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NCT Number: NCT00388661

Melatonin and Quality of Life in Dialysis 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.

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Key information

Conditions

Sleep Problems Apnea Dyssomnias Haemodialysis Mental Disorders Nervous System Diseases Parasomnias Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Meander Medical Center, Amersfoort, Netherlands

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About this study

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:

  • improvement of vitality (dimension quality of life) by 15 points (RAND SF 36)
  • improvement general health by 15 points (dimension quality of life, RAND SF 36)

Secondary study parameters/outcome of the study:

  • Change in biochemical parameters
  • Change in ProBNP
  • Change in nutritional status
  • Change in use of medication
  • Change in preload

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin tablet 3 mg once daily

Drug

Melatonin tablet 3 mg once daily

placebo comparator

Drug

Placebo comparator

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Meander Medical Center

Other

Collaborators

  • Dutch Kidney Foundation

Registry information

Official study title

Double Blind Placebo-controlled Study on the Efficacy of Melatonin on Sleep, Resulting in an Improved Quality of Life in Hemodialysis Patients

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 17, 2006
Registry last updated
Jul 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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