UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004330 |
|---|---|
| Receipt number | R000005182 |
| Scientific Title | The relationship between serum vitamin D level and bronchial asthma. |
| Date of disclosure of the study information | 2010/10/06 |
| Last modified on | 2016/10/14 07:22:01 |
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Basic information
Public title
The relationship between serum vitamin D level and bronchial asthma.
Acronym
The relationship between serum vitamin D level and bronchial asthma.
Scientific Title
The relationship between serum vitamin D level and bronchial asthma.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Mitsuru Munakata |
Organization
School of Medicine, Fukushima Medical University
Division name
Department of Pulmonary Medicine
Zip code
Address
1-Hikarigaoka, Fukushima City, Japan
TEL
024-547-1360
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Suguru Sato |
Organization
School of Medicine, Fukushima Medical University
Division name
Department of Pulmonary Medicine
Zip code
Address
1-Hikarigaoka, Fukushima City, Japan
TEL
024-547-1360
Homepage URL
http://www.fmu.ac.jp/
pulmo@fmu.ac.jp
Sponsor or person
Institute
Department of Pulmonary Medicine, School of Medicine, Fukushima Medical University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2010 | Year | 09 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005182
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
