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Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation (BFe01B1)

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ClinicalTrials.gov Identifier: NCT00760890
Recruitment Status : Completed
First Posted : September 26, 2008
Last Update Posted : September 26, 2008
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Iron Deficiency Dietary Supplement: Fer-In-Sol (ferrous sulfate) Dietary Supplement: Iron fortified cereal

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation
Study Start Date : June 2001
Primary Completion Date : June 2005
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: A
Medicinal Iron
Dietary Supplement: Fer-In-Sol (ferrous sulfate)
7.5 mg/day in the form of 0.3 ml once each day
Experimental: B
Iron fortified wet pack cereal
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.
No Intervention: C

Outcome Measures

Primary Outcome Measures :
  1. Iron status [ Time Frame: 3 times during the intervention ]

Secondary Outcome Measures :
  1. Growth [ Time Frame: At the end of intervention ]
  2. Tolerance (gastrointestinal) [ Time Frame: During intervention ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Predominantly breastfed (at 4 months) term infants

Exclusion Criteria:

  • Not predominantly breastfed at 4 months
  • Premature infants
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): NCT00760890

United States, Iowa
Fomon Infant Nutrition Unit
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
National Institutes of Health (NIH)
Principal Investigator: Ekhard E Ziegler, M.D. University of Iowa
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ekhard E. Ziegler, M.D., University of Iowa
ClinicalTrials.gov Identifier: NCT00760890     History of Changes
Other Study ID Numbers: R01HD040315 ( U.S. NIH Grant/Contract )
First Posted: September 26, 2008    Key Record Dates
Last Update Posted: September 26, 2008
Last Verified: September 2008

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Iron, breastfed infant

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