NCT00760890

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: National Institutes of Health (NIH) · NIH
• Sex: All
• Age: 1 Month – 24 Months
• Healthy volunteers: Accepted

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.

Conditions

• Iron Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fer-In-Sol (ferrous sulfate)	7.5 mg/day in the form of 0.3 ml once each day
DIETARY_SUPPLEMENT	Iron fortified cereal	1 jar each day of one of three wet pack cereals manufactured by the Gerber Company: Each jar provided 7 mg of ferrous sulfate.

Timeline

• Start date: 2001-06-01
• Primary completion: 2005-06-01
• Completion: 2005-10-01
• First posted: 2008-09-26
• Last updated: 2008-09-26

Locations

1 site across 1 country: United States