Clinical trial NCT01119131: Effects of Vitamin D in Parkinson's Disease (PD)
Official title: The Effects of Vitamin D on Balance in Persons With PD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Accidental Falls
Keywords: Vitamin D
Parkinson disease
accidental falls
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Oregon Health and Science University
First posted: 2010-05-07
Enrollment: 101
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3)
timeFrame: Baseline, 16 weeks
measure: Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration
timeFrame: Baseline and 16 weeks
measure: Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work)
timeFrame: Baseline, 16 weeks
measure: Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6)
timeFrame: Baseline, 16 weeks
measure: Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work)
timeFrame: Baseline, 16 weeks
Secondary outcomes:
measure: Change in Cognition (Trail Making Test B-A)
timeFrame: Baseline, 16 weeks
measure: Change in Quality of Life as Recorded Using Quality of Life Scales (PDQ39)
timeFrame: Baseline, 16 weeks
measure: Change in Parkinsonism as Measured by the UPDRS
timeFrame: Baseline, 16 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: Amie Hiller, MD BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hiller AL, Murchison CF, Lobb BM, O'Connor S, O'Connor M, Quinn JF. A randomized, controlled pilot study of the effects of vitamin D supplementation on balance in Parkinson's disease: Does age matter? PLoS One. 2018 Sep 26;13(9):e0203637. doi: 10.1371/journal.pone.0203637. eCollection 2018.