Iron Supplementation Among Low-Income Postpartum Women
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Daily iron supplements of 65 mg a day for 3 months
Universal anemia screening and treatment
Selective anemia screening and treatment
Sponsored by
About this trial
This is an interventional prevention trial for Anemia focused on measuring Anemia, Postpartum, iron, supplements
Eligibility Criteria
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
Sites / Locations
- Center for Community Health, University of Southern Mississippi
Outcomes
Primary Outcome Measures
anemia
Secondary Outcome Measures
Full Information
NCT ID
NCT00207610
First Posted
September 16, 2005
Last Updated
January 30, 2009
Sponsor
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT00207610
Brief Title
Iron Supplementation Among Low-Income Postpartum Women
Official Title
Phase 3 Study of the Prevention of Postpartum Anemia by Three Different Strategies
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centers for Disease Control and Prevention
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Anemia is common among low-income women after they have given birth. Anemia, or low hemoglobin in the blood cells, is usually caused by not having enough iron. Blood cells usually carry oxygen to other parts of the body. Without enough hemoglobin, the ability of blood cells to carry oxygen is decreased. Memory and work may be impaired. The purpose of this study is to evaluate three methods of giving iron to prevent anemia among low-income women after they have given birth.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
Anemia, Postpartum, iron, supplements
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
959 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Daily iron supplements of 65 mg a day for 3 months
Intervention Type
Behavioral
Intervention Name(s)
Universal anemia screening and treatment
Intervention Type
Behavioral
Intervention Name(s)
Selective anemia screening and treatment
Primary Outcome Measure Information:
Title
anemia
Time Frame
6 months postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal K Mitra, MD, DrPH
Organizational Affiliation
University of Southern Mississippi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Community Health, University of Southern Mississippi
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39406-5122
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Iron Supplementation Among Low-Income Postpartum Women
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