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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).
Randomized placebo controlled trial of vitamin D supplementation in HIV infected subjects with vitamin D deficiency
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants that have been randomized into this arm will receive placebo pills. |
|
| Vitamin D 4000 IU | Active Comparator | Participants that have been randomized into this arm will receive Vitamin D 4000 IU (International Units) daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | Vitamin D 4000 IU will be administered to enrollees on the active comparator arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Endothelial Function | Endothelial function measured by flow mediated brachial artery dilation | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum 25-hydroxyvitamin D Concentration in Both Groups | Baseline and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Cleveland Case Medical Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22293363 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 15 participants were randomized to matching placebo for 12 weeks |
| FG001 | Vitamin D 4000 IU | 30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 15 participants were randomized to matching placebo for 12 weeks |
| BG001 | Vitamin D 4000 IU | 30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Endothelial Function | Endothelial function measured by flow mediated brachial artery dilation | Posted | Median | Inter-Quartile Range | percent change in endothelial function | Baseline and 12 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 15 participants were randomized to matching placebo for 12 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grace McComsey, MD | University Hospitals Case Medical Center | 2168443607 | gam9@case.edu |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D014808 | Vitamin D Deficiency |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Placebo | Other | Placebo pills will be administered to enrollees in this arm |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Change in Serum 25-hydroxyvitamin D Concentration in Both Groups | Posted | Median | Inter-Quartile Range | ng/mL | Baseline and 12 weeks |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Vitamin D 4000 IU | 30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks | 0 | 30 | 0 | 30 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |