Skip to content

Melatonin Pharmacokinetics in Dialysis Patients

Melatonin Pharmacokinetics in Dialysis Patients - Melatonin kinetics in dialysis / MEKDIP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40235
Enrollment
8
Registered
2013-09-24
Start date
2014-02-20
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialyse

Interventions

Discontinuation of melatonin for 7 days

Sponsors

Meander Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Hemodialysis patients Age: 18-85 years Informed consent Good knowledge of dutch language Melatonine use for at least 12 weeks

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
Melatonin concentration measured in saliva versus time of day during 24 hours.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)