Last reviewed · How we verify
Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Nicotinamide in Patients With and Liver Fibrosis (NICOFIB)
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.
Details
| Lead sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 30 |
| Start date | 2024-04-23 |
| Completion | 2028-12 |
Conditions
- Fatty Liver
- Obesity
- Hepatic Fibrosis
- NAFLD
- Nicotinamide
- Overweight and Obese Adults
Interventions
- Nicotinamide
- Placebo
Primary outcomes
- Effect of nicotinamide on hepatic fibrosis — Fibroscan at 0 and 12 months.
Measurement of hepatic fibrosis by Fibroscan, to asses the arrest or improvement of fibrosis (lower value than basal Fibroscan result)
Countries
Spain