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

Completed · Not applicable

Conditions studied: Iron Deficiency

In brief

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.

Key facts

Study ID
NCT00760890
Run by
National Institutes of Health (NIH)
People needed
171
Starts
2001-06-01
Expected to finish
2005-10-01
Last updated by the study team
2008-09-26

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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