Study of Vitamin D and Effect on Heart Disease and Insulin Resistance
NCT ID: NCT01093417
Last Updated: 2016-07-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
45 participants
INTERVENTIONAL
2010-01-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TRIPLE
Study Groups
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Placebo
Participants that have been randomized into this arm will receive placebo pills.
Placebo
Placebo pills will be administered to enrollees in this arm
Vitamin D 4000 IU
Participants that have been randomized into this arm will receive Vitamin D 4000 IU (International Units) daily.
Vitamin D
Vitamin D 4000 IU will be administered to enrollees on the active comparator arm
Interventions
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Vitamin D
Vitamin D 4000 IU will be administered to enrollees on the active comparator arm
Placebo
Placebo pills will be administered to enrollees in this arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HIV-RNA \< 400 copies/ml at study entry and for 12 wks. prior
* 25-hydroxyvitamin D level \<20
* On a stable anti-retroviral (ARV) regimen for at least 12 weeks prior to study entry
Exclusion Criteria
* Diabetes
* Creatinine Clearance \<50
* Any active infectious or inflammatory condition
* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 within 6 months prior to study entry
18 Years
ALL
No
Sponsors
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University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Grace McComsey
Chief, Peds ID, Rheumatology and Global Health
Locations
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University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, United States
Countries
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References
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Longenecker CT, Hileman CO, Carman TL, Ross AC, Seydafkan S, Brown TT, Labbato DE, Storer N, Tangpricha V, McComsey GA. Vitamin D supplementation and endothelial function in vitamin D deficient HIV-infected patients: a randomized placebo-controlled trial. Antivir Ther. 2012;17(4):613-21. doi: 10.3851/IMP1983. Epub 2011 Nov 17.
Other Identifiers
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11-09-30
Identifier Type: -
Identifier Source: org_study_id
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