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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This study will evaluate the safety over 6 months of two different doses of vitamin D (cholecalciferol) in men and women age 65 and older. It will also evaluate if supplementation with vitamin D improves physical performance.
120 ambulatory men and women ages 65 to 95 will be enrolled in this study. Each subject will participate in the clinical trial for 6 months.
Parathyroid hormone, vitamin D, and serum and urinary calcium will be measured periodically. Physical performance will be tested at baseline and throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | vitamin D (cholecalciferol) 400 IU daily orally - low dose |
|
| 2 | Active Comparator | vitamin D (cholecalciferol) 2000 IU daily orally - high dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholecalciferol (vitamin D) | Dietary Supplement | 400 IU daily (low dose) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Develop Hypercalcemia | calcium serum levels measured at baseline and at the end of the intervention (6-months) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Serum 25-hydroxyvitamin D Levels | baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silvina Levis, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23553992 | Background | Lagari V, Gomez-Marin O, Levis S. The role of vitamin D in improving physical performance in the elderly. J Bone Miner Res. 2013 Oct;28(10):2194-201. doi: 10.1002/jbmr.1949. | |
| 22784845 | Result | Lagari VS, Gomez-Marin O, Levis S. Differences in vitamin D3 dosing regimens in a geriatric community-dwelling population. Endocr Pract. 2012 Nov-Dec;18(6):847-54. doi: 10.4158/EP12081.OR. |
| Label | URL |
|---|---|
| link to Pubmed abstract | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D 400 IU | participants received one tablet containing cholecalciferol 400 IU daily orally (low dose) |
| FG001 | Vitamin D 2000 IU | participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D 400 IU | participants received one tablet containing cholecalciferol 400 IU daily orally (low dose) |
| BG001 | Vitamin D 2000 IU | participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants Who Develop Hypercalcemia | calcium serum levels measured at baseline and at the end of the intervention (6-months) | Posted | Number | participants | 6 months |
|
|
Adverse events were collected during the 6 months of the intervention.
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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 | Vitamin D 400 IU | participants received one tablet containing cholecalciferol 400 IU daily orally (low dose) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypercalcemia | Endocrine disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Silvina Levis | University of Miami | 305-575-3388 | slevis@miami.edu |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| cholecalciferol (vitamin D) |
| Dietary Supplement |
2000 IU daily (high dose) |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Change From Baseline in Serum 25-hydroxyvitamin D Levels | Posted | Mean | Standard Deviation | ng/ml | baseline and 6 months |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Vitamin D 2000 IU | participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose) | 0 | 71 | 2 | 71 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |