Phase 2
N=68
Effects of Vitamin D in Parkinson's Disease (PD)
Parkinson Disease · Accidental Falls
Bottom Line
View on ClinicalTrials.gov: NCT01119131 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3) — -3.25; 2.05; 1.78 units on a scale — p=0.699
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vitamin D3 (Drug); calcium (Dietary_supplement); Placebo (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3) |
-3.25; 2.05; 1.78 | 0.699 |
| PRIMARY Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration |
0.32; 0.09; -0.07 | 0.308 |
| PRIMARY Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work) |
83.07; 6.89; 35.19 | 0.419 |
| PRIMARY Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6) |
-1.56; 2.272; -1.89 | — |
| PRIMARY Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work) |
18.11; 23.33; 17.49 | 0.949 |
| SECONDARY Change in Cognition (Trail Making Test B-A) |
8.00; 12.13; -17.33 | 0.253 |
| SECONDARY Change in Quality of Life as Recorded Using Quality of Life Scales (PDQ39) |
-0.16; -0.02; -0.14 | 0.793 |
| SECONDARY Change in Parkinsonism as Measured by the UPDRS |
0.25; 0.48; -0.18 | 0.957 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01119131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.