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

This study has been completed.
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Identifier:
First received: February 9, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
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.

Condition Intervention
Iron Deficiency
Dietary Supplement: electrolytic iron
Dietary Supplement: ferrous fumarate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Breast Feeding and Iron: Comparison of Cereals Fortified With Different Forms of Iron

Resource links provided by NLM:

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • plasma ferritin [ Time Frame: 280 days ]

Secondary Outcome Measures:
  • hemoglobin [ Time Frame: 280 ]

Enrollment: 111
Study Start Date: July 2003
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • supplementing formula
  • no iron drops
  Contacts and Locations
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Please refer to this study by its identifier: NCT00841061

United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
National Institutes of Health (NIH)
Principal Investigator: Ekhard E Ziegler, MD University of Iowa
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Ekhard E. Ziegler, University of Iowa Identifier: NCT00841061     History of Changes
Other Study ID Numbers: B530500
Study First Received: February 9, 2009
Last Updated: February 9, 2009

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ferrous fumarate
Trace Elements
Growth Substances
Physiological Effects of Drugs processed this record on May 22, 2017