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Study of Vitamin D and Effect on Heart Disease and Insulin Resistance
This study has been completed.
Sponsor:
University Hospitals Cleveland Medical Center
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
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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 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 |
Resource links provided by NLM:
Further study details as provided by Grace McComsey, University Hospital Case Medical Center:
Primary Outcome Measures:
- Change in Endothelial Function [ Time Frame: Baseline and 12 weeks ]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 ]
| 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) |
| 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
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
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 |
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 |
ClinicalTrials.gov processed this record on September 19, 2017