Prevention of Iron Deficiency in Breastfed Infants

March 29, 2017 updated by: Ekhard Ziegler, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
With early screening and appropriate iron supplementation, iron deficiency in the first year of life can be prevented in breastfed infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

219

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 9 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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
OTHER: Control
No intervention
Other: control
No dietary supplements

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5.5 mo

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
9 mo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborators

University of Iowa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

September 28, 2011

First Submitted That Met QC Criteria

September 28, 2011

First Posted (ESTIMATE)

September 30, 2011

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2017

Last Update Submitted That Met QC Criteria

March 29, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BFe10D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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