UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012410 |
|---|---|
| Receipt number | R000014525 |
| Scientific Title | Association between Helicobacter pylori infection and vitamin B1 deficiency |
| Date of disclosure of the study information | 2013/11/27 |
| Last modified on | 2013/11/26 21:31:49 |
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Basic information
Public title
Association between Helicobacter pylori infection and vitamin B1 deficiency
Acronym
Association between H. pylori infection and vitamin B1 deficiency
Scientific Title
Association between Helicobacter pylori infection and vitamin B1 deficiency
Scientific Title:Acronym
Association between H. pylori infection and vitamin B1 deficiency
Region
| Japan |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Gastroenterology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We assume the existence of the potential stomach lesion as a cause of the vitamin B1 deficiency and investigate association between the vitamin B1 deficiency and Helicobacter pylori infection which plays a substantial role in the stomach lesion formation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of vitamin B1 values before and after Helicobacter pylori eradication
Key secondary outcomes
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Blood sampling for comparison of vitamin B1 values before and after Helicobacter pylori eradication
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A patient to plan Helicobacter pylori elimination
Key exclusion criteria
Patients taking oral agent containing vitamin B1
Patients taking an unbalanced diet
Patients with heavy use of alcohol
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yosuke Kudo |
Organization
Yokohama City University School of Medicine
Division name
Department of Neurology
Zip code
Address
3-9,Fukuura,Kanazawa-ku,Yokohama-shi,Kanagawa
TEL
045-787-2800
ykudo15@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Kudo |
Organization
Yokohama City University School of Medicine
Division name
Department of Neurology
Zip code
Address
3-9,Fukuura,Kanazawa-ku,Yokohama-shi,Kanagawa
TEL
045-787-2800
Homepage URL
ykudo15@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
横浜市立大学附属病院 Yokohama City University Hospital
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 27 | 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
| 2013 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 26 | Day |
Last modified on
| 2013 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014525
