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Trial of Vitamins in HIV Progression and Transmission

This study has been completed.
Sponsor:
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by:
Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT00197743
First received: September 13, 2005
Last updated: November 9, 2010
Last verified: November 2010

September 13, 2005
November 9, 2010
April 1995
August 2003   (final data collection date for primary outcome measure)
To examine the effect of multivitamin and/or Vitamin A supplements on the risk of perinatal transmission of HIV and rate of HIV disease progression [ Time Frame: until the end of follow-up in August, 2003 ] [ Designated as safety issue: No ]
To examine the effect of multivitamin and/or Vitamin A supplements on the risk of perinatal transmission of HIV and rate of HIV disease progression
Complete list of historical versions of study NCT00197743 on ClinicalTrials.gov Archive Site
To examine the effect of multivitamin and/or Vitamin A supplements on child and maternal morbidity, child growth and child mortality [ Time Frame: until the end of follow-up in August 2003 ] [ Designated as safety issue: No ]
To examine the effect of multivitamin and/or Vitamin A supplements on child and maternal morbidity, child growth and child mortality
Not Provided
Not Provided
 
Trial of Vitamins in HIV Progression and Transmission
Trial of Vitamins in HIV Progression and Transmission

This study tested the hypothesis that multivitamin supplementation given to HIV+ pregnant women in Tanzania would slow disease progression and enhance their overall health.

In this study, we sought to examine whether the administration of multivitamins excluding vitamin A, multivitamins including vitamin A, or vitamin A alone would reduce the risk of perinatal transmission of HIV and slow the rate of disease progression in a group of pregnant HIV infected women. We also examined the efficacy of the supplements on pregnancy outcomes, and risks of maternal and child morbidity and wasting.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • HIV Infections
  • Disease Transmission, Vertical
  • Dietary Supplement: Vitamin A + Beta Carotene
    one daily oral dose of 30 mg beta-carotene + 5000 IU preformed vitamin A
  • Dietary Supplement: Multivitamins
    one daily oral dose of 20 mg thiamine (vitamin B-1), 20 mg riboflavin (vitamin B-2), 25 mg vitamin B-6, 100 mg niacin, 50 ug cobalamin (vitamin B-12), 500 mg vitamin C, 30 mg vitamin E, and 0.8 mg folic acid
  • Other: Placebo
    Placebo pill
  • Active Comparator: Vitamin A
    Vitamin A + Beta Carotene
    Intervention: Dietary Supplement: Vitamin A + Beta Carotene
  • Active Comparator: Multivitamins
    Vitamins B, C, and E
    Intervention: Dietary Supplement: Multivitamins
  • Active Comparator: Vitamin A + Multivitamins
    Vitamin A + Beta Carotene, Vitamins B, C, and E
    Interventions:
    • Dietary Supplement: Vitamin A + Beta Carotene
    • Dietary Supplement: Multivitamins
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1085
August 2003
August 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-infected women presenting to antenatal care between 12 and 27 weeks of gestation:

Exclusion Criteria:

-

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00197743
HD32257
Yes
Wafaie Fawzi, Harvard School of Public Health
Harvard School of Public Health
Muhimbili University of Health and Allied Sciences
Principal Investigator: Wafaie W Fawzi, MD,DrPh Harvard School of Public Health
Harvard School of Public Health
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP