Malaria in Pregnancy: Nutrition and Immunologic Effects (MAL2)
Primary Purpose
Malaria, Low Birth Weight, Anemia
Status
Completed
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Vitamin A
Zinc
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Malaria focused on measuring Malaria, Low birth weight, Anemia, Perinatal mortality, Vitamin A, Zinc
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
Sites / Locations
- Muhimbili University of Health And Allied Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Vitamin A
Zinc
Vitamin A + Zinc
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Low birth weight
Low birth weight will be defined as birth weight less than 2500 grams.
Secondary Outcome Measures
Maternal anemia
Anemia is defined as hemoglobin less than 11 g/dl. Severe anemia is less than 8.5 g/dl.
Perinatal death
Maternal malaria
Maternal malaria will be defined as fever within the last 72 hours with any parasitemia on a peripheral blood smear.
Full Information
NCT ID
NCT01115478
First Posted
April 30, 2010
Last Updated
April 22, 2015
Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Muhimbili University of Health and Allied Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01115478
Brief Title
Malaria in Pregnancy: Nutrition and Immunologic Effects
Acronym
MAL2
Official Title
Malaria in Pregnancy: Nutrition and Immunologic Effects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Muhimbili University of Health and Allied Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Low Birth Weight, Anemia, Perinatal Mortality
Keywords
Malaria, Low birth weight, Anemia, Perinatal mortality, Vitamin A, Zinc
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin A
Arm Type
Active Comparator
Arm Title
Zinc
Arm Type
Active Comparator
Arm Title
Vitamin A + Zinc
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin A
Intervention Description
Daily oral dose of 2500 IU from enrollment until delivery
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc
Intervention Description
Daily oral dose of 25 mg from enrollment until delivery
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Daily oral dose from enrollment until delivery
Primary Outcome Measure Information:
Title
Incidence of placental malaria
Description
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.
Time Frame
Delivery
Title
Low birth weight
Description
Low birth weight will be defined as birth weight less than 2500 grams.
Time Frame
Delivery
Secondary Outcome Measure Information:
Title
Maternal anemia
Description
Anemia is defined as hemoglobin less than 11 g/dl. Severe anemia is less than 8.5 g/dl.
Time Frame
Delivery
Title
Perinatal death
Time Frame
at or after 28 weeks of gestation and in the first 7 days of life
Title
Maternal malaria
Description
Maternal malaria will be defined as fever within the last 72 hours with any parasitemia on a peripheral blood smear.
Time Frame
During pregnancy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wafaie W Fawzi, MD, DrPH
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ferdinand Mugusi, MD, MMed
Organizational Affiliation
Muhimbili University of Health and Allied Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muhimbili University of Health And Allied Sciences
City
Dar es Salaam
ZIP/Postal Code
PO BOX 65001
Country
Tanzania
12. IPD Sharing Statement
Citations:
PubMed Identifier
33546607
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.
Results Reference
derived
Learn more about this trial
Malaria in Pregnancy: Nutrition and Immunologic Effects
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