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

• ClinicalTrials.gov Identifier: NCT01119131
• Recruitment Status: Completed
• First Posted: May 7, 2010
• Results First Posted: March 7, 2016
• Last Update Posted: March 7, 2016
• Sponsor: VA Office of Research and Development
• Collaborator: Oregon Health and Science University
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease; Accidental Falls	Drug: Vitamin D3; Dietary Supplement: calcium; Other: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 101 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effects of Vitamin D on Balance in Persons With PD
• Study Start Date: May 2011
• Actual Primary Completion Date: January 2015
• Actual Study Completion Date: January 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Arm 1; Will be on high dose vitamin D3 (10,000 IU daily) and 1000 mg of calcium	Drug: Vitamin D3; Vitamin D3 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 D3 will be given to those in the placebo arm

Outcome Measures

Primary Outcome Measures :

1. Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3) [ Time Frame: Baseline, 16 weeks ]
   Sensory organization test (SOT) is a form of posturography. which is designed to assess quantitatively an individual's ability to use visual, proprioceptive and vestibular cues to maintain postural stability in stance. The SOT measures sway during 6 scenarios. In scenarios 1-3 the base is stable and eyes are open, then closed, and then the visual surround moves. SOT 1-3 is an average measurement of equilibrium - the average center of gravity sway for each condition. It generates a score of 0 (fall) up to 100 for each scenario and an overall composite score. Change score is measurement at 16 weeks minus measurement at baseline.
2. Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration [ Time Frame: Baseline and 16 weeks ]
   This is a test that measures ambulatory balance and mobility. The instrumented timed up and go (iTUG) is an average time (seconds) of three trials that involve the participant arising from a chair, walking 25 feet turning around, walking back to the chair, and sitting down. The turn duration is the average time to turn at the end of the 25 foot walk. Longer duration of time (seconds) indicates more rigidity, a proxy measure for "ON" time in Parkinson's disease. Change score is measurement at 16 weeks minus measurement at baseline.
3. Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work) [ Time Frame: Baseline, 16 weeks ]
   Defined as the total muscular force output for the repetition with the greatest amount of work. The equation for work is: W = F x D. Change score is measurement at 16 weeks minus measurement at baseline.
4. Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6) [ Time Frame: Baseline, 16 weeks ]
   Sensory organization test (SOT) is a form of posturography. which is designed to assess quantitatively an individual's ability to use visual, proprioceptive and vestibular cues to maintain postural stability in stance. The SOT measures sway during 6 scenarios. In 4-6 the base moves and the subject has eyes open, then closed, then the visual surround moves. SOT 4-6 is an average measurement of equilibrium - the average center of gravity sway for each condition. It generates a score of 0 (fall) up to 100 for each scenario and an overall composite score. Change score is measurement at 16 weeks minus measurement at baseline.
5. Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work) [ Time Frame: Baseline, 16 weeks ]
   Defined as the total muscular force output for the repetition with the greatest amount of work. The equation for work is: W = F x D. Change score is measurement at 16 weeks minus measurement at baseline.

Secondary Outcome Measures :

1. Change in Cognition (Trail Making Test B-A) [ Time Frame: Baseline, 16 weeks ]
   The Trail Making Test (TMT) consists of two parts (A & B) in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test provides information about visual search speed, scanning, speed of processing, and executive functioning. Part A measures processing speed and part B measures executive functioning. The TMT is time to complete each part of the test in seconds. Higher scores indicate greater impairment. Subtracting part A from part B is theorized to reduce the influence of the working memory and visuospatial demands and, therefore, provides a relatively pure indicator of executive function. Change score is measurement (Part B - Part A) at 16 weeks minus measurement (Part B - Part A) at baseline, negative scores indicate a improvement in executive functioning.
2. Change in Quality of Life as Recorded Using Quality of Life Scales (PDQ39) [ Time Frame: Baseline, 16 weeks ]
   The PDQ39 is a 39 item patient completed survey targeting well-being and functioning in PD. This scale address 8 dimensions (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort). The PDQ39 dimension scores are on a scale of 0 ("Never") to 4 ("Always/Cannot Do"). Scale scores are summed and range from 0 to 100 with 100 being the maximum level of problems. For a single index figure to characterize the impact of Parkinson's disease upon PD patients (PDSI), all 39 items of the PDQ39 can be summed. The PDQ39 and the use of a PDSI have shown adequate reliability and convergent validity. Change score is measurement at 16 weeks minus baseline measurement, negative scores indicate an improvement in quality of life.
3. Change in Parkinsonism as Measured by the UPDRS [ Time Frame: Baseline, 16 weeks ]
   This is the motor subsection of the UPDRS and is a commonly used tool to rate the symptoms of Parkinson's disease. This scale rates from 0 (normal) to 4 (Can barely perform the task) several motor areas including speech, facial expression, tremor, rigidity, hand movements, agility, posture, and gait. A sum score represents motor function with higher values on this scale represent a more severe stage of the disease. Change is measurement at 16 weeks minus baseline measurement, negative scores indicate an improvement in Parkinson's motor symptoms.

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Oregon

VA Portland Health Care System, Portland, OR

Portland, Oregon, United States, 97239

Sponsors and Collaborators

VA Office of Research and Development

Oregon Health and Science University

Investigators

• Principal Investigator: Amie Hiller, MD BS; VA Portland Health Care System, Portland, OR

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01119131
• Other Study ID Numbers: B7051-W
• First Posted: May 7, 2010
• Results First Posted: March 7, 2016
• Last Update Posted: March 7, 2016
• Last Verified: February 2016

Keywords provided by VA Office of Research and Development:

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; Synucleinopathies; Neurodegenerative Diseases; Vitamin D; Cholecalciferol; Calcium; Vitamins; Micronutrients; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Bone Density Conservation Agents