Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection
1 other identifier
interventional
915
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hiv-infections
Started Sep 2003
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedNovember 11, 2010
November 1, 2010
2.9 years
September 12, 2005
November 9, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in CD4 cell counts and viral load from baseline to six weeks and six months postpartum in HIV-1 positive women
Enrollment (12-27 wks gestation) to 6 months postpartum
Risk of lower genital shedding of HIV-1 infected cells at 36 wks gestation
At 36 wks gestation
Secondary Outcomes (2)
Risk of subclinical mastitis as defined by elevated sodium concentrations in breastmilk at 6 weeks postpartum
6 weeks postpartum
Fetal death, premature delivery, and low birth weight
Delivery
Study Arms (2)
Selenium
ACTIVE COMPARATORSelenium (200 ug as selenomethionine)
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Taken orally once per day from randomization through delivery and through the first 6 months after delivery.
200 ug of selenomethionine taken orally once per day from randomization through delivery and for the first 6 months after delivery
Eligibility Criteria
You may qualify if:
- HIV-1 Infected women between 12 and 27 weeks of gestation
You may not qualify if:
- Women with clinical AIDS defined according to WHO Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Muhimibili University College of Health Scienes
Upanga, Dar Es Salaaam, Tanzania
Related Publications (2)
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.
PMID: 19368503RESULTKupka 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.
PMID: 18541571DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wafaie W. Fawzi, MD, DrPH
Harvard School of Public Health (HSPH)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
September 1, 2003
Primary Completion
August 1, 2006
Study Completion
August 1, 2006
Last Updated
November 11, 2010
Record last verified: 2010-11