Back to resultsPartnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection
Primary Purpose
HIV Infections, Pregnancy Complications
Status
Completed
Phase
Phase 3
Locations
Tanzania
Study Type
Interventional
Intervention
Placebo
Selenium
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV, Selenium, Nutrition, Women, Pregnancy, Tanzania, Maternal and child health outcomes, HIV/AIDS, Pregnancy Outcome
Eligibility Criteria
Inclusion Criteria: HIV-1 Infected women between 12 and 27 weeks of gestation Exclusion Criteria: Women with clinical AIDS defined according to WHO Criteria
Sites / Locations
- Muhimibili University College of Health Scienes
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Selenium
Placebo
Arm Description
Selenium (200 ug as selenomethionine)
Placebo
Outcomes
Primary Outcome Measures
Change in CD4 cell counts and viral load from baseline to six weeks and six months postpartum in HIV-1 positive women
Risk of lower genital shedding of HIV-1 infected cells at 36 wks gestation
Secondary Outcome Measures
Risk of subclinical mastitis as defined by elevated sodium concentrations in breastmilk at 6 weeks postpartum
Fetal death, premature delivery, and low birth weight
Full Information
NCT ID
NCT00197561
First Posted
September 12, 2005
Last Updated
November 9, 2010
Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Muhimbili University of Health and Allied Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00197561
Brief Title
Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection
Official Title
Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
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 whether the oral administration of daily selenium supplements to HIV-1 positive pregnant women: enhances immune status and reduces the HIV-1 viral load at six months postpartum, reduces the risk of lower genital shedding of HIV-1 infected cells at 36 weeks of gestation, and reduces the risk of mastitis at six weeks postpartum, compared to placebo.
Detailed Description
We are recruiting pregnant women who are infected with HIV and assign them to receive selenium or placebo. All women will be given standard prenatal care, including nevirapine for the prevention of mother-to-child transmission and prenatal multivitamin supplements. We will examine the effect of the selenium supplements on intermediate outcomes predictive of the risks of transmission of HIV and to disease progression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Pregnancy Complications
Keywords
HIV, Selenium, Nutrition, Women, Pregnancy, Tanzania, Maternal and child health outcomes, HIV/AIDS, Pregnancy Outcome
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
915 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Selenium
Arm Type
Active Comparator
Arm Description
Selenium (200 ug as selenomethionine)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Taken orally once per day from randomization through delivery and through the first 6 months after delivery.
Intervention Type
Dietary Supplement
Intervention Name(s)
Selenium
Intervention Description
200 ug of selenomethionine taken orally once per day from randomization through delivery and for the first 6 months after delivery
Primary Outcome Measure Information:
Title
Change in CD4 cell counts and viral load from baseline to six weeks and six months postpartum in HIV-1 positive women
Time Frame
Enrollment (12-27 wks gestation) to 6 months postpartum
Title
Risk of lower genital shedding of HIV-1 infected cells at 36 wks gestation
Time Frame
At 36 wks gestation
Secondary Outcome Measure Information:
Title
Risk of subclinical mastitis as defined by elevated sodium concentrations in breastmilk at 6 weeks postpartum
Time Frame
6 weeks postpartum
Title
Fetal death, premature delivery, and low birth weight
Time Frame
Delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV-1 Infected women between 12 and 27 weeks of gestation
Exclusion Criteria:
Women with clinical AIDS defined according to WHO Criteria
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
Facility Information:
Facility Name
Muhimibili University College of Health Scienes
City
Upanga
State/Province
Dar es Salaaam
Country
Tanzania
12. IPD Sharing Statement
Citations:
PubMed Identifier
19368503
Citation
Kupka R, Mugusi F, Aboud S, Hertzmark E, Spiegelman D, Fawzi WW. Effect of selenium supplements on hemoglobin concentration and morbidity among HIV-1-infected Tanzanian women. Clin Infect Dis. 2009 May 15;48(10):1475-8. doi: 10.1086/598334.
Results Reference
result
PubMed Identifier
18541571
Citation
Kupka R, Mugusi F, Aboud S, Msamanga GI, Finkelstein JL, Spiegelman D, Fawzi WW. Randomized, double-blind, placebo-controlled trial of selenium supplements among HIV-infected pregnant women in Tanzania: effects on maternal and child outcomes. Am J Clin Nutr. 2008 Jun;87(6):1802-8. doi: 10.1093/ajcn/87.6.1802.
Results Reference
derived
Learn more about this trial
Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection
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