Malaria in Pregnancy: Nutrition and Immunologic Effects (MAL2)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Malaria Low Birth Weight Anemia Perinatal Mortality |
Dietary Supplement: Vitamin A Dietary Supplement: Zinc Other: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Malaria in Pregnancy: Nutrition and Immunologic Effects |
- Incidence of placental malaria [ Time Frame: Delivery ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Low birth weight will be defined as birth weight less than 2500 grams.
- Maternal malaria [ Time Frame: 20 weeks, 30 weeks, Delivery, 6 weeks post-partum ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2500 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Vitamin A |
Dietary Supplement: Vitamin A
Daily oral dose of 2500 IU from enrollment until delivery
|
| Active Comparator: Zinc |
Dietary Supplement: Zinc
Daily oral dose of 25 mg from enrollment until delivery
|
| Active Comparator: Vitamin A + Zinc |
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
|
| Placebo Comparator: Placebo |
Other: Placebo
Daily oral dose from enrollment until delivery
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Primigravida or secundigravidae
- At or before 8 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
- Before 13 weeks of gestation
HIV-positive
- Do not intend to stay in Dar es Salaam until delivery and for at least 6 weeks thereafter
Contacts and Locations| Contact: Wafaie W Fawzi, MD, DrPH | 617-432-5299 | mina@hsph.harvard.edu |
| Tanzania | |
| Muhimbili University of Health And Allied Sciences | Recruiting |
| Dar es Salaam, Tanzania, PO BOX 65001 | |
| Contact: Ferdinand Mugusi, MD, MMed 2617135 fmugusi@muhas.ac.tz | |
| 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 |
More Information
No publications provided
| Responsible Party: | Wafaie Fawzi, Chair, Department of Global Health and Population, Harvard School of Public Health |
| ClinicalTrials.gov Identifier: | NCT01115478 History of Changes |
| Other Study ID Numbers: | HD57941-01A2 |
| Study First Received: | April 30, 2010 |
| Last Updated: | May 8, 2013 |
| Health Authority: | United States: Institutional Review Board Tanzania: Food & Drug Administration Tanzania: National Institute for Medical Research |
Keywords provided by Harvard School of Public Health:
|
Malaria Low birth weight Anemia |
Perinatal mortality Vitamin A Zinc |
Additional relevant MeSH terms:
|
Anemia Birth Weight Malaria Hematologic Diseases Body Weight Signs and Symptoms Protozoan Infections Parasitic Diseases Vitamin A Vitamins Zinc Retinol palmitate |
Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses Trace Elements |
ClinicalTrials.gov processed this record on May 21, 2013