• Sant-Rayn Pasricha, M Imrul Hasan, Sabine Braat, Leila M Larson, S M Mulk-Uddin Tipu, Sheikh J Hossain, Shamima Shiraji, Andrew Baldi, Mohammad S A Bhuiyan, Fahmida Tofail, Jane Fisher, Sally Grantham-McGregor, Julie A Simpson, Jena D Hamadani, and Beverley-Ann Biggs.
• From the Population Health and Immunity Division, Walter and Eliza Hall Institute of Medical Research (S.-R.P., S.B., L.M.L., A.B.), Diagnostic Haematology, Royal Melbourne Hospital (S.-R.P.), Clinical Haematology, Peter MacCallum Cancer Centre and Royal Melbourne Hospital (S.-R.P.), the Department of Medical Biology (S.-R.P., A.B.), the Departments of Medicine and Infectious Diseases, Peter Doherty Institute for Infection and Immunity (S.B., L.M.L., B.-A.B.), and the Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health (S.B., J.A.S.), University of Melbourne, and the Victorian Infectious Diseases Service, Royal Melbourne Hospital (B.-A.B.), Parkville, VIC, and the Department of Public Health and Preventive Medicine, Monash University, Melbourne, VIC (J.F.) - all in Australia; the International Center for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh (M.I.H., S.M.M.U.T., S.J.H., S.S., M.S.A.B., F.T., J.D.H.); the Department of Health Promotion, Education and Behavior, Arnold School of Public Health, University of South Carolina, Columbia (L.M.L.); and the Institute of Child Health, University College London, London (S.G.-M.).
• N. Engl. J. Med. 2021 Sep 9; 385 (11): 982-995.

BackgroundUniversal provision of iron supplements (drops or syrup) or multiple micronutrient powders to young children in low-to-middle-income countries where anemia is prevalent is recommended by the World Health Organization and widely implemented. The functional benefits and safety of these interventions are unclear.MethodsWe conducted a three-group, double-blind, double-dummy, individually randomized, placebo-controlled trial to assess the immediate and medium-term benefits and risks of 3 months of daily supplementation with iron syrup or iron-containing multiple micronutrient powders, as compared with placebo, in 8-month-old children in rural Bangladesh. The primary outcome was cognitive development, as assessed by the cognitive composite score on the Bayley Scales of Infant and Toddler Development, third edition, immediately after completion of the assigned 3-month regimen; scores range from 55 to 145, with higher scores indicating better cognitive performance. Secondary outcomes included the cognitive composite score at 9 months after completion of the assigned regimen; behavioral, language, and motor development, as well as growth and hematologic markers, immediately after completion and at 9 months after completion; and safety.ResultsWe randomly assigned 3300 infants to receive iron syrup (1101 infants), multiple micronutrient powders (1099), or placebo (1100) daily. After completion of the assigned 3-month regimen, no apparent effect on the cognitive composite score was observed with iron syrup as compared with placebo (mean between-group difference in change in score from baseline, -0.30 points; 95% confidence interval [CI], -1.08 to 0.48) or with multiple micronutrient powders as compared with placebo (mean between-group difference in change in score from baseline, 0.23 points; 95% CI, -0.55 to 1.00). No apparent effect on any other developmental or growth outcome was observed immediately after completion of the assigned regimen or at 9 months after completion. At 9 months after completion of the assigned regimen, the prevalences of anemia, iron deficiency, and iron deficiency anemia increased in all three trial groups but remained lower among the children who received iron syrup or multiple micronutrient powders than among those who received placebo. The risk of serious adverse events and incidence of symptoms of infection were similar in the three trial groups.ConclusionsIn this trial involving infants in Bangladesh, 3 months of daily supplementation with iron syrup or multiple micronutrient powders did not appear to have an effect on child development or other functional outcomes as compared with placebo. (Funded by the National Health and Medical Research Council of Australia; BRISC Australian New Zealand Clinical Trials Registry number, ACTRN12617000660381.).Copyright © 2021 Massachusetts Medical Society.

21 keywords...

hide…