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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032611
Receipt No. R000036879
Scientific Title Efficacy of vitamin B6 against NAFLD : Invetigator-initiated, single-center, open-label, single-group, proof-of-concept study
Date of disclosure of the study information 2018/05/20
Last modified on 2019/06/05

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Basic information
Public title Efficacy of vitamin B6 against NAFLD : Invetigator-initiated, single-center, open-label, single-group, proof-of-concept study
Acronym Efficacy of vitamin B6 against NAFLD
Scientific Title Efficacy of vitamin B6 against NAFLD : Invetigator-initiated, single-center, open-label, single-group, proof-of-concept study
Scientific Title:Acronym Efficacy of vitamin B6 against NAFLD
Region
Japan

Condition
Condition non alcoholic fatty liver disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Administer vitamin B6 to nonalcoholic fatty liver disease and examine change in ALT.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in ALT from baseline at 12 weeks
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 Treatment
Type of intervention
Medicine
Interventions/Control_1 administration of vitamin B6
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients aged 20 to 85 years old at the time of acquisition.
2) Patients with NAFLD who have ineffective diet exercise therapy for 3 months.
3) Patients who can understand written consent about participation, observe compliance matters, undergo examination prescribed in this research plan, and can declare symptoms.
4) Patient diagnosed as fatty liver by abdominal ultrasound.
5) Patients who have fat liver greater than S1 stage by MRI.
6) Patients with fibrosis grade F3 or lower by MRI.
7) Patients with ALT of 40 IU / I or higher at screening .
8) Patients without drinking habits. (Alcohol consumption is equivalent to ethanol per day, in men less than 30 g / day, in women less than 20 g.)
9) Patients who are suspected of vitamin B6 deficiency by clinical symptoms (angularitis, cheilitis, glossitis, acute / chronic eczema, seborrheic eczema, contact dermatitis, peripheral neuritis, radiation disorder).
Key exclusion criteria 1) Patient who has a change in internal medicine within 3 months before acquiring consent.
2) Patients whom the drug is contraindicated for and who have a history of hypersensitivity to the ingredients of the drug.
3) Patients with complications of other hepatic diseases such as hepatitis C, hepatitis B, autoimmune hepatitis.
4) Patients with current or past medical history of severe cardiovascular system, blood system, respiratory system, liver, kidney, digestive system, or neuropsychiatric disorder.
5) Patients with drug-induced or symptomatic NAFLD.
6) Patients who participated in other clinical trials and received administration of test drugs within one month prior to the start of the study (calculated from the day of study drug administration).
7) Patients with insulin injections for diabetic patients.
8) Patients with history of abdominal gastrointestinal surgery excluding appendicitis.
9) Patients with breastfeeding or who may be pregnant.
10) Patients who are judged inappropriate as subjects of this research by researchers.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takaomi Kessoku
Organization Yokohama City University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 3-9, Fukuura, Kanazawa-ku Yokohama-shi, Kanagawa Prefecture 236-0004
TEL 0457872640
Email takaomi0027@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takaomi Kessoku
Organization Yokohama City University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 3-9, Fukuura, Kanazawa-ku Yokohama-shi, Kanagawa Prefecture 236-0004
TEL 0457872640
Homepage URL
Email takaomi0027@gmail.com

Sponsor
Institute Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Yokohama City University Graduate School of Medicine
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
Address
Tel
Email

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
2018 Year 05 Month 20 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 No longer recruiting
Date of protocol fixation
2018 Year 03 Month 05 Day
Date of IRB
2018 Year 04 Month 06 Day
Anticipated trial start date
2018 Year 05 Month 02 Day
Last follow-up date
2019 Year 06 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 16 Day
Last modified on
2019 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036879

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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