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

March 24, 2010
January 28, 2012
January 2010
October 2010   (final data collection date for primary outcome measure)
Change in Endothelial Function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Endothelial function measured by flow mediated brachial artery dilation
The Mean Change in FMD measurements in both groups [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01093417 on ClinicalTrials.gov Archive Site
Change in Serum 25(OH)D Concentration in Both Groups [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
Study of Vitamin D and Effect on Heart Disease and Insulin Resistance
The Effect of Vitamin D Supplementation on Endothelial Function, Inflammation and Insulin Resistance in HIV

The purpose of this study is to evaluate how Vitamin D affects endothelial function, inflammation, lipids, insulin resistance, vitamin D levels, and PTH.

Randomized placebo controlled trial of vitamin D supplementation in HIV infected subjects with vitamin D deficiency

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
  • HIV
  • Vitamin D Deficiency
  • HIV Infections
Drug: Vitamin D
Vitamin D 4000 IU will be administered to enrollees on the active comparator arm
Other Name: Calciferol
  • 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
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.
 
Completed
45
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01093417
11-09-30
No
Grace McComsey, University Hospitals of Cleveland
University Hospital Case Medical Center
Not Provided
Not Provided
University Hospital Case Medical Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP