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The Effects of Melatonin on Elevated Liver Enzymes During Statins Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03121521
Recruitment Status : Completed
First Posted : April 20, 2017
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Cezary Chojnacki, Medical Universtity of Lodz

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatopathy Drug: Melatonin 10 mg Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Melatonin on Elevated Liver Enzymes During Statins Treatment
Actual Study Start Date : September 1, 2012
Actual Primary Completion Date : September 30, 2016
Actual Study Completion Date : December 15, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: melatonin
Melatonin 10mg/d p.o.
Drug: Melatonin 10 mg
melatonin 10mg daily p.o.
Other Name: Melatonin Lek-AM 10mg

Placebo Comparator: placebo
placebo 10mg/d p.o.
Drug: Placebo
Placebo 10mg daily p.o.
Other Name: Placebo 10mg




Primary Outcome Measures :
  1. liver enzymes [ Time Frame: 6 months ]
    levels



Information from the National Library of Medicine

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Ages Eligible for Study:   47 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- hyperlipidemia treated with statins for minimum 6 months

  • at least 2-fold increase in the level of aspartate and alanine aminotransferase found in two consecutive tests
  • the persistence of increased aminotransferase levels despite the reduction in the statin dose At the time of the inclusion of patients in the study, 38 subjects were taking atorvastatin ( 20 mg), and 26 - rosuvastatin at the dose 40 mg (3 patients), - 20mg (19 patients) and 15 mg (4 patients).

Exclusion Criteria:- history of viral hepatitis

  • cholelithiasis 4
  • body mass index (BMI)>30kg/m2
  • alcohol abuse
  • familial hypercholesterolemia
  • established hypertension
  • thyroid diseases
  • other organic, metabolic or mental diseases
  • hormone replacement therapy
  • taking other medications, especially analgesics and psychotropic drugs
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Responsible Party: Cezary Chojnacki, Head of Department of Clinical Nutrition and Gastroenterological Diagnostics, Medical Universtity of Lodz
ClinicalTrials.gov Identifier: NCT03121521    
Other Study ID Numbers: NN 402 54 37/40
RNN/45/12/KB ( Other Identifier: Bioethics Committee of the Medical University in Lodz )
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cezary Chojnacki, Medical Universtity of Lodz:
statins liver enzymes melatonin
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants