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Published on: May 10, 2022
A double-masked, randomized control trial of iron supplementation in early infancy in healthy term breast-fed infants
James K Friel1, Khalid Aziz, Wayne L Andrews
1Department of Pediatrics, Memorial University of Newfoundland, St John's, Newfoundland, Canada. frielj@ms.umanitoba.ca
Insights
Iron supplementation for breast-fed infants showed improved hematologic and developmental outcomes, including better visual acuity and psychomotor development. This intervention appears safe and potentially beneficial for infant health.
Area of Science:
- Pediatrics
- Nutritional Science
- Developmental Biology
Background:
- Breast-fed infants are at risk for iron deficiency.
- Early iron status impacts long-term health and development.
- Supplementation strategies require careful evaluation.
Purpose of the Study:
- To determine the effects of iron supplementation on hematologic, biochemical, and developmental markers in term breast-fed infants.
- To assess the safety and efficacy of early iron intake.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 77 term breast-fed infants.
- Infants received 7.5 mg of elemental iron or placebo daily from 1 to 6 months.
- Hematologic, biochemical, and developmental assessments (including Bayley scales and visual acuity) were conducted up to 18 months.
Main Results:
- Iron supplementation led to higher hemoglobin and mean corpuscular volume at 6 months.
- Significantly improved visual acuity and psychomotor developmental index (PDI) were observed at 13 months.
- No differences were noted in anthropometrics, compliance, or other biochemical markers.
Conclusions:
- Iron supplementation in breast-fed infants is safe.
- It may offer hematologic and developmental advantages for some infants.
- Further research can clarify optimal supplementation protocols.
Objectives:
To test whether iron supplementation affects hematologic, biochemical, and developmental status in term breast-fed infants.
Study Design:
Term breast-fed infants (n=77) were randomly selected to receive either 7.5 mg per day of elemental iron as ferrous sulfate or placebo from 1 to 6 months of age. Investigators and families were unaware of group assignment. Complete blood count and ferritin, red cell superoxide dismutase, catalase, plasma ferric reducing antioxidant power, and zinc and copper levels were analyzed at 1, 3.5, 6, and 12 months of age. Bayley mental and psychomotor developmental indexes (MDI and PDI) and visual acuity (with the use of Teller acuity cards) were assessed from 12 to 18 months of age. Analysis performed by analysis of variance and t tests was by intention to treat.
Results:
Iron supplementation resulted in higher hemoglobin and mean corpuscular volume at 6 months of age and significantly higher visual acuity and PDI at 13 months of age (100+/-12 vs 93+/-9 [+/-SD]). Treatment and placebo groups did not differ in anthropometric indexes, compliance, biochemical status, or demographic characteristics.
Conclusions:
Iron supplementation of breast-fed infants appears safe and might have beneficial hematologic and developmental effects for some infants.
