- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00207610
Iron Supplementation Among Low-Income Postpartum Women
Phase 3 Study of the Prevention of Postpartum Anemia by Three Different Strategies
Study Overview
Status
Conditions
Detailed Description
Currently the Centers for Disease Control and Prevention recommendations to prevent iron deficiency advocate selective screening and treatment of anemia at about 6 weeks postpartum. However, among some groups, such as low income women, data suggest that anemia and iron deficiency are common. This study aims to evaluate the effectiveness of three stategies to prevent iron deficiency among low income postpartum women in Mississippi.
Comparisons: Clinics will be randomized to one of three strategies: 1)Selective anemia screening and treatment of anemic women, 2)universal anemia screening and treatment of anemic women, or 3)universal iron supplementation of 65 mg a day for three months.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Mississippi
-
Hattiesburg, Mississippi, United States, 39406-5122
- Center for Community Health, University of Southern Mississippi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- postpartum girls and women, 2-6 weeks after birth
- age 13 years or more
- WIC certified
Exclusion Criteria:
- sickle cell anemia
- Hemoglobin < 7 g/dL
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
anemia
Time Frame: 6 months postpartum
|
6 months postpartum
|
Collaborators and Investigators
Investigators
- Principal Investigator: Amal K Mitra, MD, DrPH, University of Southern Mississippi
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-NCCDPHP-TS-0780
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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