Overview

This trial is active, not recruiting.

Conditions parkinson disease, accidental falls
Treatments vitamin d, calcium, placebo
Phase phase 2
Sponsor Department of Veterans Affairs
Collaborator Oregon Health and Science University
Start date May 2011
End date January 2015
Trial size 140 participants
Trial identifier NCT01119131, B7051-W

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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 Comparator)
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

Primary Outcomes

Measure
Change in static and dynamic balance as recorded using dynamic posturography with the sensory organization test
time frame: 16 weeks

Secondary Outcomes

Measure
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 strength as recorded by measuring knee flexion and extension using Biodex
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
Fall rates over the 16 weeks of the study as recorded using patient diaries
time frame: 16 weeks
Change in quality of life as recorded using multiple quality of life scales
time frame: 16 weeks

Eligibility Criteria

Male or female participants at least 50 years old.

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

Additional Information

Official title The Effects of Vitamin D on Balance in Persons With PD
Principal investigator Amie Hiller, MD BS
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. We 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.