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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Human Immunodeficiency Virus (HIV) Vitamin D Deficiency HIV Infections | Drug: Vitamin D Other: Placebo | Phase 2 |
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 |
Actual Primary Completion Date : | October 2010 |
Actual Study Completion Date : | October 2010 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Participants that have been randomized into this arm will receive placebo pills.
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Other: Placebo
Placebo pills will be administered to enrollees in this arm
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Active Comparator: Vitamin D 4000 IU
Participants that have been randomized into this arm will receive Vitamin D 4000 IU (International Units) daily.
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Drug: Vitamin D
Vitamin D 4000 IU will be administered to enrollees on the active comparator arm
Other Name: Calciferol
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- Change in Endothelial Function [ Time Frame: Baseline and 12 weeks ]Endothelial function measured by flow mediated brachial artery dilation
- Change in Serum 25-hydroxyvitamin D Concentration in Both Groups [ Time Frame: Baseline and 12 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Ohio | |
University Hospitals of Cleveland Case Medical Center | |
Cleveland, Ohio, United States, 44106 |
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 |