Iron Supplementation Among Low-Income Postpartum Women - Full Text View

Sponsored by:	Centers for Disease Control and Prevention
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00207610

Purpose

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.

Condition	Intervention	Phase
Anemia	Behavioral: Daily iron supplements of 65 mg a day for 3 months Behavioral: Universal anemia screening and treatment Behavioral: Selective anemia screening and treatment	Phase III

MedlinePlus related topics: Anemia Dietary Supplements

Drug Information available for: Ferrous sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Phase 3 Study of the Prevention of Postpartum Anemia by Three Different Strategies

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:

Anemia at 6 months postpartum

Estimated Enrollment:	3000
Study Start Date:	June 2003
Estimated Study Completion Date:	September 2007

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.

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207610

Locations

United States, Mississippi
Center for Community Health, University of Southern Mississippi
Hattiesburg, Mississippi, United States, 39406-5122

Sponsors and Collaborators

Centers for Disease Control and Prevention

Investigators

Principal Investigator:

Amal K Mitra, MD, DrPH

University of Southern Mississippi

More Information

Study ID Numbers:	CDC-NCCDPHP-TS-0780
Study First Received:	September 16, 2005
Last Updated:	September 20, 2007
ClinicalTrials.gov Identifier:	NCT00207610
Health Authority:	United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:

Anemia
Postpartum
iron
supplements

Study placed in the following topic categories:

Hematologic Diseases
Anemia
Iron

ClinicalTrials.gov processed this record on January 16, 2009