Melatonin and Quality of Life in Dialysis Patients

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

Sponsors

Lead Sponsor: Meander Medical Center

Collaborator: Dutch Kidney Foundation

Source 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.

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

Overall Status Completed
Start Date April 2007
Completion Date December 2009
Primary Completion Date October 2009
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Secondary Outcome
Measure Time Frame
Change in biochemical parameters 3-6-9-12 months
Change in ProBNP 12 months
Change in nutritional status 12 months
Change in use of medication 6-12 months
Change in preload 12 months
Enrollment 68
Condition
Intervention

Intervention Type: Drug

Intervention Name: Melatonin tablet 3 mg once daily

Description: Melatonin tablet 3 mg once daily

Arm Group Label: Melatonin

Intervention Type: Drug

Intervention Name: Placebo comparator

Description: Placebo comparator

Arm Group Label: Placebo

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Pieter ter Wee, MD, PhD Study Chair VU University Medical Center
Location
Facility:
Meander Medical Center | Amersfoort, 3800 BM, Netherlands
Kennemer Gasthuis | Haarlem, 2035 RC, Netherlands
Location Countries

Netherlands

Verification Date

July 2011

Responsible Party

Name Title: Department of Clinical Pharmacy

Organization: Meander Medical Center

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Melatonin

Type: Active Comparator

Description: melatonin 3mg

Label: Placebo

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov