Iron supplementation of breastfed infants from an early age.
What this study found
Iron supplementation transiently improved iron status during the supplementation period but did not improve hemoglobin or produce lasting hematologic benefit after supplementation ended. Plasma ferritin declined less in the iron group, with significant differences at 4 and 5.5 months for adjusted ferritin and at 5.5 and 7.5 months for unadjusted ferritin; soluble transferrin receptor was lower at 5.5 months (P = 0.005), and ln(sTfR/PF) was better at 5.5 months (P = 0.001) and 7.5 months (P = 0.006). Hemoglobin did not differ at any age, and later differences in RDW and MCV were modest. The…
- Study & population
- Randomized, placebo-controlled trial in healthy term infants who were exclusively breastfed at enrollment at 1 month of age in Iowa, United States.
- Intervention
- Infants in the active arm received 7 mg/day of iron as ferrous sulfate in a multivitamin preparation (Tri-Vi-Sol with Iron), given orally as 0.7 mL drops directly into the mouth once daily at the beginning of a feeding from 1 to 5.5 months of age.
- Key limitation
- The trial was small and underpowered to determine whether early iron supplementation prevents iron deficiency or iron deficiency anemia.
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Open PDFOriginal abstract
BACKGROUND In breastfed infants, iron deficiency at <6 mo of life, although uncommon, is observed in industrialized countries. Iron supplementation starting at an early age may prevent iron deficiency. OBJECTIVE The study assessed the effect of early iron supplementation of breastfed infants and tested the hypothesis that iron supplementation enhances iron status. Potential adverse effects (tolerance and growth) were monitored. DESIGN The prospective, placebo-controlled study involved exclusively breastfed infants who were randomly assigned at 1 mo of age to iron (n = 37) or placebo (n = 38). Iron (7 mg/d as multivitamin preparation with ferrous sulfate) or placebo (multivitamin preparation without iron) was given from 1 to 5.5 mo of age. Complementary foods were allowed at >4 mo. Infants were followed to 18 mo. Blood concentrations of ferritin, transferrin receptor, hemoglobin, and red cell indexes were determined at bimonthly intervals. Stool consistency and color and feeding behavior were recorded. RESULTS Iron supplementation caused modest augmentation of iron status during the intervention at 4 and 5.5 mo but not thereafter. Iron supplements were well tolerated and had no measurable effect on growth. One infant developed iron deficiency anemia by 5.5 mo of age. Plasma ferritin and hemoglobin tracked over time. CONCLUSION Early iron supplementation of breastfed infants is feasible and transiently increases iron status but not hematologic status. Iron is tolerated by most infants. The prevalence of iron deficiency anemia is low (3%) among unsupplemented breastfed infants in the first 6 mo of life.