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

• Status: Completed
• Trial end date: 2017-03-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Treatments: Melatonin

Criteria

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