Melatonin and Quality of Life in Dialysis Patients

Sponsor

Meander Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00388661

Collaborator

Dutch Kidney Foundation (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Problems Haemodialysis	Drug: Melatonin tablet 3 mg once daily Drug: Placebo comparator	Phase 3

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:

improvement of vitality (dimension quality of life) by 15 points (RAND SF 36)
improvement general health by 15 points (dimension quality of life, RAND SF 36)

Secondary study parameters/outcome of the study:

Change in biochemical parameters
Change in ProBNP
Change in nutritional status
Change in use of medication
Change in preload

Study Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Melatonin melatonin 3mg	Drug: Melatonin tablet 3 mg once daily Melatonin tablet 3 mg once daily
Placebo Comparator: Placebo	Drug: Placebo comparator Placebo comparator

Arm

Intervention/Treatment

Active Comparator: Melatonin

melatonin 3mg

Drug: Melatonin tablet 3 mg once daily

Melatonin tablet 3 mg once daily

Placebo Comparator: Placebo

Drug: Placebo comparator

Placebo comparator

Outcome Measures

Primary Outcome Measures

Improvement of vitality (dimension quality of life) by 15 points (RAND SF 36) [6-12 months]
Improvement general health by 15 points (dimension quality of life, RAND SF 36) [6-12 months]

Secondary Outcome Measures

Change in biochemical parameters [3-6-9-12 months]
Change in ProBNP [12 months]
Change in nutritional status [12 months]
Change in use of medication [6-12 months]
Change in preload [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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