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Recruiting participants for study on Vit. D and Parkinson's


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#1 Kathrynne Holden, MS

Kathrynne Holden, MS

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Posted 18 April 2013 - 06:14 PM

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A service of the U.S. National Institutes of Health

Example: "Heart attack" AND "Los Angeles"Search for studies:


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


This study is currently recruiting participants.
Verified April 2013 by Department of Veterans Affairs
Sponsor:
Department of Veterans Affairs
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
History of ChangesPosted Image 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:


Genetics Home Reference related topics: Parkinson disease Perry syndrome
MedlinePlus related topics: Calcium Falls Parkinson's Disease Vitamin D
Drug Information available for: Calcium Gluconate Vitamin DU.S. FDA Resources

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


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
Department of Veterans Affairs
Oregon Health and Science University
Investigators Principal Investigator: Amie Peterson, MD BS VA Medical Center, Portland
Posted Image 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 April 16, 2013

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Best regards,

Kathrynne Holden, MS

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#2 Beachdog

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Posted 18 April 2013 - 06:51 PM

10,000 iu's of Vitamin D certainly sounds like a boatload. Somehow that doesn't sound beneficial. HA... from the Mayo website:
"the recommended dietary allowance (RDA) for most adults of 600 IU of vitamin D a day.".

I think I will skip this trial.

#3 Kathrynne Holden, MS

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Posted 19 April 2013 - 06:51 PM

Yes, it is a very high level. However, a number of conditions, such as breast cancer, asthma, type I diabetes, autoimmune diseases, and PD, are associated with deficiency; and in some cases, unusually high amounts of vitamin D -- even higher than 10,000 IUs -- have ameliorated symptoms. The researchers want to find out if this could be true for PD. I am keeping my fingers crossed that this will be the case, because it would be a noninvasive, inexpensive means of reducing symptoms.

The question (well, in my mind) is -- does PD result from a deficiency of vit. D, or is deficiency caused by PD? If the latter, then repletion might not be the solution.
Best regards,

Kathrynne Holden, MS

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