UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized trial of vitamin D supplementation to prevent seasonal influenza infection in inflammatory bowel disease patients.
Title of the study (Brief title)	Randomized trial of vitamin D supplementation to prevent seasonal influenza infection in inflammatory bowel disease patients.
Region	Japan

Condition
Condition	inflammatory bowel disease
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	We will determine if vitamin D3 peroral administration of 500IU/day can prevent seasonal influenza infection, by conducting a double blind randomized controlled clinical trial.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	doctor diagnosed influenza virus infection
Key secondary outcomes	upper and lower respiratory symptoms influenza antibody titer subgroup analysis of Vitamin D receptor polymorphism

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	Prevention
Type of intervention	Food
Interventions/Control_1	VitaminD3
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	18 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1. Person who agreed to participate in the trial with written form of consent 2. Nothing correspond to excluding criteria
Key exclusion criteria	1. Person who was already infected with influenza virus infection since May 2014. 2. Person who has past history of urinary tract stone 3. Person who is taking vitamin D supplement 5. Person who has drug allergy including Vitamin D supplement or serious allergy
Target sample size	240

Research contact person
Name of lead principal investigator	Arihiro Seiji
Organization	Jikei University School of Medicine
Division name	Division of Gastroenterology and Hepatology, Department of Internal Medicine
Address	3-25-8 Nishi-shimbashi, Minato-ku, Tokyo, 1058461 JAPAN
TEL	03-3433-1111
Email	sarihiro@gmail.com

Public contact
Name of contact person	Mitsuyoshi Urashima
Organization	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
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)

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	2014 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 01 Day
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date	2015 Year 08 Month 01 Day
Date of closure to data entry	2015 Year 08 Month 31 Day
Date trial data considered complete	2015 Year 08 Month 31 Day
Date analysis concluded	2015 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 01 Day
Last modified on	2018 Year 02 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017136