Comparative Clinical Study to Evaluate the Efficacy and Safety of Rosuvastatin Vs CoQ10 on Nonalcoholic Steatohepatitis

Nonalcoholic Steatohepatitis Clinical Trial

Official title:

Comparative Clinical Study to Evaluate the Possible Efficacy and Safety of Rosuvastatin Versus Coenzyme Q10 on Nonalcoholic Steatohepatitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05731596
• Other study ID #: Rosuvastatin vs Co Q10 on NASH
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2023
• Est. completion date: April 2024

Study information

• Verified date: May 2023
• Source: Tanta University
• Contact: Hadeer Ahmed Alsayed, B.Sc. Degree
• Phone: 00201011611651
• Email: hader.ahmed41996[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be a randomized, controlled, parallel study that aims to evaluate the efficacy and safety of Rosuvastatin versus Coenzyme Q10 on nonalcoholic steatohepatitis patients.

Description:

• This study will be a randomized, controlled, parallel study.

• It will be conducted on 46 patients diagnosed with NASH

• The patients will be randomized into two groups:

Group 1(n=23): patients will receive Rosuvastatin 20mg/day orally

Group 2(n=23): patients will receive Coenzyme Q10 100 mg/day orally

The patients will be selected from community awareness campaigns about NASH in Alexandria , Egypt . Written informed consent will be obtained from all patients. This study will be approved by the Research Ethics Committee of Tanta University and Alexandria university.

The study duration will be 3 months.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: April 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age: = 18 years.

• Gender: Both male and female patients will be included.

• Patients have established diagnosis of NASH (based on liver ultrasonography).

Exclusion Criteria:

• Young ages <18 years

• Secondary causes of hepatic fat accumulation such as Significant alcohol consumption as defined by an average daily consumption of alcohol greater than 30 g/day in men and greater than 20 g/day in women or Long-term use of a steatogenic medication (e.g., non-Steroidal anti-inflammatory drugs (NSAIDs) amiodarone, methotrexate, tamoxifen, corticosteroids)

• Patients with a known history of viral hepatitis, hemochromatosis, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, biliary obstruction.

• Patients with inflammatory diseases.

• Subjects using any other lipid-lowering agents, or any supplements known to have antioxidant activity and omega-3 supplementation for at least 3 months before participation in the trial

• Current Pregnancy

• Breastfeeding

• Females On Oral Contraceptive pills

• Patients with renal impairment

• Patients with heart failure

• Patients with cancer or with a history of cancer treatment

• Any contraindications to coenzyme Q 10 Or statins like hypersensitivity to anyone

• Patients with predisposing risk factors for myopathy/rhabdomyolysis.

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis

Intervention

Drug:
• Rosuvastatin 20 Mg Oral Tablet
Rosuvastatin 20 mg will be administered orally once daily for 3 Months
• Coenzyme Q10 100 MG Oral Capsule
Coenzyme Q10 100 mg will be administered orally once daily for 3 Months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

References & Publications (12)

Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, Sanyal AJ. The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018 Jan;67(1):328-357. doi: 10.1002/hep.29367. Epub 2017 Sep 29. No abstract available. — View Citation

Chen K , Chen X , Xue H , Zhang P , Fang W , Chen X , Ling W . Coenzyme Q10 attenuates high-fat diet-induced non-alcoholic fatty liver disease through activation of the AMPK pathway. Food Funct. 2019 Feb 20;10(2):814-823. doi: 10.1039/c8fo01236a. — View Citation

Ekstedt M, Hagstrom H, Nasr P, Fredrikson M, Stal P, Kechagias S, Hultcrantz R. Fibrosis stage is the strongest predictor for disease-specific mortality in NAFLD after up to 33 years of follow-up. Hepatology. 2015 May;61(5):1547-54. doi: 10.1002/hep.27368. Epub 2015 Mar 23. — View Citation

Estes C, Anstee QM, Arias-Loste MT, Bantel H, Bellentani S, Caballeria J, Colombo M, Craxi A, Crespo J, Day CP, Eguchi Y, Geier A, Kondili LA, Kroy DC, Lazarus JV, Loomba R, Manns MP, Marchesini G, Nakajima A, Negro F, Petta S, Ratziu V, Romero-Gomez M, Sanyal A, Schattenberg JM, Tacke F, Tanaka J, Trautwein C, Wei L, Zeuzem S, Razavi H. Modeling NAFLD disease burden in China, France, Germany, Italy, Japan, Spain, United Kingdom, and United States for the period 2016-2030. J Hepatol. 2018 Oct;69(4):896-904. doi: 10.1016/j.jhep.2018.05.036. Epub 2018 Jun 8. — View Citation

Farsi F, Mohammadshahi M, Alavinejad P, Rezazadeh A, Zarei M, Engali KA. Functions of Coenzyme Q10 Supplementation on Liver Enzymes, Markers of Systemic Inflammation, and Adipokines in Patients Affected by Nonalcoholic Fatty Liver Disease: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial. J Am Coll Nutr. 2016 May-Jun;35(4):346-53. doi: 10.1080/07315724.2015.1021057. Epub 2015 Jul 9. — View Citation

Mantovani A, Scorletti E, Mosca A, Alisi A, Byrne CD, Targher G. Complications, morbidity and mortality of nonalcoholic fatty liver disease. Metabolism. 2020 Oct;111S:154170. doi: 10.1016/j.metabol.2020.154170. Epub 2020 Jan 30. — View Citation

Pramfalk C, Parini P, Gustafsson U, Sahlin S, Eriksson M. Effects of high-dose statin on the human hepatic expression of genes involved in carbohydrate and triglyceride metabolism. J Intern Med. 2011 Mar;269(3):333-9. doi: 10.1111/j.1365-2796.2010.02305.x. Epub 2010 Nov 18. — View Citation

Spahillari A, Mukamal KJ, DeFilippi C, Kizer JR, Gottdiener JS, Djousse L, Lyles MF, Bartz TM, Murthy VL, Shah RV. The association of lean and fat mass with all-cause mortality in older adults: The Cardiovascular Health Study. Nutr Metab Cardiovasc Dis. 2016 Nov;26(11):1039-1047. doi: 10.1016/j.numecd.2016.06.011. Epub 2016 Jun 28. — View Citation

Tzanaki I, Agouridis AP, Kostapanos MS. Is there a role of lipid-lowering therapies in the management of fatty liver disease? World J Hepatol. 2022 Jan 27;14(1):119-139. doi: 10.4254/wjh.v14.i1.119. — View Citation

Vanni E, Marengo A, Mezzabotta L, Bugianesi E. Systemic Complications of Nonalcoholic Fatty Liver Disease: When the Liver Is Not an Innocent Bystander. Semin Liver Dis. 2015 Aug;35(3):236-49. doi: 10.1055/s-0035-1562944. Epub 2015 Sep 17. — View Citation

Wang W, Zhao C, Zhou J, Zhen Z, Wang Y, Shen C. Simvastatin ameliorates liver fibrosis via mediating nitric oxide synthase in rats with non-alcoholic steatohepatitis-related liver fibrosis. PLoS One. 2013 Oct 2;8(10):e76538. doi: 10.1371/journal.pone.0076538. eCollection 2013. — View Citation

Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in liver stiffness measurement (LSM)	LSM will be assessed by Fibro scan	At baseline and 12th week
Primary	Change in ultrasound score	Ultrasound score will be assessed by Ultrasonography	At baseline and 12th week
Secondary	Demonstrate changes in Alanine aminotransferase (ALT)	Alanine aminotransferase (ALT) in U/L	At baseline and 12th week
Secondary	Demonstrate changes in Aspartate aminotransferase (AST)	Aspartate aminotransferase (AST) in U/L	At baseline and 12th week
Secondary	Demonstrate changes in Alkaline phosphatase (ALP)	Alkaline phosphatase (ALP) in U/L	At baseline and 12th week
Secondary	Demonstrate changes in ?-glutamyltranspeptidase (GGT)	?-glutamyltranspeptidase (GGT) in U/L	At baseline and 12th week
Secondary	Demonstrate changes in Direct bilirubin	Direct bilirubin in mg/dl	At baseline and 12th week
Secondary	Demonstrate changes in the Lipid values	Total cholesterol(TC) in mg/dl , Triglycerides(TG) in mg/dl , LDL-Cholesterol in mg/dl , HDL-Cholesterol in mg/dl	At baseline and 12th week
Secondary	Demonstrate changes in the body weight and body mass index (BMI)	BMI in kg/m^2 will be calculated using the formula: BMI= [Weight (kg)/Height (m2)].	At baseline and 12th week
Secondary	Demonstrate changes in the Inflammatory marker : CRP	C-reactive protein in mg/L	At baseline and 12th week
Secondary	Demonstrate changes in Serum cytokeratin 18 (Ck-18)	Serum cytokeratin 18 (Ck-18) will be determined by Enzyme-linked Immunosorbent assay kits.	At baseline and 12th week
Secondary	Demonstrate changes in Serum transforming growth factor-beta1 (TGF-ß1)	Serum transforming growth factor-beta1 (TGF-ß1) will be determined by Enzyme-linked Immunosorbent assay kits.	At baseline and 12th week
Secondary	Serum Retinol binding protein 4 (RBP-4)	Serum Retinol binding protein 4 (RBP-4) will be determined by Enzyme-linked Immunosorbent assay kits.	At baseline and 12th week