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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
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A trial to measure the effects of vitamin D (versus a placebo) on balance, gait, falls, strength, and cognition in persons with Parkinson's disease.
The proposed study is a randomized, double-blinded, placebo controlled intervention trial to measure the effects of vitamin D at (10,000IU/day) versus placebo on balance and falls in Parkinson's disease. The investigators will measure static, dynamic, and ambulatory balance, as well as strength, falls, and cognition before and after 16 weeks of therapy. Dynamic posturography will be used to measure static and ambulatory balance, a device called iMOBILITY will measure a timed up and go, and strength will be measured with the Biodex machine checking knee flexion and extension. Multiple quality of life and cognitive tests will also be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Will be on high dose vitamin D3 (10,000 IU daily) and 1000 mg of calcium |
|
| Arm 2 | Placebo Comparator | Will be on placebo and 1000mg of calcium. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | Vitamin D3 at 10,000 IU a day |
| |
| calcium |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3) | Sensory organization test (SOT) is a form of posturography. which is designed to assess quantitatively an individual's ability to use visual, proprioceptive and vestibular cues to maintain postural stability in stance. The SOT measures sway during 6 scenarios. In scenarios 1-3 the base is stable and eyes are open, then closed, and then the visual surround moves. SOT 1-3 is an average measurement of equilibrium - the average center of gravity sway for each condition. It generates a score of 0 (fall) up to 100 for each scenario and an overall composite score. Change score is measurement at 16 weeks minus measurement at baseline. | Baseline, 16 weeks |
| Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration | This is a test that measures ambulatory balance and mobility. The instrumented timed up and go (iTUG) is an average time (seconds) of three trials that involve the participant arising from a chair, walking 25 feet turning around, walking back to the chair, and sitting down. The turn duration is the average time to turn at the end of the 25 foot walk. Longer duration of time (seconds) indicates more rigidity, a proxy measure for "ON" time in Parkinson's disease. Change score is measurement at 16 weeks minus measurement at baseline. | Baseline and 16 weeks |
| Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work) | Defined as the total muscular force output for the repetition with the greatest amount of work. The equation for work is: W = F x D. Change score is measurement at 16 weeks minus measurement at baseline. | Baseline, 16 weeks |
| Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6) | Sensory organization test (SOT) is a form of posturography. which is designed to assess quantitatively an individual's ability to use visual, proprioceptive and vestibular cues to maintain postural stability in stance. The SOT measures sway during 6 scenarios. In 4-6 the base moves and the subject has eyes open, then closed, then the visual surround moves. SOT 4-6 is an average measurement of equilibrium - the average center of gravity sway for each condition. It generates a score of 0 (fall) up to 100 for each scenario and an overall composite score. Change score is measurement at 16 weeks minus measurement at baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cognition (Trail Making Test B-A) | The Trail Making Test (TMT) consists of two parts (A & B) in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test provides information about visual search speed, scanning, speed of processing, and executive functioning. Part A measures processing speed and part B measures executive functioning. The TMT is time to complete each part of the test in seconds. Higher scores indicate greater impairment. Subtracting part A from part B is theorized to reduce the influence of the working memory and visuospatial demands and, therefore, provides a relatively pure indicator of executive function. Change score is measurement (Part B - Part A) at 16 weeks minus measurement (Part B - Part A) at baseline, negative scores indicate a improvement in executive functioning. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amie Hiller, MD BS | VA Portland Health Care System, Portland, OR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30256811 | Derived | Hiller AL, Murchison CF, Lobb BM, O'Connor S, O'Connor M, Quinn JF. A randomized, controlled pilot study of the effects of vitamin D supplementation on balance in Parkinson's disease: Does age matter? PLoS One. 2018 Sep 26;13(9):e0203637. doi: 10.1371/journal.pone.0203637. eCollection 2018. |
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Excluded (n=33) Not meeting criteria (n=32) (16 have vitamin D levels that were too high, 4 hx of renal stones, 3 with a history of tuberculosis, and 9 other) Lost to follow-up (n=1)
Participants were recruited from two large treatment centers in the Pacific Northwest and from the community during the time period 2011 - 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D (Open Label) | Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium Vitamin D: Vitamin D at 10,000 IU a day calcium: 1000mg calcium daily |
| FG001 | Vitamin D | Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium Vitamin D: Vitamin D at 10,000 IU a day calcium: 1000mg calcium daily |
| FG002 | Placebo | Will be on placebo and 1000mg of calcium. calcium: 1000mg calcium daily Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D (Open Label) | Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium Vitamin D: Vitamin D at 10,000 IU a day calcium: 1000mg calcium daily |
| BG001 | Vitamin D |
| 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 Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3) | Sensory organization test (SOT) is a form of posturography. which is designed to assess quantitatively an individual's ability to use visual, proprioceptive and vestibular cues to maintain postural stability in stance. The SOT measures sway during 6 scenarios. In scenarios 1-3 the base is stable and eyes are open, then closed, and then the visual surround moves. SOT 1-3 is an average measurement of equilibrium - the average center of gravity sway for each condition. It generates a score of 0 (fall) up to 100 for each scenario and an overall composite score. Change score is measurement at 16 weeks minus measurement at baseline. | Missing data N=2, test not performed due to participant fatigue. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 16 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 | Vitamin D (Open Label) | Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium Vitamin D: Vitamin D at 10,000 IU a day calcium: 1000mg calcium daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Illness | General disorders | Non-systematic Assessment | Non-Specified Illness |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amie Hiller, MD | VA Portland Health Care System | 503.721.1091 | peterami@ohsu.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D002118 | Calcium |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Dietary Supplement |
1000mg calcium daily |
|
| Placebo | Other | A placebo pill with similar appearance to the vitamin D3 will be given to those in the placebo arm |
|
| Baseline, 16 weeks |
| Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work) | Defined as the total muscular force output for the repetition with the greatest amount of work. The equation for work is: W = F x D. Change score is measurement at 16 weeks minus measurement at baseline. | Baseline, 16 weeks |
| Baseline, 16 weeks |
| Change in Quality of Life as Recorded Using Quality of Life Scales (PDQ39) | The PDQ39 is a 39 item patient completed survey targeting well-being and functioning in PD. This scale address 8 dimensions (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort). The PDQ39 dimension scores are on a scale of 0 ("Never") to 4 ("Always/Cannot Do"). Scale scores are summed and range from 0 to 100 with 100 being the maximum level of problems. For a single index figure to characterize the impact of Parkinson's disease upon PD patients (PDSI), all 39 items of the PDQ39 can be summed. The PDQ39 and the use of a PDSI have shown adequate reliability and convergent validity. Change score is measurement at 16 weeks minus baseline measurement, negative scores indicate an improvement in quality of life. | Baseline, 16 weeks |
| Change in Parkinsonism as Measured by the UPDRS | This is the motor subsection of the UPDRS and is a commonly used tool to rate the symptoms of Parkinson's disease. This scale rates from 0 (normal) to 4 (Can barely perform the task) several motor areas including speech, facial expression, tremor, rigidity, hand movements, agility, posture, and gait. A sum score represents motor function with higher values on this scale represent a more severe stage of the disease. Change is measurement at 16 weeks minus baseline measurement, negative scores indicate an improvement in Parkinson's motor symptoms. | Baseline, 16 weeks |
| Physician Decision |
|
Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily
| BG002 | Placebo | Will be on placebo and 1000mg of calcium. calcium: 1000mg calcium daily Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hoehn & Yahr | This is an objective staging scale for rating the clinical functioning of Parkinson's disease patients, combining functional deficits (disability) and objective signs (impairment). This staging scale is commonly used in both research settings and clinical practice. The Hoehn & Yahr is an ordinal scale ranging from 0 (no signs of disease) to 5 (wheelchair bound/bedridden). The modified version of the scale includes increments of 0.5. The HY has shown good inter-rater reliability and, although it is used worldwide, the clinimetric validity has not been established. | Mean | Standard Deviation | units on a scale |
|
| UPDRS | This is the motor subsection of the UPDRS and is a commonly used tool to rate the symptoms of Parkinson's disease. Each item is rated from 0 (normal) to 4 (Can barely perform the task) several motor areas including speech, facial expression, tremor, rigidity, hand movements, agility, posture, and gait. Total score ranges from 0 to 108 with higher values on this scale represent a more severe stage of the disease. | Mean | Standard Deviation | units on a scale |
|
| Baseline Vitamin D | Mean | Standard Deviation | ng/ml |
|
| MoCA | The MoCA is a short cognitive screening test designed to assist health care professionals for the detection of mild cognitive impairment. The MoCA assesses cognitive function across a variety of domains, such as visuospatial /executive functioning, naming (animals), memory, attention, language, abstraction, delayed recall, and orientation. The MoCA is scored on a 0 to 30 scale, with lower numbers indicating more cognitive impairment. A point is added to the MoCA if the subject's education high school or less (12 years or less education). | Mean | Standard Deviation | units on a scale |
|
| Falls Self-Report | Mean | Standard Deviation | Falls |
|
Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
Vitamin D: Vitamin D at 10,000 IU a day
calcium: 1000mg calcium daily
| OG001 | Vitamin D | Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium Vitamin D: Vitamin D at 10,000 IU a day calcium: 1000mg calcium daily |
| OG002 | Placebo | Will be on placebo and 1000mg of calcium. calcium: 1000mg calcium daily Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm |
|
|
|
| Primary | Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration | This is a test that measures ambulatory balance and mobility. The instrumented timed up and go (iTUG) is an average time (seconds) of three trials that involve the participant arising from a chair, walking 25 feet turning around, walking back to the chair, and sitting down. The turn duration is the average time to turn at the end of the 25 foot walk. Longer duration of time (seconds) indicates more rigidity, a proxy measure for "ON" time in Parkinson's disease. Change score is measurement at 16 weeks minus measurement at baseline. | Missing data N=14, test not performed due to either participant fatigue (N = 2) or mechanical/computer issues (N = 12). | Posted | Mean | Standard Deviation | seconds | Baseline and 16 weeks |
|
|
|
|
| Primary | Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work) | Defined as the total muscular force output for the repetition with the greatest amount of work. The equation for work is: W = F x D. Change score is measurement at 16 weeks minus measurement at baseline. | Missing data N=4, test not performed due to participant fatigue (N = 2), mechanical/computer issues (N = 1), illness of operator (N = 1). | Posted | Mean | Standard Deviation | foot pounds | Baseline, 16 weeks |
|
|
|
|
| Secondary | Change in Cognition (Trail Making Test B-A) | The Trail Making Test (TMT) consists of two parts (A & B) in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test provides information about visual search speed, scanning, speed of processing, and executive functioning. Part A measures processing speed and part B measures executive functioning. The TMT is time to complete each part of the test in seconds. Higher scores indicate greater impairment. Subtracting part A from part B is theorized to reduce the influence of the working memory and visuospatial demands and, therefore, provides a relatively pure indicator of executive function. Change score is measurement (Part B - Part A) at 16 weeks minus measurement (Part B - Part A) at baseline, negative scores indicate a improvement in executive functioning. | Missing data (N = 8) due to scheduling difficulties (N = 3), neuropsychological administration errors (N = 2), patient discontinuing (N = 1), maximum time allowance met and discontinued test (N = 2). | Posted | Mean | Standard Deviation | seconds | Baseline, 16 weeks |
|
|
|
|
| Secondary | Change in Quality of Life as Recorded Using Quality of Life Scales (PDQ39) | The PDQ39 is a 39 item patient completed survey targeting well-being and functioning in PD. This scale address 8 dimensions (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort). The PDQ39 dimension scores are on a scale of 0 ("Never") to 4 ("Always/Cannot Do"). Scale scores are summed and range from 0 to 100 with 100 being the maximum level of problems. For a single index figure to characterize the impact of Parkinson's disease upon PD patients (PDSI), all 39 items of the PDQ39 can be summed. The PDQ39 and the use of a PDSI have shown adequate reliability and convergent validity. Change score is measurement at 16 weeks minus baseline measurement, negative scores indicate an improvement in quality of life. | Missing data (N = 3), patient forgot form and did not return mailed form (N = 3). | Posted | Mean | Standard Deviation | units on a scale | Baseline, 16 weeks |
|
|
|
|
| Primary | Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6) | Sensory organization test (SOT) is a form of posturography. which is designed to assess quantitatively an individual's ability to use visual, proprioceptive and vestibular cues to maintain postural stability in stance. The SOT measures sway during 6 scenarios. In 4-6 the base moves and the subject has eyes open, then closed, then the visual surround moves. SOT 4-6 is an average measurement of equilibrium - the average center of gravity sway for each condition. It generates a score of 0 (fall) up to 100 for each scenario and an overall composite score. Change score is measurement at 16 weeks minus measurement at baseline. | Missing data N=3, test not performed due to participant fatigue (N = 2) or computer/mechanical error (N = 1). | Posted | Mean | Standard Deviation | units on a scale | Baseline, 16 weeks |
|
|
|
| Primary | Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work) | Defined as the total muscular force output for the repetition with the greatest amount of work. The equation for work is: W = F x D. Change score is measurement at 16 weeks minus measurement at baseline. | Missing data N=4, test not performed due to participant fatigue (N = 2), mechanical/computer issues (N = 1), illness of operator (N = 1). | Posted | Mean | Standard Deviation | foot pounds | Baseline, 16 weeks |
|
|
|
|
| Secondary | Change in Parkinsonism as Measured by the UPDRS | This is the motor subsection of the UPDRS and is a commonly used tool to rate the symptoms of Parkinson's disease. This scale rates from 0 (normal) to 4 (Can barely perform the task) several motor areas including speech, facial expression, tremor, rigidity, hand movements, agility, posture, and gait. A sum score represents motor function with higher values on this scale represent a more severe stage of the disease. Change is measurement at 16 weeks minus baseline measurement, negative scores indicate an improvement in Parkinson's motor symptoms. | Missing data (N = 2), invalid sum due to missing rating (N = 1), not completed due to scheduling conflicts (N = 1). | Posted | Mean | Standard Deviation | units on a scale | Baseline, 16 weeks |
|
|
|
|
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | Vitamin D | Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium Vitamin D: Vitamin D at 10,000 IU a day calcium: 1000mg calcium daily | 0 | 28 | 1 | 28 |
| EG002 | Placebo | Will be on placebo and 1000mg of calcium. calcium: 1000mg calcium daily Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm | 0 | 30 | 2 | 30 |
| Injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |