Impact of CoQ10 on patients with fatty liver disease
Effect of Coenzyme Q10 on the Outcome of Metabolic Dysfunction-Associated Fatty Liver Disease Patients
This study is testing if taking high doses of CoQ10 can help people with fatty liver disease feel better by reducing inflammation and improving their health markers.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Drugs / interventions | Methotrexate |
| Locations | 1 site (Cairo) |
| Trial ID | NCT05984745 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Coenzyme Q10 (CoQ10) on patients diagnosed with metabolic-dysfunction associated fatty liver disease (MAFLD). The study aims to evaluate whether high doses of CoQ10 can reduce systemic inflammation and improve biochemical markers associated with the disease. Participants will undergo a thorough evaluation to confirm the presence of metabolic dysregulation criteria before receiving CoQ10 Forte® capsules. The trial is designed to provide insights into a potential new treatment option for this increasingly prevalent liver condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with diagnosed MAFLD and evidence of metabolic dysregulation.
Not a fit: Patients who are pregnant or do not meet the metabolic dysregulation criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a novel therapeutic approach to managing MAFLD and improving liver health.
How similar studies have performed: While the use of CoQ10 has been explored in various contexts, this specific application in MAFLD is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All study subjects and prior to consenting to the ICF, laboratory and imaging work-up will be evaluated for the presence of three out of five criteria for metabolic dysregulation in the context of metabolic -dysfunction associated fatty liver disease (MAFLD): 1. Waist circumference (WC) ≥ 102/88 cm for men and women respectively. 2. HDL cholesterol \<40 mg/dl in men and \<50 mg/dl in women or on specific drug therapy. 3. Plasma Triglycerides ≥ 150 mg/dl or on specific drug therapy. 4. Blood pressure ≥130 and/or ≥ 85 or on specific anti-hypertensive therapy. 5. Fasting blood glucose ≥ 100 mg/dl or on specific anti hyperglycemic therapy * Patients who agree to sign an informed consent * Adult patients \>18 years old. * Males and females * Willing to comply with procedures and follow up * Elevated serum transaminases (1-4 times the ULN) * Imaging evidence of fatty liver: pelviabdominal ultrasound and Fibro- CAP study Exclusion Criteria: * Pregnancy or lactating * Physical or mental abnormalities * HCV infection * HBV infection * Anaemia * Thrombocytopenia * Haematological malignancies * Ongoing alcoholism (Male: \>30g/day, Female: \>20g/day) * Patients with renal failure * Autoimmune hepatitis * Celiac disease * Wilson's disease * Hemochromatosis * Drugs: Tamoxifen, Valproic acid, Amiodarone, Methotrexate, Steroids, Anticoagulants, All anti-oxidative stress agents, Cos, IUD * Chronic use of systematically immunosuppressive agent or drugs that can affect liver profile. * Hypo/Hyper-thyroidism * Bypass surgeries * TPN (Total Parenteral Nutrition)
Where this trial is running
Cairo
- National Hepatology and tropical medicine research institute — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Mariam Seif
- Email: mariam.talaat@pharma.asu.edu.eg
- Phone: +201112720114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.