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Vitamins, Breastmilk HIV Shedding, and Child Health

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:
NCT00197756
First received: September 12, 2005
Last updated: August 20, 2009
Last verified: August 2009
History of Changes
  Purpose
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.

Condition Intervention Phase
Maternal and Child Health Outcomes
 Dietary Supplement: Vitamin A alone
Dietary Supplement: Multivitamins excluding vitamin A
Dietary Supplement: multivitamins including vitamin A
Other: Placebo
 Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vitamins, Breastmilk HIV Shedding, and Child Health

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • cell-free viral load and/or cell-associated proviral load in breast milk [ Time Frame: Delivery, 3 months, and 6 months after delivery ] [ Designated as safety issue: Yes ]
  • concentration of vitamins A, B12, and E in breast milk [ Time Frame: Delivery, 3 months, and 6 months post-delivery ] [ Designated as safety issue: No ]
  • subclinical mastitis [ Time Frame: Delivery, 3 months, and 6 months after delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • post-natal mother-to-child transmission of HIV [ Time Frame: Delivery, 3 months, and 6 months post-delivery ] [ Designated as safety issue: No ]
  • infant mortality and morbidity from diarrhea [ Time Frame: Delivery, 3 months and 6 months after delivery ] [ Designated as safety issue: No ]
  • a.) CCR5 expression in differentiating monocytes and differentiated monocyte-derived macrophages [ Time Frame: N/A (in vitro experiment) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
Breast milk samples collected from breast at delivery and at 3 month intervals thereafter.

Enrollment: 771
Study Start Date: September 2004
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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
  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: NCT00197756

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: Eduardo Villamor, MD,DrPH Harvard School of Public Health
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eduardo Villamor, MD, DrPH, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT00197756     History of Changes
Other Study ID Numbers: HD45134 
Study First Received: September 12, 2005
Last Updated: August 20, 2009
Health Authority: United States: Federal Government
Tanzania: Ministry of Health

Keywords provided by Harvard School of Public Health:
HIV
Breastfeeding
Vitamins
Tanzania
Children

Additional relevant MeSH terms:
Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 28, 2016