UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017499 |
|---|---|
| Receipt number | R000020283 |
| Scientific Title | Effectiveness of dietary intervention by dietitian for metal allergy patients |
| Date of disclosure of the study information | 2015/05/11 |
| Last modified on | 2016/06/21 14:50:46 |
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Basic information
Public title
Effectiveness of dietary intervention by dietitian for metal allergy patients
Acronym
Dietary intervention for metal allergy patients
Scientific Title
Effectiveness of dietary intervention by dietitian for metal allergy patients
Scientific Title:Acronym
Dietary intervention for metal allergy patients
Region
| Japan |
Condition
Condition
Metal allergy patients
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness of dietary intervention by dietitian for metal allergy patients
Basic objectives2
Others
Basic objectives -Others
Improvement of clinical symptom, Food intake and QOL
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of clinical symptom after one month
Key secondary outcomes
Improvement of food intake and QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Instruction by the doctor(+),Instruction by the administrative dietitian(+)
Interventions/Control_2
Instruction by the doctor(+),Instruction by the administrative dietitian(-)
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Metal allergy patients who have no dietary intervention, over 16 years of age, male and female
Key exclusion criteria
Metal allergy patients who are already treated by dietitian, or, less than 16 years old
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Miyoshi |
Organization
Kobe University Graduate School of Health Sciences
Division name
Department of Biophysics
Zip code
Address
7-10-2, Tomogaoka, Suma-ku, Kobe-shi, Hyogo
TEL
078-796-4581
miyoshi@harbor.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Reiko Mikajiri |
Organization
Kobe University Hospital
Division name
Department of Nutrition
Zip code
Address
7-5-2, Kusucho, Kobe-shi, Hyogo
TEL
078-382-5111(5262)
Homepage URL
mikajiri@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Health Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 11 | Day |
Related information
URL releasing protocol
http://www.hosp.kobe-u.ac.jp/nest/
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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 11 | Day |
Last modified on
| 2016 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020283
| 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 |
