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

NCT01119131 | Completed Phase 2 Results DMC

• 1 other identifier: B7051-W
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Accidental Falls

Keywords

Vitamin D; Parkinson disease; accidental falls

Outcome Measures

Primary Outcomes (5)

• Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3)

  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.

  Baseline, 16 weeks

• Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration

  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.

  Baseline and 16 weeks

• Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work)

  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.

  Baseline, 16 weeks

• Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6)

  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.

  Baseline, 16 weeks

• Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work)

  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.

  Baseline, 16 weeks

Secondary Outcomes (3)

• Change in Cognition (Trail Making Test B-A)

  Baseline, 16 weeks

• Change in Quality of Life as Recorded Using Quality of Life Scales (PDQ39)

  Baseline, 16 weeks

• Change in Parkinsonism as Measured by the UPDRS

  Baseline, 16 weeks

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Will be on high dose vitamin D3 (10,000 IU daily) and 1000 mg of calcium

Drug: Vitamin D3; Dietary Supplement: calcium

Arm 2

PLACEBO COMPARATOR

Will be on placebo and 1000mg of calcium.

Dietary Supplement: calcium; Other: Placebo

Interventions

Vitamin D3 DRUG

Vitamin D3 at 10,000 IU a day

Arm 1

calcium DIETARY_SUPPLEMENT

1000mg calcium daily

Arm 1; Arm 2

Placebo OTHER

A placebo pill with similar appearance to the vitamin D3 will be given to those in the placebo arm

Arm 2

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 30256811 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Cholecalciferol; Calcium

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Results Point of Contact

• Title: Amie Hiller, MD
• Organization: VA Portland Health Care System

peterami@ohsu.edu

503.721.1091

Study Officials

• Amie Hiller, MD BS

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: May 7, 2010
• Study Start: May 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 7, 2016
• Results First Posted: March 7, 2016

Record last verified: 2016-02

Locations

US (1)