UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014743
Receipt No. R000017136
Scientific Title Randomized trial of vitamin D supplementation to prevent seasonal influenza infection in inflammatory bowel disease patients.
Date of disclosure of the study information 2014/08/01
Last modified on 2018/02/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Randomized trial of vitamin D supplementation to prevent seasonal influenza infection in inflammatory bowel disease patients.
Acronym Randomized trial of vitamin D supplementation to prevent seasonal influenza infection in inflammatory bowel disease patients.
Scientific Title Randomized trial of vitamin D supplementation to prevent seasonal influenza infection in inflammatory bowel disease patients.
Scientific Title:Acronym 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
1st name
Middle name
Last name Arihiro Seiji
Organization Jikei University School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
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
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
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)

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
2014 Year 08 Month 01 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
2014 Year 05 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000017136

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.