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

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ClinicalTrials.gov Identifier: NCT01093417
Recruitment Status : Completed
First Posted : March 25, 2010
Results First Posted : February 29, 2012
Last Update Posted : July 14, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Human Immunodeficiency Virus (HIV) Vitamin D Deficiency HIV Infections Drug: Vitamin D Other: Placebo Phase 2

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: The Effect of Vitamin D Supplementation on Endothelial Function, Inflammation and Insulin Resistance in HIV
Study Start Date : January 2010
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Change in Endothelial Function [ Time Frame: Baseline and 12 weeks ]
    Endothelial function measured by flow mediated brachial artery dilation


Secondary Outcome Measures :
  1. Change in Serum 25-hydroxyvitamin D Concentration in Both Groups [ Time Frame: Baseline and 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: March 25, 2010    Key Record Dates
Results First Posted: February 29, 2012
Last Update Posted: July 14, 2016
Last Verified: June 2016

Keywords provided by Grace McComsey, University Hospital Case 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