Effects of Vitamin D in Parkinson's Disease (PD)
This study is currently recruiting participants.
Verified April 2013 by Department of Veterans Affairs
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01119131
First received: April 23, 2010
Last updated: April 9, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson Disease Accidental Falls |
Drug: Vitamin D Dietary Supplement: calcium Other: Placebo |
Phase 2 |
| 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 |
| Official Title: | The Effects of Vitamin D on Balance in Persons With PD |
Resource links provided by NLM:
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
- Change in static and dynamic balance as recorded using dynamic posturography with the sensory organization test [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in ambulatory balance as recorded using iMOBILTY with an instrumented timed up and go to measure turn duration [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Change in strength as recorded by measuring knee flexion and extension using Biodex [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Change in cognition as recorded using a battery of tests to look at executive function, visuospatial function, and attention [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Fall rates over the 16 weeks of the study as recorded using patient diaries [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Change in quality of life as recorded using multiple quality of life scales [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 140 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm 1
Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium
|
Drug: Vitamin D
Vitamin D at 10,000 IU a day
Dietary Supplement: calcium
1000mg calcium daily
|
|
Placebo Comparator: Arm 2
Will be on placebo and 1000mg of calcium.
|
Dietary Supplement: calcium
1000mg calcium daily
Other: Placebo
A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm
|
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. 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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119131
Contacts
| Contact: Brenna M Lobb | (503) 220-8262 ext 51871 | Brenna.Lobb@va.gov |
Locations
| United States, Oregon | |
| VA Medical Center, Portland | Recruiting |
| Portland, Oregon, United States, 97201 | |
| Contact: Brenna M Lobb 503-220-8262 ext 51871 Brenna.Lobb@va.gov | |
| Principal Investigator: Amie Peterson, MD BS | |
Sponsors and Collaborators
Oregon Health and Science University
Investigators
| Principal Investigator: | Amie Peterson, MD BS | VA Medical Center, Portland |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01119131 History of Changes |
| Other Study ID Numbers: | B7051-W |
| Study First Received: | April 23, 2010 |
| Last Updated: | April 9, 2013 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Department of Veterans Affairs:
|
Vitamin D Parkinson disease accidental falls |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Calcium, Dietary |
Vitamin D Ergocalciferols Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 16, 2013