Cereals as a Source of Iron for Breastfed Infants

Iron Deficiency Clinical Trial

— Bfe03B  

Official title:

Breast Feeding and Iron: Comparison of Cereals Fortified With Different Forms of Iron

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841061
• Other study ID #: B530500
• Secondary ID: HD40315-01
• Status: Completed
• Phase: N/A
• First received: February 9, 2009
• Last updated: February 9, 2009
• Start date: July 2003
• Est. completion date: May 2006

Study information

• Verified date: January 2009
• 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

The purpose of this research study is to determine whether the type of iron in infant cereals makes a differance in how well the cereal helps infants remain free of iron deficiency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

Inclusion Criteria:

• exclusively breastfed

• birth weight between 2500 and 4200g

• gestational age >36 weeks

Exclusion Criteria:

• supplementing formula

• no iron drops

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Dietary Supplement:
• electrolytic iron
1/4 a cup of cereal fortified with electrolytic iron per day between the ages of 112 days and 280 days of age
• ferrous fumarate
1/4 cup of cereal fortified with ferrous fumarate to be fed per day between ages of 112 days and 280 days of age

Locations

Country	Name	City	State
United States	University of Iowa	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	plasma ferritin		280 days	No
Secondary	hemoglobin		280	No