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Prevention of Iron Deficiency in Breastfed Infants

This study is currently recruiting participants.
Verified April 2012 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Information provided by (Responsible Party):
Ekhard Ziegler, University of Iowa
ClinicalTrials.gov Identifier:
NCT01444261
First received: September 28, 2011
Last updated: April 26, 2012
Last verified: April 2012
History of Changes
  Purpose

With early screening and appropriate iron supplementation, iron deficiency in the first year of life can be prevented in breastfed infants.


Condition Intervention Phase
Iron Deficiency
Anemia
 Dietary Supplement: Fer-in-Sol
Other: control
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Iron Deficiency in Breastfed Infants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Iron deficiency anemia will be prevented in all infants before 5.5 mo of age [ Time Frame: 5.5 mo ] [ Designated as safety issue: No ]
    Iron deficiency anemia will be defined as plasma ferritin less than 10 ug/L and hemoglobin less than 105 g/L. The expected outcome is there will be no infants with iron deficiency anemia before 5.5 mo of age.


Secondary Outcome Measures:
  • Determine the number of infants with iron deficiency between 5.5 and 9 mo of age [ Time Frame: 9 mo ] [ Designated as safety issue: No ]
    Iron deficiency will be determined as plasma ferritin less than 10 ug/L. We will determine the number of infants with iron deficiency between 5.5 and 9 mo of age


Estimated Enrollment: 133
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention
Fer-in-Sol drops and iron-fortified cereal
 Dietary Supplement: Fer-in-Sol
Fer-in-Sol drops providing 7.5 mg iron in 0.3 ml per day given from 84 to 168 d of age and iron-fortified cereal
No Intervention: Control Other: control
No dietary supplements

  Eligibility

Ages Eligible for Study:   up to 9 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Term infants
  • gestational age 37-42 weeks
  • birth weight > 2500 g
  • exclusively breastfed at 28 d of age
  • intend to breast feed until 9 mo of age

Exclusion Criteria:

  • supplemental formula before 4 mo of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444261

Locations
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Ekhard E Ziegler, MD     319-335-4570     ekhard-ziegler@uiowa.edu    
Sponsors and Collaborators
University of Iowa
  More Information

No publications provided

Responsible Party: Ekhard Ziegler, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01444261     History of Changes
Other Study ID Numbers: BFe10D
Study First Received: September 28, 2011
Last Updated: April 26, 2012
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
iron deficiency
anemia

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

ClinicalTrials.gov processed this record on May 16, 2013