Iron Supplementation Among Low-Income Postpartum Women

NCT ID: NCT00207610

Last Updated: 2009-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 959 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2007-09-30

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.

Conditions

Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Daily iron supplements of 65 mg a day for 3 months

Intervention Type: BEHAVIORAL

Universal anemia screening and treatment

Intervention Type: BEHAVIORAL

Selective anemia screening and treatment

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 13 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: lead

Principal Investigators

Amal K Mitra, MD, DrPH

Role: PRINCIPAL_INVESTIGATOR

University of Southern Mississippi

Locations

Center for Community Health, University of Southern Mississippi

Hattiesburg, Mississippi, United States

Countries

United States

Other Identifiers

CDC-NCCDPHP-TS-0780

Identifier Type: -

Identifier Source: org_study_id