Clinical trial NCT00388661: Melatonin and Quality of Life in Dialysis Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sleep Problems
Haemodialysis
Keywords: sleep problems
quality of life
melatonin
sleep apnea
medication
preload
nutritional status
ProBNP
Lead sponsor: Meander Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Kidney Foundation
First posted: 2006-10-17
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Improvement of vitality (dimension quality of life) by 15 points (RAND SF 36)
timeFrame: 6-12 months
measure: Improvement general health by 15 points (dimension quality of life, RAND SF 36)
timeFrame: 6-12 months
Secondary outcomes:
measure: Change in biochemical parameters
timeFrame: 3-6-9-12 months
measure: Change in ProBNP
timeFrame: 12 months
measure: Change in nutritional status
timeFrame: 12 months
measure: Change in use of medication
timeFrame: 6-12 months
measure: Change in preload
timeFrame: 12 months
Other outcomes:
Locations:
city: Amersfoort
country: Netherlands
facility: Meander Medical Center
city: Haarlem
country: Netherlands
facility: Kennemer Gasthuis
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Pieter ter Wee, MD, PhD
role: STUDY_CHAIR
References: