UMIN-CTR Clinical Trial

Basic information
Public title	Effect of low gluten diet on disease activity of rheumatoid arthritis
Acronym	Effect of low gluten diet on disease activity of rheumatoid arthritis
Scientific Title	Effect of low gluten diet on disease activity of rheumatoid arthritis
Scientific Title:Acronym	Effect of low gluten diet on disease activity of rheumatoid arthritis
Region	Japan

Condition
Condition	rheumatoid arthritis
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examine whether gluten-reduced diet affect the disease activity of rheumatoid arthritis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The disease activity is measured by joint symptom, finding of joint, and hematological data, and is compared among at baseline and 8 and 16 weeks after the diet.
Key secondary outcomes	The extent of gluten-reduction is classified into three groups, and the level of disease activity after the diet is compared among the groups.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	The subject takes a low gluten diet for 16 weeks.
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	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who have been diagnosed as rheumatoid arthritis
Key exclusion criteria	Patients who can not select the menu of diet
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Kenji Middle name Last name Tani
Organization	Tokushima University Hospital
Division name	Department of General Medicine and Primary Care
Zip code	770-8503
Address	50 Kuramoto-cho 2, Tokushima city, Japan
TEL	088-633-9614
Email	taniken@tokushima-u.ac.jp

Public contact
Name of contact person	1st name Kenji Middle name Last name Tani
Organization	Tokushima University Hospital
Division name	Department of General Medicine and Primary Care
Zip code	770-8503
Address	50 Kuramoto-cho 2, Tokushima city, Japan
TEL	088-633-9614
Homepage URL
Email	taniken@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University
Institute
Department

Funding Source
Organization	TOkushima University
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	Tokushima University Hospital Clinical Research Center
Address	50 Kuramoto-cho2, Tokushima city, Tokushima
Tel	088-633-9294
Email	awachiken@tokushima-u.ac.jp

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	2020 Year 08 Month 28 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	109
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	2019 Year 06 Month 01 Day
Date of IRB	2019 Year 07 Month 26 Day
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2020 Year 06 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 08 Month 27 Day
Last modified on	2020 Year 08 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047460