Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT06599918
Brief 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.
Detailed Description:
Patients with a Fibroscan \> 8 kPa will be offered to participate in this study. Participants will receive either placebo or a NAM dose adjusted to body weight. The duration of the treatment is 12 months.
Participants will be subjected to a total of 5 follow-up and/or control visits:
Visit 1
* Physical examination(weight, height, BMI, waist circumference, neck circumference, blood pressure, and heart rate).
* Assessment of muscle status and risk of sarcopenia: grip strength, chair test.
* Basal electrocardiogram.
* Blood analysis.
* Bioelectrical impedance analysis.
* Nuclear magnetic resonance.
* Thermographic image.
* Food questionnaire (PREDIMED).
* International Physical Activity Questionnaire (IPAQ).
* Collection of blood, urine, and feces samples for storage in the biobank.
Visit 2. Control visit (time month 1)
* Monitoring of adverse events (AE) and adverse reactions (AR).
* Electrocardiogram.
* Control blood analysis: sodium, potassium, liver biochemistry (AST, ALT, bilirubin, GGT, FA), renal function (urea, creatinine, estimated glomerular filtration), and coagulation tests.
* Physical examination and measurement of vital signs.
Visit 3. Follow-up visit (time month 3)
* Monitoring of AE and AR.
* Drug adherence questionnaire.
* Electrocardiogram.
* Blood analysis.
* Physical examination (weight, BMI, waist circumference, neck circumference, blood pressure, and heart rate).
* Collection of blood, urine, and feces samples for biobank.
* Collection of concomitant medication.
* Adherence to study treatment and dietary recommendations.
Visit 4. Follow-up visit (time month 6)
* Monitoring of AE and AR.
* Drug adherence questionnaire.
* Electrocardiogram.
* Blood analysis.
* Physical examination (weight, BMI, waist circumference, neck circumference, blood pressure, and heart rate).
* Collection of blood, urine, and feces samples for biobank.
* Collection of concomitant medication.
* Adherence to study treatment and dietary recommendations.
Visit 5. Control visit (time month 9).
* Monitoring of AE and AR.
* Drug adherence questionnaire.
* Electrocardiogram.
* Control blood analysis.
* Physical examination.
* Collection of concomitant medication.
Visit 6. Final exploration (time month 12)
* Monitoring of AE and AR.
* Drug adherence questionnaire.
* Food questionnaire (PREDIMED).
* Physical Activity Questionnaire (IPAQ).
* Physical examination and measurement of vital signs (weight, BMI, waist circumference, neck circumference, blood pressure, and heart rate).
* Assessment of muscle status and risk of sarcopenia: FPM, chair test.
* Electrocardiogram.
* Blood analysis.
* Measurement of NAM and derived metabolites in serum and urine.
* Nuclear magnetic resonance.
* Bioimpedance.
* Thermographic image.
* Fibroscan® with CAP.
* Collection of blood, urine, and feces samples for biobank
The safety of the participants will be assessed using a record of the AEs and ARs that could arise and their annotation in the EDC, as well as a regular evaluation of liver, kidney, and heart function at baseline, 1, 3, 6, 9 and 12 months
Study:
NCT06599918
Study Brief:
Protocol Section:
NCT06599918