Actively Recruiting
Randomized, Double-blind, Placebo-controlled 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
52 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
This clinical trial is a pilot study investigating the effects of nicotinamide (NAM) on people with hepatic fibrosis, a liver condition. Researchers aim to determine if NAM treatment can stop or reduce liver fibrosis and study its impact on general health factors like weight, insulin resistance, fat distribution, inflammation, fat tissue activity, and gut microbiota composition. The study compares NAM to a placebo to understand these effects better. Participants will receive either NAM or a placebo adjusted to their body weight, taken orally every day for one year. The NAM dose is 1.2 g/m2 per day. The study includes six visits over 12 months, starting with a thorough initial assessment including physical exams, muscle function tests, electrocardiograms, blood tests, imaging, thermography, questionnaires, and sample collection. Follow-up visits monitor safety, adherence, and health status with repeated tests and sample collections. Participants will be closely monitored through physical exams, blood and urine tests, imaging, and questionnaires at various points during the year. Researchers will evaluate liver fibrosis using Fibroscan at the start and end of the study and assess other health measures at multiple timepoints. Safety is tracked by recording any adverse events and regularly checking liver, kidney, and heart function. The study concludes after 12 months of treatment and evaluations.
CONDITIONS
Brief 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) by their referring physician
- Body mass index (BMI) between 27 and 40 kg/m2
- Fibroscan value greater than 9.2 kPa obtained within the last 6 months prior to the study start
You will not qualify if you...
- Any medical condition that may interfere with study results or ability to complete the study
- History of significant heart disease or heart failure (ejection fraction less than 40%, NYHA Class greater than 2)
- Decreased kidney function (estimated glomerular filtration rate less than 45 mL/min/1.73 m2)
- Alcohol consumption exceeding 30 g/day in men or 20 g/day in women
- Significant liver function impairment (AST, ALT, bilirubin over 3 times upper normal limit)
- Positive for hepatitis B or C
- Hepatocellular carcinoma or liver cirrhosis
- Diagnosis of HIV infection
- Allergy or hypersensitivity to nicotinamide or capsule ingredients
- Allergy to iodinated contrast agents
- Autoimmune disorders requiring systemic corticosteroids or immunosuppressants
- Treatment with hepatotoxic or certain antidiabetic drugs
- Use of narcotic or psychotropic substances with liver toxicity
- Incapacitating diseases or cognitive impairment
- Institutionalized or without fixed address
- Low adherence risk or life expectancy less than 12 months
- Participation in other interventional trials recently
- Recent use of vitamin B3 (NAM) within 3 months
- Pregnancy or breastfeeding
- Use of vitamin E or probiotics
- Waiting for bariatric surgery within 12 months
- Contraindications to contrast agents used in imaging tests
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive daily oral doses of nicotinamide or placebo for 12 months while undergoing regular monitoring and assessments.
6 visits at baseline, 1, 3, 6, 9, and 12 months
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
J
Josep Julve, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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