Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation — BFe01B1  

Iron Deficiency Clinical Trial

Official title: Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation

Status Completed

Clinical Trial Summary

Normal breastfed infants can develop iron deficiency by 6 months of age. This trial tested the hypothesis that regular provision of a source of iron beginning at 4 months of age improves iron status and could prevent iron deficiency. This was a prospective randomized trial involving breastfed infants. To be eligible, infants had to be predominantly breastfed (<200 ml/day of formula) at 4 months of age. At 4 months infants were randomly assigned to one of two interventions or to control. The interventions consisted in the daily administration of medicinal iron in a dose of 7.5 mg (Medicinal Iron Group) or in the daily feeding of one jar of an iron-fortified cereal providing 7 mg of iron each day (Cereal Group). The control group received complementary foods chosen by he parents but no source of iron provided by the investigators. The interventions took place from 4 to 9 months. All infants were subsequently followed to 2 years of age.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

• NCT number: NCT00760890
• Study type: Interventional
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Status: Completed
• Phase: N/A
• Start date: June 2001
• Completion date: October 2005