Melatonin and Quality of Life in Dialysis Patients

Haemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388661
• Other study ID #: R-06.31 M / Melody
• Secondary ID: R-06.31 M
• Status: Completed
• Phase: Phase 3
• First received: October 16, 2006
• Last updated: July 19, 2011
• Start date: April 2007
• Est. completion date: December 2009

Study information

• Verified date: July 2011
• Source: Meander Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyssomnias
• Haemodialysis
• Parasomnias
• Sleep Disorders
• Sleep Problems

Intervention

Drug:
• Melatonin tablet 3 mg once daily
Melatonin tablet 3 mg once daily
• Placebo comparator
Placebo comparator

Locations

Country	Name	City	State
Netherlands	Meander Medical Center	Amersfoort
Netherlands	Kennemer Gasthuis	Haarlem

Sponsors (2)

Lead Sponsor	Collaborator
Meander Medical Center	Dutch Kidney Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of vitality (dimension quality of life) by 15 points (RAND SF 36)		6-12 months	No
Primary	Improvement general health by 15 points (dimension quality of life, RAND SF 36)		6-12 months	No
Secondary	Change in biochemical parameters		3-6-9-12 months	No
Secondary	Change in ProBNP		12 months	No
Secondary	Change in nutritional status		12 months	No
Secondary	Change in use of medication		6-12 months	No
Secondary	Change in preload		12 months	No