Early iron supplementation in exclusively breastfed Gambian infants: a randomized controlled trial

Abstract

Objective To investigate the effect of daily iron supplementation for 14 weeks on the serum iron concentration and other markers of iron status in exclusively breastfed infants in Gambia. Methods A placebo-controlled, randomized, double-blind trial was performed in rural Gambia between 3 August 2021 and 9 March 2022. Overall, 101 healthy, exclusively breastfed infants aged 6 to 10 weeks were recruited at vaccination clinics and through community health workers. Infants were randomized to receive iron supplementation (7.5 mg/day as ferrous sulfate in sorbitol solution) or placebo for 98 days. Venous blood samples were collected at baseline and on day 99 to assess the serum iron concentration and other markers of iron and haematological status. Findings At day 99, the serum iron concentration was significantly higher in the iron supplementation group than the placebo group (crude difference in means: 2.5 µmol/L; 95% confidence interval: 0.6 to 4.3) and there were significant improvements in other iron and haematological markers. There were 10 serious adverse events (five in each group), 106 non-serious adverse events (54 with iron supplementation; 52 with placebo) and no deaths. There was no marked difference between the groups in maternally reported episodes of diarrhoea, fever, cough, skin infection, eye infection or nasal discharge. Conclusion In exclusively breastfed Gambian infants, iron supplementation from 6 weeks of age was associated with a significant improvement in markers of iron status at around 6 months of age. There was no indication of adverse effects on growth or infections.

Haem iron versus ferrous iron salts to treat iron deficiency anaemia in Gambian children: protocol for randomised controlled trial {1}

“…Therefore, if proven efficacious and safe, the implications of this research could extend beyond individual health benefits potentially leading to policy changes. Although daily supplementation for 84 days presents a potential adherence challenge, we can draw confidence from the high adherence rates reported in our previous trial conducted in the same study location [16]. To further enhance adherence, we will implement the following strategies:…”

“…This study will be exclusively conducted in rural Gambia, where the Medical Research Council Unit The Gambia (MRCG) has been actively involved for several years. Building upon the successful completion of another iron supplement study in the same area [16], which enjoyed high participation rates, we have established a strong relationship with the local population. Recognising the significant contributions made by the Gambian people to medical science in general and to our nutritional studies and considering the direct relevance of this study's findings to them, we have made a commitment to prioritise our public engagement efforts locally.…”