MedTrace Logo

Study of the Efficacy and Safety of Nicotinamide in Patients With Liver Fibrosis (NICOFIB)

NCT06599918 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-11-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Nicotinamide

Administration of NAM on a variable dose depending on the participant's body weight. Administration is done orally, daily.

DRUG

Placebo

Administration of placebo on a variable dose depending on the participant's body weight. Administration is done orally, daily.

Sponsors & Collaborators

  • Germans Trias i Pujol Hospital

    collaborator OTHER

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-23
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06599918 on ClinicalTrials.gov