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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
  Purpose

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
HIV
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:

Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by University Hospitals of Cleveland:

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093417

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

No publications provided by University Hospitals of Cleveland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Grace McComsey, Chief, Peds ID, Rheumatology and Global Health, University Hospitals of Cleveland
ClinicalTrials.gov 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: January 28, 2012
Health Authority: USA:Internal Review Board

Keywords provided by University Hospitals of Cleveland:
Vitamin D
Human Immunodeficiency Virus
Complementary Therapies

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Insulin Resistance
Vitamin D Deficiency
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Hyperinsulinism
 Glucose Metabolism Disorders
Metabolic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013