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

Iron Deficiency Clinical Trial

— BFe01B1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00760890
• Other study ID #: R01HD040315
• Status: Completed
• Phase: N/A
• First received: September 25, 2008
• Last updated: September 25, 2008
• Start date: June 2001
• Est. completion date: October 2005

Study information

• Verified date: September 2008
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: October 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Month to 24 Months

Eligibility

Inclusion Criteria:

• Predominantly breastfed (at 4 months) term infants

Exclusion Criteria:

• Not predominantly breastfed at 4 months

• Premature infants

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

Intervention

Dietary Supplement:
• Fer-In-Sol (ferrous sulfate)
7.5 mg/day in the form of 0.3 ml once each day
• 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.

Locations

Country	Name	City	State
United States	Fomon Infant Nutrition Unit	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iron status		3 times during the intervention	Yes
Secondary	Growth		At the end of intervention	Yes
Secondary	Tolerance (gastrointestinal)		During intervention	No