Trial Outcomes & Findings for Effects of Vitamin D in Parkinson's Disease (PD) (NCT NCT01119131)
NCT ID: NCT01119131
Last Updated: 2016-03-07
Results Overview
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.
COMPLETED
PHASE2
101 participants
Baseline, 16 weeks
2016-03-07
Participant Flow
Participants were recruited from two large treatment centers in the Pacific Northwest and from the community during the time period 2011 - 2014.
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)
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
28
|
30
|
|
Overall Study
COMPLETED
|
8
|
27
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
6
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
|
Overall Study
Non-Compliance
|
1
|
0
|
4
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
Baseline Characteristics
Effects of Vitamin D in Parkinson's Disease (PD)
Baseline characteristics by cohort
| Measure |
Vitamin D (Open Label)
n=10 Participants
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
|
Vitamin D
n=28 Participants
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
|
Placebo
n=30 Participants
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
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.1 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
64.5 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
68.8 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
67.2 years
STANDARD_DEVIATION 8.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
28 participants
n=7 Participants
|
30 participants
n=5 Participants
|
68 participants
n=4 Participants
|
|
Hoehn & Yahr
|
2.35 units on a scale
STANDARD_DEVIATION 0.34 • n=5 Participants
|
2.48 units on a scale
STANDARD_DEVIATION 0.46 • n=7 Participants
|
2.46 units on a scale
STANDARD_DEVIATION 0.47 • n=5 Participants
|
2.45 units on a scale
STANDARD_DEVIATION 0.44 • n=4 Participants
|
|
UPDRS
|
24.20 units on a scale
STANDARD_DEVIATION 11.06 • n=5 Participants
|
22.36 units on a scale
STANDARD_DEVIATION 8.56 • n=7 Participants
|
25.3 units on a scale
STANDARD_DEVIATION 11.5 • n=5 Participants
|
23.93 units on a scale
STANDARD_DEVIATION 10.25 • n=4 Participants
|
|
Baseline Vitamin D
|
14.7 ng/ml
STANDARD_DEVIATION 3.86 • n=5 Participants
|
30.21 ng/ml
STANDARD_DEVIATION 5.32 • n=7 Participants
|
29.43 ng/ml
STANDARD_DEVIATION 6.46 • n=5 Participants
|
27.59 ng/ml
STANDARD_DEVIATION 7.78 • n=4 Participants
|
|
MoCA
|
26.67 units on a scale
STANDARD_DEVIATION 1.94 • n=5 Participants
|
24.07 units on a scale
STANDARD_DEVIATION 2.91 • n=7 Participants
|
24.86 units on a scale
STANDARD_DEVIATION 3.00 • n=5 Participants
|
24.78 units on a scale
STANDARD_DEVIATION 2.93 • n=4 Participants
|
|
Falls Self-Report
|
5.86 Falls
STANDARD_DEVIATION 14.18 • n=5 Participants
|
3.79 Falls
STANDARD_DEVIATION 14.85 • n=7 Participants
|
3.05 Falls
STANDARD_DEVIATION 7.26 • n=5 Participants
|
3.75 Falls
STANDARD_DEVIATION 11.6 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 16 weeksPopulation: Missing data N=2, test not performed due to participant fatigue.
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.
Outcome measures
| Measure |
Vitamin D (Open Label)
n=7 Participants
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
|
Vitamin D
n=27 Participants
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
|
Placebo
n=23 Participants
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
|
|---|---|---|---|
|
Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3)
|
-3.25 units on a scale
Standard Deviation 2.93
|
2.05 units on a scale
Standard Deviation 8.85
|
1.78 units on a scale
Standard Deviation 21.66
|
PRIMARY outcome
Timeframe: Baseline and 16 weeksPopulation: Missing data N=14, test not performed due to either participant fatigue (N = 2) or mechanical/computer issues (N = 12).
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.
Outcome measures
| Measure |
Vitamin D (Open Label)
n=6 Participants
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
|
Vitamin D
n=21 Participants
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
|
Placebo
n=18 Participants
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
|
|---|---|---|---|
|
Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration
|
0.32 seconds
Standard Deviation 0.25
|
0.09 seconds
Standard Deviation 0.54
|
-0.07 seconds
Standard Deviation 0.62
|
PRIMARY outcome
Timeframe: Baseline, 16 weeksPopulation: Missing data N=4, test not performed due to participant fatigue (N = 2), mechanical/computer issues (N = 1), illness of operator (N = 1).
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.
Outcome measures
| Measure |
Vitamin D (Open Label)
n=7 Participants
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
|
Vitamin D
n=26 Participants
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
|
Placebo
n=22 Participants
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
|
|---|---|---|---|
|
Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work)
|
83.07 foot pounds
Standard Deviation 117.40
|
6.89 foot pounds
Standard Deviation 176.40
|
35.19 foot pounds
Standard Deviation 80.74
|
PRIMARY outcome
Timeframe: Baseline, 16 weeksPopulation: Missing data N=3, test not performed due to participant fatigue (N = 2) or computer/mechanical error (N = 1).
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.
Outcome measures
| Measure |
Vitamin D (Open Label)
n=7 Participants
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
|
Vitamin D
n=27 Participants
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
|
Placebo
n=22 Participants
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
|
|---|---|---|---|
|
Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6)
|
-1.56 units on a scale
Standard Deviation 11.91
|
2.272 units on a scale
Standard Deviation 12.63
|
-1.89 units on a scale
Standard Deviation 14.23
|
PRIMARY outcome
Timeframe: Baseline, 16 weeksPopulation: Missing data N=4, test not performed due to participant fatigue (N = 2), mechanical/computer issues (N = 1), illness of operator (N = 1).
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.
Outcome measures
| Measure |
Vitamin D (Open Label)
n=7 Participants
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
|
Vitamin D
n=26 Participants
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
|
Placebo
n=22 Participants
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
|
|---|---|---|---|
|
Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work)
|
18.11 foot pounds
Standard Deviation 66.65
|
23.33 foot pounds
Standard Deviation 83.16
|
17.49 foot pounds
Standard Deviation 32.02
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: 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).
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.
Outcome measures
| Measure |
Vitamin D (Open Label)
n=7 Participants
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
|
Vitamin D
n=23 Participants
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
|
Placebo
n=21 Participants
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
|
|---|---|---|---|
|
Change in Cognition (Trail Making Test B-A)
|
8.00 seconds
Standard Deviation 30.89
|
12.13 seconds
Standard Deviation 49.83
|
-17.33 seconds
Standard Deviation 74.7
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: Missing data (N = 3), patient forgot form and did not return mailed form (N = 3).
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.
Outcome measures
| Measure |
Vitamin D (Open Label)
n=8 Participants
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
|
Vitamin D
n=24 Participants
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
|
Placebo
n=24 Participants
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
|
|---|---|---|---|
|
Change in Quality of Life as Recorded Using Quality of Life Scales (PDQ39)
|
-0.16 units on a scale
Standard Deviation 0.96
|
-0.02 units on a scale
Standard Deviation 0.47
|
-0.14 units on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: Missing data (N = 2), invalid sum due to missing rating (N = 1), not completed due to scheduling conflicts (N = 1).
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.
Outcome measures
| Measure |
Vitamin D (Open Label)
n=8 Participants
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
|
Vitamin D
n=27 Participants
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
|
Placebo
n=22 Participants
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
|
|---|---|---|---|
|
Change in Parkinsonism as Measured by the UPDRS
|
0.25 units on a scale
Standard Deviation 8.33
|
0.48 units on a scale
Standard Deviation 5.60
|
-0.18 units on a scale
Standard Deviation 9.73
|
Adverse Events
Vitamin D (Open Label)
Vitamin D
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vitamin D (Open Label)
n=10 participants at risk
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
|
Vitamin D
n=28 participants at risk
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
|
Placebo
n=30 participants at risk
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
|
|---|---|---|---|
|
General disorders
Illness
|
10.0%
1/10 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/10
|
0.00%
0/28
|
3.3%
1/30 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place