Vitamins, Breastmilk HIV Shedding, and Child Health - Full Text View

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:

MedlinePlus related topics: Breast Feeding HIV/AIDS HIV/AIDS and Pregnancy Vitamin A

Drug Information available for: Retinol Vitamin A palmitate

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
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

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

No publications provided by Harvard School of Public Health

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

Villamor E, Koulinska IN, Aboud S, Murrin C, Bosch RJ, Manji KP, Fawzi WW. Effect of vitamin supplements on HIV shedding in breast milk. Am J Clin Nutr. 2010 Oct;92(4):881-6. Epub 2010 Aug 25.

Webb AL, Aboud S, Furtado J, Murrin C, Campos H, Fawzi WW, Villamor E. Effect of vitamin supplementation on breast milk concentrations of retinol, carotenoids and tocopherols in HIV-infected Tanzanian women. Eur J Clin Nutr. 2009 Mar;63(3):332-9. Epub 2007 Oct 17.

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:

Vitamin A
Vitamins
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 16, 2012