Benefits and Risks of Iron Interventions in Infants in Rural Bangladesh.
Study Goal
The researchers aimed to assess the immediate and medium-term benefits and risks of daily iron syrup or iron-containing multiple micronutrient powders compared to placebo in 8-month-old children in rural Bangladesh, focusing on cognitive development and other functional outcomes.
Results Summary
The study found no apparent effect of iron syrup or multiple micronutrient powders on cognitive development, behavioral, language, motor development, or growth outcomes compared to placebo. While anemia and iron deficiency increased in all groups over time, they remained lower in the iron-supplemented groups than in the placebo group, with no significant differences in serious adverse events or infection symptoms.
Population
8-month-old children in rural Bangladesh.
Effective Dosage
Daily supplementation (exact dosage not specified in the abstract).
Duration
3 months.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
iron syrup | no change | cognitive composite score | 8-month-old children in rural Bangladesh | mean between-group difference in change in score from baseline, -0.30 points; 95% confidence interval [CI], -1.08 to 0.48 | no apparent effect | #1 |
multiple micronutrient powders | no change | cognitive composite score | 8-month-old children in rural Bangladesh | mean between-group difference in change in score from baseline, 0.23 points; 95% CI, -0.55 to 1.00 | no apparent effect | #2 |
iron syrup | no change | any other developmental or growth outcome | 8-month-old children in rural Bangladesh | - | no apparent effect | #3 |
multiple micronutrient powders | no change | any other developmental or growth outcome | 8-month-old children in rural Bangladesh | - | no apparent effect | #4 |
iron syrup | decrease | prevalences of anemia, iron deficiency, and iron deficiency anemia | children who received iron syrup | - | remained lower | #5 |
multiple micronutrient powders | decrease | prevalences of anemia, iron deficiency, and iron deficiency anemia | children who received multiple micronutrient powders | - | remained lower | #6 |
iron syrup | no change | risk of serious adverse events and incidence of symptoms of infection | children who received iron syrup | - | similar | #7 |
multiple micronutrient powders | no change | risk of serious adverse events and incidence of symptoms of infection | children who received multiple micronutrient powders | - | similar | #8 |
iron syrup | no change | child development or other functional outcomes | infants in Bangladesh | - | did not appear to have an effect | #9 |
multiple micronutrient powders | no change | child development or other functional outcomes | infants in Bangladesh | - | did not appear to have an effect | #10 |
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. (Funded by the National Health and Medical Research Council of Australia; BRISC Australian New Zealand Clinical Trials Registry number, ACTRN12617000660381.).