Cereals as a Source of Iron for Breastfed Infants (Bfe03B)

February 9, 2009 updated by: National Institutes of Health (NIH)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • exclusively breastfed
  • birth weight between 2500 and 4200g
  • gestational age >36 weeks

Exclusion Criteria:

  • supplementing formula
  • no iron drops

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cereal L
Rice cereal with electrolytic iron
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
Active Comparator: Cereal M
Rice cereal with ferrous fumarate
Dietary supplement: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
plasma ferritin
Time Frame: 280 days
280 days

Secondary Outcome Measures

Outcome Measure
Time Frame
hemoglobin
Time Frame: 280
280

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Ekhard E Ziegler, MD, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

February 9, 2009

First Submitted That Met QC Criteria

February 9, 2009

First Posted (Estimate)

February 11, 2009

Study Record Updates

Last Update Posted (Estimate)

February 11, 2009

Last Update Submitted That Met QC Criteria

February 9, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B530500
  • HD40315-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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