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

HIV Infections Clinical Trial

Official title:

The Effect of Vitamin D Supplementation on Endothelial Function, Inflammation and Insulin Resistance in HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01093417
• Other study ID #: 11-09-30
• Status: Completed
• Phase: Phase 2
• First received: March 24, 2010
• Last updated: December 18, 2014
• Start date: January 2010
• Est. completion date: October 2010

Study information

• Verified date: December 2014
• Source: University Hospital Case Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: USA:Internal Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• HIV
• HIV Infections
• Insulin Resistance
• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D
Vitamin D 4000 IU will be administered to enrollees on the active comparator arm

Locations

Country	Name	City	State
United States	University Hospitals of Cleveland Case Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Case Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Endothelial Function	Endothelial function measured by flow mediated brachial artery dilation	12 weeks	No
Secondary	Change in Serum 25(OH)D Concentration in Both Groups		12 weeks	No