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The Effects of Melatonin on Elevated Liver Enzymes During Statins Treatment

NCT03121521 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-04-20

No results posted yet for this study

Summary

Introduction. Statins are generally well tolerated but not devoid of side effects. Quite often it is manifested by asymptomatic increase in the level of aspartate and alanine aminotransferase. In such cases patients to administer hepatoprotective drugs, but most of them used for this purpose are ineffective. The aim of this study was assess the usefulness of melatonin in counteracting the adverse hepatic events from statins. Methods. The research program included 60 patients(aged 47-65 years, 41 women and 23 men)with hyperlipidemia taking atorvastatin or rosuvastatin in dose 20-40 mg daily. The patients were randomly allocated in two groups. Group I (n=30) was recommended to take the same statin at a standardized daily dose of 20 mg together with melatonin at a dose 2 x 5 mg, at 7:00 and 21:00. In group II (n=30) patients took statins with placebo at the same time of the day. Follow-up laboratory tests (AST, ALT, GGT, ALP, cholesterol, triglycerides) were evaluated after 2,4 and 6 mounts of treatment.

Conditions

  • Hepatopathy

Interventions

DRUG

Melatonin 10 mg

melatonin 10mg daily p.o.

DRUG

Placebo

Placebo 10mg daily p.o.

Sponsors & Collaborators

  • Medical University of Lodz

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
47 Years
Max Age
68 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-01
Primary Completion
2016-09-30
Completion
2016-12-15

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03121521 on ClinicalTrials.gov