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Prevention of Iron Deficiency in Breastfed Infants

Primary Purpose

Iron Deficiency, Anemia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fer-in-Sol
control
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Iron Deficiency focused on measuring iron deficiency, anemia

Eligibility Criteria

4 Weeks - 9 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Iowa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Intervention

Control

Arm Description

Fer-in-Sol drops and iron-fortified cereal

No intervention

Outcomes

Primary Outcome Measures

Iron deficiency anemia will be prevented in all infants before 5.5 mo of age
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
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

Full Information

First Posted
September 28, 2011
Last Updated
March 29, 2017
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT01444261
Brief Title
Prevention of Iron Deficiency in Breastfed Infants
Official Title
Prevention of Iron Deficiency in Breastfed Infants
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
University of Iowa

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency, Anemia
Keywords
iron deficiency, anemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
219 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Fer-in-Sol drops and iron-fortified cereal
Arm Title
Control
Arm Type
Other
Arm Description
No intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Fer-in-Sol
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
No dietary supplements
Primary Outcome Measure Information:
Title
Iron deficiency anemia will be prevented in all infants before 5.5 mo of age
Description
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.
Time Frame
5.5 mo
Secondary Outcome Measure Information:
Title
Determine the number of infants with iron deficiency between 5.5 and 9 mo of age
Description
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
Time Frame
9 mo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
9 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ekhard Ziegler, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Prevention of Iron Deficiency in Breastfed Infants

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