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

NCT00760890 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2008-09-26

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    lead NIH

Principal Investigators

  • Ekhard E Ziegler, M.D. · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-06-30
Primary Completion
2005-06-30
Completion
2005-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00760890 on ClinicalTrials.gov