Study of Vitamin D and Effect on Heart Disease and Insulin Resistance

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Grace McComsey, University Hospitals of Cleveland

ClinicalTrials.gov Identifier:

NCT01093417

First received: March 24, 2010

Last updated: January 28, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 24, 2010
Last Updated Date	January 28, 2012
Start Date ^ICMJE	January 2010
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 28, 2012)	Change in Endothelial Function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Endothelial function measured by flow mediated brachial artery dilation
Original Primary Outcome Measures ^ICMJE (submitted: March 24, 2010)	The Mean Change in FMD measurements in both groups [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01093417 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 28, 2012)	Change in Serum 25(OH)D Concentration in Both Groups [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: March 24, 2010)	Change from baseline in markers of endothelial dysfunction, inflammatory cytokines, bone markers, oxidative markers and insulin resistance. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of Vitamin D and Effect on Heart Disease and Insulin Resistance
Official Title ^ICMJE	The Effect of Vitamin D Supplementation on Endothelial Function, Inflammation and Insulin Resistance in HIV
Brief Summary	The purpose of this study is to evaluate how Vitamin D affects endothelial function, inflammation, lipids, insulin resistance, vitamin D levels, and PTH.
Detailed Description	Randomized placebo controlled trial of vitamin D supplementation in HIV infected subjects with vitamin D deficiency
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator)
Condition ^ICMJE	HIV Vitamin D Deficiency HIV Infections
Intervention ^ICMJE	Drug: Vitamin D Vitamin D 4000 IU will be administered to enrollees on the active comparator arm Other Name: Calciferol
Study Arm (s)	Placebo Comparator: Placebo Participants will be randomized to either Vitamin D 4000 IU daily or placebo Intervention: Drug: Vitamin D Active Comparator: Vitamin D 4000 IU Participants will be randomized on a 2:1 basis to either Vitamin D or Placebo Intervention: Drug: Vitamin D
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	45
Completion Date	October 2010
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: HIV infected HIV-RNA < 400 copies/ml at study entry and for 12 wks. prior 25 (OH)D level <20 On a stable ARV regimen for at least 12 weeks prior to study entry Exclusion Criteria: Pregnancy or Breast Feeding Diabetes Creatinine Clearance <50 Any active infectious or inflammatory condition AST or ALT >2.5 within 6 mos. prior to study entry
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01093417
Other Study ID Numbers ^ICMJE	11-09-30
Has Data Monitoring Committee	No
Responsible Party	Grace McComsey, University Hospitals of Cleveland
Study Sponsor ^ICMJE	University Hospitals of Cleveland
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University Hospitals of Cleveland
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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