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Melatonin and Quality of Life in Dialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00388661
Recruitment Status : Completed
First Posted : October 17, 2006
Last Update Posted : July 20, 2011
Sponsor:
Collaborator:
Dutch Kidney Foundation
Information provided by:
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.


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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
Drug Information available for: Melatonin

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Improvement of vitality (dimension quality of life) by 15 points (RAND SF 36) [ Time Frame: 6-12 months ]
  2. Improvement general health by 15 points (dimension quality of life, RAND SF 36) [ Time Frame: 6-12 months ]

Secondary Outcome Measures :
  1. Change in biochemical parameters [ Time Frame: 3-6-9-12 months ]
  2. Change in ProBNP [ Time Frame: 12 months ]
  3. Change in nutritional status [ Time Frame: 12 months ]
  4. Change in use of medication [ Time Frame: 6-12 months ]
  5. Change in preload [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388661


Locations
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Netherlands
Meander Medical Center
Amersfoort, Netherlands, 3800 BM
Kennemer Gasthuis
Haarlem, Netherlands, 2035 RC
Sponsors and Collaborators
Meander Medical Center
Dutch Kidney Foundation
Investigators
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Study Chair: Pieter ter Wee, MD, PhD VU University Medical Center
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Responsible Party: Department of Clinical Pharmacy, Meander Medical Center
ClinicalTrials.gov Identifier: NCT00388661    
Other Study ID Numbers: R-06.31 M / Melody
R-06.31 M
First Posted: October 17, 2006    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: July 2011
Keywords provided by Meander Medical Center:
sleep problems
quality of life
melatonin
sleep apnea
medication
preload
nutritional status
ProBNP
Additional relevant MeSH terms:
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Dyssomnias
Parasomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants