UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001841 |
|---|---|
| Receipt number | 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 13:58:53 |
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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
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
urashima@jikei.ac.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002217
