Malaria in Pregnancy: Nutrition and Immunologic Effects (MAL2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by (Responsible Party):
Wafaie Fawzi, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01115478
First received: April 30, 2010
Last updated: November 20, 2013
Last verified: November 2013
  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

Resource links provided by NLM:


Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115478

Locations
Tanzania
Muhimbili University of Health And Allied Sciences
Dar es Salaam, Tanzania, PO BOX 65001
Sponsors and Collaborators
Harvard School of Public Health
Muhimbili University of Health and Allied Sciences
Investigators
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: November 20, 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 July 23, 2014