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Prevention of Iron Deficiency in Breastfed Infants

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ClinicalTrials.gov Identifier: NCT01444261
Recruitment Status : Completed
First Posted : September 30, 2011
Last Update Posted : March 31, 2017
Sponsor:
Collaborator:
University of Iowa
Information provided by (Responsible Party):
Ekhard Ziegler, University of Iowa

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

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

Detailed Description:
Infants with low ferritin at 1 month are at high risk of iron deficiency. They will receive iron drops starting at 2 months. All other infants are at low risk of iron deficiency. All infants will receive iron-fortified cereal starting at 4 months of age.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Iron Deficiency in Breastfed Infants
Study Start Date : December 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

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Arms and Interventions
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Arm Intervention/treatment
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
Control
No intervention
 Other: control
No dietary supplements


Outcome Measures
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Primary Outcome Measures :
  1. Iron deficiency anemia will be prevented in all infants before 5.5 mo of age [ Time Frame: 5.5 mo ]
    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 :
  1. Determine the number of infants with iron deficiency between 5.5 and 9 mo of age [ Time Frame: 9 mo ]
    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


Eligibility Criteria
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Ages Eligible for Study:   up to 9 Months   (Child)
Sexes Eligible for Study:   All
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
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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): NCT01444261


Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Iowa
Investigators
Principal Investigator: Ekhard Ziegler, MD University of Iowa
More Information
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Responsible Party: Ekhard Ziegler, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01444261     History of Changes
Other Study ID Numbers: BFe10D
First Posted: September 30, 2011    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017

Keywords provided by Ekhard Ziegler, University of Iowa:
iron deficiency
anemia

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