C; Hurrell, RF; Polvo, GO; Rivera, JA; Villalpando, S; Walczyk, T; Zeder, C; Zimmermann, MB, 2011
)
0.37
" All iron premix formulations exhibited high particle density, good bioavailability and acceptable organoleptic properties."( Optimisation of polymer coating process for microencapsulating ferrous fumarate for salt double fortification with iodine and iron.
Diosady, LL; Olive Li, Y; Wesley, AS; Yadava, D, 2012
)
0.38
"A MNP containing a low dose of highly bioavailable iron reduces anaemia, and the addition of GOS mitigates most of the adverse effects of iron on the gut microbiome and morbidity in African infants."( Prebiotic galacto-oligosaccharides mitigate the adverse effects of iron fortification on the gut microbiome: a randomised controlled study in Kenyan infants.
Barth-Jaeggi, T; Boekhorst, J; Cercamondi, CI; Karanja, S; Kortman, GAM; Lacroix, C; Moretti, D; Paganini, D; Schwab, C; Timmerman, HM; Uyoga, MA; Zimmermann, MB, 2017
)
0.46
"Fe fortification of wheat flour was proposed in Haiti to combat Fe deficiency, but Fe bioavailability from fortificants has never been investigated in Haitian women or preschool children, two key target groups."( In Haitian women and preschool children, iron absorption from wheat flour-based meals fortified with sodium iron EDTA is higher than that from meals fortified with ferrous fumarate, and is not affected by Helicobacter pylori infection in children.
Eliancy, K; Herter-Aeberli, I; Loechl, CU; Marhône Pierre, J; Rathon, Y; Zimmermann, MB, 2017
)
0.46
" The above results show that Fe-Gly can improve the bioavailability and antioxidant capacity of iron and reduce the iron output of feces after enteric coating."( Influences of different Fe sources on Fe bioavailability and homeostasis in SD rats.
Fu, Z; Gong, S; Hu, H; Lin, Y; Shu, X; Wang, WX, 2019
)
0.51

Dosage Studied

Wheat flour and maize meal were sourced in Kenya, South Africa, and Tanzania. The iron compound (sodium iron ethylenediaminetetraacetate [NaFeEDTA], ferrous fumarate, or ferrous sulfate) was varied.

ExcerptRelevanceReference
" Half the donors received ferrous fumarate at a dosage of 66."( A laboratory report on iron supplementation in blood donors. I.
Camp, FR; Dedich, SN; Linville, A; Parrish, J; Tobias, KI; White, WD, 1981
)
0.26
" This study further shows that Chemiron has a better haematological effect than Ferrous Gluconate at the dosage used."( The effect of 61 days of combined iron (Chemiron) and single iron therapy on haemoglobin, packed cell volume, platelets and reticulocytes during pregnancy. Preliminary report.
Ajayi, GO; Fadiran, EO, 1998
)
0.3
" This study gives an estimate of iron dosage in individual iron prophylaxis adjusted to serum ferritin levels in early pregnancy."( Body iron and individual iron prophylaxis in pregnancy--should the iron dose be adjusted according to serum ferritin?
Bergholt, T; Byg, KE; Eriksen, L; Hvas, AM; Milman, N, 2006
)
0.33
"Wheat flour and maize meal were sourced in Kenya, South Africa, and Tanzania, and the iron compound (sodium iron ethylenediaminetetraacetate [NaFeEDTA], ferrous fumarate, or ferrous sulfate) was varied and dosed at rates according to the WHO guidelines for consumption of 75 to 149 g/day of wheat flour and > 300 g/day of maize meal and tested again for 150 to 300 g/day for both."( Fortification of wheat flour and maize meal with different iron compounds: results of a series of baking trials.
Johnson, Q; Randall, P; Verster, A, 2012
)
0.38
" The current recommended dosage for oral supplementation of 200 mg ferrous fumarate 3x per day however, is based on a single small study of poor quality."( [Iron supplementation in iron deficiency anaemia].
de Wit, HAJM; Kramers, K; Rennings, AJM; Swinkels, DW; van Heek, J, 2019
)
0.51
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (1)

ClassDescription
dicarboxylic acidAny carboxylic acid containing two carboxy 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]

Research

Studies (223)

TimeframeStudies, This Drug (%)All Drugs %
pre-199050 (22.42)18.7374
1990's33 (14.80)18.2507
2000's54 (24.22)29.6817
2010's62 (27.80)24.3611
2020's24 (10.76)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials92 (39.66%)5.53%
Reviews9 (3.88%)6.00%
Case Studies17 (7.33%)4.05%
Observational0 (0.00%)0.25%
Other114 (49.14%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (48)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase III, Randomized, Open-label, Active-controlled, Multicenter Trial to Study the Contraceptive Efficacy and Safety of the Commercial Batch of Oral Tablets of MK-8175A (Nomegestrol Acetate - 17ß-estradiol) in Healthy, Sexually-active Women Aged 18-50 [NCT01656434]Phase 33,173 participants (Actual)Interventional2012-11-02Terminated(stopped due to Business reasons)
The Effect of Prebiotics on Iron Absorption in Women With Low Iron Stores: Determination of a Dose-dependent Effect of Galacto-oligosaccharides on Iron Absorption, With and Without Addition of Ascorbic Acid [NCT03762148]46 participants (Actual)Interventional2019-04-01Completed
A Phase IV, Unicenter, Randomized, Double-Blind, Parallel-Group, Comparaty Study of Intravenous and Oral Iron vs Placebo in Patient Under Extracorporeal Circulation in Cardiovascular Surgery [NCT01078818]Phase 4159 participants (Actual)Interventional2007-05-31Completed
Lactoferrin Versus Ferrous Fumarate for Treatment of Mild to Moderate Iron Deficiency Anemia During Pregnancy [NCT03484845]Phase 1/Phase 2150 participants (Anticipated)Interventional2018-11-01Not yet recruiting
Effects of Iron and Zinc Supplementation on Neuropsychological and Educational Achievement in Lead-exposed School Children [NCT02346188]602 participants (Actual)Interventional2000-01-31Completed
Improving Efficacy and Safety of Oral Iron Supplementation in HIV-infected Children by Providing Prebiotic Galacto-oligosaccharides as Adjunct Treatment: A Randomized Controlled Trial [NCT04931641]100 participants (Anticipated)Interventional2021-08-01Recruiting
Iron Absorption From Wheat Flour in Haiti [NCT02096250]44 participants (Actual)Interventional2014-06-30Completed
A Study to Compare the Gastrointestinal Tolerability of Ferrochel®, Sumalate®,Ferrous Fumarate, Ferrous Sulfate, Ferric Glycinate, and Placebo [NCT02128971]Phase 2108 participants (Anticipated)Interventional2014-04-30Recruiting
[NCT02228902]Phase 424 participants (Actual)Interventional2014-08-31Completed
Thrice-weekly Versus Thrice-daily Oral Ferrous Fumarate Treatment in Adult Patients With Iron Deficiency Anemia [NCT04130828]Phase 366 participants (Actual)Interventional2020-01-21Completed
Health Economics of the Use of Ferrous Iron Salts in Primary Care in the UK. [NCT02300428]406,902 participants (Actual)Observational2014-11-30Completed
Effects Intravenous Iron and Oral Iron Therapy on Erythropoietin Dose in Maintenance Hemodialysis Patients: An Open-label, Randomized, Controlled Study [NCT04464850]Phase 3124 participants (Anticipated)Interventional2020-07-29Recruiting
South African Paediatric Surgical Outcomes Study-2 (SAPSOS-2). A South African Multi-centre Pilot Trial to Assess the Feasibility and Clinical Efficacy of Preoperative Oral Iron to Treat Preoperative Iron-deficiency Anaemia in Children Undergoing Elective [NCT05681871]Phase 2/Phase 3420 participants (Anticipated)Interventional2023-01-16Not yet recruiting
A Randomized, Open-Label, Active-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of Ferumoxytol Compared With Oral Iron for the Treatment of Iron Deficiency Anemia in Pediatric Subjects With Chronic Kidney Disease [NCT01155375]Phase 314 participants (Actual)Interventional2011-10-17Terminated(stopped due to Several factors contributed to significant challenges in enrollment and led the Sponsor to discontinue the AMAG-FER-CKD-251 study as designed.)
Effect of Prebiotics on Iron Absorption in Women With Low Iron Stores [NCT03325270]46 participants (Actual)Interventional2018-01-10Completed
Effect of Iron Status on Occurrence of Non-transferrin-bound Iron (NTBI) in Serum in Response to an Oral Iron Load [NCT02831712]50 participants (Anticipated)Interventional2013-04-30Active, not recruiting
Comparison Between Aminoacid Chelated Iron and Iron Salt in Treatment of Iron Deficiency Anemia With Pregnancy [NCT02005588]Early Phase 1150 participants (Actual)Interventional2013-12-31Completed
Preoperative, Single-dose Intravenous Iron Formulation to Reduce Post-surgical Complications in Patients Undergoing Major Abdominal Surgery: a Pilot Randomised Control Trial (PIRCAS Trial - Pilot) [NCT03295851]Phase 460 participants (Anticipated)Interventional2017-11-22Recruiting
Multicenter Randomized Controlled Trial Comparing Ferric(III)Carboxymaltose Infusion With Oral Iron Suppletion in the Treatment of Preoperative Anaemia in Colorectal Cancer Patients [NCT02243735]Phase 4198 participants (Anticipated)Interventional2014-11-30Recruiting
Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy: a Randomised, Comparative, Open-label Trial [NCT03188445]Phase 4201 participants (Actual)Interventional2017-07-11Completed
The Effect of Human Milk Oligosaccharides (HMOs) (2'-Fucosyllactose (2'-FL) and Lacto-N-neotetraose (LNnT)) and Galacto-oligosaccharides (GOS) on Iron Absorption From a Maize-based Porridge in Kenyan Infants [NCT04163406]55 participants (Actual)Interventional2019-11-21Completed
Breast Feeding and Iron: Comparison of Cereals Fortified With Different Forms of Iron [NCT00841061]111 participants (Actual)Interventional2003-07-31Completed
The Efficacy of Intermittent Versus Daily Oral Iron Supplementation in Anaemic Pregnant Women. [NCT05278793]Phase 458 participants (Anticipated)Interventional2022-01-07Recruiting
Investigation of the Physical and Psychosocial Status and Quality of Life of People With Meniere's Disease [NCT05844657]34 participants (Actual)Observational2023-05-15Completed
Determination of Iron Absorption Mechanism From Ferrous Fumarate With Galacto-oligosaccharides Using Stable Isotope Appearance Curves [NCT03996421]12 participants (Actual)Interventional2019-10-23Completed
Do Iron Supplements Impact the Gut Microbiome of Women of Reproductive Age? [NCT05033483]82 participants (Actual)Interventional2021-08-31Completed
Periconceptional Iron Supplementation on Iron and Folate Indicators Among Pregnant and Non-pregnant Women in Rural Bangladesh. [NCT00953134]Early Phase 1273 participants (Actual)Interventional2007-02-28Completed
The Usefulness of Ferrous Fumarate and Ferric Pyrophosphate as Food Fortificants in Developing Countries [NCT00867867]Phase 1235 participants (Actual)Interventional2003-10-31Completed
Post Operative Continuous Active Combination Sex Steroids for the Prevention of Recurrent Endometrioma Formation [NCT00999479]0 participants (Actual)Interventional2009-10-31Withdrawn(stopped due to Poor enrollment)
Evaluation of the Effects of Routine Iron Supplementation in Children on Gastrointestinal Iron Losses. [NCT04721964]24 participants (Actual)Interventional2021-02-25Completed
A Randomized Controlled Trial of Pre-Operative Treatment With Ferrous Fumarate 300 mg Once Daily Versus Placebo in Newly Diagnoses Gynecologic Oncology Patients Who Are Primary Surgical Candidates. [NCT01953107]Phase 4200 participants (Anticipated)Interventional2013-11-30Completed
A Randomized, Open-Label, Active-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of Ferumoxytol Compared With Oral Iron for the Treatment of Iron Deficiency Anemia in Pediatric Subjects With Nondialysis-dependent Chronic Kidney Disease [NCT01155388]Phase 314 participants (Actual)Interventional2011-10-17Terminated(stopped due to Several factors contributed to significant challenges in enrollment and led the Sponsor to discontinue the AMAG-FER-CKD-252 study as designed.)
[NCT02271997]Phase 4120 participants (Actual)Interventional2014-12-04Completed
Autologous-Allogeneic Tandem Stem Cell Transplantation and Maintenance Therapy With Thalidomide/ DLI for Patients With Multiple Myeloma (MM) and Age < _60 Years: A Phase II-study [NCT00777998]Phase 2221 participants (Actual)Interventional2008-10-14Completed
Total Dose Infusion of Iron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant Women: a Randomized Controlled Trial [NCT03212781]Phase 366 participants (Actual)Interventional2016-06-30Completed
Amino Acid Chelated Iron Versus Ferrous Fumarate in the Treatment of Iron Deficiency Anemia With Pregnancy: Randomized Controlled Trial [NCT03830034]Phase 4150 participants (Anticipated)Interventional2019-02-02Recruiting
Adherence With Iron Sprinkles Among High-Risk Infants [NCT00136266]Phase 3128 participants (Actual)Interventional2005-03-31Completed
The Value of Iron Treatment for Postoperative Obstetric Patients With Anemia: a Randomized Double Blind Controlled Trial [NCT01975272]Phase 427 participants (Actual)Interventional2015-03-02Terminated(stopped due to Disapointing randomization rate)
A Phase I, Open Label, Randomized, Four-Period Crossover Study to Evaluate the Effects of Calcium Carbonate 1200 mg and Ferrous Fumarate 324 mg on Pharmacokinetics of Dolutegravir 50 mg in Healthy Adult Subjects [NCT01762995]Phase 124 participants (Actual)Interventional2012-12-31Completed
Evaluating the National Fortification Policy in Senegal Assessment of Iron Bio-availability in Mother and Child Pairs From Wheat Flour Fortified With Iron With and Without Phenolic Containing Beverages [NCT02437955]34 participants (Actual)Interventional2015-04-30Completed
Predicting Response to Iron Supplementation in Patients With Active Inflammatory Bowel Disease [NCT05456932]Phase 490 participants (Anticipated)Interventional2022-08-19Recruiting
Ovulation Incidence in Oral Contraceptive Users [NCT03106454]Phase 358 participants (Anticipated)Interventional2014-08-31Suspended(stopped due to Investigator leave of absence)
The Pediatric Artificial Pancreas (PEDAP) Trial: A Randomized Controlled Comparison of the Control-IQ Technology Versus Standard of Care in Young Children in Type 1 Diabetes [NCT04796779]102 participants (Actual)Interventional2021-04-21Completed
Oral Versus Intravenous Iron in IBD Patients With Anti-inflammatory Therapy [NCT05581420]152 participants (Anticipated)Interventional2022-06-02Recruiting
The Effect of Single Dose Oral Galacto-oligosaccharides, Fructo-oligosaccharides and Acacia Gum on Iron Absorption From Single 100 mg Oral Iron Doses Given as Ferrous Fumarate in Women Living in Switzerland [NCT04194255]30 participants (Actual)Interventional2020-07-20Completed
Efficacy and Adverse Side Effects of Two Forms of Iron in Prenatal Micronutrient Supplements (EASE-Iron): A Randomized Controlled Trial [NCT06014983]208 participants (Anticipated)Interventional2023-10-31Not yet recruiting
Iron Bisglycinate Chelate or Ferrous Fumarate in Treatment of Iron Deficiency Anemia in Pregnant Women [NCT03378791]Phase 3120 participants (Actual)Interventional2015-12-31Completed
Comparison of the Rate of Preoperative Haemoglobin After Administration of Epoetin Alpha Associated With an Oral Medical Supplementation Versus Intravenous Before Surgery of Craniosynostosis at the Child [NCT03231085]100 participants (Anticipated)Interventional2017-10-31Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT01656434 (3) [back to overview]Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event
NCT01656434 (3) [back to overview]Percentage of Participants Who Experienced At Least One Adverse Event
NCT01656434 (3) [back to overview]Change From Baseline in Body Weight
NCT01975272 (3) [back to overview]Hemoglobin
NCT01975272 (3) [back to overview]Serum Ferritin
NCT01975272 (3) [back to overview]Serum Hepcidin
NCT04796779 (6) [back to overview]CGM-measured Mean Glucose
NCT04796779 (6) [back to overview]CGM-measured Percent Above 250 mg/dL
NCT04796779 (6) [back to overview]CGM-measured Percent Below 54 mg/dL
NCT04796779 (6) [back to overview]CGM-measured Percent Below 70 mg/dL
NCT04796779 (6) [back to overview]HbA1c at 13 Weeks
NCT04796779 (6) [back to overview]Time in Range

Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event

(NCT01656434)
Timeframe: Up to 54 weeks

InterventionParticipants (Number)
NOMAC-E20
NETA-EE1

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Percentage of Participants Who Experienced At Least One Adverse Event

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. (NCT01656434)
Timeframe: Up to 54 weeks

InterventionPercentage of Participants (Number)
NOMAC-E241.2
NETA-EE45.2

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Change From Baseline in Body Weight

Participants' body weights were measured in a consistent manner throughout the trial, using standardized equirpment. Last In-Treatment Measurement refers to a participant's end of trial visit, the timing of which differed among participants. (NCT01656434)
Timeframe: Baseline and Week 52

,
Interventionkilograms (Mean)
After Cycle 3 (n=2135; n=527)After Cycle 6 (n=1809; n=459)After Cycle 9 (n=1468; n=391)After Cycle 13 (n=462; n=145)Last In-Treatment Measurement (n=2231; n=549)
NETA-EE0.410.290.320.900.75
NOMAC-E20.140.641.211.571.39

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Hemoglobin

Serum hemoglobin level (NCT01975272)
Timeframe: 3 weeks postoperative

Interventionmmol/L (Mean)
Ferinject8.4
Ferrous Fumarate7.9
Placebo Infusion and Tablets7.1

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Serum Ferritin

Serum levels of ferritin (NCT01975272)
Timeframe: 3 weeks postoperative

Interventionmicrogram/L (Mean)
Ferinject422
Ferrous Fumarate57
Placebo Infusion and Tablets37

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Serum Hepcidin

Serum hepcidin level (NCT01975272)
Timeframe: 3 weeks postoperative

Interventionnmol/L (Mean)
Ferinject11.6
Ferrous Fumarate2.2
Placebo Infusion and Tablets1.7

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CGM-measured Mean Glucose

Average glucose value measured by CGM (NCT04796779)
Timeframe: 13 weeks

,
Interventionmg/dL (Mean)
BaselineWeek 13
CLC Group173155
SC Group176174

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CGM-measured Percent Above 250 mg/dL

Percentage of time with a glucose above 250 mg/dL as measured by CGM (NCT04796779)
Timeframe: 13 weeks

,
InterventionPercent of time (Mean)
BaselineWeek 13
CLC Group14.88.4
SC Group16.015.0

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CGM-measured Percent Below 54 mg/dL

Percentage of time with glucose below 54 mg/dL as measured by CGM (NCT04796779)
Timeframe: 13 weeks

,
InterventionPercent of time (Mean)
BaselineWeek 13
CLC Group0.60.6
SC Group0.50.5

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CGM-measured Percent Below 70 mg/dL

Percentage of time with glucose below 70 mg/dL as measured by CGM (NCT04796779)
Timeframe: 13 weeks

,
InterventionPercent of time (Mean)
BaselineWeek 13
CLC Group3.03.0
SC Group2.73.0

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HbA1c at 13 Weeks

HbA1c at 13 weeks (NCT04796779)
Timeframe: 13 weeks

,
InterventionPercentage of glycosylated hemoglobin (Mean)
BaselineWeek 13
CLC Group7.57.0
SC Group7.77.5

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Time in Range

Time in range is the amount of time spent in the target glucose range-between 70 and 180 mg/dL-as measured by CGM (NCT04796779)
Timeframe: 13 weeks

,
InterventionPercent of time (Mean)
BaselineWeek 13
CLC Group56.769.3
SC Group54.955.9

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