Benefits and risks of iron interventions in infants in rural Bangladesh

Pasricha, SR; Hasan, MI; Braat, S; Larson, LM; Tipu, SMM; Hossain, SJ; Shiraji, S; Baldi, A; Bhuiyan, MSA; Tofail, F; Fisher, J; Grantham-McGregor, S; Simpson, JA; Hamadani, JD; Biggs, BA

Author(s): Pasricha, SR; Hasan, MI; Braat, S; Larson, LM; Tipu, SMM; Hossain, SJ; Shiraji, S; Baldi, A; Bhuiyan, MSA; Tofail, F; Fisher, J; Grantham-McGregor, S; Simpson, JA; Hamadani, JD; Biggs, BA;
Details: Publication Year 2021-09-09,Volume 385,Issue #11,Page 982-995
Journal Title: New England Journal of Medicine
Abstract: BACKGROUND: Universal 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. METHODS: We 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. RESULTS: We 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. CONCLUSIONS: In 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.
Research Division(s): Population Health And Immunity
PubMed ID: 34496174
Publisher's Version: https://doi.org/10.1056/NEJMoa2034187
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2021-09-17 11:23:23

Last Modified: 2021-09-17 11:57:26