UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of dietary intervention by dietitian for metal allergy patients
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Makoto Miyoshi
Organization	Kobe University Graduate School of Health Sciences
Division name	Department of Biophysics
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	Reiko Mikajiri
Organization	Kobe University Hospital
Division name	Department of Nutrition
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 07 Month 23 Day
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

Related information
URL releasing protocol	http://www.hosp.kobe-u.ac.jp/nest/
Publication of results	Unpublished
URL releasing results
Results
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