Prevention of Iron Deficiency in Breastfed Infants
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Iowa
Information provided by (Responsible Party):
Ekhard Ziegler, University of Iowa
ClinicalTrials.gov Identifier:
NCT01444261
First received: September 28, 2011
Last updated: April 26, 2012
Last verified: April 2012
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Primary Outcome Measures:
- Iron deficiency anemia will be prevented in all infants before 5.5 mo of age [ Time Frame: 5.5 mo ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 133 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 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
|
| No Intervention: Control |
Other: control
No dietary supplements
|
Eligibility| Ages Eligible for Study: | up to 9 Months |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Ekhard E Ziegler, MD 319-335-4570 ekhard-ziegler@uiowa.edu | |
Sponsors and Collaborators
University of Iowa
More Information
No publications provided
| 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: | April 26, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
iron deficiency anemia |
Additional relevant MeSH terms:
|
Anemia, Iron-Deficiency Anemia Anemia, Hypochromic |
Hematologic Diseases Iron Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on February 27, 2015