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Original Investigation
September 4, 2013

Effect of Iron Fortification on Malaria Incidence in Infants and Young Children in Ghana: A Randomized Trial

Author Affiliations
  • 1Global Child Health, Hospital for Sick Children, Toronto, Ontario, Canada
  • 2Kintampo Health Research Centre, Kintampo, Ghana
  • 3Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada
  • 4Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada
  • 5Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada
  • 6Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada
JAMA. 2013;310(9):938-947. doi:10.1001/jama.2013.277129

Importance  In sub-Saharan Africa, malaria is a leading cause of childhood morbidity and iron deficiency is among the most prevalent nutritional deficiencies. In 2006, the World Health Organization and the United Nations Children’s Fund released a joint statement that recommended limiting use of iron supplements (tablets or liquids) among children in malaria-endemic areas because of concern about increased malaria risk. As a result, anemia control programs were either not initiated or stopped in these areas.

Objective  To determine the effect of providing a micronutrient powder (MNP) with or without iron on the incidence of malaria among children living in a high malaria-burden area.

Design, Setting, and Participants  Double-blind, cluster randomized trial of children aged 6 to 35 months (n = 1958 living in 1552 clusters) conducted over 6 months in 2010 in a rural community setting in central Ghana, West Africa. A cluster was defined as a compound including 1 or more households. Children were excluded if iron supplement use occurred within the past 6 months, they had severe anemia (hemoglobin level <7 g/dL), or severe wasting (weight-for-length z score <−3).

Interventions  Children were randomized by cluster to receive a MNP with iron (iron group; 12.5 mg/d of iron) or without iron (no iron group). The MNP with and without iron were added to semiliquid home-prepared foods daily for 5 months followed by 1-month of further monitoring. Insecticide-treated bed nets were provided at enrollment, as well as malaria treatment when indicated.

Main Outcomes and Measures  Malaria episodes in the iron group compared with the no iron group during the 5-month intervention period.

Results  In intention-to-treat analyses, malaria incidence overall was significantly lower in the iron group compared with the no iron group (76.1 and 86.1 episodes/100 child-years, respectively; risk ratio (RR), 0.87 [95% CI, 0.79-0.97]), and during the intervention period (79.4 and 90.7 episodes/100 child-years, respectively; RR, 0.87 [95% CI, 0.78-0.96]). In secondary analyses, these differences were no longer statistically significant after adjusting for baseline iron deficiency and anemia status overall (adjusted RR, 0.87; 95% CI, 0.75-1.01) and during the intervention period (adjusted RR, 0.86; 95% CI, 0.74-1.00).

Conclusion and Relevance  In a malaria-endemic setting in which insecticide-treated bed nets were provided and appropriate malaria treatment was available, daily use of a MNP with iron did not result in an increased incidence of malaria among young children.

Trial Registration  clinicaltrials.gov Identifier: NCT01001871