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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033600
Receipt No. R000038317
Official scientific title of the study The effect of Vitamin D on early-life wheezing after RS virus infection: A randomized, double-blinded placebo-controlled study
Date of disclosure of the study information 2018/08/02
Last modified on 2018/08/02

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Basic information
Official scientific title of the study The effect of Vitamin D on early-life wheezing after RS virus infection: A randomized, double-blinded placebo-controlled study
Title of the study (Brief title) The effect of Vitamin D on early-life wheezing after RS virus infection: A randomized, double-blinded placebo-controlled study
Region
Japan

Condition
Condition RS virus infection
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the effect of Vitamin D for preventing early-life wheezing on RS virus infection.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Number of wheezing for 12 months after entry.
Key secondary outcomes Duration of administration
Duration of oxygen supply

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 Treatment
Type of intervention
Food
Interventions/Control_1 Vitamin D
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
2 months-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are administered for RS virus infection
Key exclusion criteria Patients who are already taking Vitamin D
Patients who thought to require advanced airway management on administration
Target sample size 150

Research contact person
Name of lead principal investigator Kyohei Takahashi
Organization National Sagamihara Hospital
Division name Department of Pediatrics
Address Sakuradai 18-1, Minami-ward, Sagamihara city, Kanagawa pref., Japan
TEL 042-742-8311
Email kcrt@kcrt.net

Public contact
Name of contact person Kyohei Takahashi
Organization National Sagamihara Hospital
Division name Department of Pediatrics
Address Sakuradai 18-1, Minami-ward, Sagamihara city, Kanagawa pref., Japan
TEL 042-742-8311
Homepage URL
Email kcrt@kcrt.net

Sponsor
Institute National Sagamihara Hospital
Department of Pediatrics
Institute
Department

Funding Source
Organization Kawano Masanori Memorial Public Interest Incorporated Foundation for Promotion of Pediatrics
Organization
Division
Category of Funding Organization Non profit foundation
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
2018 Year 08 Month 02 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 07 Month 03 Day
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

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


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038317

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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