UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014743
Receipt number 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 00:18:25

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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 or person

Institute

Jikei University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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