Vitamins, Breastmilk HIV Shedding, and Child Health
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ClinicalTrials.gov Identifier: NCT00197756 |
Recruitment Status
:
Completed
First Posted
: September 20, 2005
Last Update Posted
: August 21, 2009
|
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Condition or disease | Intervention/treatment |
---|---|
Maternal and Child Health Outcomes | Dietary Supplement: Vitamin A alone Dietary Supplement: Multivitamins excluding vitamin A Dietary Supplement: multivitamins including vitamin A Other: Placebo |
Study Type : | Observational |
Actual Enrollment : | 771 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Vitamins, Breastmilk HIV Shedding, and Child Health |
Study Start Date : | September 2004 |
Actual Primary Completion Date : | August 2007 |
Actual Study Completion Date : | August 2007 |
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
|
- cell-free viral load and/or cell-associated proviral load in breast milk [ Time Frame: 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 ]
- subclinical mastitis [ Time Frame: Delivery, 3 months, and 6 months after delivery ]
- post-natal mother-to-child transmission of HIV [ Time Frame: Delivery, 3 months, and 6 months post-delivery ]
- infant mortality and morbidity from diarrhea [ Time Frame: 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) ]
- 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) ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197756
United States, Massachusetts | |
Harvard School of Public Health | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Eduardo Villamor, MD,DrPH | Harvard School of Public Health |
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 |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | August 21, 2009 |
Last Verified: | August 2009 |
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 |