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

February 9, 2009
February 9, 2009
July 2003
May 2006   (final data collection date for primary outcome measure)
plasma ferritin [ Time Frame: 280 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
hemoglobin [ Time Frame: 280 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cereals as a Source of Iron for Breastfed Infants
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Iron Deficiency
  • 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
  • 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
  • Active Comparator: Cereal L
    Rice cereal with electrolytic iron
    Intervention: Dietary Supplement: electrolytic iron
  • Active Comparator: Cereal M
    Rice cereal with ferrous fumarate
    Intervention: Dietary Supplement: ferrous fumarate
Ziegler EE, Fomon SJ, Nelson SE, Jeter JM, Theuer RC. Dry cereals fortified with electrolytic iron or ferrous fumarate are equally effective in breast-fed infants. J Nutr. 2011 Feb;141(2):243-8. doi: 10.3945/jn.110.127266. Epub 2010 Dec 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
May 2006
May 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • supplementing formula
  • no iron drops
Both
up to 1 Year
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00841061
B530500, HD40315-01
No
Dr. Ekhard E. Ziegler, University of Iowa
National Institutes of Health (NIH)
Not Provided
Principal Investigator: Ekhard E Ziegler, MD University of Iowa
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP