Vitamins, Breastmilk HIV Shedding, and Child Health

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: Maternal and Child Health Outcomes
• Intervention / Treatment: Dietary supplement: Vitamin A alone; Dietary supplement: Multivitamins excluding vitamin A; Dietary supplement: multivitamins including vitamin A; Other: Placebo

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

4

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	Delivery, 3 months, and 6 months after delivery
concentration of vitamins A, B12, and E in breast milk	Delivery, 3 months, and 6 months post-delivery
subclinical mastitis	Delivery, 3 months, and 6 months after delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
post-natal mother-to-child transmission of HIV	Delivery, 3 months, and 6 months post-delivery
infant mortality and morbidity from diarrhea	Delivery, 3 months and 6 months after delivery
a.) CCR5 expression in differentiating monocytes and differentiated monocyte-derived macrophages	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.	N/A (in vitro experiment)

Collaborators and Investigators

• 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

General Publications

• 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. doi: 10.3945/ajcn.2010.29339. 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. doi: 10.1038/sj.ejcn.1602929. Epub 2007 Oct 17.

Study record dates

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: HIV; Children; Tanzania; Breastfeeding; Vitamins
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Protective Agents; Micronutrients; Antioxidants; Anticarcinogenic Agents; Vitamins; Vitamin A; Retinol palmitate
• Other Study ID Numbers: HD45134