Effects of Vitamin D in Parkinson's Disease (PD)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effects of Vitamin D on Balance in Persons With PD

Conditions
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Parkinson Disease, Accidental Falls

Intervention / Treatment
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* Drug: Vitamin D3
* Dietary Supplement: calcium
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parkinson's disease; ability to ambulate 50 feet; ability to cooperate with balance testing; vitamin D level less than 40ng/ml; balance problems; ability to walk 50 feet without the help of another person Exclusion Criteria: MMSE < 25; another neurological or orthopedic deficit that in the examiner's opinion would affect testing; history of renal stones or hypercalcemia; unwillingness to not be on other vitamin D supplementation during the study

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Will be on high dose vitamin D3 (10,000 IU daily) and 1000 mg of calcium | Drug: Vitamin D3<br>* Vitamin D3 at 10,000 IU a day<br>Dietary Supplement: calcium<br>* 1000mg calcium daily<br>|
| Placebo Comparator: Arm 2<br>Will be on placebo and 1000mg of calcium. | Dietary Supplement: calcium<br>* 1000mg calcium daily<br>Other: Placebo<br>* A placebo pill with similar appearance to the vitamin D3 will be given to those in the placebo arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Parkinson disease, accidental falls