Official Title: “Double Blind Placebo-Controlled Study on the Efficacy of Melatonin on Sleep, Resulting in an Improved Quality of Life in Hemodialysis Patients”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: February 2009

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

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Melatonin
  • melatonin 3mg
• Placebo Comparator: Placebo

Primary Measures

• Improvement of vitality (dimension quality of life) by 15 points (RAND SF 36)
  • Time Frame: 6-12 months
    Safety Issue?: No
• Improvement general health by 15 points (dimension quality of life, RAND SF 36)
  • Time Frame: 6-12 months
    Safety Issue?: No

Secondary Measures

• Change in biochemical parameters
  • Time Frame: 3-6-9-12 months
    Safety Issue?: No
• Change in ProBNP
  • Time Frame: 12 months
    Safety Issue?: No
• Change in nutritional status
  • Time Frame: 12 months
    Safety Issue?: No
• Change in use of medication
  • Time Frame: 6-12 months
    Safety Issue?: No
• Change in preload
  • Time Frame: 12 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Meander Medical Center

Overall Clinical Trial Officials and Contacts

Pieter ter Wee, MD, PhD Study Chair VU University Medical Center  

Overall Contact: Birgit Koch, PharmD + 31 850 4608 BCP.Koch@meandermc.nl

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00388661

Study ID Number: R-06.31 M / Melody

ClinicalTrials.gov Identifier: NCT00388661

Health Authority: Netherlands: Medical Ethics Review Committee (METC)