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Evaluating the effect of 12 weeks of supplementation with ferrous sulfate, ferrous bisglycinate or placebo, on iron status and gut inflammation in Cambodian women

University of British Columbia

The WHO recommends 12 weeks daily iron supplementation for women in countries where anemia prevalence is ≥40%, such as in Cambodia. However, if iron deficiency is not a major cause of anemia, then, at best, untargeted iron supplementation is a waste of resources; at worst, it could cause harm. My aim was to assess the non-inferiority of 12 weeks of ferrous sulfate and ferrous bisglycinate supplementation on ferritin concentrations and the effect on gut inflammation concentrations in Cambodian women, as compared to placebo. A double-blind, three-arm, randomized controlled trial was conducted in Kampong Thom province, Cambodia. Non-pregnant women (n=480, 18-45 years) were randomized to receive 60 mg ferrous sulfate, 18 mg ferrous bisglycinate, or placebo. Non-fasting blood and stool samples were collected at baseline and 12 weeks. Ferritin was measured with an ELISA, and values were adjusted for inflammation. Fecal calprotectin was measured as an indicator of gut inflammation with use of an ELISA kit (BÜHLMANN fCAL®). Mixed-effects generalized linear models were used to assess the effect of the two iron interventions on ferritin and fecal calprotectin concentration at 12 weeks, as compared to placebo. A total of 480 women were enrolled with 88% (n=421) trial retention at 12 weeks. Our non-inferiority analysis was inconclusive to determine if ferrous bisglycinate was non-inferior to ferrous sulfate, as the CI for our predicted mean difference in ferritin concentrations between the two iron interventions crossed our ‘a priori’ defined margin of non-inferiority (20 μg/L). In a secondary analysis with use of a superiority approach, mean ferritin concentration at 12 weeks was significantly higher in the ferrous sulfate group (98.6 [94.7,102.6] µg/L, P<0.001) than in the ferrous bisglycinate (84.0 [79.9, 88.2] µg/L) and placebo groups (77.8 [73.9, 81.7] µg/L). No differences in fecal calprotectin were detected across groups at 12 weeks. We were unable to establish non-inferiority between the two iron interventions; however, we did confirm that 12 weeks of 60 mg ferrous sulfate significantly increased serum ferritin concentrations as compared to 18 mg ferrous bisglycinate or placebo with no differences in gut inflammation across groups in this population of predominantly iron-replete, non-anemic women.

Text

2022-04-30

Attribution-NonCommercial-NoDerivatives 4.0 International

http://hdl.handle.net/2429/77899

Human Nutrition

University of British Columbia

UBCV

http://creativecommons.org/licenses/by-nc-nd/4.0/