Malaria in Pregnancy: Nutrition and Immunologic Effects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Malaria Low Birth Weight Anemia Perinatal Mortality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin A

Group Type ACTIVE_COMPARATOR

Vitamin A

Intervention Type DIETARY_SUPPLEMENT

Daily oral dose of 2500 IU from enrollment until delivery

Zinc

Group Type ACTIVE_COMPARATOR

Zinc

Intervention Type DIETARY_SUPPLEMENT

Daily oral dose of 25 mg from enrollment until delivery

Vitamin A + Zinc

Group Type ACTIVE_COMPARATOR

Vitamin A

Intervention Type DIETARY_SUPPLEMENT

Daily oral dose of 2500 IU from enrollment until delivery

Zinc

Intervention Type DIETARY_SUPPLEMENT

Daily oral dose of 25 mg from enrollment until delivery

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Daily oral dose from enrollment until delivery

Interventions

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Vitamin A

Daily oral dose of 2500 IU from enrollment until delivery

Intervention Type DIETARY_SUPPLEMENT

Zinc

Daily oral dose of 25 mg from enrollment until delivery

Intervention Type DIETARY_SUPPLEMENT

Placebo

Daily oral dose from enrollment until delivery

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes