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| Name | Class |
|---|---|
| Emory University | OTHER |
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The purpose of this study is to determine the correct dose of Vitamin D to give to prevent HIV related complications.
The purpose of the this study was to compare control dose of vitamin D (low dose of 600 IU/d) to supplementation dose (medium dose of 2000 IU/d or higher doses of vitamin D of 4000 IU/d) on HIV-related comorbidities including immune activation, inflammation, cardiovascular diseases, and metabolic complications in HIV-infected youth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV + Young Adults | Active Comparator | All will be HIV+ and receiving randomized dose of vitamin D control dose (low dose) or supplementation dose (vitamin D medium dose or vitamin D high dose) |
|
| HIV - Controls | Active Comparator | HIV negative controls will be receiving randomized Vitamin D doses: control vitamin D dose (low dose) or vitamin D supplementation dose (vitamin D medium dose or vitamin D high dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D control dose | Drug | 18,000 IU per month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Serum 25(OH)D3 Levels | Evaluate the dose-related efficacy of correction of Vitamin D deficiency for 25(OH)D3 levels in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral Vitamin D supplementation: control dose (18,000 IU per month) or supplemented dose (medium 60,000IU per month or high dose 120,000IU/month ) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Vitamin D Binding Protein (VDBP) | Evaluate the dose-related efficacy of vitamin D binding Protein in levels in the blood in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral vitamin D supplementation. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grace McComsey, MD, FIDSA | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Children's Center | Atlanta | Georgia | 30322 | United States | ||
| University Hospitals Case Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28994661 | Derived | Eckard AR, O'Riordan MA, Rosebush JC, Lee ST, Habib JG, Ruff JH, Labbato D, Daniels JE, Uribe-Leitz M, Tangpricha V, Chahroudi A, McComsey GA. Vitamin D supplementation decreases immune activation and exhaustion in HIV-1-infected youth. Antivir Ther. 2018;23(4):315-324. doi: 10.3851/IMP3199. | |
| 28327462 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | HIV+ With Vit D Supplementation | HIV-infected adults who were supplemented with vit D ( medium dose: 60,000 IU per month or vitamin D high dose: 120,000 IU/month ) were combined into the supplementation group and compared to the standard control vitamin D dose |
| FG001 | HIV+ Young Adults With Vitamin D Control Dose | HIV+ receiving Vitamin D low dose: 18,000 IU per month |
| FG002 | HIV - With Vitamin D Supplementation | HIV-uninfected adults who were supplemented with vitamin D: a medium dose of 60,000 IU per month or a higher dose of 120,000 IU/month. |
| FG003 | HIV - With Vitamin D Control Dose | HIV uninfected controls receiving Vitamin D low dose: 18,000 IU per month |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 190 subjects were enrolled, including 102 HIV-infected subjects: 66 on vitamin D supplementation dose, 36 on vitamin D control dose and 88 healthy controls: 58 on vitamin D supplementation dose, 30 on vitamin D control dose. By design, groups were well matched for age, sex and race.
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| ID | Title | Description |
|---|---|---|
| BG000 | HIV+ With Vit D Supplementation | HIV-infected adults who were supplemented with vit D ( medium dose: 60,000 IU per month or vitamin D high dose: 120,000 IU/month ) were combined into the supplementation group and compared to the standard control vitamin D dose |
| BG001 | HIV+ Young Adults With Vitamin D Control Dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Changes in Serum 25(OH)D3 Levels | Evaluate the dose-related efficacy of correction of Vitamin D deficiency for 25(OH)D3 levels in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral Vitamin D supplementation: control dose (18,000 IU per month) or supplemented dose (medium 60,000IU per month or high dose 120,000IU/month ) | HIV-infected on vitamin D control or supplementation dose and matched HIV-uninfected group on control or supplementation dose | Posted | Median | Inter-Quartile Range | ng/mL | 6 months |
|
Adverse events were collected throughout the study duration, at baseline, 6 months, and 12 months.
The same definitions are used. Systematic assessments of adverse events were done at each visit date by questionnaires, physical exam and vitamin D levels assessment by the study team. In case of adverse events they were reported to the principal investigator and then assessed in Data Safety and Monitory Board regular meetings.
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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 | HIV + on Vitamin D Control Dose | HIV+ receiving vitamin D control dose ( low dose: 18,000 IU per month) |
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Limitations to this study include the lack of adherence measures to study drug such as pill counts and the small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Grace McComsey | University Hospitals Cleveland Medical Center | 216-844-2739 | Grace.McComsey@UHhospitals.org |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D002112 | Calcifediol |
| ID | Term |
|---|---|
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
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| Vitamin D supplementation- | Drug | 60,000 IU per month(medium dose) or 120,000 IU/month(high dose) |
|
|
| Cleveland |
| Ohio |
| 44106 |
| United States |
| Eckard AR, Rosebush JC, O'Riordan MA, Graves CC, Alexander A, Grover AK, Lee ST, Habib JG, Ruff JH, Chahroudi A, McComsey GA. Neurocognitive dysfunction in HIV-infected youth: investigating the relationship with immune activation. Antivir Ther. 2017;22(8):669-680. doi: 10.3851/IMP3157. |
| 26890209 | Derived | Hileman CO, Overton ET, McComsey GA. Vitamin D and bone loss in HIV. Curr Opin HIV AIDS. 2016 May;11(3):277-84. doi: 10.1097/COH.0000000000000272. |
HIV+ receiving Vitamin D low dose: 18,000 IU per month |
| BG002 | HIV - With Vitamin D Supplementation | HIV-uninfected adults who were supplemented with vitamin D: a medium dose of 60,000 IU per month or a higher dose of 120,000 IU/month. |
| BG003 | HIV - With Vitamin D Control Dose | HIV uninfected controls receiving Vitamin D low dose: 18,000 IU per month |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
HIV-infected young adults receiving a supplementation dose of vitamin D (either medium dose of 60,000 IU per month or a high dose of 120,000 IU/month) |
| OG002 | HIV Negative on Vitamin D Control Dose | HIV negative controls receiving Vitamin D low dose: 18,000 IU per month |
| OG003 | HIV Negative on Vitamin D Supplementation Dose | HIV negative controls receiving Vitamin D medium dose: 60,000 IU per month or vitamin D high dose: 120,000 IU/month |
|
|
| Secondary | Changes in Vitamin D Binding Protein (VDBP) | Evaluate the dose-related efficacy of vitamin D binding Protein in levels in the blood in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral vitamin D supplementation. | HIV-infected children and young adults and matched healthy control group. Results were not analyzed were captured comparing HIV+ young adults on control or supplementation vit D to HIV - controls | Posted | Median | Inter-Quartile Range | ng/mL | 6 months |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | HIV+ on Vitamin D Supplementation Dose | HIV+ receiving vitamin D supplementation doses (medium dose of 60,000 IU per month or higher dose of 120,000 IU/month) | 0 | 66 | 0 | 66 | 0 | 66 |
| EG002 | HIV - on Vitamin D Control Dose | HIV negative patients receiving vitamin D control dose (low dose of 18,000 IU per month) | 0 | 58 | 0 | 30 | 0 | 30 |
| EG003 | HIV- on Vitamin D Supplementation Dose | HIV negative patients receiving vitamin D supplementation doses (medium dose of 60,000 IU per month or higher dose of 120,000 IU/month) | 0 | 30 | 0 | 58 | 0 | 58 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | 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 |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |