Melatonin and Quality of Life in Dialysis Patients

This study has been completed.
Sponsor:
Collaborator:
Dutch Kidney Foundation
Information provided by:
Meander Medical Center
ClinicalTrials.gov Identifier:
NCT00388661
First received: October 16, 2006
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Sleep Problems
Haemodialysis
Drug: Melatonin tablet 3 mg once daily
Drug: Placebo comparator
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double Blind Placebo-controlled Study on the Efficacy of Melatonin on Sleep, Resulting in an Improved Quality of Life in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Meander Medical Center:

Primary Outcome Measures:
  • Improvement of vitality (dimension quality of life) by 15 points (RAND SF 36) [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]
  • Improvement general health by 15 points (dimension quality of life, RAND SF 36) [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in biochemical parameters [ Time Frame: 3-6-9-12 months ] [ Designated as safety issue: No ]
  • Change in ProBNP [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in nutritional status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in use of medication [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]
  • Change in preload [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: April 2007
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Melatonin
melatonin 3mg
Drug: Melatonin tablet 3 mg once daily
Melatonin tablet 3 mg once daily
Placebo Comparator: Placebo Drug: Placebo comparator
Placebo comparator

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388661

Locations
Netherlands
Meander Medical Center
Amersfoort, Netherlands, 3800 BM
Kennemer Gasthuis
Haarlem, Netherlands, 2035 RC
Sponsors and Collaborators
Meander Medical Center
Dutch Kidney Foundation
Investigators
Study Chair: Pieter ter Wee, MD, PhD VU University Medical Center
  More Information

No publications provided

Responsible Party: Department of Clinical Pharmacy, Meander Medical Center
ClinicalTrials.gov Identifier: NCT00388661     History of Changes
Other Study ID Numbers: R-06.31 M / Melody, R-06.31 M
Study First Received: October 16, 2006
Last Updated: July 19, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Meander Medical Center:
sleep problems
quality of life
melatonin
sleep apnea
medication
preload
nutritional status
ProBNP

Additional relevant MeSH terms:
Dyssomnias
Sleep Disorders
Parasomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014