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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000001841 |
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Date of registration:
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02/04/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A randomized, double blind, comparative study of vitamin D3 versus placebo in patients with Parkinson disease aged between 45 and 85 years old to improve neurological signs and quality of life
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Scientific title:
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A randomized, double blind, comparative study of vitamin D3 versus placebo in patients with Parkinson disease aged between 45 and 85 years old to improve neurological signs and quality of life - RCT with vitamin D for Parkinson disease |
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Date of first enrolment:
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2009/04/01 |
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Target sample size:
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120 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002217 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Mitsuyoshi Urashima |
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Address:
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3-25-8 Nishi-shimbashi, Minato-ku, Tokyo 105-8461, Japan
Japan |
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Telephone:
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03-3433-1111 |
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Email:
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Affiliation:
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Jikei University School of Medicine Division of Molecular Epidemiology |
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Name:
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Emi Suzuki |
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Address:
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Japan |
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Telephone:
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Email:
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urashima@jikei.ac.jp |
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Affiliation:
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Jikei University School of Medicine Division of Molecular Epidemiology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1. Already taking vitamin D supplement or 1,25 vitamin D 2. History of kidney stone 3. Familial or early onset (< 55 years old) type of Parkinson disease 4. Osteoporosis 5. Other difficulties judged by the physician in charge
Age minimum:
45years-old
Age maximum:
85years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Parkinson disease
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Intervention(s)
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Vitamin D3
placebo
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Primary Outcome(s)
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changes of UPDRS, HY stage, MMSE
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Secondary Outcome(s)
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changes of PDQ-39 and EQ-5D
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Source(s) of Monetary Support
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Jikei University School of Medicine
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Ethics review
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Status: YES
Approval date:
Contact:
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