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

Study acronym: NICOFIB
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Eligibility criteria shortened, about 10 words
    • Study description shortened, about 20 words
    • Site details revised
    • Study title shortened, about 5 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06599918
Lead Sponsor Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators: Germans Trias i Pujol Hospital
Conditions
(from sponsor)		 Fatty Liver, Obesity, Hepatic Fibrosis, NAFLD, Nicotinamide, Overweight and Obese Adults
Related terms Fatty Liver, Liver Cirrhosis, Non-alcoholic Fatty Liver Disease, Obesity, Overweight
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov