NCT00148629

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.)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,500

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2004

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

February 13, 2026

Status Verified

January 1, 2022

Enrollment Period

3.8 years

First QC Date

September 6, 2005

Last Update Submit

February 11, 2026

Conditions

AnemiaLow Birth WeightNeonatal Mortality

Keywords

AnemiaBirth weightNeonatal MortalityTanzaniaPregnancy

Outcome Measures

Primary Outcomes (2)

  • Incidence of severe anemia (Hb < 7 g/dL)

  • Cure of severe anemia

Secondary Outcomes (4)

  • Infant birth weight

  • Neonatal mortality

  • Neonatal morbidity

  • Blood loss during delivery

Interventions

multivitamin, mebendazoleDRUG

Eligibility Criteria

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

You may qualify if:

  • Pregnant woman

You may not qualify if:

  • Not a permanent resident of the community

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Health Laboratory "Ivo de Carneri"

Wawi, Zanzibar, Tanzania

Location

MeSH Terms

Conditions

AnemiaBirth Weight

Interventions

GeritolMebendazole

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Rebecca J Stoltzfus, PhD

    Cornell University

    PRINCIPAL INVESTIGATOR

  • James M Tielsch, PhD

    The Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

April 1, 2004

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

February 13, 2026

Record last verified: 2022-01

Locations

TA(1)