Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT06599918
Eligibility Criteria:
Inclusion Criteria:
* Patients aged between 18 and 85 years.
* Diagnosis of non-alcoholic fatty liver disease (NAFLD) by their referring physicians (NAFLD defined as the presence of hepatic steatosis and in the absence of significant alcohol consumption, having excluded other liver diseases).
* BMI between 27-40 kg/m2.
* Fibroscan® value greater than 9.2 kPa, obtained within the last 6 months prior to the start of the study.
Exclusion Criteria:
* Patients with any medical condition or illness that, in the opinion of the investigator, could interfere with the study results and/or affect the patients' ability to participate or complete the study.
* History of clinically significant heart disease (ejection fraction \<40% \[normal range 50-70%\], heart failure defined as New York Heart Association \[NYHA\] Class \> 2; clinically significant congenital or acquired valvular disease; symptomatic coronary artery disease such as myocardial infarction or angina, history of unstable arrhythmias, history of atrial fibrillation).
* Decreased renal function (estimated glomerular filtration rate \<45 mL/min/1.73 m2, calculated using the CKD-EPI formula) at screening.
* Alcohol consumption exceeding 30 g/day in men or 20 g/day in women.
* Patients with significant impairment of liver function in the selection analysis defined as repeated values of AST, ALT, and bilirubin \> 3 times the upper limit of normal.
* Positive for hepatitis B surface antigen or hepatitis C antibodies.
* Patients with hepatocellular carcinoma.
* Patients with liver cirrhosis (Fibroscan® \> 18, compatible biopsy, or those who have experienced decompensations of cirrhosis).
* Patients diagnosed with human immunodeficiency virus (HIV).
* Patients with hypersensitivity or a history of severe allergies to NAM or excipients used in the preparation of capsules (NAM and placebo).
* Patients with iodinated contrast allergy.
* History or evidence of an autoimmune disorder considered clinically significant by the investigator or requiring systemic, chronic use of systemic corticosteroids or other immunosuppressants.
* Patients on treatment with hepatotoxic drugs (amiodarone, immunosuppressants, ART, antituberculosis drugs, corticosteroids, etc.).
* Patients consuming narcotic and psychotropic substances with hepatotoxic effects.
* Individuals with incapacitating diseases or cognitive impairment.
* Institutionalized patients or those without a fixed address.
* Principal investigator's discretion in case of indications of low adherence to the trial or follow-up visits.
* Individuals with a life expectancy of less than 12 months.
* Patients participating in another interventional clinical trial, excluding observational/natural history studies, at the start of the study or within the last 30 days before the start of the study.
* Previous use of vitamin B3 (NAM), with abstinence required for at least 3 months before screening.
* Pregnant women as determined by a positive high-sensitivity serum or urine pregnancy test (minimum sensitivity of 25 IU/L or equivalent units of hCG) within 24 hours prior to screening, dosing, or completion of the study. Women of childbearing potential (WOCBP) will undergo a pregnancy test (serum or urine) 24 hours prior to screening, dosing, or completion of the study. Such participants must use a highly effective contraceptive method, such as combined hormonal contraceptives or intrauterine device (IUD), in accordance with the Clinical Trial Facilitation Group, throughout the entire study.
* Breastfeeding women.
* Patients undergoing treatment/supplementation with vitamin E.
* Patients receiving probiotics.
* Patients on the waiting list for bariatric surgery in the next 12 months.
* Patients undergoing treatment with drugs that may have an effect on the progression of liver disease.
* Drugs for the treatment of T2DM with effects on NAFLD (GLP-1 analogs, thiazolidinediones such as pioglitazone) initiated within 6 months before the study start.
* Drugs for the treatment of T2DM with effects on intestinal microbiota (metformin, α-GI inhibitors, DPP-4 inhibitors, and SGLT-2 inhibitors) initiated within 6 months before the study start.
* Patients who do not sign the informed consent.
* Patients with contraindications to the contrast agent to be used in imaging tests.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06599918
Study Brief:
Protocol Section:
NCT06599918