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

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01119131
• Collaborator: Oregon Health and Science University (Other)
• Enrollment: 101
• Location: 1
• Arms: 2
• Duration (Months): 44.1
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease; Accidental Falls	Drug: Vitamin D3; Dietary Supplement: calcium; Other: Placebo	Phase 2

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
• Actual Enrollment: 101 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effects of Vitamin D on Balance in Persons With PD
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3) [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.

2. Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration [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.

3. Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work) [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.

4. Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6) [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.

5. Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work) [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.

Secondary Outcome Measures

1. Change in Cognition (Trail Making Test B-A) [Baseline, 16 weeks]

   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.

2. Change in Quality of Life as Recorded Using Quality of Life Scales (PDQ39) [Baseline, 16 weeks]

   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.

3. Change in Parkinsonism as Measured by the UPDRS [Baseline, 16 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 99 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Portland Health Care System, Portland, OR	Portland	Oregon	United States	97239

Sponsors and Collaborators

• VA Office of Research and Development
• Oregon Health and Science University

Investigators

• Principal Investigator: Amie Hiller, MD BS, VA Portland Health Care System, Portland, OR

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01119131
• Other Study ID Numbers: B7051-W
• First Posted: May 7, 2010
• Last Update Posted: Mar 7, 2016
• Last Verified: Feb 1, 2016

• Keywords provided by VA Office of Research and Development: Vitamin D; Parkinson disease; accidental falls
• Additional relevant MeSH terms: Parkinson Disease; Vitamin D; Cholecalciferol; Calcium

Study Results

Participant Flow

Recruitment Details	Participants were recruited from two large treatment centers in the Pacific Northwest and from the community during the time period 2011 - 2014.
Pre-assignment Detail	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)

Arm/Group Title	Vitamin D (Open Label)	Vitamin D	Placebo
Arm/Group Description	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	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	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
Period Title: Overall Study
STARTED	10	28	30
COMPLETED	8	27	24
NOT COMPLETED	2	1	6

Baseline Characteristics

Arm/Group Title	Vitamin D (Open Label)	Vitamin D	Placebo	Total
Arm/Group Description	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	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	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	Total of all reporting groups
Overall Participants	10	28	30	68
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.1 (8.0)	64.5 (8.0)	68.8 (8.1)	67.2 (8.3)
Sex: Female, Male (Count of Participants)
Female	1 10%	5 17.9%	10 33.3%	16 23.5%
Male	9 90%	23 82.1%	20 66.7%	52 76.5%
Region of Enrollment (participants) [Number]
United States	10 100%	28 100%	30 100%	68 100%
Hoehn & Yahr (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.35 (0.34)	2.48 (0.46)	2.46 (0.47)	2.45 (0.44)
UPDRS (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	24.20 (11.06)	22.36 (8.56)	25.3 (11.5)	23.93 (10.25)
Baseline Vitamin D (ng/ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ng/ml]	14.7 (3.86)	30.21 (5.32)	29.43 (6.46)	27.59 (7.78)
MoCA (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	26.67 (1.94)	24.07 (2.91)	24.86 (3.00)	24.78 (2.93)
Falls Self-Report (Falls) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Falls]	5.86 (14.18)	3.79 (14.85)	3.05 (7.26)	3.75 (11.6)

Outcome Measures

1. Primary Outcome

Title	Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3)
Description	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.
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

Missing data N=2, test not performed due to participant fatigue.

Arm/Group Title	Vitamin D (Open Label)	Vitamin D	Placebo
Arm/Group Description	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	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	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
Measure Participants	7	27	23
Mean (Standard Deviation) [units on a scale]	-3.25 (2.93)	2.05 (8.85)	1.78 (21.66)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vitamin D (Open Label), Vitamin D, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.699
	Comments
	Method	ANOVA
	Comments

2. Primary Outcome

Title	Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration
Description	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.
Time Frame	Baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

Missing data N=14, test not performed due to either participant fatigue (N = 2) or mechanical/computer issues (N = 12).

Arm/Group Title	Vitamin D (Open Label)	Vitamin D	Placebo
Arm/Group Description	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	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	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
Measure Participants	6	21	18
Mean (Standard Deviation) [seconds]	0.32 (0.25)	0.09 (0.54)	-0.07 (0.62)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vitamin D (Open Label), Vitamin D, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.308
	Comments
	Method	ANOVA
	Comments

3. Primary Outcome

Title	Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work)
Description	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.
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

Missing data N=4, test not performed due to participant fatigue (N = 2), mechanical/computer issues (N = 1), illness of operator (N = 1).

Arm/Group Title	Vitamin D (Open Label)	Vitamin D	Placebo
Arm/Group Description	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	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	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
Measure Participants	7	26	22
Mean (Standard Deviation) [foot pounds]	83.07 (117.40)	6.89 (176.40)	35.19 (80.74)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vitamin D (Open Label), Vitamin D, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.419
	Comments
	Method	ANOVA
	Comments

4. Secondary Outcome

Title	Change in Cognition (Trail Making Test B-A)
Description	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.
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Vitamin D (Open Label)	Vitamin D	Placebo
Arm/Group Description	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	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	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
Measure Participants	7	23	21
Mean (Standard Deviation) [seconds]	8.00 (30.89)	12.13 (49.83)	-17.33 (74.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vitamin D (Open Label), Vitamin D, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.253
	Comments
	Method	ANOVA
	Comments

5. Secondary Outcome

Title	Change in Quality of Life as Recorded Using Quality of Life Scales (PDQ39)
Description	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.
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

Missing data (N = 3), patient forgot form and did not return mailed form (N = 3).

Arm/Group Title	Vitamin D (Open Label)	Vitamin D	Placebo
Arm/Group Description	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	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	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
Measure Participants	8	24	24
Mean (Standard Deviation) [units on a scale]	-0.16 (0.96)	-0.02 (0.47)	-0.14 (0.79)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vitamin D (Open Label), Vitamin D, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.793
	Comments
	Method	ANOVA
	Comments

6. Primary Outcome

Title	Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6)
Description	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.
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

Missing data N=3, test not performed due to participant fatigue (N = 2) or computer/mechanical error (N = 1).

Arm/Group Title	Vitamin D (Open Label)	Vitamin D	Placebo
Arm/Group Description	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	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	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
Measure Participants	7	27	22
Mean (Standard Deviation) [units on a scale]	-1.56 (11.91)	2.272 (12.63)	-1.89 (14.23)

7. Primary Outcome

Title	Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work)
Description	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.
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

Missing data N=4, test not performed due to participant fatigue (N = 2), mechanical/computer issues (N = 1), illness of operator (N = 1).

Arm/Group Title	Vitamin D (Open Label)	Vitamin D	Placebo
Arm/Group Description	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	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	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
Measure Participants	7	26	22
Mean (Standard Deviation) [foot pounds]	18.11 (66.65)	23.33 (83.16)	17.49 (32.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vitamin D (Open Label), Vitamin D, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.949
	Comments
	Method	ANOVA
	Comments

8. Secondary Outcome

Title	Change in Parkinsonism as Measured by the UPDRS
Description	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.
Time Frame	Baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

Missing data (N = 2), invalid sum due to missing rating (N = 1), not completed due to scheduling conflicts (N = 1).

Arm/Group Title	Vitamin D (Open Label)	Vitamin D	Placebo
Arm/Group Description	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	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	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
Measure Participants	8	27	22
Mean (Standard Deviation) [units on a scale]	0.25 (8.33)	0.48 (5.60)	-0.18 (9.73)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Vitamin D (Open Label), Vitamin D, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.957
	Comments
	Method	ANOVA
	Comments

Adverse Events

Arm/Group Title	Vitamin D (Open Label)		Vitamin D		Placebo
Arm/Group Description	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		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		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
All Cause Mortality
	Vitamin D (Open Label)		Vitamin D		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Vitamin D (Open Label)		Vitamin D		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/28 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Vitamin D (Open Label)		Vitamin D		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/10 (10%)		1/28 (3.6%)		2/30 (6.7%)
General disorders
Illness	1/10 (10%)	1	1/28 (3.6%)	1	1/30 (3.3%)	1
Injury, poisoning and procedural complications
Injury	0/10 (0%)	0	0/28 (0%)	0	1/30 (3.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.