Treatment and Prevention of Severe Anemia in Pregnant Zan... | NCT00148629

Studies
Treatment and Prevention of Severe Anemia in Pregnant Zanzibari Women

NCT00148629

Sponsor

Cornell University

Status

Completed

Last Update Posted

Feb 13, 2026Actual

Enrollment

2,500

Phase

Phase 3

Conditions

Anemia
Low Birth Weight
Neonatal Mortality

Interventions

multivitamin, mebendazole

Countries

Tanzania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2004Actual

Primary Completion Date

Jan 2008Actual

Completion Date

Jan 2008Actual

First Submitted Date

Sep 6, 2005

First Submission Date that Met QC Criteria

Sep 6, 2005

First Posted Date

Sep 8, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2026

Last Update Posted Date

Feb 13, 2026Actual

Name	Class
Bill and Melinda Gates Foundation	OTHER
UNICEF	OTHER
Johns Hopkins Bloomberg School of Public Health	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,500

Name	Type	Description	Arm Group Labels	Other Names
multivitamin, mebendazole	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of severe anemia (Hb < 7 g/dL)
Cure of severe anemia

Secondary Outcomes

Measure	Description	Time Frame
Infant birth weight
Neonatal mortality
Neonatal morbidity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant woman

Exclusion Criteria:

Not a permanent resident of the community

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rebecca J Stoltzfus, PhD	Cornell University	Principal Investigator
James M Tielsch, PhD	The Johns Hopkins Bloomberg School of Public Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Public Health Laboratory "Ivo de Carneri"		Wawi	Zanzibar		Tanzania

Condition Browse Module

MeSH Terms

ID	Term
D000740	Anemia
D001724	Birth Weight

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D001835	Body Weight
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C067316	Geritol
D008463	Mebendazole

Ancestor Terms

ID	Term
D002219	Carbamates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided