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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001841
Receipt No. R000002217
Scientific Title 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
Date of disclosure of the study information 2009/04/02
Last modified on 2013/10/02

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Basic information
Public title 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
Acronym RCT with vitamin D for Parkinson disease
Scientific Title 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
Scientific Title:Acronym RCT with vitamin D for Parkinson disease
Region
Japan

Condition
Condition Parkinson disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 We will determine if vitamin D3 peroral administration of 1200IU/day for 1 year can prevent progression or improve signs of Parkinson disease evaluated with UPDRS, HY stage, MMSE, PDQ-39 and EQ-5D, by conducting a double blind randomized controlled clinical trial and by targeting age 55 to 75 years old.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes changes of UPDRS, HY stage, MMSE
Key secondary outcomes changes of PDQ-39 and EQ-5D

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Vitamin D3
Interventions/Control_2 placebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
45 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria 1. Enrollment at Jikei University Aoto hospital
2. Obtained informed consent
3. Age 45 and more and less than 85 years old
Key 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
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuyoshi Urashima
Organization Jikei University School of Medicine
Division name Division of Molecular Epidemiology
Zip code
Address 3-25-8 Nishi-shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL 03-3433-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Emi Suzuki
Organization Jikei University School of Medicine
Division name Division of Molecular Epidemiology
Zip code
Address
TEL
Homepage URL http://docrd.jp
Email urashima@jikei.ac.jp

Sponsor
Institute Jikei University School of Medicine
Institute
Department

Funding Source
Organization Jikei University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 04 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/23485413
Number of participants that the trial has enrolled
Results
Vitamin D3 supplementation may stabilize PD for a short period in patients with FokI TT or CT genotypes without triggering hypercalcemia, although this effect may be nonspecific for PD. This trial was registered at UMIN Clinical Trials Registry as UMIN000001841.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 03 Month 09 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2012 Year 03 Month 31 Day
Date of closure to data entry
2012 Year 04 Month 30 Day
Date trial data considered complete
2012 Year 05 Month 31 Day
Date analysis concluded
2012 Year 06 Month 30 Day

Other
Other related information



Am J Clin Nutr. 2013 May;97(5):1004-13. doi: 10.3945/ajcn.112.051664. Epub 2013 Mar 13.

Randomized, double-blind, placebo-controlled trial of vitamin D supplementation in Parkinson disease.

Suzuki M, Yoshioka M, Hashimoto M, Murakami M, Noya M, Takahashi D, Urashima M.

Management information
Registered date
2009 Year 04 Month 02 Day
Last modified on
2013 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002217

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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