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

This study has been completed.
Information provided by (Responsible Party):
Grace McComsey, University Hospital Case Medical Center Identifier:
First received: March 24, 2010
Last updated: December 18, 2014
Last verified: December 2014
The purpose of this study is to evaluate how Vitamin D affects endothelial function, inflammation, lipids, insulin resistance, vitamin D levels, and PTH.

Condition Intervention Phase
Vitamin D Deficiency
HIV Infections
Drug: Vitamin D
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: The Effect of Vitamin D Supplementation on Endothelial Function, Inflammation and Insulin Resistance in HIV

Resource links provided by NLM:

Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Change in Endothelial Function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Endothelial function measured by flow mediated brachial artery dilation

Secondary Outcome Measures:
  • Change in Serum 25(OH)D Concentration in Both Groups [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: January 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Participants will be randomized to either Vitamin D 4000 IU daily or placebo
Drug: Vitamin D
Vitamin D 4000 IU will be administered to enrollees on the active comparator arm
Other Name: Calciferol
Active Comparator: Vitamin D 4000 IU
Participants will be randomized on a 2:1 basis to either Vitamin D or Placebo
Drug: Vitamin D
Vitamin D 4000 IU will be administered to enrollees on the active comparator arm
Other Name: Calciferol

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01093417

United States, Ohio
University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospital Case Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Grace McComsey, Chief, Peds ID, Rheumatology and Global Health, University Hospital Case Medical Center Identifier: NCT01093417     History of Changes
Other Study ID Numbers: 11-09-30 
Study First Received: March 24, 2010
Results First Received: January 28, 2012
Last Updated: December 18, 2014
Health Authority: USA:Internal Review Board

Keywords provided by University Hospital Case Medical Center:
Vitamin D
Human Immunodeficiency Virus
Complementary Therapies

Additional relevant MeSH terms:
Insulin Resistance
Vitamin D Deficiency
Deficiency Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Vitamin D
Bone Density Conservation Agents
Growth Substances
Physiological Effects of Drugs processed this record on May 26, 2016