A Trial of Vitamins and HAART in HIV Disease Progression
NCT ID: NCT00383669
Last Updated: 2020-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
4012 participants
INTERVENTIONAL
2006-11-30
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
QUADRUPLE
Study Groups
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Multiple RDA multivitamins
Multivitamins (including B, C, and E)
Multivitamins (including B, C and E)
One daily oral dose of 20 mg B1, 20 mg B2, 25 mg B6, 100 mg niacin, 50 μg B12, 0.8 mg folic acid, 500 mg C, and 30 mg vitamin E taken taken from randomization until the end of follow-up (24-28 months).
Single RDA Multivitamins
Multivitamins (including B, C, and E)
Multivitamins B, C and E
One daily oral dose of 1.2 mg vitamin B1, 1.2 mg vitamin B2, 1.3 mg vitamin B6, 15 mg niacin, 2.4 μg vitamin B12, 0.4 mg folic acid, 80 mg vitamin C, and 15 mg vitamin E taken taken from randomization until the end of follow-up (24-28 months).
Interventions
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Multivitamins (including B, C and E)
One daily oral dose of 20 mg B1, 20 mg B2, 25 mg B6, 100 mg niacin, 50 μg B12, 0.8 mg folic acid, 500 mg C, and 30 mg vitamin E taken taken from randomization until the end of follow-up (24-28 months).
Multivitamins B, C and E
One daily oral dose of 1.2 mg vitamin B1, 1.2 mg vitamin B2, 1.3 mg vitamin B6, 15 mg niacin, 2.4 μg vitamin B12, 0.4 mg folic acid, 80 mg vitamin C, and 15 mg vitamin E taken taken from randomization until the end of follow-up (24-28 months).
Eligibility Criteria
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Inclusion Criteria
* Men or Women
* 18 Years of Age or older
* Initiating HAART at time of randomization
Exclusion Criteria
* Individuals at pre-HAART disease stages
* BMI less than 16
18 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Harvard School of Public Health (HSPH)
OTHER
Responsible Party
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Wafaie Fawzi
Chair, Department of Global Health and Population
Principal Investigators
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Wafaie W Fawzi, MD,DrPH
Role: PRINCIPAL_INVESTIGATOR
Harvard School of Public Health (HSPH)
Locations
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Muhimbili University College of Health Sciences
Dar es Salaam, , Tanzania
Countries
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References
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Abioye AI, Hughes MD, Sudfeld CR, Noor RA, Isanaka S, Lukmanji Z, Mugusi F, Fawzi WW. Dietary Iron Intake and HIV-Related Outcomes Among Adults Initiating Antiretroviral Therapy in Tanzania. J Acquir Immune Defic Syndr. 2023 Sep 1;94(1):57-65. doi: 10.1097/QAI.0000000000003221.
Noor RA, Abioye AI, Hertzmark E, Darling AM, Aboud S, Mugusi FM, Sudfeld CR, Spiegelman D, Fawzi WW. Impaired Hematological Status Increases the Risk of Mortality among HIV-Infected Adults Initiating Antiretroviral Therapy in Tanzania. J Nutr. 2020 Sep 1;150(9):2375-2382. doi: 10.1093/jn/nxaa172.
Abioye AI, Isanaka S, Liu E, Mwiru RS, Noor RA, Spiegelman D, Mugusi F, Fawzi W. Gender differences in diet and nutrition among adults initiating antiretroviral therapy in Dar es Salaam, Tanzania. AIDS Care. 2015;27(6):706-15. doi: 10.1080/09540121.2014.996517. Epub 2015 Jan 6.
Sudfeld CR, Isanaka S, Mugusi FM, Aboud S, Wang M, Chalamilla GE, Giovannucci EL, Fawzi WW. Weight change at 1 mo of antiretroviral therapy and its association with subsequent mortality, morbidity, and CD4 T cell reconstitution in a Tanzanian HIV-infected adult cohort. Am J Clin Nutr. 2013 Jun;97(6):1278-87. doi: 10.3945/ajcn.112.053728. Epub 2013 May 1.
Isanaka S, Mugusi F, Hawkins C, Spiegelman D, Okuma J, Aboud S, Guerino C, Fawzi WW. Effect of high-dose vs standard-dose multivitamin supplementation at the initiation of HAART on HIV disease progression and mortality in Tanzania: a randomized controlled trial. JAMA. 2012 Oct 17;308(15):1535-44. doi: 10.1001/jama.2012.13083.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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P12981-101
Identifier Type: -
Identifier Source: secondary_id
HD32257-01
Identifier Type: -
Identifier Source: org_study_id
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