CompletedPhase 3

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

Germany, Italy46 participantsStarted 2015-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male and female above the age of 18 * Night shift workers on regular night shifts (at least 6 months before inclusion into the study and at least 4 night shifts per month during the study period Exclusion Criteria: * pregnancy or breast feeding * Known autoimmune disease * Current or relevant history of physical or psychiatric illness * Evidence of renal insufficiency or liver disease * Known or suspected intolerance or hypersensitivity to the study medication * Use of certain drugs within 4 weeks prior to the inclusion to the study

What they're measuring

Efficacy (AUC)

Timeframe: baseline and 12 weeks

Trial details

NCT IDNCT02108353

SponsorUniversitätsklinikum Hamburg-Eppendorf

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-03-29

View on ClinicalTrials.gov More Sleep Disorders, Circadian Rhythm trials