Parkinson DiseasePhase 2NCT01119131

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

A Phase 2 study testing Vitamin D3 and calcium in people with Parkinson Disease and Accidental Falls, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 50 to 99 years
Conditions the study is for: Parkinson Disease, Accidental Falls
What is being tested?: Vitamin D3 and calcium
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 101 participants
Where: 1 siteUnited States
Study dates: May 2011to Jan 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: The Effects of Vitamin D on Balance in Persons With PD

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.

Read the 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.

Conditions: Parkinson Disease, Accidental Falls
Being tested: Vitamin D3, calcium, Placebo
Keywords: Vitamin D, Parkinson disease, accidental falls
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin D3Drug
Vitamin D3 at 10,000 IU a day
calciumDietary supplement
1000mg calcium daily
PlaceboOther
A placebo pill with similar appearance to the vitamin D3 will be given to those in the placebo arm

Study groups in NCT01119131
Study group	Role	What they receive
Arm 1	Active comparator	Will be on high dose vitamin D3 (10,000 IU daily) and 1000 mg of calcium Receives: Drug: Vitamin D3; Dietary Supplement: calcium
Arm 2	Placebo comparator	Will be on placebo and 1000mg of calcium. Receives: Dietary Supplement: calcium; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 16 weeks

Secondary outcomes (3)

Change in Cognition (Trail Making Test B-A)
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.
Measured: Baseline, 16 weeks
Change in Quality of Life as Recorded Using Quality of Life Scales (PDQ39)
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.
Measured: Baseline, 16 weeks
Change in Parkinsonism as Measured by the UPDRS
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.
Measured: Baseline, 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Jan 2015

First posted7 May 2010 (estimated)
Study startMay 2011
Primary completionJan 2015
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01119131
Sponsor's protocol ID: B7051-W
Status last verified: Feb 2016
First submitted: 23 Apr 2010
Last updated: 7 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 30256811

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Vitamin D on Balance in Persons With PD
ClinicalTrials.gov ID: NCT01119131
Acronym / sponsor ID: B7051-W
Conditions: Parkinson Disease, Accidental Falls
Keywords: Vitamin D, Parkinson disease, accidental falls
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Collaborators: Oregon Health and Science University
Study start: May 2011
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 7 May 2010 (estimated)
Results: Posted 7 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Arm 1	Active comparator	Drug: Vitamin D3, Dietary Supplement: calciumWill be on high dose vitamin D3 (10,000 IU daily) and 1000 mg of calcium
Arm 2	Placebo comparator	Dietary Supplement: calcium, Other: PlaceboWill be on placebo and 1000mg of calcium.

Who may qualify

Ages: 50 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Parkinson's disease;
ability to ambulate 50 feet;
ability to cooperate with balance testing;
vitamin D level less than 40ng/ml;
balance problems;

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vitamin D3Vitamin D3 at 10,000 IU a day	Drug	Arm 1
calcium1000mg calcium daily	Dietary supplement	Arm 1, Arm 2
PlaceboA placebo pill with similar appearance to the vitamin D3 will be given to those in the placebo arm	Other	Arm 2

Primary outcome

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.
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.
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.
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.
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.

3 secondary outcomes

Change in Cognition (Trail Making Test B-A)
Time frame: Baseline, 16 weeks
Change in Quality of Life as Recorded Using Quality of Life Scales (PDQ39)
Time frame: Baseline, 16 weeks
Change in Parkinsonism as Measured by the UPDRS
Time frame: Baseline, 16 weeks

Results and safety

Results posted to the registry on 7 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vitamin D (Open Label)	10	8
Vitamin D	28	27
Placebo	30	24

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

Time frame: Baseline, 16 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Vitamin D (Open Label) n = 7	Vitamin D n = 27	Placebo n = 23
Value	-3.25 (2.93)	2.05 (8.85)	1.78 (21.66)

Vitamin D (Open Label) vs Vitamin D vs Placebo: p = 0.699, ANOVA

Population analysed: Missing data N=2, test not performed due to participant fatigue.

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

Time frame: Baseline and 16 weeks. Mean (Standard Deviation). Unit: seconds

Measure	Vitamin D (Open Label) n = 6	Vitamin D n = 21	Placebo n = 18
Value	0.32 (0.25)	0.09 (0.54)	-0.07 (0.62)

Vitamin D (Open Label) vs Vitamin D vs Placebo: p = 0.308, ANOVA

Population analysed: Missing data N=14, test not performed due to either participant fatigue (N = 2) or mechanical/computer issues (N = 12).

Primary outcome: Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work)

Time frame: Baseline, 16 weeks. Mean (Standard Deviation). Unit: foot pounds

Measure	Vitamin D (Open Label) n = 7	Vitamin D n = 26	Placebo n = 22
Value	83.07 (117.40)	6.89 (176.40)	35.19 (80.74)

Vitamin D (Open Label) vs Vitamin D vs Placebo: p = 0.419, ANOVA

Population analysed: Missing data N=4, test not performed due to participant fatigue (N = 2), mechanical/computer issues (N = 1), illness of operator (N = 1).

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

Time frame: Baseline, 16 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Vitamin D (Open Label) n = 7	Vitamin D n = 27	Placebo n = 22
Value	-1.56 (11.91)	2.272 (12.63)	-1.89 (14.23)

Population analysed: Missing data N=3, test not performed due to participant fatigue (N = 2) or computer/mechanical error (N = 1).

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vitamin D (Open Label)	0 of 10 (0%)	1 of 10 (10%)	Not reported
Vitamin D	0 of 28 (0%)	1 of 28 (3.6%)	Not reported
Placebo	0 of 30 (0%)	2 of 30 (6.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30256811Hiller 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amie Hiller, MD BS principal investigator

VA Portland Health Care System, Portland, OR

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vitamin D3 and calcium in people with Parkinson Disease and Accidental Falls, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3) (time frame: Baseline, 16 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01119131, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2016.