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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 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 1, 2014
Last verified: April 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 1, 2014
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 July 28, 2014