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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04017598
Other study ID # H18-02610
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 10, 2019
Est. completion date December 1, 2023

Study information

Verified date May 2024
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 480
Est. completion date December 1, 2023
Est. primary completion date May 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - apparently healthy - consent to participate in the study and provide blood, flocked rectal swab and stool samples - expected to reside in the study location for the study period. Exclusion Criteria: - any known illness or disease - pregnant - taking antibiotics, non-steroidal anti-inflammatory drugs, dietary supplements, or vitamin and mineral supplements in the previous 12 weeks.

Study Design


Intervention

Dietary Supplement:
Ferrous sulfate
60 mg elemental iron as ferrous sulfate
Ferrous Bisglycinate
18 mg elemental iron as ferrous bisglycinate
Placebo of microcrystalline cellulose
placebo

Locations

Country Name City State
Cambodia Prey Kuy, Srayov and Tboung Krapeu Health Centres Kampong Thom

Sponsors (5)

Lead Sponsor Collaborator
University of British Columbia BC Children's Hospital Research Institute, Helen Keller International, NCHADS - Ministry of Health of Cambodia, The National Institute of Public Health Laboratory, Phnom Penh

Country where clinical trial is conducted

Cambodia, 

Outcome

Type Measure Description Time frame Safety issue
Other Reported side effects (e.g., gastrointestinal pain) as a quality of life measure. Continuous over 12 weeks
Other Genetic hemoglobinopathies Genotyping to detect the presence of the most common hemoglobinopathies Baseline
Other 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). 12 weeks
Primary Serum Ferritin Serum ferritin concentration (µg/l) at 12 weeks 12 weeks
Primary Fecal calprotectin Fecal calprotectin concentration (mg/kg stool) at 12 weeks as a measure of gut inflammation. 12 weeks
Secondary Gut pathogen abundance Real-time PCR nucleic acid amplification assay with an enteric bacterial panel. 12 weeks
Secondary Gut parasite abundance Real-time PCR nucleic acid amplification assay with an enteric parasite panel. 12 weeks
Secondary 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). 12 weeks
Secondary Alpha-1 acid glycoprotein (AGP, g/l) 12 weeks
Secondary C-reactive protein (CRP, mg/l) 12 weeks
Secondary Hemoglobin (g/L) 12 weeks
Secondary Folate (ng/ml) 12 weeks
Secondary Vitamin B12 (pmol/l) 12 weeks
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