Unique ID issued by UMIN | UMIN000032611 |
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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 |
Efficacy of vitamin B6 against NAFLD : Invetigator-initiated, single-center, open-label, single-group, proof-of-concept study
Efficacy of vitamin B6 against NAFLD
Efficacy of vitamin B6 against NAFLD : Invetigator-initiated, single-center, open-label, single-group, proof-of-concept study
Efficacy of vitamin B6 against NAFLD
Japan |
non alcoholic fatty liver disease
Hepato-biliary-pancreatic medicine |
Others
NO
Administer vitamin B6 to nonalcoholic fatty liver disease and examine change in ALT.
Efficacy
Changes in ALT from baseline at 12 weeks
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
administration of vitamin B6
20 | years-old | <= |
85 | years-old | >= |
Male and Female
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).
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.
23
1st name | Takaomi |
Middle name | |
Last name | Kessoku |
Yokohama City University Graduate School of Medicine
Department of Gastroenterology and Hepatology
236-0004
3-9, Fukuura, Kanazawa-ku Yokohama-shi, Kanagawa Prefecture 236-0004
0457872640
takaomi0027@gmail.com
1st name | Takaomi |
Middle name | |
Last name | Takaomi |
Yokohama City University Graduate School of Medicine
Department of Gastroenterology and Hepatology
236-0004
3-9, Fukuura, Kanazawa-ku Yokohama-shi, Kanagawa Prefecture 236-0004
0457872640
takaomi0027@gmail.com
Yokohama City University Graduate School of Medicine
Yokohama City University Graduate School of Medicine
Self funding
Yokohama City University Graduate School of Medicine
3-9, Fukuura, Kanazawa-ku Yokohama-shi, Kanagawa Prefecture 236-0004
0457872640
tkhkcb@gmail.com
NO
2018 | Year | 05 | Month | 20 | Day |
https://pubmed.ncbi.nlm.nih.gov/33879971/
Published
https://pubmed.ncbi.nlm.nih.gov/33879971/
22
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.
2022 | Year | 05 | Month | 21 | Day |
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.
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.
Only one adverse event of rash occurred in 23 patients (4.34%); there were no serious adverse events.
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.
Completed
2018 | Year | 03 | Month | 05 | Day |
2018 | Year | 04 | Month | 06 | Day |
2018 | Year | 06 | Month | 01 | Day |
2019 | Year | 07 | Month | 09 | Day |
2018 | Year | 05 | Month | 16 | Day |
2022 | Year | 05 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036879
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