Viewing Study NCT00388661



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Study NCT ID: NCT00388661
Status: COMPLETED
Last Update Posted: 2011-07-20
First Post: 2006-10-16

Brief Title: Melatonin and Quality of Life in Dialysis Patients
Sponsor: Meander Medical Center
Organization: Meander Medical Center

Study Overview

Official Title: Double Blind Placebo-controlled Study on the Efficacy of Melatonin on Sleep Resulting in an Improved Quality of Life in Hemodialysis Patients
Status: COMPLETED
Status Verified Date: 2011-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 parametersoutcome 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 parametersoutcome 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R-0631 M None None None