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Completed

NCT Number: NCT01115478

Malaria in Pregnancy: Nutrition and Immunologic Effects

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin A

Dietary Supplement

Daily oral dose of 2500 IU from enrollment until delivery

Zinc

Dietary Supplement

Daily oral dose of 25 mg from enrollment until delivery

Placebo

Other

Daily oral dose from enrollment until delivery

Primary outcomes

  1. 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.

  2. Low birth weight

    Time frame: Delivery

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

Secondary outcomes

  1. Maternal anemia

    Time frame: Delivery

    Anemia is defined as hemoglobin less than 11 g/dl. Severe anemia is less than 8.5 g/dl.

  2. Perinatal death

    Time frame: at or after 28 weeks of gestation and in the first 7 days of life

  3. Maternal malaria

    Time frame: During pregnancy

    Maternal malaria will be defined as fever within the last 72 hours with any parasitemia on a peripheral blood smear.

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • Muhimbili University of Health and Allied Sciences

Registry information

Acronym: MAL2

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 4, 2010
Registry last updated
Apr 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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