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 mulitvitamins and a 2nd dose of anthelminthic.)

Condition	Intervention	Phase
Anemia Low birth weight Neonatal Mortality	Drug: multivitamin, mebendazole	Phase III

Further Study Details: 

Primary Outcomes: Incidence of severe anemia (Hb < 7 g/dL); Cure of severe anemia
Secondary Outcomes: Infant birth weight; Neonatal mortality; Neonatal morbidity; Blood loss during delivery
Expected Total Enrollment:  2500

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.

Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Pregnant woman

Exclusion Criteria:

• Not a permanent resident of the community

Tanzania, Zanzibar
      Public Health Laboratory "Ivo de Carneri", Wawi,  Zanzibar,  Tanzania

Study chairs or principal investigators

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

Study ID Numbers:  UCHS 02-10-030
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00148629
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13