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Circadian Phase Adjustment and Improvement of Metabolic Control in Night Shift Workers

NCT02108353 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2017-05-25

No results posted yet for this study

Summary

EuRhythDia II is a multicenter, randomized, double-blind controlled study. The rationale of EuRhythdia is to explore the effects of 12 weeks of timed melatonin treatment on circadian rhythm, metabolic control and cardiovascular function in night shift workers. The 12 weeks of intervention will be followed by 12 weeks of washing out.

Conditions

  • Sleep Disorders, Circadian Rhythm

Interventions

DRUG

Melatonin 2mg

once daily, 0.5-1 hours before going to bed and 1-2 hours after the last meal for 12 weeks.

DRUG

Placebo

once daily, 0.5-1 hours before going to bed and 1-2 hours after the last meal for 12 weeks.

Sponsors & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Rainer H Boeger, MD · Universitätsklinikum Hamburg-Eppendorf

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-03-29
Completion
2017-03-29

Countries

  • Germany
  • Italy

Study Locations

More Related Trials

Entities

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 NCT02108353 on ClinicalTrials.gov