UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032611
Receipt number 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 2022/05/21 16:30:49

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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

23


Research contact person

Name of lead principal investigator

1st name Takaomi
Middle name
Last name Kessoku

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

236-0004

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 Takaomi
Middle name
Last name Takaomi

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

236-0004

Address

3-9, Fukuura, Kanazawa-ku Yokohama-shi, Kanagawa Prefecture 236-0004

TEL

0457872640

Homepage URL


Email

takaomi0027@gmail.com


Sponsor or person

Institute

Yokohama City University Graduate School of Medicine

Institute

Department

Personal name



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

Yokohama City University Graduate School of Medicine

Address

3-9, Fukuura, Kanazawa-ku Yokohama-shi, Kanagawa Prefecture 236-0004

Tel

0457872640

Email

tkhkcb@gmail.com


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

https://pubmed.ncbi.nlm.nih.gov/33879971/

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/33879971/

Number of participants that the trial has enrolled

22

Results

Serum alanine aminotransferase levels, the primary endpoint, did not change significantly after vitamin B6 treatment. On the other hand, magnetic resonance imaging-based proton density fat fraction, a parameter of hepatic lipid accumulation, was significantly reduced despite no significant changes in body mass index, even in those not taking Vitamin E.

Results date posted

2022 Year 05 Month 21 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Ten patients (43.5%) had type 2 diabetes and 17 (73.9%) had dyslipidemia. The mean baseline MRI-PDFF, MRE, ALT, and Body Mass Index (BMI) were 18.4%, 2.8kPa, 82.6U/L, and 28.31 kg/m2, respectively. Five patients took VitE orally, and all of them had been taking it for more than a year at the time they were enrolled.

Participant flow

We screened patients who visited the Yokohama City University Hospital (Yokohama, Japan)
between June 2018 and March 2019. The follow-up of participants ended in July 2019. Of the 23 patients (mean age = 50.6y) enrolled in this study, 22 completed the study protocol.

Adverse events

Only one adverse event of rash occurred in 23 patients (4.34%); there were no serious adverse events.

Outcome measures

Serum alanine aminotransferase levels, the primary endpoint, did not change significantly after vitamin B6 treatment (93.6 to 93.9, p=0.976). On the other hand, magnetic resonance imaging-based proton density fat fraction, a parameter of hepatic lipid accumulation, was significantly reduced (18.7 to 16.4, p<0.001) despite no significant changes in body
mass index, even in those not taking Vitamin E (n=17, 18.8 to 16.7, p=0.0012). Vitamin B6 administration significantly ameliorated hepatic fat accumulation.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

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 06 Month 01 Day

Last follow-up date

2019 Year 07 Month 09 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

2022 Year 05 Month 21 Day



Link to view the page

Value
https://center6.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