UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036787 |
|---|---|
| Receipt number | 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 | 2020/05/19 22:39:17 |
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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
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
yuuki1228@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
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
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 25 | Day |
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
| 2020 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041772
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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