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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007002
Receipt No. 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

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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
Email 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/
Email urashima@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007962

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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