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.