UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized, double blind, comparative study of vitamin D3 versus placebo in post-stroke rehabilitation patients
Title of the study (Brief title)	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	Ryo Momosaki
Organization	The Jikei University School of Medicine
Division name	Department of Rehabilitation Medicine
Address	3-25-8 Nishi-shimbashi, Minato-ku
TEL	03-3433-1111
Email	momosakiryo@gmail.com

Public contact
Name of contact person	Mitsuyoshi Urashima
Organization	The Jikei University School of Medicine
Division name	Division of Molecular Epidemiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000007962