UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046664 |
|---|---|
| Receipt number | R000053232 |
| Scientific Title | Randomized interventional study of add-on effects of the nutritional therapy on standard treatments for patients with ulcerative colitis |
| Date of disclosure of the study information | 2022/01/17 |
| Last modified on | 2022/01/17 22:34:01 |
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Basic information
Public title
Randomized interventional study of add-on effects of the nutritional therapy on standard treatments for patients with ulcerative colitis
Acronym
Nutritional Therapy Intervention Study for Patients with Ulcerative Colitis
Scientific Title
Randomized interventional study of add-on effects of the nutritional therapy on standard treatments for patients with ulcerative colitis
Scientific Title:Acronym
Nutritional Therapy Intervention Study for Patients with Ulcerative Colitis
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigated whether nutritional guidance to promote zinc intake and a Japanese diet (high in n-3 fatty acids) could induce clinical remission in patients with mild active ulcerative colitis (UC).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint was clinical remission at 24 weeks.
Key secondary outcomes
Secondary endpoints were the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) scores, the clinical activity index (CAI) evaluated based on symptoms, and biomarkers, including the zinc levels, at 12 and 24 weeks.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
nutritional guidance (intervention group)
Interventions/Control_2
control group
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
| 15 | years-old | <= |
Age-upper limit
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients had mild active UC (patients with a UCEIS score of 2-4 points, CAI score of 5-6 points, and a distribution of the UCEIS and CAI scores at admission indicating that the patient was not in remission) were enrolled in the study.
Key exclusion criteria
Patients undergoing colonoscopy without pretreatment; those with difficulty following nutritional guidance; those with an intestinal obstruction, fistula, history of colorectal surgery, moderate to severe active-phase UC, diverticulitis, or massive colorectal bleeding; and those with anemia or other underlying conditions except UC were excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Tsuzuki |
Organization
Saitama medical university
Division name
Department of Gastroenterology
Zip code
350-0451
Address
Morohongo38, Moroyamamachi, Iruma-gun, Saitama Japan
TEL
+81-49-276-1667
ytsuzuki38@gmail.com
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Miyaguchi |
Organization
Saitama Medical University
Division name
Department of Gastroenterology
Zip code
350-0451
Address
Morohongo38, Moroyamamachi, Iruma-gun, Saitama Japan
TEL
+81-49-276-1667
Homepage URL
kaz.hr77@gmail.com
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama medical university IRB Committee
Address
Morohongo38, Moroyamamachi, Iruma-gun, Saitama Japan
Tel
+81492761667
hirb@saitama-med.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
| 2022 | Year | 01 | Month | 17 | 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
20
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
| 2018 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 17 | Day |
Last modified on
| 2022 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053232
