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

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ClinicalTrials.gov Identifier: NCT00841061
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : February 11, 2009
Information provided by:
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.

Condition or disease Intervention/treatment
Iron Deficiency Dietary Supplement: electrolytic iron Dietary Supplement: ferrous fumarate

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Breast Feeding and Iron: Comparison of Cereals Fortified With Different Forms of Iron
Study Start Date : July 2003
Primary Completion Date : May 2006
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding Iron
U.S. FDA Resources

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

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

Secondary Outcome Measures :
  1. hemoglobin [ Time Frame: 280 ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Ekhard E. Ziegler, University of Iowa
ClinicalTrials.gov Identifier: NCT00841061     History of Changes
Other Study ID Numbers: B530500
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: February 11, 2009
Last Verified: January 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