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

This study has been completed.
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Identifier:
First received: September 25, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
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 Intervention
Iron Deficiency
Dietary Supplement: Fer-In-Sol (ferrous sulfate)
Dietary Supplement: Iron fortified cereal

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation

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:
  • Iron status [ Time Frame: 3 times during the intervention ]

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

Enrollment: 171
Study Start Date: June 2001
Study Completion Date: October 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
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Please refer to this study by its identifier: 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 Identifier (NCT Number):
Responsible Party: Ekhard E. Ziegler, M.D., University of Iowa Identifier: NCT00760890     History of Changes
Other Study ID Numbers: R01HD040315 ( US NIH Grant/Contract Award Number )
Study First Received: September 25, 2008
Last Updated: September 25, 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 processed this record on May 25, 2017