NCT05984745 Effect of CoQ10 on the Outcome of MAFLD Patients
| NCT ID | NCT05984745 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ain Shams University |
| Condition | Fatty Liver |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-10-31 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2023-10-31 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
So far there has been no universal treatment for MAFLD since it has a complex etiology that involves ethnic, genetic, metabolic and environmental factors. However, therapeutic life changes including: diet, weight loss, and physical activity remain the cornerstone of treatment and is recommended by both American and European associations. Inflammatory biomarkers, such as tumor necrosis factor-alpha, and adipokines play key roles in the pathogenesis of MAFLD, hence, the anti-inflammatory and antioxidant effects of coenzyme Q10 especially at high doses that have not been tested are hypothesized to have a beneficial role in improving the systemic inflammation and biochemical variables. This study is conducted to test this hypothesis
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05984745 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Fatty Liver. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05984745 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05984745 currently recruiting?
Yes, NCT05984745 is actively recruiting participants. Contact the research team at mariam.talaat@pharma.asu.edu.eg for enrollment information.
Where is the NCT05984745 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT05984745 clinical trial?
NCT05984745 is sponsored by Ain Shams University. The trial plans to enroll 60 participants.