Actively Recruiting
Study of the Efficacy and Safety of Nicotinamide in Patients With Liver Fibrosis (NICOFIB)
Led by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Updated on 2025-11-18
30
Participants Needed
1
Research Sites
240 weeks
Total Duration
On this page
Sponsors
F
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead Sponsor
G
Germans Trias i Pujol Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study of the Efficacy and Safety of Nicotinamide in Patients With Liver Fibrosis (NICOFIB)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 18 and 85 years
- Diagnosis of non-alcoholic fatty liver disease (NAFLD) confirmed by a physician
- Body mass index (BMI) between 27 and 40 kg/m2
- Fibroscan value greater than 9.2 kPa within 6 months before the study start
You will not qualify if you...
- Any medical condition that may interfere with study results or participation
- History of significant heart disease or heart failure (ejection fraction <40%, NYHA Class >2)
- Decreased kidney function (eGFR <45 mL/min/1.73 m2)
- Alcohol consumption above 30 g/day for men or 20 g/day for women
- Significant liver function impairment (AST, ALT, bilirubin >3 times normal)
- Positive for hepatitis B or C
- Hepatocellular carcinoma or liver cirrhosis
- HIV infection
- Allergy to nicotinamide or capsule ingredients
- Allergy to iodinated contrast
- Significant autoimmune disorder requiring immunosuppressants
- Use of hepatotoxic drugs or narcotic/psychotropic substances with liver effects
- Incapacitating disease or cognitive impairment
- Institutionalized or without fixed address
- Low adherence indication by investigator
- Life expectancy less than 12 months
- Participation in another interventional trial within 30 days
- Recent use of vitamin B3 (NAM) within 3 months
- Pregnant or breastfeeding women
- Use of vitamin E or probiotics treatment
- Waiting for bariatric surgery within 12 months
- Treatment with drugs affecting liver disease or certain diabetes medications initiated within 6 months
- Refusal to sign informed consent
- Contraindication to contrast agent used in imaging tests
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Actively Recruiting
Research Team
D
Didac Mauricio, Md PhD
CONTACT
J
Josep Julve, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here