The Effects of Melatonin on Elevated Liver Enzymes During Statins Treatment

NCT03121521 | Completed Phase 4

• 2 other identifiers: NN 402 54 37/40RNN/45/12/KB
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatopathy

Keywords

statins liver enzymes melatonin

Outcome Measures

Primary Outcomes (1)

• liver enzymes

  levels

  6 months

Study Arms (2)

melatonin

EXPERIMENTAL

Melatonin 10mg/d p.o.

Drug: Melatonin 10 mg

placebo

PLACEBO COMPARATOR

placebo 10mg/d p.o.

Drug: Placebo

Interventions

Melatonin 10 mg DRUG

melatonin 10mg daily p.o.

Also known as: Melatonin Lek-AM 10mg

melatonin

Placebo DRUG

Placebo 10mg daily p.o.

Also known as: Placebo 10mg

placebo

Eligibility Criteria

• Age: 47 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 2-fold increase in the level of aspartate and alanine aminotransferase found in two consecutive tests

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lodz: lead

MeSH Terms

Conditions

Digestive System Diseases

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Clinical Nutrition and Gastroenterological Diagnostics

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 20, 2017
• Study Start: September 1, 2012
• Primary Completion: September 30, 2016
• Study Completion: December 15, 2016
• Last Updated: April 20, 2017

Record last verified: 2017-04