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

• Register: ClinicalTrials.gov
• Last refreshed on: 15 April 2013
• Main ID: NCT01119131
• Date of registration: 23/04/2010
• Primary sponsor: Department of Veterans Affairs
• Public title: Effects of Vitamin D in Parkinson's Disease (PD)
• Scientific title: The Effects of Vitamin D on Balance in Persons With PD
• Date of first enrolment: May 2011
• Target sample size: 140
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01119131
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Brenna M Lobb

• Name: Brenna M Lobb

• Name: Amie Peterson, MD BS
• Affiliation: VA Medical Center, Portland

Key inclusion & exclusion 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



Age minimum: 50 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Accidental Falls

Parkinson Disease

Intervention(s)

Dietary Supplement: calcium

Drug: Vitamin D

Other: Placebo

Primary Outcome(s)

Change in static and dynamic balance as recorded using dynamic posturography with the sensory organization test [Time Frame: 16 weeks]

Secondary Outcome(s)

Change in ambulatory balance as recorded using iMOBILTY with an instrumented timed up and go to measure turn duration [Time Frame: 16 weeks]

Change in cognition as recorded using a battery of tests to look at executive function, visuospatial function, and attention [Time Frame: 16 weeks]

Change in quality of life as recorded using multiple quality of life scales [Time Frame: 16 weeks]

Change in strength as recorded by measuring knee flexion and extension using Biodex [Time Frame: 16 weeks]

Fall rates over the 16 weeks of the study as recorded using patient diaries [Time Frame: 16 weeks]

Secondary ID(s)

B7051-W

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Oregon Health and Science University