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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00841061
First Posted: February 11, 2009
Last Update Posted: February 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  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
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

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

  Eligibility

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
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
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


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

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
First Submitted: February 9, 2009
First Posted: February 11, 2009
Last Update Posted: February 11, 2009
Last Verified: January 2009

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