Effectiveness of vitamin E on the levels of liver enzymes in patients with high-dose statins-induced hepatic failure

Phase 2

• Conditions: Hepatic failure.; Hepatic failure, not elsewhere classified

• Registration Number: IRCT20220516054874N10
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Patients receiving high doses of statins (Atorvastatin with a dose of more than 40 mg or Rosuvastatin with a dose of more than 20 mg)
Abnormalities in liver function tests (increased aminotransferase level equal to or more than 1.5 and less than 3 times the upper limit of the normal range)
Consent to admission to the study
No previous medical history of liver disease or elevated aminotransferase before statin initiation

Exclusion Criteria

Receiving other drugs that may affect the increase of liver enzymes
Elevation of LFT equal to or greater than 3 times

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in ALT levels. Timepoint: At the beginning of the study and after 8 weeks of treatment. Method of measurement: Laboratory kit.

Secondary Outcome Measures

Name	Time	Method
Changes in AST levels. Timepoint: At the beginning of the study and after 8 weeks of treatment. Method of measurement: Laboratory kit.;Changes in CBC diff. Timepoint: At the beginning of the study and after 8 weeks of treatment. Method of measurement: Laboratory kit.;Changes in lipid profile levels. Timepoint: At the beginning of the study and after 8 weeks of treatment. Method of measurement: Laboratory kit.;Changes in hs-CRP serum level. Timepoint: At the beginning of the study and after 8 weeks of treatment. Method of measurement: Laboratory kit.