Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01119131
Recruitment Status : Completed
First Posted : May 7, 2010
Results First Posted : March 7, 2016
Last Update Posted : March 7, 2016
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Parkinson Disease
Accidental Falls
Interventions Drug: Vitamin D3
Dietary Supplement: calcium
Other: Placebo
Enrollment 101
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 Details 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
Hide 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
Reason Not Completed
Adverse Event             1             1             1
Non-Compliance             1             0             4
Physician Decision             0             0             1
Arm/Group Title Vitamin D (Open Label) Vitamin D Placebo Total
Hide 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 Number of Baseline Participants 10 28 30 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 28 participants 30 participants 68 participants
70.1  (8.0) 64.5  (8.0) 68.8  (8.1) 67.2  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 28 participants 30 participants 68 participants
Female
1
  10.0%
5
  17.9%
10
  33.3%
16
  23.5%
Male
9
  90.0%
23
  82.1%
20
  66.7%
52
  76.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 28 participants 30 participants 68 participants
10 28 30 68
Hoehn & Yahr   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 10 participants 28 participants 30 participants 68 participants
2.35  (0.34) 2.48  (0.46) 2.46  (0.47) 2.45  (0.44)
[1]
Measure Description: 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.
UPDRS   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 10 participants 28 participants 30 participants 68 participants
24.20  (11.06) 22.36  (8.56) 25.3  (11.5) 23.93  (10.25)
[1]
Measure Description: 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.
Baseline Vitamin D  
Mean (Standard Deviation)
Unit of measure:  Ng/ml
Number Analyzed 10 participants 28 participants 30 participants 68 participants
14.7  (3.86) 30.21  (5.32) 29.43  (6.46) 27.59  (7.78)
MoCA   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 10 participants 28 participants 30 participants 68 participants
26.67  (1.94) 24.07  (2.91) 24.86  (3.00) 24.78  (2.93)
[1]
Measure Description: 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).
Falls Self-Report  
Mean (Standard Deviation)
Unit of measure:  Falls
Number Analyzed 10 participants 28 participants 30 participants 68 participants
5.86  (14.18) 3.79  (14.85) 3.05  (7.26) 3.75  (11.6)
1.Primary Outcome
Title Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data N=2, test not performed due to participant fatigue.
Arm/Group Title Vitamin D (Open Label) Vitamin D Placebo
Hide 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

Overall Number of Participants Analyzed 7 27 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.25  (2.93) 2.05  (8.85) 1.78  (21.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D (Open Label), Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.699
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 6 21 18
Mean (Standard Deviation)
Unit of Measure: seconds
0.32  (0.25) 0.09  (0.54) -0.07  (0.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D (Open Label), Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.308
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Primary Outcome
Title Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 7 26 22
Mean (Standard Deviation)
Unit of Measure: foot pounds
83.07  (117.40) 6.89  (176.40) 35.19  (80.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D (Open Label), Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.419
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Primary Outcome
Title Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 7 27 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.56  (11.91) 2.272  (12.63) -1.89  (14.23)
5.Primary Outcome
Title Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 7 26 22
Mean (Standard Deviation)
Unit of Measure: foot pounds
18.11  (66.65) 23.33  (83.16) 17.49  (32.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D (Open Label), Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.949
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Change in Cognition (Trail Making Test B-A)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 7 23 21
Mean (Standard Deviation)
Unit of Measure: seconds
8.00  (30.89) 12.13  (49.83) -17.33  (74.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D (Open Label), Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.253
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Change in Quality of Life as Recorded Using Quality of Life Scales (PDQ39)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 8 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.16  (0.96) -0.02  (0.47) -0.14  (0.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D (Open Label), Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.793
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
8.Secondary Outcome
Title Change in Parkinsonism as Measured by the UPDRS
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 8 27 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.25  (8.33) 0.48  (5.60) -0.18  (9.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D (Open Label), Vitamin D, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.957
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vitamin D (Open Label) Vitamin D Placebo
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide 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 (0.00%)      0/28 (0.00%)      0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Vitamin D (Open Label) Vitamin D Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/10 (10.00%)      1/28 (3.57%)      2/30 (6.67%)    
General disorders       
Illness * [1]  1/10 (10.00%)  1 1/28 (3.57%)  1 1/30 (3.33%)  1
Injury, poisoning and procedural complications       
Injury   0/10 (0.00%)  0 0/28 (0.00%)  0 1/30 (3.33%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Non-Specified Illness
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Amie Hiller, MD
Organization: VA Portland Health Care System
Phone: 503.721.1091
EMail: peterami@ohsu.edu
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01119131     History of Changes
Other Study ID Numbers: B7051-W
First Submitted: April 23, 2010
First Posted: May 7, 2010
Results First Submitted: November 17, 2015
Results First Posted: March 7, 2016
Last Update Posted: March 7, 2016