Malaria in Pregnancy: Nutrition and Immunologic Effects
Information source: Harvard School of Public Health
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria; Low Birth Weight; Anemia; Perinatal Mortality
Intervention: Vitamin A (Dietary Supplement); Zinc (Dietary Supplement); Placebo (Other)
Phase: N/A
Status: Completed
Sponsored by: Harvard School of Public Health Official(s) and/or principal investigator(s): Wafaie W Fawzi, MD, DrPH, Principal Investigator, Affiliation: Harvard School of Public Health Ferdinand Mugusi, MD, MMed, Principal Investigator, Affiliation: Muhimbili University of Health and Allied Sciences
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.
Clinical Details
Official title: Malaria in Pregnancy: Nutrition and Immunologic Effects
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Incidence of placental malariaLow birth weight
Secondary outcome: Maternal anemiaPerinatal death Maternal malaria
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Muhimbili University of Health And Allied Sciences, Dar es Salaam PO BOX 65001, Tanzania
Additional Information
Starting date: July 2010
Last updated: April 22, 2015
|