UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007002 |
|---|---|
| Receipt number | R000007962 |
| Scientific Title | A randomized, double blind, comparative study of vitamin D3 versus placebo in post-stroke rehabilitation patients |
| Date of disclosure of the study information | 2012/01/02 |
| Last modified on | 2017/08/28 20:55:31 |
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Basic information
Public title
A randomized, double blind, comparative study of vitamin D3 versus placebo in post-stroke rehabilitation patients
Acronym
RCT with vitamin D for post-stroke rehabilitation patients
Scientific Title
A randomized, double blind, comparative study of vitamin D3 versus placebo in post-stroke rehabilitation patients
Scientific Title:Acronym
RCT with vitamin D for post-stroke rehabilitation patients
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will determine if vitamin D3 peroral administration of 2000IU/day for 3 month can enhance effectiveness of poststroke rehabilitation, by conducting a double blind randomized controlled clinical trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
FIM gain(8 weeks)
Key secondary outcomes
FIM efficiency, Calf circumference(8 weeks),
Grip strength(8 weeks), Brunnstrom recovery stage(8 weeks)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Vitamin D3 (2000IU/day)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Poststroke patients hospitalized for rehabilitation
2. Obtained informed consent
3. 20 years of age or older
4. Rehabilitation doctors judge that patients require inpatient rehabilitation for 3 months.
Key exclusion criteria
1. Taking vitamin D supplement or 1,25 vitamin D, Calcium
2. History of kidney stone and bone fracture
3. Ingestion of vitamin D capsule orally is impossible
4. Independent walking or total assistance on admission
5. Other difficulties judged by the surgeon in charge
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryo Momosaki |
Organization
The Jikei University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
3-25-8 Nishi-shimbashi, Minato-ku
TEL
03-3433-1111
momosakiryo@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuyoshi Urashima |
Organization
The Jikei University School of Medicine
Division name
Division of Molecular Epidemiology
Zip code
Address
3-25-8 Nishi-shimbashi, Minato-ku
TEL
03-3433-1111
Homepage URL
http://docrd.jp/
urashima@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The 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
| 2012 | Year | 01 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2011 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 17 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 02 | Day |
Last modified on
| 2017 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007962
