A Phase 4 interventional study of Ferrous sulfate and Ferrous Bisglycinate in Anemia, Iron Deficiency, Anemia and Intestinal Inflammation, sponsored by University of British Columbia. Completed at 1 site in Cambodia. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by University of British Columbia · Phase 4, Interventional, and Treatment
In 2016, the World Health Organization (WHO) set a global policy recommending daily oral iron supplementation (60 mg iron) for 12 weeks for all women living in countries where anemia prevalence is >40%, such as in Cambodia. However, recent studies have shown the prevalence of iron deficiency to be low in Cambodian women and that supplementation would likely only benefit \~10% of women.
Iron supplementation may be harmful in women with genetic blood disorders (e.g. thalassemia), which are common in Cambodia, as these individuals are already at an increased risk of iron overload. The risks are made greater by the fact that iron absorption from most common form of supplementation, ferrous sulfate, is low. Typically less than 20% is absorbed in the gut; the remaining 80% passes unabsorbed into the colon where it can increase the risk of pathogen growth and gut inflammation. Alternatively, ferrous bisglycinate is a newer supplemental form of iron. This amino acid chelate has 2-4x higher bioavailability than ferrous sulfate and is associated with fewer GI side-effects.
In view of WHO policy and risks of supplementation, there is a need to determine the potential for harm, and if novel forms of iron supplements are safer.
The World Health Organization (WHO) set a Global Nutrition Target to reduce anemia in women of reproductive age by 50% by 2025. In 2016, the WHO implemented a global policy recommending oral iron supplementation (60 mg daily for 12 weeks) for all women where anemia prevalence is more than 40%, such as in Cambodia.
However, recent studies have shown the prevalence of iron deficiency to be low in Cambodian women. If iron deficiency is not the cause of anemia, then iron supplementation will not be effective at treating it. Further, iron supplementation may be harmful in some individuals, especially those with anemia caused by genetic blood disorders (which are common in Cambodia), as these individuals are already at an increased risk of iron overload. The risks are made greater by the fact that the type of iron that is commonly used in supplements (ferrous sulfate) is poorly absorbed. Typically, less than 20% is absorbed in the gut; the remaining 80% is unabsorbed in the colon where it can increase the risk of pathogen growth and gut inflammation.
To investigate the safety of untargeted iron supplementation, we will undertake a new study in Cambodia, where we will evaluate a newer type of iron supplement that may be absorbed better, and thus, safer than the conventional type. We will recruit non-pregnant women (18-45 years) and ask them to take one of the two forms of iron (ferrous sulfate or ferrous bisglycinate) or a placebo for 12 weeks (in line with the WHO global policy). We will measure hemoglobin and ferritin levels, which are markers of anemia and iron status, and markers of gut inflammation and gut pathogen abundance, before and after the intervention. This study will contribute to the evidence for safe and effective iron supplementation for women worldwide.
660 studies on the registry are indexed under Anemia, Iron-Deficiency; 106 are open to participants now.
This study's enrollment of 480 is above the median of 100 across 515 interventional studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →University of British Columbia is the lead sponsor of 1,335 studies on the registry; 256 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
Iron will be given orally in the form of tablets. A supplement of 60 mg will be taken daily for 12 weeks. World Health Organization standard dose and commonly used form of iron.
Dietary Supplement: Ferrous sulfate
Iron will be given orally in the form of tablets. A supplement of 18 mg will be taken daily for 12 weeks. Ferrous bisglycinate has a bioavailability 2-4x greater than ferrous sulfate.
Dietary Supplement: Ferrous Bisglycinate
Placebo will be given orally in the form of tablets as a control made of microcrystalline cellulose.
Dietary Supplement: Placebo of microcrystalline cellulose
60 mg elemental iron as ferrous sulfate
Also known as: iron sulfate, ferrous sulphate, iron sulphate, Iron(II) sulfate
18 mg elemental iron as ferrous bisglycinate
Also known as: iron amino acid chelate, Iron glycinate, Bisglycine iron(II) salt, Iron(II) bisglycinate, Ferrous Bis-glycinate
placebo
Also known as: Control
Serum Ferritin
Serum ferritin concentration (µg/l) at 12 weeks
Time frame: 12 weeks
Fecal calprotectin
Fecal calprotectin concentration (mg/kg stool) at 12 weeks as a measure of gut inflammation.
Time frame: 12 weeks
Gut pathogen abundance
Real-time PCR nucleic acid amplification assay with an enteric bacterial panel.
Time frame: 12 weeks
Gut parasite abundance
Real-time PCR nucleic acid amplification assay with an enteric parasite panel.
Time frame: 12 weeks
DNA damage
DNA damage will be assessed by measuring DNA single-strand breaks, indicated by olive tail movement with use of alkali single-cell gel electrophoresis (Comet assay).
Time frame: 12 weeks
Alpha-1 acid glycoprotein (AGP, g/l)
Time frame: 12 weeks
C-reactive protein (CRP, mg/l)
Time frame: 12 weeks
Hemoglobin (g/L)
Time frame: 12 weeks
Folate (ng/ml)
Time frame: 12 weeks
Vitamin B12 (pmol/l)
Time frame: 12 weeks
Reported side effects
(e.g., gastrointestinal pain) as a quality of life measure.
Time frame: Continuous over 12 weeks
Genetic hemoglobinopathies
Genotyping to detect the presence of the most common hemoglobinopathies
Time frame: Baseline
Gut Pathogen abundance
Whole metagenome shotgun 16S ribosomal RNA sequencing will be conducted on fecal samples, in order to validate the method against the established BD MAX panel in a subset of 150 women from our trial (50 from each study arm).
Time frame: 12 weeks
Plan to share: No — There is not a plan to make IPD available.
Ran from Dec 2019 to primary completion in May 2020, 5 months.
Of 50 non-industry phase 4 interventional studies under Anemia, Iron-Deficiency, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 51. This study's 5 months is below that.
Counting every sponsor, half of 61 studies reached it within 24 months; a quarter within 17 and three quarters within 35.
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ferrous bisglycinate
University of British Columbia →