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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 Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01093417
First received: March 24, 2010
Last updated: June 14, 2016
Last verified: June 2016
  Purpose
The purpose of this study is to evaluate how Vitamin D affects endothelial function, inflammation, lipids, insulin resistance, vitamin D levels, and parathyroid hormone (PTH).

Condition Intervention Phase
Human Immunodeficiency Virus (HIV)
Vitamin D Deficiency
HIV Infections
Drug: Vitamin D
Other: Placebo
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 Hospitals Cleveland Medical Center:

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


Secondary Outcome Measures:
  • Change in Serum 25-hydroxyvitamin D Concentration in Both Groups [ Time Frame: Baseline and 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 that have been randomized into this arm will receive placebo pills.
Other: Placebo
Placebo pills will be administered to enrollees in this arm
Active Comparator: Vitamin D 4000 IU
Participants that have been randomized into this arm will receive Vitamin D 4000 IU (International Units) daily.
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   (Adult, Senior)
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-hydroxyvitamin D level <20
  • On a stable anti-retroviral (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
  • aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 within 6 months 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 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 Cleveland Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Grace McComsey, Chief, Peds ID, Rheumatology and Global Health, University Hospital Case Medical Center
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: June 14, 2016
Health Authority: USA:Internal Review Board

Keywords provided by University Hospitals Cleveland Medical Center:
Vitamin D
Human Immunodeficiency Virus (HIV)
Complementary Therapies

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

ClinicalTrials.gov processed this record on September 29, 2016