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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036787
Receipt No. R000041772
Scientific Title A prospective observational study on the effects and mechanisms of zinc deficiency in patients with ulcerative colitis
Date of disclosure of the study information 2019/06/01
Last modified on 2019/05/17

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Basic information
Public title A prospective observational study on the effects and mechanisms of zinc deficiency in patients with ulcerative colitis
Acronym A prospective observational study on the effects and mechanisms of zinc deficiency in patients with ulcerative colitis
Scientific Title A prospective observational study on the effects and mechanisms of zinc deficiency in patients with ulcerative colitis
Scientific Title:Acronym A prospective observational study on the effects and mechanisms of zinc deficiency in patients with ulcerative colitis
Region
Japan

Condition
Condition Ulcerative colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to analyze the expressions and activities of zinc-requiring ectoenzymes in the intestinal tissue and serum zinc concentration in patients with ulcerative colitis, and to clarify the relationship between the pathogenesis of ulcerative colitis and zinc deficiency and its mechanism.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between zinc deficiency and the expressions and activities of ATP-requiring ATP metabolism related enzymes in the intestinal tissue.
Key secondary outcomes 1. Correlation between zinc deficiency or the expressions and activities of zinc-requiring ATP metabolism related enzyme in the intestinal tissue, and clinical symptoms of the enzyme, blood test findings, diesase severity (CAI, endoscopic severity), prognosis (active phase: improvement rate, remission rate, mucosal healing rate, cumulative surgery rate, remission period rate, relapse rate).
2.Correlation between expressions and activities of zinc-requiring ATP metabolism related enzymes and expressions of inflammation related mediators.
3. Correlation between enhancers of zinc absorption and expressions of inflammatory mediators.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
12 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients older than 12 years of age at the time of consent acquisition.
2. Out- or inatients with ulcerative colitis in our hospital.
3. Treatment history is not matter.
4. The severity, activity and remission periods are not matter.
5. Patients who obtained written consent for the participation of this study
Key exclusion criteria 1. Patients under 12 years old
2. Patient with right-sided ulcerative colitis (as it is difficult to determine by biopsy from the rectum).
3. Patients with difficulty for perfoming colonoscopy and biopsy.
4. In addition, patients whom the doctor in charge judged as inappropriate.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Mikihiro
Middle name
Last name Fujiya
Organization Asahikawa Medical University
Division name Department of Medicine, Division of Gastroenterology and Hematology/Oncology
Zip code 078-8510
Address 2-1-1-1-, Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
TEL 0166-68-2462
Email fjym@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Murakami
Organization Asahikawa Medical University
Division name Department of Medicine, Division of Gastroenterology and Hematology/Oncology
Zip code 078-8510
Address 2-1-1-1-, Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
TEL 0166-68-2462
Homepage URL
Email yuuki1228@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization Nobelpharma Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Applied Molecular Biology, Division of Integrated Life Science, Graduate School of Biostudies, Kyoto University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Asahikawa Medical University Research Ethics Committee
Address 2-1-1-1-, Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
Tel 0166-68-2297
Email rs-kk.g@asahikawa-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 旭川医科大学病院

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 01 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
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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Association between zinc deficiency and the pathogenesis of ulcerative colitis and its mechanism

Management information
Registered date
2019 Year 05 Month 17 Day
Last modified on
2019 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041772

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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