UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The relationship between serum vitamin D level and bronchial asthma.
Title of the study (Brief title)	The relationship between serum vitamin D level and bronchial asthma.
Region	Japan

Condition
Condition	bronchial asthma
Classification by specialty	Pneumology Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the relationship of serum vitamin D level and clinical characteristics of bronchial asthma.
Basic objectives2	Others
Basic objectives -Others	To evaluate the usefulness of serum vitamin D as a biomarker.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary outcome is evaluating the correlation between serum vitamin D level and asthma severity.
Key secondary outcomes	The secondary outcome is evaluating the correlation between serum vitamin D level and fractional exhaled nitric oxide levels.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who were or will be diagnosed as having bronchial asthma in department of pulmonary medicine, Fukushima Medical University Hospital and normal volunteers, they received or will receive fractional exhaled nitric oxide measurements, serum sampling, and agreed or agree to be involved in this clinical study.
Key exclusion criteria	Asthmatic patients without measurement of fractional exhaled nitric oxide before treatment.
Target sample size	500

Research contact person
Name of lead principal investigator	Mitsuru Munakata
Organization	School of Medicine, Fukushima Medical University
Division name	Department of Pulmonary Medicine
Address	1-Hikarigaoka, Fukushima City, Japan
TEL	024-547-1360
Email

Public contact
Name of contact person	Suguru Sato
Organization	School of Medicine, Fukushima Medical University
Division name	Department of Pulmonary Medicine
Address	1-Hikarigaoka, Fukushima City, Japan
TEL	024-547-1360
Homepage URL	http://www.fmu.ac.jp/
Email	pulmo@fmu.ac.jp

Sponsor
Institute	Department of Pulmonary Medicine, School of Medicine, Fukushima Medical University
Institute
Department

Funding Source
Organization	Department of Pulmonary Medicine, School of Medicine, Fukushima Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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	福島県立医科大学病院（福島県）

Other administrative information
Date of disclosure of the study information	2010 Year 10 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 09 Month 01 Day
Anticipated trial start date	2010 Year 09 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	The relation between serum vitamin D and pathophysiology of asthma have been studied but its clinical significance has not been established. For this reason, we will perform the prospective observational study to evaluate the relationship among serum vitamin D level, asthma severity, and fractional exhaled nitric oxide levels. For the subjects who already underwent the fractional exhaled nitric oxide measurements, blood sampling and agree to be involved in this clinical study will be included and analyzed retrospectively.

Management information
Registered date	2010 Year 10 Month 05 Day
Last modified on	2016 Year 10 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005182