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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017499
Receipt No. 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

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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
Email 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
Email mikajiri@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Health Sciences
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020283

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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