Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
190 participants
INTERVENTIONAL
2011-12-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HIV + Young Adults
All will be HIV+ and receiving randomized dose of vitamin D control dose (low dose) or supplementation dose (vitamin D medium dose or vitamin D high dose)
Vitamin D control dose
18,000 IU per month
Vitamin D supplementation-
60,000 IU per month(medium dose) or 120,000 IU/month(high dose)
HIV - Controls
HIV negative controls will be receiving randomized Vitamin D doses: control vitamin D dose (low dose) or vitamin D supplementation dose (vitamin D medium dose or vitamin D high dose)
Vitamin D control dose
18,000 IU per month
Vitamin D supplementation-
60,000 IU per month(medium dose) or 120,000 IU/month(high dose)
Interventions
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Vitamin D control dose
18,000 IU per month
Vitamin D supplementation-
60,000 IU per month(medium dose) or 120,000 IU/month(high dose)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented HIV-1 infection
* On stable antiretroviral therapy for \> 3 months
* Cumulative antiretroviral therapy of at least 6 months
* 25(OH)D level \< 30 ng/ml at screening
Exclusion Criteria
* Parathyroid/calcium disorders
* Active malignancy
* Pregnancy/intent to become pregnant/breastfeeding
* Chronic infectious/inflammatory conditions
* Creatinine clearance \< 50 ml/min
* Hemoglobin \< 9.0 g/dL
* Aspartate aminotransferase and alanine aminotransferase \> 2.5 upper limit of normal
* Diabetes requiring hypoglycemic agents
* Known coronary artery disease
* Inability to swallow pills
8 Years
25 Years
ALL
Yes
Sponsors
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Emory University
OTHER
University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Grace McComsey
Professor of Pediatrics and Medicine, Chief Pediatric Infectious Diseases, Rheumatology and Global Health
Principal Investigators
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Grace McComsey, MD, FIDSA
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Locations
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Emory Children's Center
Atlanta, Georgia, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Countries
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References
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Eckard AR, O'Riordan MA, Rosebush JC, Lee ST, Habib JG, Ruff JH, Labbato D, Daniels JE, Uribe-Leitz M, Tangpricha V, Chahroudi A, McComsey GA. Vitamin D supplementation decreases immune activation and exhaustion in HIV-1-infected youth. Antivir Ther. 2018;23(4):315-324. doi: 10.3851/IMP3199.
Eckard AR, Rosebush JC, O'Riordan MA, Graves CC, Alexander A, Grover AK, Lee ST, Habib JG, Ruff JH, Chahroudi A, McComsey GA. Neurocognitive dysfunction in HIV-infected youth: investigating the relationship with immune activation. Antivir Ther. 2017;22(8):669-680. doi: 10.3851/IMP3157.
Hileman CO, Overton ET, McComsey GA. Vitamin D and bone loss in HIV. Curr Opin HIV AIDS. 2016 May;11(3):277-84. doi: 10.1097/COH.0000000000000272.
Other Identifiers
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09-11-06
Identifier Type: -
Identifier Source: org_study_id
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