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

Not Applicable

Completed

• Conditions: Iron Deficiency
• Interventions: Dietary Supplement: Fer-In-Sol (ferrous sulfate); Dietary Supplement: Iron fortified cereal

• Registration Number: NCT00760890
• Lead Sponsor: National Institutes of Health (NIH)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-06
• Primary Completion: 2005-06
• Study Completion: 2005-10
• Status Verified: 2008-09
• Study First Submitted: 2008-09-25
• Study First Submitted QC: 2008-09-25
• Last Update Submitted: 2008-09-25
• Study First Posted: 2008-09-26
• Last Update Posted: 2008-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

• Predominantly breastfed (at 4 months) term infants

Exclusion Criteria

• Not predominantly breastfed at 4 months
• Premature infants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Fer-In-Sol (ferrous sulfate)	Medicinal Iron
B	Iron fortified cereal	Iron fortified wet pack cereal

Primary Outcome Measures

Name	Time	Method
Iron status	3 times during the intervention

Secondary Outcome Measures

Name	Time	Method
Growth	At the end of intervention
Tolerance (gastrointestinal)	During intervention

Trial Locations

Locations (1)

Fomon Infant Nutrition Unit; 🇺🇸 Iowa City, Iowa, United States