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

Abstract

To investigate the effect of daily iron supplementation for 14weeks on the serum iron concentration and other markers of iron status in exclusively breastfed infants in Gambia. A placebo-controlled, randomized, double-blind trial was performed in rural Gambia between 3August 2021 and 9March 2022. Overall, 101 healthy, exclusively breastfed infants aged 6 to 10weeks were recruited at vaccination clinics and through community health workers. Infants were randomized to receive iron supplementation (7.5mg/day as ferrous sulfate in sorbitol solution) or placebo for 98days. Venous blood samples were collected at baseline and on day99 to assess the serum iron concentration and other markers of iron and haematological status. At day99, the serum iron concentration was significantly higher in the iron supplementation group than the placebo group (crude difference in means: 2.5µmol/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. In exclusively breastfed Gambian infants, iron supplementation from 6weeks of age was associated with a significant improvement in markers of iron status at around 6months of age. There was no indication of adverse effects on growth or infections.