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: December 18, 2014

Last verified: December 2014

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:

MedlinePlus related topics: Diabetes Medicines HIV/AIDS Vitamin D

Drug Information available for: Vitamin D

U.S. FDA Resources

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

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

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 Hospital Case Medical Center

More Information

No publications provided by University Hospital Case Medical Center

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

Longenecker CT, Hileman CO, Carman TL, Ross AC, Seydafkan S, Brown TT, Labbato DE, Storer N, Tangpricha V, McComsey GA. Vitamin D supplementation and endothelial function in vitamin D deficient HIV-infected patients: a randomized placebo-controlled trial. Antivir Ther. 2012;17(4):613-21. doi: 10.3851/IMP1983. Epub 2011 Nov 17.


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:	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 Avitaminosis Deficiency Diseases Glucose Metabolism Disorders Hyperinsulinism Malnutrition Metabolic Diseases Nutrition Disorders	Ergocalciferols Vitamin D Vitamins Bone Density Conservation Agents Growth Substances Micronutrients Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 27, 2015

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