UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041572 |
|---|---|
| Receipt number | R000047460 |
| Scientific Title | Effect of low gluten diet on disease activity of rheumatoid arthritis |
| Date of disclosure of the study information | 2020/08/28 |
| Last modified on | 2020/08/27 10:16:55 |
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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
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
taniken@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047460
