Melatonin and Quality of Life in Dialysis Patients

• ClinicalTrials.gov Identifier: NCT00388661
• Recruitment Status: Completed
• First Posted: October 17, 2006
• Last Update Posted: July 20, 2011
• Sponsor: Meander Medical Center
• Collaborator: Dutch Kidney Foundation
• Information provided by: Meander Medical Center

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

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

• 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
• 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:

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