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Malaria in Pregnancy: Nutrition and Immunologic Effects

Information source: Harvard School of Public Health
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malaria; Low Birth Weight; Anemia; Perinatal Mortality

Intervention: Vitamin A (Dietary Supplement); Zinc (Dietary Supplement); Placebo (Other)

Phase: N/A

Status: Completed

Sponsored by: Harvard School of Public Health

Official(s) and/or principal investigator(s):
Wafaie W Fawzi, MD, DrPH, Principal Investigator, Affiliation: Harvard School of Public Health
Ferdinand Mugusi, MD, MMed, Principal Investigator, Affiliation: Muhimbili University of Health and Allied Sciences

Summary

The purpose of this study is to determine the efficacy of zinc and/or vitamin A supplementation in reducing the risk of placental malaria and its associated adverse pregnancy outcomes.

Clinical Details

Official title: Malaria in Pregnancy: Nutrition and Immunologic Effects

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Incidence of placental malaria

Low birth weight

Secondary outcome:

Maternal anemia

Perinatal death

Maternal malaria

Detailed description: Malaria accounts for a major proportion of the disease burden in Tanzania with 14 to 18 million new malaria cases being reported each year resulting in 100,000-125,000 deaths. Malaria results in impaired productivity for those between 15-55 years and lost learning opportunities in the 5-25 year age group. Dar es Salaam is characterized as an area with endemic and perennial malaria, with transmission occurring during the entire year. P. falciparum accounts for more than 95% of malaria infections. A number of interventions have contributed to reducing the burden of the disease in some settings in Tanzania and beyond, including vector control measures, bed nets, and prophylaxis and treatment of malaria. However, malaria remains a serious problem among pregnant women and children. We will examine the efficacy of micronutrient supplements as a means of enhancing immune response to malaria in pregnancy and reducing the risks of associated adverse clinical outcomes. If successful, such a low-cost intervention would be added to the armamentarium against this disease. NOTE: The time frames listed for the maternal malaria and hemoglobin outcomes were updated on 4/22/15. This record initially indicated that maternal malaria anemia and hemoglobin would be measured at several specific time points throughout the study. Instead, maternal malaria was measured throughout pregnancy and hemoglobin was measured only at delivery. Due to an oversight, we did not update this record when this protocol change took effect at the start of the study.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Primigravida or secundigravidae

- At or before 13 weeks of gestation

- HIV-negative

- Intend to stay in Dar es Salaam until delivery and for at least 6 weeks thereafter

Exclusion Criteria:

- Not primigravida or secundigravidae

- After 13 weeks of gestation

- HIV-positive

- Do not intend to stay in Dar es Salaam until delivery and for at least 6 weeks

thereafter

Locations and Contacts

Muhimbili University of Health And Allied Sciences, Dar es Salaam PO BOX 65001, Tanzania
Additional Information

Starting date: July 2010
Last updated: April 22, 2015

Page last updated: August 20, 2015

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