Effi cacy of iron-fortifi ed whole maize fl our on iron status of schoolchildren in Kenya: a randomised controlled trial

Background Sodium iron edetic acid (NaFeEDTA) might be a more bioavailable source of iron than electrolytic iron, when added to maize fl our. We aimed to assess the eff ect, on children’s iron status, of consumption of whole maize fl our fortifi ed with iron as NaFeEDTA or electrolytic iron. Methods 516 children, aged 3–8 years, from four schools in Marafa, Kenya, were randomly assigned to four groups. All were given the same amount of porridge fi ve times a week. The porridge for one group was made from unfortifi ed whole maize fl our; for the other three groups it was fortifi ed with either high-dose NaFeEDTA (56 mg/kg), low-dose NaFeEDTA (28 mg/kg), or electrolytic iron (56 mg/kg). Concentrations of haemoglobin, plasma ferritin, and transferrin receptor were analysed in samples taken at baseline and at the end of the 5-month intervention. The primary outcome was iron-defi ciency anaemia. We analysed data on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT00386074. Findings The prevalence of iron-defi ciency anaemia in children given unfortifi ed fl our was 10%. Compared with placebo, the prevalence of iron-defi ciency anaemia in children given fl our fortifi ed with high-dose NaFeEDTA, low-dose NaFeEDTA, and electrolytic iron changed by −89 % (95 % CI −97 % to −49%), −48 % (−77 % to 20%), and 59% (−18 % to 209%), respectively. Consumption of high-dose NaFeEDTA improved all measured iron-status indicators. Low-dose NaFeEDTA decreased the prevalence of iron defi ciency but did not noticeably change the prevalence o