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

This study has been completed.
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID) Identifier:
First received: February 3, 2003
Last updated: September 17, 2007
Last verified: August 2007
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 Intervention Phase
HIV Infections
Vitamin A Deficiency
HIV Seronegativity
Drug: Vitamin A
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Prevention of HIV Shedding in Women - Trial of Vitamin A

Resource links provided by NLM:

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 400
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.


Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HIV infected

Exlusion Criteria:

  • Pregnant
  Contacts and Locations
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Please refer to this study by its identifier: NCT00053612

Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Joan Kreiss, MD, MPH Universiy of Washington, Seattle, WA
  More Information Identifier: NCT00053612     History of Changes
Other Study ID Numbers: R01AI343844  R01-AI343844 
Study First Received: February 3, 2003
Last Updated: September 17, 2007
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vitamin A

Additional relevant MeSH terms:
Night Blindness
Vitamin A Deficiency
Deficiency Diseases
Eye Diseases
Nutrition Disorders
Vision Disorders
Retinol palmitate
Vitamin A
Anticarcinogenic Agents
Antineoplastic Agents
Growth Substances
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protective Agents processed this record on May 24, 2016