Treatment and Prevention of Severe Anemia in Pregnant Zanzibari Women

NCT ID: NCT00148629

Last Updated: 2022-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Brief Summary

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The purpose of this research is to compare the efficacy of two low-cost low intervention packages to prevent and treat severe anemia in pregnant women in Zanzibar, Tanzania. The two packages are Standard of Care as described by the WHO (presumptive treatment for malaria and helminths plus daily iron + folic acid supplements) and Enhanced Care (Standard of Care plus daily multivitamins and a 2nd dose of anthelminthic.)

Detailed Description

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This is a clinic-randomized trial involving 8 antenatal clinics and approximately 2500 women. The specific aims are:

Aim 1: To evaluate the efficacy of the current internationally recommended standard of care, as described by the WHO, for the prevention of severe anemia among pregnant Zanzibari women. This aim will be achieved through a pre-post intervention comparison.

Aim 2: To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to prevent severe anemia among pregnant Zanzibari women.

Aim 3: To evaluate the efficacy of the current internationally recommended standard of care, as described by the WHO, for the cure of severe anemia among pregnant Zanzibari women.

Aim 4: To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to cure severe anemia among pregnant Zanzibari women.

Conditions

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Anemia Low Birth Weight Neonatal Mortality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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multivitamin, mebendazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pregnant woman

Exclusion Criteria

* Not a permanent resident of the community
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

UNICEF

OTHER

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role collaborator

Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca J Stoltzfus, PhD

Role: PRINCIPAL_INVESTIGATOR

Cornell University

James M Tielsch, PhD

Role: PRINCIPAL_INVESTIGATOR

The Johns Hopkins Bloomberg School of Public Health

Locations

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Public Health Laboratory "Ivo de Carneri"

Wawi, Zanzibar, Tanzania

Site Status

Countries

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Tanzania

Other Identifiers

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UCHS 02-10-030

Identifier Type: -

Identifier Source: org_study_id

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