Vitamins, Breastmilk HIV Shedding, and Child Health

NCT00197756 | Completed

• 1 other identifier: HD45134
• Study Type: observational
• Target: 771
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Maternal and Child Health Outcomes

Keywords

HIV; Breastfeeding; Vitamins; Tanzania; Children

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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)

Study Arms (4)

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

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; Dietary Supplement: multivitamins including vitamin A; Other: Placebo

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; Dietary Supplement: Multivitamins excluding vitamin A; Dietary Supplement: multivitamins including vitamin A

No Multivitamins

Participants from the parent study who had been randomized to vitamin A alone or placebo

Dietary Supplement: Vitamin A alone; Other: Placebo

Interventions

Vitamin A alone DIETARY_SUPPLEMENT

30 mg beta-carotene plus 5000 IU preformed vitamin A) taken orally once per during pregnancy and lactation

Multivitamins; No Multivitamins; Vitamin A

Multivitamins excluding vitamin A DIETARY_SUPPLEMENT

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

Multivitamins; No Vitamin A

multivitamins including vitamin A DIETARY_SUPPLEMENT

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

Multivitamins; No Vitamin A

Placebo OTHER

Placebo pill taken orally once per day during pregnancy and lactation

No Multivitamins; No Vitamin A

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Muhimbili University of Health and Allied Sciences: collaborator

Study Sites (1)

Harvard School of Public Health

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• 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.

  PMID: 20739426 DERIVED

• 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.

  PMID: 17940544 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breast milk samples collected from breast at delivery and at 3 month intervals thereafter.

MeSH Terms

Conditions

Breast Feeding

Interventions

Vitamin A

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Eduardo Villamor, MD,DrPH

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: September 1, 2004
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: August 21, 2009

Record last verified: 2009-08

Locations

US (1)