NCT00207610

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
959

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2003

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

February 3, 2009

Status Verified

January 1, 2009

Enrollment Period

4.3 years

First QC Date

September 16, 2005

Last Update Submit

January 30, 2009

Conditions

Anemia

Keywords

AnemiaPostpartumironsupplements

Outcome Measures

Primary Outcomes (1)

  • anemia

    6 months postpartum

Interventions

Daily iron supplements of 65 mg a day for 3 monthsBEHAVIORAL
Universal anemia screening and treatmentBEHAVIORAL
Selective anemia screening and treatmentBEHAVIORAL

Eligibility Criteria

Age13 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • postpartum girls and women, 2-6 weeks after birth
  • age 13 years or more
  • WIC certified

You may not qualify if:

  • sickle cell anemia
  • Hemoglobin \< 7 g/dL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Community Health, University of Southern Mississippi

Hattiesburg, Mississippi, 39406-5122, United States

Location

MeSH Terms

Conditions

Anemia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Amal K Mitra, MD, DrPH

    University of Southern Mississippi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 21, 2005

Study Start

June 1, 2003

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

February 3, 2009

Record last verified: 2009-01

Locations

US(1)