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Vitamin A to Reduce HIV in Vaginal Secretions and Prevent Viral Transmission

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00053612
Recruitment Status : Completed
First Posted : February 5, 2003
Last Update Posted : December 14, 2016
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
HIV infected individuals with vitamin A deficiency may be more likely to transmit the virus to others than HIV infected individuals who have normal levels of vitamin A. The presence of HIV DNA in vaginal secretions may indicate a greater risk for transmission of HIV to others. The purpose of this study is to determine if taking vitamin A decreases the level of HIV DNA in vaginal secretions.

Condition or disease Intervention/treatment Phase
HIV Infections Vitamin A Deficiency HIV Seronegativity Drug: Vitamin A Phase 2

Detailed Description:

Vitamin A deficiency leads to pathological changes in mucosal epithelium, including the vagina, and is correlated with immune dysfunction in both HIV-1 infected and uninfected individuals. Recent studies of genital tract shedding of HIV-1 DNA in infected women have found that lower serum concentrations of vitamin A were strongly associated with detection of HIV-1 in vaginal secretions. In addition, maternal vitamin A deficiency has been associated with significantly increased risk of vertical HIV-1 transmission. This study will assess the effect of vitamin A supplementation on the prevalence and quantity of HIV-1 DNA and RNA in cervical and vaginal secretions.

Participants in this study will be HIV infected nonpregnant women in Mombasa, Kenya. Participants will be randomized to receive 6 weeks of daily dosage of either 10,000 IU vitamin A or placebo. Cervical and vaginal swabs will be obtained at enrollment and at Week 6 for detection and quantification of HIV-1 DNA and RNA. In addition, venous blood will be obtained at the two time points for quantification of plasma HIV-1 RNA, CD4 lymphocyte count, and serum vitamin A levels.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Prevention of HIV Shedding in Women - Trial of Vitamin A
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Vitamin A

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HIV infected

Exlusion Criteria:

  • Pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00053612

Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Joan Kreiss, MD, MPH Universiy of Washington, Seattle, WA
Layout table for additonal information Identifier: NCT00053612    
Other Study ID Numbers: R01AI343844
First Posted: February 5, 2003    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: August 2007
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vitamin A
Additional relevant MeSH terms:
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Night Blindness
Vitamin A Deficiency
Deficiency Diseases
Nutrition Disorders
Vision Disorders
Eye Diseases
Vitamin A
Growth Substances
Physiological Effects of Drugs