Background: Anemia during infancy impairs neurodevelopment. Little information has been published about the effectiveness of large-scale programs on anemia and iron-deficiency prevention.
Objective: The objective was to assess the effectiveness of a large-scale program that distributes subsidized iron-fortified milk in Mexico on anemia and iron deficiency in children aged 12-30 mo.
Design: A double-blinded, group-randomized effectiveness trial was conducted in 12 milk distribution clusters assigned to consume iron-fortified (FM; n = 7) or nonfortified (NFM; n = 5) milk. A daily portion of FM contained 5.28 mg Fe (ferrous gluconate) and 48 mg sodium ascorbate.
Results: Overall treatment effects were documented at 6 and 12 mo for anemia and for iron deficiency assessed by both serum ferritin (SF) and serum soluble transferrin receptor (sTfR) (interaction: P < 0.10). Differential effects at 6 mo (P = 0.004) and 12 mo (P = 0.664) were documented only for sTfR. Estimated prevalences (EPs) of anemia (hemoglobin < 110 g/L) from baseline to 6 and 12 mo decreased from 42.6% to 19.7% and 9.4%, respectively, in the NFM group (n = 210) and from 44.5% to 12.7% and 4.0%, respectively, in the FM group (n = 357). EPs of SF < 12 mug/L from baseline to 6 and 12 mo changed from 36.0% to 41.8% and 17.1%, respectively, in the NFM group (n = 43) and from 29.8% to 18.6% and 5.7%, respectively, in the FM group (n = 144). EPs of sTfR > 3.3 mg/L from baseline to 6 and 12 mo decreased from 16.2% to 8.3% and 2.0%, respectively, in the NFM group (n = 114) and from 15.5% to 0.7% and 1.1%, respectively, in the FM group.
Conclusion: A large-scale iron-fortified subsidized-milk program was effective at reducing the rates of anemia and iron deficiency in Mexican children during 12 mo of implementation. This trial was registered at clinicaltrials.gov as NCT00508131.