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Trial of Vitamins in HIV Progression and Transmission

Primary Purpose

HIV Infections, Disease Transmission, Vertical

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Vitamin A + Beta Carotene
Multivitamins
Placebo
Sponsored by
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, Multivitamins, Pregnancy outcomes, Tanzania, Women

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Harvard School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Vitamin A

Multivitamins

Vitamin A + Multivitamins

Placebo

Arm Description

Vitamin A + Beta Carotene

Vitamins B, C, and E

Vitamin A + Beta Carotene, Vitamins B, C, and E

Placebo

Outcomes

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

Secondary Outcome Measures

To examine the effect of multivitamin and/or Vitamin A supplements on child and maternal morbidity, child growth and child mortality

Full Information

First Posted
September 13, 2005
Last Updated
November 9, 2010
Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Muhimbili University of Health and Allied Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00197743
Brief Title
Trial of Vitamins in HIV Progression and Transmission
Official Title
Trial of Vitamins in HIV Progression and Transmission
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
April 1995 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
August 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Muhimbili University of Health and Allied Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Disease Transmission, Vertical
Keywords
HIV, Multivitamins, Pregnancy outcomes, Tanzania, Women

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1085 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin A
Arm Type
Active Comparator
Arm Description
Vitamin A + Beta Carotene
Arm Title
Multivitamins
Arm Type
Active Comparator
Arm Description
Vitamins B, C, and E
Arm Title
Vitamin A + Multivitamins
Arm Type
Active Comparator
Arm Description
Vitamin A + Beta Carotene, Vitamins B, C, and E
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin A + Beta Carotene
Intervention Description
one daily oral dose of 30 mg beta-carotene + 5000 IU preformed vitamin A
Intervention Type
Dietary Supplement
Intervention Name(s)
Multivitamins
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo pill
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV-infected women presenting to antenatal care between 12 and 27 weeks of gestation: Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wafaie W Fawzi, MD,DrPh
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harvard School of Public Health
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15229304
Citation
Fawzi WW, Msamanga GI, Spiegelman D, Wei R, Kapiga S, Villamor E, Mwakagile D, Mugusi F, Hertzmark E, Essex M, Hunter DJ. A randomized trial of multivitamin supplements and HIV disease progression and mortality. N Engl J Med. 2004 Jul 1;351(1):23-32. doi: 10.1056/NEJMoa040541.
Results Reference
result
PubMed Identifier
12351954
Citation
Fawzi WW, Msamanga GI, Hunter D, Renjifo B, Antelman G, Bang H, Manji K, Kapiga S, Mwakagile D, Essex M, Spiegelman D. Randomized trial of vitamin supplements in relation to transmission of HIV-1 through breastfeeding and early child mortality. AIDS. 2002 Sep 27;16(14):1935-44. doi: 10.1097/00002030-200209270-00011.
Results Reference
result
PubMed Identifier
10839660
Citation
Fawzi WW, Msamanga G, Hunter D, Urassa E, Renjifo B, Mwakagile D, Hertzmark E, Coley J, Garland M, Kapiga S, Antelman G, Essex M, Spiegelman D. Randomized trial of vitamin supplements in relation to vertical transmission of HIV-1 in Tanzania. J Acquir Immune Defic Syndr. 2000 Mar 1;23(3):246-54. doi: 10.1097/00126334-200003010-00006.
Results Reference
result
PubMed Identifier
9605804
Citation
Fawzi WW, Msamanga GI, Spiegelman D, Urassa EJ, McGrath N, Mwakagile D, Antelman G, Mbise R, Herrera G, Kapiga S, Willett W, Hunter DJ. Randomised trial of effects of vitamin supplements on pregnancy outcomes and T cell counts in HIV-1-infected women in Tanzania. Lancet. 1998 May 16;351(9114):1477-82. doi: 10.1016/s0140-6736(98)04197-x.
Results Reference
result
PubMed Identifier
25173342
Citation
Khavari N, Jiang H, Manji K, Msamanga G, Spiegelman D, Fawzi W, Duggan C. Maternal multivitamin supplementation reduces the risk of diarrhoea among HIV-exposed children through age 5 years. Int Health. 2014 Dec;6(4):298-305. doi: 10.1093/inthealth/ihu061. Epub 2014 Aug 30.
Results Reference
derived
PubMed Identifier
23053555
Citation
Natchu UC, Liu E, Duggan C, Msamanga G, Peterson K, Aboud S, Spiegelman D, Fawzi WW. Exclusive breastfeeding reduces risk of mortality in infants up to 6 mo of age born to HIV-positive Tanzanian women. Am J Clin Nutr. 2012 Nov;96(5):1071-8. doi: 10.3945/ajcn.111.024356. Epub 2012 Oct 10.
Results Reference
derived

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Trial of Vitamins in HIV Progression and Transmission

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