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Clinical Trials

MainTitle

Trial of Vitamins in HIV Progression and Transmission

This study has been completed
Sponsor
Harvard School of Public Health

Collaborator
Muhimbili University of Health and Allied Sciences

Information provided by (Responsible Party)
Harvard School of Public Health
ClinicalTrials.gov Identifier
NCT00197743

First received: September 13, 2005
Last updated: November 9, 2010
Last Verified: November 2010
History of Changes
Purpose

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
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

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 ]
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 ]

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

Eligibility

Ages Eligible for Study: 18 Years and older  
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

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

More Information


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  

Keywords provided by Harvard School of Public Health:

HIV
Multivitamins
Pregnancy outcomes
Tanzania
Women

Additional relevant MeSH terms:
HIV Infections
Vitamins
Vitamin A
Beta Carotene
Retinol palmitate
Carotenoids

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.