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

8. februar 2016 opdateret af: VA Office of Research and Development

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

101

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • VA Portland Health Care System, Portland, OR

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år til 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm 1
Will be on high dose vitamin D3 (10,000 IU daily) and 1000 mg of calcium
Medicin: Vitamin D3
Vitamin D3 at 10,000 IU a day
Kosttilskud: calcium
1000mg calcium daily
Placebo komparator: Arm 2
Will be on placebo and 1000mg of calcium.
Kosttilskud: calcium
1000mg calcium daily
Andet: Placebo
A placebo pill with similar appearance to the vitamin D3 will be given to those in the placebo arm

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3)
Tidsramme: 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.
Baseline, 16 weeks
Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration
Tidsramme: 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.
Baseline and 16 weeks
Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work)
Tidsramme: 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.
Baseline, 16 weeks
Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6)
Tidsramme: 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.
Baseline, 16 weeks
Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work)
Tidsramme: 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.
Baseline, 16 weeks

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

VA Office of Research and Development

Samarbejdspartnere

Oregon Health and Science University

Efterforskere

  • Ledende efterforsker: Amie Hiller, MD BS, VA Portland Health Care System, Portland, OR

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2011

Primær færdiggørelse (Faktiske)

1. januar 2015

Studieafslutning (Faktiske)

1. januar 2015

Datoer for studieregistrering

Først indsendt

23. april 2010

Først indsendt, der opfyldte QC-kriterier

5. maj 2010

Først opslået (Skøn)

7. maj 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. februar 2016

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B7051-W

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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