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
  Purpose

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


Condition Intervention Phase
HIV Infections
Disease Transmission, Vertical
Dietary Supplement: Vitamin A + Beta Carotene
Dietary Supplement: Multivitamins
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Trial of Vitamins in HIV Progression and Transmission

Resource links provided by NLM:


Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1085
Study Start Date: April 1995
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin A
Vitamin A + Beta Carotene
Dietary Supplement: Vitamin A + Beta Carotene
one daily oral dose of 30 mg beta-carotene + 5000 IU preformed vitamin A
Active Comparator: Multivitamins
Vitamins B, C, and E
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
Active Comparator: Vitamin A + Multivitamins
Vitamin A + Beta Carotene, Vitamins B, C, and E
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
Placebo Comparator: Placebo
Placebo
Other: Placebo
Placebo pill

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197743

Locations
United States, Massachusetts
Harvard School of Public Health
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Harvard School of Public Health
Muhimbili University of Health and Allied Sciences
Investigators
Principal Investigator: Wafaie W Fawzi, MD,DrPh Harvard School of Public Health
  More Information

Publications:
Responsible Party: Wafaie Fawzi, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT00197743     History of Changes
Other Study ID Numbers: HD32257
Study First Received: September 13, 2005
Last Updated: November 9, 2010
Health Authority: United States: Institutional Review Board
Tanzania: National Institute for Medical Research

Keywords provided by Harvard School of Public Health:
HIV
Multivitamins
Pregnancy outcomes
Tanzania
Women

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Carotenoids
Retinol palmitate
Vitamin A
Vitamins
Beta Carotene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014