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Trial of Vitamins in HIV Progression and 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.
ClinicalTrials.gov Identifier: NCT00197743
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 11, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Disease Transmission, Vertical Dietary Supplement: Vitamin A + Beta Carotene Dietary Supplement: Multivitamins Other: Placebo Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1085 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Trial of Vitamins in HIV Progression and Transmission
Study Start Date : April 1995
Primary Completion Date : August 2003
Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Vitamin A
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

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 ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wafaie Fawzi, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT00197743     History of Changes
Other Study ID Numbers: HD32257
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 11, 2010
Last Verified: November 2010

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

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