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Prevention of Iron Deficiency in Breastfed Infants
This study has been completed.
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator:
University of Iowa
Information provided by (Responsible Party):
Ekhard Ziegler, University of Iowa
ClinicalTrials.gov Identifier:
NCT01444261
First received: September 28, 2011
Last updated: March 29, 2017
Last verified: March 2017
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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 Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
| Official Title: | Prevention of Iron Deficiency in Breastfed Infants |
Resource links provided by NLM:
Further study details as provided by Ekhard Ziegler, University of Iowa:
Primary Outcome Measures:
- 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:
- 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
| Enrollment: | 219 |
| Study Start Date: | December 2010 |
| Study Completion Date: | April 2014 |
| Primary Completion Date: | April 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
|
|
Control
No intervention
|
Other: control
No dietary supplements
|
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.
Eligibility| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01444261
Please refer to this study by its ClinicalTrials.gov identifier: 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
| 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: | March 29, 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 |
ClinicalTrials.gov processed this record on August 17, 2017