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
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Growth [ Time Frame: At the end of intervention ] [ Designated as safety issue: Yes ]
  • Tolerance (gastrointestinal) [ Time Frame: During intervention ] [ Designated as safety issue: No ]

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
Control

  Eligibility

Ages Eligible for Study:   1 Month to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Predominantly breastfed (at 4 months) term infants

Exclusion Criteria:

  • Not predominantly breastfed at 4 months
  • Premature infants
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760890

Locations
United States, Iowa
Fomon Infant Nutrition Unit
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Investigators
Principal Investigator: Ekhard E Ziegler, M.D. University of Iowa
  More Information

No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional 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: R01 HD 40315
Study First Received: September 25, 2008
Last Updated: September 25, 2008
Health Authority: United States: Federal Government

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
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on October 23, 2014