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Partnership on Nutrition and HIV/AIDS Research in Tanzania: Exploratory Research Study on Selenium and HIV Infection

NCT ID: NCT00197561

Last Updated: 2010-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

915 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2006-08-31

Brief Summary

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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

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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.

Conditions

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HIV Infections Pregnancy Complications

Keywords

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HIV Selenium Nutrition Women Pregnancy Tanzania Maternal and child health outcomes HIV/AIDS Pregnancy Outcome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Selenium

Selenium (200 ug as selenomethionine)

Group Type ACTIVE_COMPARATOR

Selenium

Intervention Type DIETARY_SUPPLEMENT

200 ug of selenomethionine taken orally once per day from randomization through delivery and for the first 6 months after delivery

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Taken orally once per day from randomization through delivery and through the first 6 months after delivery.

Interventions

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Placebo

Taken orally once per day from randomization through delivery and through the first 6 months after delivery.

Intervention Type DIETARY_SUPPLEMENT

Selenium

200 ug of selenomethionine taken orally once per day from randomization through delivery and for the first 6 months after delivery

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* HIV-1 Infected women between 12 and 27 weeks of gestation

Exclusion Criteria

* Women with clinical AIDS defined according to WHO Criteria
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Muhimbili University of Health and Allied Sciences

OTHER

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role lead

Responsible Party

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Harvard School of Public Health

Principal Investigators

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Wafaie W. Fawzi, MD, DrPH

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Locations

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Muhimibili University College of Health Scienes

Upanga, Dar Es Salaaam, Tanzania

Site Status

Countries

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United States Tanzania

References

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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.

Reference Type RESULT
PMID: 19368503 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18541571 (View on PubMed)

Other Identifiers

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HD43555

Identifier Type: -

Identifier Source: org_study_id