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Malaria in Pregnancy: Nutrition and Immunologic Effects (MAL2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01115478
First Posted: May 4, 2010
Last Update Posted: April 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by (Responsible Party):
Wafaie Fawzi, Harvard School of Public Health
April 30, 2010
May 4, 2010
April 24, 2015
July 2010
June 2014   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01115478 on ClinicalTrials.gov Archive Site
  • Maternal anemia [ Time Frame: Delivery ]
    Anemia is defined as hemoglobin less than 11 g/dl. Severe anemia is less than 8.5 g/dl.
  • Perinatal death [ Time Frame: at or after 28 weeks of gestation and in the first 7 days of life ]
  • 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.
  • Maternal malaria [ Time Frame: 20 weeks, 30 weeks, Delivery, 6 weeks post-partum ]
    Maternal malaria will be defined as fever within the last 72 hours with any density of parasitemia.
  • Maternal anemia [ Time Frame: 20 weeks, 30 weeks, Delivery, 6 weeks post-partum ]
    Anemia is defined as hemoglobin less than 11 g/dl. Severe anemia is less than 8.5 g/dl.
  • Perinatal death [ Time Frame: at or after 28 weeks of gestation and in the first 7 days of life ]
Not Provided
Not Provided
 
Malaria in Pregnancy: Nutrition and Immunologic Effects
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Malaria
  • Low Birth Weight
  • Anemia
  • Perinatal Mortality
  • Dietary Supplement: Vitamin A
    Daily oral dose of 2500 IU from enrollment until delivery
  • Dietary Supplement: Zinc
    Daily oral dose of 25 mg from enrollment until delivery
  • Other: Placebo
    Daily oral dose from enrollment until delivery
  • Active Comparator: Vitamin A
    Intervention: Dietary Supplement: Vitamin A
  • Active Comparator: Zinc
    Intervention: Dietary Supplement: Zinc
  • Active Comparator: Vitamin A + Zinc
    Interventions:
    • Dietary Supplement: Vitamin A
    • Dietary Supplement: Zinc
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2500
June 2014
June 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
 
NCT01115478
HD57941-01A2
Yes
Not Provided
Not Provided
Wafaie Fawzi, Harvard School of Public Health
Harvard School of Public Health
Muhimbili University of Health and Allied Sciences
Principal Investigator: Wafaie W Fawzi, MD, DrPH Harvard School of Public Health
Principal Investigator: Ferdinand Mugusi, MD, MMed Muhimbili University of Health and Allied Sciences
Harvard School of Public Health
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP