- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01444261
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
-
-
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
|
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
|
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.
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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