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Vitamin D insufficiency is a problem of growing concern, given its prevalence in older persons and the association of low vitamin D with multiple major health problems, including mobility and balance deterioration and falls, cardiovascular disease, diabetes, and certain cancers. Sedentary persons are particularly vulnerable for these health problems and generally not adherent to prescribed physical activity. This study will investigate if treatment with vitamin D will benefit physical performance in male veterans age 65 to 95.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Arm | Placebo Comparator | placebo capsule |
|
| Cholecalciferol 4000 IU | Experimental | cholecalciferol 4000 IU daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D | Dietary Supplement | cholecalciferol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Short Physical Performance Battery Test Score | The short physical performance battery (SPPB) examines 3 areas of lower extremity function: static balance test, gait speed test and getting in and out of a chair test. The total SPPB score is the sum of the scores of the 3 components and can range from 0 to 12, with 0 reflecting severe limitations and 12 minimal or no limitations. The ranges for each subscale are: balance (0-4), gait speed (0-4), sit-to-stand (0-4). In all the subscales, 0 reflects worse outcome and 4 best outcome. | baseline and 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silvina Levis-Dusseau, MD | VA Medical Center, Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Miami | Miami | Florida | 33125 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Arm | placebo capsule placebo: placebo tablet participants received one daily tablet containing placebo for 9 months |
| FG001 | Cholecalciferol 4000 IU | cholecalciferol 4000 IU daily vitamin D: cholecalciferol participants received one daily tablet containing cholecalciferol 4000 IU for 9 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Arm | placebo capsule placebo: placebo tablet participants received one daily tablet containing placebo for 9 months |
| BG001 | Cholecalciferol 4000 IU | cholecalciferol 4000 IU daily vitamin D: cholecalciferol participants received one daily tablet containing cholecalciferol 4000 IU for 9 months |
| 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 | Change in Short Physical Performance Battery Test Score | The short physical performance battery (SPPB) examines 3 areas of lower extremity function: static balance test, gait speed test and getting in and out of a chair test. The total SPPB score is the sum of the scores of the 3 components and can range from 0 to 12, with 0 reflecting severe limitations and 12 minimal or no limitations. The ranges for each subscale are: balance (0-4), gait speed (0-4), sit-to-stand (0-4). In all the subscales, 0 reflects worse outcome and 4 best outcome. | Posted | Mean | Standard Deviation | units on a scale | baseline and 9 months |
|
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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 Arm | placebo capsule placebo: placebo tablet participants received one daily tablet containing placebo for 9 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cancer | Skin and subcutaneous tissue disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypercalcemia | Endocrine disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Silvina Levis MD | Miami VA Medical Center | 305-575-3388 | silvina.levis-dusseau@va.gov |
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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 |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| placebo |
| Dietary Supplement |
placebo tablet |
|
| Death |
|
| Adverse Event |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
cholecalciferol 4000 IU daily vitamin D: cholecalciferol participants received one daily tablet containing cholecalciferol 4000 IU for 9 months |
|
|
| 5 |
| 64 |
| 12 |
| 64 |
| EG001 | Cholecalciferol 4000 IU | cholecalciferol 4000 IU daily vitamin D: cholecalciferol participants received one daily tablet containing cholecalciferol 4000 IU for 9 months | 2 | 66 | 11 | 66 |
| pneumonia | Respiratory, thoracic and mediastinal disorders |
|
| renal mass | Renal and urinary disorders |
|
| pulmonary edema | Cardiac disorders |
|
| renal failure | Renal and urinary disorders |
|
| prostate cancer | Renal and urinary disorders |
|
| lung cancer | Respiratory, thoracic and mediastinal disorders |
|
| fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |