Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Nicotinamide in Patients With and Liver Fibrosis (NICOFIB)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The objective of this clinical trial, a pilot study, is to assess the impact of nicotinamide (NAM) on individuals with hepatic fibrosis. The main question it aims to answer is: \- To determine if the treatment with NAM is able to arrest, or even reduce, the hepatic fibrosis. In addition, we also want to study the effect of NAM on: * General parameters (weight, HOMA-IR, etc). * Adiposity distribution (liver and body). * Systemic inflammation. * Thermogenic capacity of adipose tissue. * Microbiota composition. Researchers will compare NAM to a placebo, to see if NAM can arrest or revert hepatic fibrosis and its associated effects. Participants will take either NAM or placebo. The dosage will be 1.2g/m2 NAM per day, for one year.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Patients aged between 18 and 85 years.
• Diagnosis of non-alcoholic fatty liver disease (NAFLD) by their referring physicians (NAFLD defined as the presence of hepatic steatosis and in the absence of significant alcohol consumption, having excluded other liver diseases).
• BMI between 27-40 kg/m2.
• Fibroscan® value greater than 9.2 kPa, obtained within the last 6 months prior to the start of the study.
Locations
Other Locations
Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Contact Information
Primary
Didac Mauricio, Md PhD
dmauricio@santpau.cat
003493 556 57 75
Backup
Josep Julve, PhD
jjulve@santpau.cat
0034935565617
Time Frame
Start Date:2024-04-23
Estimated Completion Date:2028-12
Participants
Target number of participants:30
Treatments
Placebo_comparator: Placebo
Administration of the placebo compound, in the same format as the active compound.~The placebo is composed by microcrystalline Cellulose (Excipient No. 1 for capsules: 98.05% microcrystalline cellulose, 1.95% colloidal silica). Molecular formula: C14H26O11 IUPAC name: methyl 4-O-methyl-hexopyranosyl-(1-\>4)-hexopyranoside Molecular weight: 370.35 g/mol Qualitative and quantitative composition (per capsule): Microcrystalline Cellulose 400 mg Pharmaceutical form: Hard gelatin capsules containing. Dose and route of administration: maximum 2.4 g daily/oral. Raw material suppliers: Fagron and Acofarma. Encapsulation location: Pharmacy Service of HSCSP.
Active_comparator: Nicotinamide
Administration of the active compound, the amide form of vitamin B3, Nicotinamide (NAM).~International Nonproprietary Name: Nicotinamide. Molecular formula: C6H6N2O IUPAC name: Pyridine-3-carboxamide. Molecular weight: 122.12 g/mol. Qualitative and quantitative composition (per capsule): Nicotinamide 500 mg. Pharmaceutical form: Hard gelatin capsules. Dose and route of administration: maximum 3 g daily/oral. Raw material suppliers: Fagron and Acofarma. Encapsulation location: Pharmacy Service of HSCSP.