Enhancing brain development by early iron supplementation of African infants: An enabling pilot study
Medical Research Council
London School of Hygiene and Tropical Medicine
Growth and organisation of the human brain is maximally active in late fetal life and early infancy. Breast milk contains very little iron and babies born to iron deficient mothers lack the full endowment of hepatic iron that usually subsidises the needs for growth and brain development in early infancy. We have recently shown that, by 5m of age, breastfed infants in rural Africa have extremely low levels of circulating iron with 95% lying below the US reference range. There is extensive evidence from human and animal studies that early iron deficiency causes irreversible deficits in psychomotor development and cognition. Hence, we plan to conduct a large-scale RCT that will introduce iron supplements much earlier than in prior and on-going trials. To inform a go/no go decision and to refine the trial design we first need to conduct an enabling trial that will address the following key questions: Can provision of a daily iron supplement as paediatric drops starting at 6wks of age reverse the profound decline in serum iron and other measures of iron status seen in rural African infants? Can we introduce supplementary iron without undermining exclusive breast-feeding? Would iron supplementation at this age alter the infant gut microbiome potentially causing diarrhoea? Does iron supplementation (through competition for divalent metal transport systems) impair zinc and/or copper status; and hence indicate a need for triple supplementation? These questions will be addressed in a pilot 'experimental medicine' two-arm RCT comparing daily iron versus placebo in 100 rural Gambian infants receiving intervention or placebo from 6wk to 5m.
4.1 Discovery and preclinical testing of markers and technologies / Research Grant