NCT05984745RecruitingPhase 2
Effect of CoQ10 on the Outcome of MAFLD Patients
Effect of Coenzyme Q10 on the Outcome of Metabolic Dysfunction-Associated Fatty Liver Disease Patients
Source: ClinicalTrials.gov · Last updated 26 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 1 Aug 2023
- Start date
- 31 Oct 2023
- Primary completion date
- Jul 2025
- Lead sponsor
- Ain Shams University
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05984745
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 31 Oct 2023 to the primary completion date, Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- HCV infection
- HBV infection
- Haematological malignancies
- Patients with renal failure
- Autoimmune hepatitis
- Celiac disease
- Wilson's disease
Other
- Pregnancy or lactating
- Physical or mental abnormalities
- Anaemia
- Thrombocytopenia
- Ongoing alcoholism (Male: \>30g/day, Female: \>20g/day)
- Hemochromatosis
- Hypo/Hyper-thyroidism
- Bypass surgeries
- TPN (Total Parenteral Nutrition)
Who the study is looking for
- 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):
- Waist circumference (WC) ≥ 102/88 cm for men and women respectively.
- HDL cholesterol \<40 mg/dl in men and \<50 mg/dl in women or on specific drug therapy.
- Plasma Triglycerides ≥ 150 mg/dl or on specific drug therapy.
- Blood pressure ≥130 and/or ≥ 85 or on specific anti-hypertensive therapy.
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Hepatology and tropical medicine research institute Coordinator of this site? Confirm its status | Cairo | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.