Cereals as a Source of Iron for Breastfed Infants

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

Sponsors

Lead Sponsor: National Institutes of Health (NIH)

Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Brief 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.

Overall Status Completed
Start Date July 2003
Completion Date May 2006
Primary Completion Date May 2006
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
plasma ferritin 280 days
Secondary Outcome
Measure Time Frame
hemoglobin 280
Enrollment 111
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: electrolytic iron

Description: 1/4 a cup of cereal fortified with electrolytic iron per day between the ages of 112 days and 280 days of age

Arm Group Label: Cereal L

Intervention Type: Dietary Supplement

Intervention Name: ferrous fumarate

Description: 1/4 cup of cereal fortified with ferrous fumarate to be fed per day between ages of 112 days and 280 days of age

Arm Group Label: Cereal M

Eligibility

Criteria:

Inclusion Criteria:

- exclusively breastfed

- birth weight between 2500 and 4200g

- gestational age >36 weeks

Exclusion Criteria:

- supplementing formula

- no iron drops

Gender: All

Minimum Age: N/A

Maximum Age: 1 Year

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Ekhard E Ziegler, MD Principal Investigator University of Iowa
Location
Facility: University of Iowa
Location Countries

United States

Verification Date

January 2009

Responsible Party

Name Title: Dr. Ekhard E. Ziegler

Organization: University of Iowa

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Cereal L

Type: Active Comparator

Description: Rice cereal with electrolytic iron

Label: Cereal M

Type: Active Comparator

Description: Rice cereal with ferrous fumarate

Acronym Bfe03B
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov