Vitamins, Breastmilk HIV Shedding, and Child Health

August 20, 2009 updated by: Harvard School of Public Health (HSPH)
The purpose of this study is to analyze stored samples and data collected during the conduct of the study "A Trial of Vitamins in HIV Progression and Transmission" (HD32257). The aims are to examine the effect of vitamin supplementation on HIV infected women during pregnancy on a number of parameters in breastmilk.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to analyze stored samples and data collected during the conduct of the study "A Trial of Vitamins in HIV Progression and Transmission" (HD32257). The aims are to examine the effect of vitamin supplementation on HIV infected women during pregnancy

Study Type

Observational

Enrollment (Actual)

771

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Harvard School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The data and samples used in this study are from HIV-infected pregnant women who participated in the "Trial of Vitamins in HIV Transmission and Progression". Between 1995 and 1997, 1,078 African, HIV positive women who were between gestatopm weeks 12 and 27 were recruited. They were followed until August 2003. This study was conducte among 771 of these women, for whom breast milk samples were available at delivery. There were no differences in baseline characteristics between this subset and the originally randomized group of 1,069.

Description

This study is analyzing samples previously collected from the study "A Trial of Vitamins in HIV Progression and Transmission" (HD32257).

The inclusion criteria in this study was:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vitamin A
Participants in the in the parent study who had been randomized to receive either Vitamin A alone or multivitamins including vitamin A.
Dietary supplement: Vitamin A alone
30 mg beta-carotene plus 5000 IU preformed vitamin A) taken orally once per during pregnancy and lactation
No Vitamin A
Participants in the parent study who were randomized to receive either multivitamins excluding vitamin A, or placebo.
Dietary supplement: Multivitamins excluding vitamin A
30 mg thiamine, 20 mg riboflavin, 20 mg B-6, 100 mg niacin, 50 ug vitamin B-12, 500 mg vitamin C, 30 mg vitamin E, 0.8 mg folic acid taken orally once per day during pregnancy and lactation
Dietary supplement: multivitamins including vitamin A
20 mg thiamine, 20 mg riboflavin, 25 mg vitamin B6, 100 mg niacin, 50 ug vitamin B12, 500 mg vitamin C, 30 mg vitamin E, and 0.8 mg folic acid taken once per day orally during pregnancy and lactation
Other: Placebo
Placebo pill taken orally once per day during pregnancy and lactation
Multivitamins
Participants in the parent study who were randomized to receive multivitamins including vitamin A or multivitamins excluding vitamin A
Dietary supplement: Vitamin A alone
30 mg beta-carotene plus 5000 IU preformed vitamin A) taken orally once per during pregnancy and lactation
Dietary supplement: Multivitamins excluding vitamin A
30 mg thiamine, 20 mg riboflavin, 20 mg B-6, 100 mg niacin, 50 ug vitamin B-12, 500 mg vitamin C, 30 mg vitamin E, 0.8 mg folic acid taken orally once per day during pregnancy and lactation
Dietary supplement: multivitamins including vitamin A
20 mg thiamine, 20 mg riboflavin, 25 mg vitamin B6, 100 mg niacin, 50 ug vitamin B12, 500 mg vitamin C, 30 mg vitamin E, and 0.8 mg folic acid taken once per day orally during pregnancy and lactation
No Multivitamins
Participants from the parent study who had been randomized to vitamin A alone or placebo
Dietary supplement: Vitamin A alone
30 mg beta-carotene plus 5000 IU preformed vitamin A) taken orally once per during pregnancy and lactation
Other: Placebo
Placebo pill taken orally once per day during pregnancy and lactation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cell-free viral load and/or cell-associated proviral load in breast milk
Time Frame: Delivery, 3 months, and 6 months after delivery
Delivery, 3 months, and 6 months after delivery
concentration of vitamins A, B12, and E in breast milk
Time Frame: Delivery, 3 months, and 6 months post-delivery
Delivery, 3 months, and 6 months post-delivery
subclinical mastitis
Time Frame: Delivery, 3 months, and 6 months after delivery
Delivery, 3 months, and 6 months after delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
post-natal mother-to-child transmission of HIV
Time Frame: Delivery, 3 months, and 6 months post-delivery
Delivery, 3 months, and 6 months post-delivery
infant mortality and morbidity from diarrhea
Time Frame: Delivery, 3 months and 6 months after delivery
Delivery, 3 months and 6 months after delivery
a.) CCR5 expression in differentiating monocytes and differentiated monocyte-derived macrophages
Time Frame: N/A (in vitro experiment)
N/A (in vitro experiment)
HIV-1 replication in differentiating monocytes acutely infected with a subtype C HIV-1 clone, differentiated non-dividing MDMs acutely infected with the HIV-1 MJ4 clone, and differentiated non-dividing MDMs chronically infected with the HIV-1 MJ4 clone.
Time Frame: N/A (in vitro experiment)
N/A (in vitro experiment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard School of Public Health (HSPH)

Collaborators

Muhimbili University of Health and Allied Sciences

Investigators

  • Principal Investigator: Eduardo Villamor, MD,DrPH, Harvard School of Public Health (HSPH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

August 21, 2009

Last Update Submitted That Met QC Criteria

August 20, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD45134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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