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

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00841061
First received: February 9, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Breast Feeding Iron
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hemoglobin [ Time Frame: 280 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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

No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional 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, HD40315-01
Study First Received: February 9, 2009
Last Updated: February 9, 2009
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ferrous fumarate
 Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2012