Primary aim: Does melatonin accumulate in hemodialysis patients after a treatment period with exogenous melatonin for at least 12 weeks ?Secondary aim:Will 7 days be enough to erase the accumulated melatonin?What are the pharmacokinetics of…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Melatonin concentration measured in saliva versus time of day during 24 hours.
Secondary outcome
Melatonin concentration measured in salvia, calculating area under the curve
Change in baseline melatonin concentration (comparising melatonin concentration
t=15:00 of 3 different days)
Objective sleepparameters using actometer and the relation to melatonin
kinetics.
Subjective sleepscore using ESS questionaire and chronotype and the relation to
melatonin kinetics.
Background summary
In previous research we showed that as the kidney function deteriorates, the
nocturnal melatonin secretion decrease. In hemodialysis patients the nocturnal
melatonin surge is frequently absent. Supplementation of melatonin in
hemodialysis patients with sleep problems indeed raises the melatonin
concentration, but the favourable impact on improvement of sleep is only
present for a few weeks or months. Because melatonin is partly cleared renal
and it is important for the impact on sleep that the difference between day
concentration and night concentration is sufficiently large, we presum that
accumulation of melatonin possibly is the cause for the decreasing clinical
effect
Study objective
Primary aim: Does melatonin accumulate in hemodialysis patients after a
treatment period with exogenous melatonin for at least 12 weeks ?
Secondary aim:
Will 7 days be enough to erase the accumulated melatonin?
What are the pharmacokinetics of melatonin after a treatment period of at least
12 weeks of exogenous melatonin in hemodialysis patients?
Study design
It concerns pharmacokinetic research in patients who get melatonin in standard
care. I.
Intervention
Discontinuation of melatonin for 7 days
Study burden and risks
The patients undergo:
analysis of 6 melaton in saliva: 3 x 6 saliva swaps at home are collected at
19:00, 21:00, 23:00, 01:00 and 07:00 and 15:00 (day 1, day 3 and day 7 after
stop), after a dialysis.
Fill in of a subjective sleep questionnaire (Epworth Sleepiness Scale: 10 short
questions): at baseline, after 6 weeks melatonin use and 7 days after stopping
melatonin. Fill in a questionnaire to determine the chronotype
(morning/evening) at baseline. (VOA: 7 short questions)
Utrechtseweg 160
Amersfoort 3800 BM
NL
Utrechtseweg 160
Amersfoort 3800 BM
NL
Listed location countries
Age
Inclusion criteria
Hemodialysis patients
Age: 18-85 years
Informed consent
Good knowledge of dutch language
Melatonine use for at least 12 weeks
Exclusion criteria
Severe comorbidy such as heart failure class IV, instable AP, pulmonal, psychiatric or neurologic disease
Blindness
Nocturnal dialysis
Documented sleep apnea
Alcohol or drug abuse
Use of hypnotics such as benzodiazepines
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43933.100.13 |