Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT05984745

Effect of CoQ10 on the Outcome of MAFLD Patients

Led by Ain Shams University · Updated on 2025-03-26

60

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Effect of CoQ10 on the Outcome of MAFLD Patients

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults older than 18 years
  • Diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) based on having at least three of five metabolic dysregulation criteria
  • Waist circumference 63; 102 cm for men and 63; 88 cm for women
  • HDL cholesterol less than 40 mg/dl in men or less than 50 mg/dl in women or on specific drug therapy
  • Plasma triglycerides 63; 150 mg/dl or on specific drug therapy
  • Blood pressure 63; 130/85 mmHg or on specific anti-hypertensive therapy
  • Fasting blood glucose 63; 100 mg/dl or on specific anti-hyperglycemic therapy
  • Elevated serum transaminases 1 to 4 times the upper limit of normal
  • Imaging evidence of fatty liver by pelviabdominal ultrasound and Fibro-CAP study
  • Willing to sign informed consent and comply with study procedures and follow-up
Not Eligible

You will not qualify if you...

  • Pregnancy or lactating
  • Physical or mental abnormalities
  • Hepatitis C virus (HCV) infection
  • Hepatitis B virus (HBV) infection
  • Anemia
  • Thrombocytopenia
  • Hematological malignancies
  • Ongoing alcoholism (more than 30g/day for men, more than 20g/day for women)
  • Renal failure
  • Autoimmune hepatitis
  • Celiac disease
  • Wilson's disease
  • Hemochromatosis
  • Use of certain drugs: Tamoxifen, Valproic acid, Amiodarone, Methotrexate, Steroids, Anticoagulants, All anti-oxidative stress agents, Contraceptives, Intrauterine devices
  • Chronic use of systemic immunosuppressive agents or drugs affecting liver profile
  • Hypothyroidism or hyperthyroidism
  • History of bypass surgeries
  • Receiving total parenteral nutrition (TPN)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Hepatology and tropical medicine research institute

Cairo, Egypt

Actively Recruiting

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Research Team

M

Mariam Seif

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Effect of CoQ10 on the Outcome of MAFLD Patients | DecenTrialz