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Double Blind Placebo-controlled Study on the Efficacy of Melatonin on Sleep, Resulting in an Improved Quality of Life in Hemodialysis Patients
Sponsor study identifier
Secondary identifiers
interventional
68
1 country
2
Study Start
April 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2009
Actual (reported)Study Completion
December 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 16, 2006
Actual (reported)October 17, 2006
Actual (reported)April 2007
Date type not reportedThis date has not been verified as actual or estimated.
October 2009
Actual (reported)December 2009
Actual (reported)Improvement of vitality (dimension quality of life) by 15 points (RAND SF 36)
6-12 months
Improvement general health by 15 points (dimension quality of life, RAND SF 36)
6-12 months
Change in biochemical parameters
3-6-9-12 months
Change in ProBNP
12 months
melatonin 3mg
Meander Medical Center
Amersfoort, 3800 BM, Netherlands
Kennemer Gasthuis
Haarlem, 2035 RC, Netherlands
Pieter ter Wee, MD, PhD
Amsterdam UMC, location VUmc
68 participants (actual enrollment reported by the registry).
First Submitted
October 16, 2006
First Posted
October 17, 2006
Study Start
April 2007
Date type not reportedThis date has not been verified as actual or estimated.
Change in nutritional status
12 months
Change in use of medication
6-12 months
Change in preload
12 months
Contact the study team to confirm eligibility.
Primary Completion
October 2009
Actual (reported)Study Completion
December 2009
Actual (reported)Last Updated
July 20, 2011
Record last verified: 2011-07
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Source: ClinicalTrials.gov.
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