Status:
COMPLETED
Melatonin and Quality of Life in Dialysis Patients
Lead Sponsor:
Meander Medical Center
Collaborating Sponsors:
Dutch Kidney Foundation
Conditions:
Sleep Problems
Haemodialysis
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
Sleep problems can lead to a bad quality of life and a raise of morbidity, also in dialysis patients. Sleep problems can be caused by a disturbance of circadian rhythms in our body. For a good regulat...
Detailed Description
Objective of the study: Does melatonin by improving sleep parameters improve quality of life of hemodialysis patients? Study design: Placebo-controlled, double-blind, randomized trial Study popula...
Eligibility Criteria
Inclusion
- Informed Consent
- Man/Women between 18 and 85 years
- Understanding and knowledge of the dutch language
- End Stage Renal Disease, stable chronic hemodialysis \> 3 months
- SpKt/V(total) \> 1,2 pro dialysis
- Validated actometer shows that sleep efficiency \< 90% or sleep latency \> 15 minutes or fragmentation index \> 25 points
Exclusion
- Known major illness, which interferes with patient's participation in the study according to the investigator)or which results in a probable patient's survival of less than 1 year.
- Instable angina pectoris, heart failure NYHA class IV
- Pregnancy
- Current use of melatonin of known allergy of melatonin
- Participation in other medication/drug research within a month before inclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00388661
Start Date
April 1 2007
End Date
December 1 2009
Last Update
July 20 2011
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Meander Medical Center
Amersfoort, Netherlands, 3800 BM
2
Kennemer Gasthuis
Haarlem, Netherlands, 2035 RC