We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00760890
Previous Study | Return to List | Next Study

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00760890
First Posted: September 26, 2008
Last Update Posted: September 26, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  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
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

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
Control

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
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
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


Locations
United States, Iowa
Fomon Infant Nutrition Unit
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
National Institutes of Health (NIH)
Investigators
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 Submitted: September 25, 2008
First Posted: September 26, 2008
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
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs