Melatonin and Quality of Life in Dialysis Patients

NCT ID: NCT00388661

Last Updated: 2011-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2009-12-31

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

Conditions

Sleep Problems; Haemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Melatonin

melatonin 3mg

Group Type: ACTIVE_COMPARATOR

Melatonin tablet 3 mg once daily

Intervention Type: DRUG

Melatonin tablet 3 mg once daily

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo comparator

Intervention Type: DRUG

Placebo comparator

Interventions

Melatonin tablet 3 mg once daily

Melatonin tablet 3 mg once daily

Intervention Type: DRUG

Placebo comparator

Placebo comparator

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dutch Kidney Foundation

OTHER

Sponsor Role: collaborator

Meander Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Meander Medical Center

Principal Investigators

Pieter ter Wee, MD, PhD

Role: STUDY_CHAIR

Amsterdam UMC, location VUmc

Locations

Meander Medical Center

Amersfoort, , Netherlands

Kennemer Gasthuis

Haarlem, , Netherlands

Countries

Netherlands

Other Identifiers

R-06.31 M

Identifier Type: -

Identifier Source: secondary_id

R-06.31 M / Melody

Identifier Type: -

Identifier Source: org_study_id