The Effects of Vitamin D on Balance in Persons With PD
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm 2
Will be on placebo and 1000mg of calcium.
Intervention: Placebo (Other)
Arm 1
Will be on high dose vitamin D3 (10,000 IU daily) and 1000 mg of calcium
Intervention: Vitamin D3 (Drug)
Arm 1
Will be on high dose vitamin D3 (10,000 IU daily) and 1000 mg of calcium
Intervention: calcium (Dietary Supplement)
Arm 2
Will be on placebo and 1000mg of calcium.
Intervention: calcium (Dietary Supplement)
Outcomes
Primary Outcomes
Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3)
Time Frame: Baseline, 16 weeks
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.
Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration
Time Frame: Baseline and 16 weeks
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.
Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work)
Time Frame: Baseline, 16 weeks
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.
Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work)
Time Frame: Baseline, 16 weeks
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.
Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6)
Time Frame: Baseline, 16 weeks
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.
Secondary Outcomes
- Change in Parkinsonism as Measured by the UPDRS(Baseline, 16 weeks)
- Change in Quality of Life as Recorded Using Quality of Life Scales (PDQ39)(Baseline, 16 weeks)
- Change in Cognition (Trail Making Test B-A)(Baseline, 16 weeks)