Trial record 1 of 1 for:    NCT00760890
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Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation (BFe01B1)

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00760890
First received: September 25, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted

September 25, 2008
September 25, 2008
June 2001
June 2005   (final data collection date for primary outcome measure)
Iron status [ Time Frame: 3 times during the intervention ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • Growth [ Time Frame: At the end of intervention ] [ Designated as safety issue: Yes ]
  • Tolerance (gastrointestinal) [ Time Frame: During intervention ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation
Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation

Normal breastfed infants can develop iron deficiency by 6 months of age. This trial tested the hypothesis that regular provision of a source of iron beginning at 4 months of age improves iron status and could prevent iron deficiency. This was a prospective randomized trial involving breastfed infants. To be eligible, infants had to be predominantly breastfed (<200 ml/day of formula) at 4 months of age. At 4 months infants were randomly assigned to one of two interventions or to control. The interventions consisted in the daily administration of medicinal iron in a dose of 7.5 mg (Medicinal Iron Group) or in the daily feeding of one jar of an iron-fortified cereal providing 7 mg of iron each day (Cereal Group). The control group received complementary foods chosen by he parents but no source of iron provided by the investigators. The interventions took place from 4 to 9 months. All infants were subsequently followed to 2 years of age.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Iron Deficiency
  • Dietary Supplement: Fer-In-Sol (ferrous sulfate)
    7.5 mg/day in the form of 0.3 ml once each day
  • Dietary Supplement: Iron fortified cereal
    1 jar each day of one of three wet pack cereals manufactured by the Gerber Company: Each jar provided 7 mg of ferrous sulfate.
  • Experimental: A
    Medicinal Iron
    Intervention: Dietary Supplement: Fer-In-Sol (ferrous sulfate)
  • Experimental: B
    Iron fortified wet pack cereal
    Intervention: Dietary Supplement: Iron fortified cereal
  • No Intervention: C
    Control
Ziegler EE, Nelson SE, Jeter JM. Iron status of breastfed infants is improved equally by medicinal iron and iron-fortified cereal. Am J Clin Nutr. 2009 Jul;90(1):76-87. Epub 2009 May 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
171
October 2005
June 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Predominantly breastfed (at 4 months) term infants

Exclusion Criteria:

  • Not predominantly breastfed at 4 months
  • Premature infants
Both
1 Month to 24 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00760890
R01 HD 40315
Not Provided
Ekhard E. Ziegler, M.D., University of Iowa
National Institutes of Health (NIH)
Not Provided
Principal Investigator: Ekhard E Ziegler, M.D. University of Iowa
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
September 2008

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