Melatonin and Quality of Life in Dialysis Patients

Phase 3

Completed

• Conditions: Sleep Problems; Haemodialysis
• Interventions: Drug: Melatonin tablet 3 mg once daily; Drug: Placebo comparator

• Registration Number: NCT00388661
• Lead Sponsor: Meander Medical Center

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.

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

Study Timeline

• Study First Submitted: 2006-10-16
• Study First Submitted QC: 2006-10-16
• Study First Posted: 2006-10-17
• Study Start: 2007-04
• Primary Completion: 2009-10
• Study Completion: 2009-12
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-19
• Last Update Posted: 2011-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin	Melatonin tablet 3 mg once daily	melatonin 3mg
Placebo	Placebo comparator	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Meander Medical Center; 🇳🇱 Amersfoort, Netherlands

Kennemer Gasthuis; 🇳🇱 Haarlem, Netherlands