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Clinical Trials/NCT01115478
NCT01115478CompletedNot Applicable

Malaria in Pregnancy: Nutrition and Immunologic Effects

Harvard School of Public Health (HSPH)2 sites in 1 country2,500 target enrollmentStarted: July 1, 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
2,500
Locations
2
Primary Endpoint
Incidence of placental malaria

Study Overview

Brief 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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Incidence of placental malaria

Time Frame: Delivery

Placental infection status will be categorized as infected if there are asexual parasites in the placenta blood; not infected if the placental blood smear is negative; or status unknown if no placental smear is available.

Low birth weight

Time Frame: Delivery

Low birth weight will be defined as birth weight less than 2500 grams.

Secondary Outcomes

  • Maternal anemia(Delivery)
  • Perinatal death(at or after 28 weeks of gestation and in the first 7 days of life)
  • Maternal malaria(During pregnancy)

Investigators

Sponsor
Harvard School of Public Health (HSPH)
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Wafaie Fawzi

Chair, Department of Global Health and Population

Harvard School of Public Health (HSPH)

Study Sites (2)

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