NCT00388661

Melatonin and Quality of Life in Dialysis Patients

Double Blind Placebo-controlled Study on the Efficacy of Melatonin on Sleep, Resulting in an Improved Quality of Life in Hemodialysis Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Meander Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 regulation of these circadian rhythms a uniform external synchronisation is necessary. This is the synchronisation of the biological clock of our body by light and other influences. In case of a disturbance of the external synchronisation, due to for example naps during the day or wake periods at night, internal rhythms can be unlinked. As a result a weakened melatonin rhythm and a problematic sleep-wake cycle can be observed. Most dialysis patients have sleep problems. Their sleep latency is prolonged. They often take a nap during the day and their sleep efficiency is poor. There has only been one study on the melatonin rhythm of dialysis patients. The conclusion of this study was that the melatonin rhythm of dialysis patients is weakened and disturbed, probably caused by renal insufficiency. In this study no link was made between melatonin rhythm and the nature and severity of possible sleep problems. In different studies with non-dialysis patients and a disturbed melatonin rhythm, exogenous melatonin at the right time leads to a recovery of the normal rhythm and the normal biological clock and a better quality of life. The aim is to improve quality of life of hemodialysis patients with a placebo-controlled study with melatonin to investigate if exogenous melatonin can improve sleep problems and on the longer term improve quality of life (and secondary morbidity) of dialysis patients.

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 population: hemodialysis patients Intervention: melatonin 3 mg once daily (or placebo) Primary study parameters/outcome of the study: 1. improvement of vitality (dimension quality of life) by 15 points (RAND SF 36) 2. improvement general health by 15 points (dimension quality of life, RAND SF 36) Secondary study parameters/outcome of the study: 1. Change in biochemical parameters 2. Change in ProBNP 3. Change in nutritional status 4. Change in use of medication 5. Change in preload

Conditions

• Sleep Problems
• Haemodialysis

Interventions

Type	Name	Description
DRUG	Melatonin tablet 3 mg once daily	Melatonin tablet 3 mg once daily
DRUG	Placebo comparator	Placebo comparator

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-10-01
• Completion: 2009-12-01
• First posted: 2006-10-17
• Last updated: 2011-07-20

Locations

2 sites across 1 country: Netherlands