Malaria in Pregnancy: Nutrition and Immunologic Effects

Anemia Clinical Trial

— MAL2  

Official title:

Malaria in Pregnancy: Nutrition and Immunologic Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115478
• Other study ID #: HD57941-01A2
• Status: Completed
• Phase: N/A
• First received: April 30, 2010
• Last updated: April 22, 2015
• Start date: July 2010
• Est. completion date: June 2014

Study information

• Verified date: April 2015
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardTanzania: Food & Drug AdministrationTanzania: National Institute for Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Birth Weight
• Low Birth Weight
• Malaria
• Perinatal Mortality

Intervention

Dietary Supplement:
• Vitamin A
Daily oral dose of 2500 IU from enrollment until delivery
• Zinc
Daily oral dose of 25 mg from enrollment until delivery

Other:
• Placebo
Daily oral dose from enrollment until delivery

Locations

Country	Name	City	State
Tanzania	Muhimbili University of Health And Allied Sciences	Dar es Salaam

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	Muhimbili University of Health and Allied Sciences

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of placental malaria	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.	Delivery	No
Primary	Low birth weight	Low birth weight will be defined as birth weight less than 2500 grams.	Delivery	No
Secondary	Maternal anemia	Anemia is defined as hemoglobin less than 11 g/dl. Severe anemia is less than 8.5 g/dl.	Delivery	No
Secondary	Perinatal death		at or after 28 weeks of gestation and in the first 7 days of life	No
Secondary	Maternal malaria	Maternal malaria will be defined as fever within the last 72 hours with any parasitemia on a peripheral blood smear.	During pregnancy	No