Clinical trial NCT01115478: Malaria in Pregnancy: Nutrition and Immunologic Effects
Official title: Malaria in Pregnancy: Nutrition and Immunologic Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Low Birth Weight
Anemia
Perinatal Mortality
Keywords: Malaria
Low birth weight
Anemia
Perinatal mortality
Vitamin A
Zinc
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Muhimbili University of Health and Allied Sciences
First posted: 2010-05-04
Enrollment: 2500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Incidence of placental malaria
timeFrame: Delivery
measure: Low birth weight
timeFrame: Delivery
Secondary outcomes:
measure: Maternal anemia
timeFrame: Delivery
measure: Perinatal death
timeFrame: at or after 28 weeks of gestation and in the first 7 days of life
measure: Maternal malaria
timeFrame: During pregnancy
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: Muhimbili University of Health And Allied Sciences
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Wafaie W Fawzi, MD, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Muhimbili University of Health and Allied Sciences
name: Ferdinand Mugusi, MD, MMed
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang J, Wang D, Darling AM, Liu E, Perumal N, Fawzi WW, Wang M. Methodological approaches to imputing early-pregnancy weight based on weight measures collected during pregnancy. BMC Med Res Methodol. 2021 Feb 5;21(1):24. doi: 10.1186/s12874-021-01210-3.