Double blind placebo controlled study on the efficacy of melatonin on sleep parameters and quality of life in hemodialysis patients

Phase 3

Completed

• Conditions: Dialysis; kidney function replacement therapy; 10019280; 10038430; 10040998

• Registration Number: NL-OMON30731
• Lead Sponsor: Meander Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 68

Inclusion Criteria

1) Informed Consent
2) Man/Women between 18 and 85 years
3) Understanding and knowledge of the dutch language
4) End Stage Renal Disease, stable chronic hemodialysis > 3 months
5) SpKt/V(total) > 1,2 pro dialysis
6) Validated actometer shows that sleep efficiency < 90% or sleep latency > 15 minutes or fragmentation index > 25 points

Exclusion Criteria

1) 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.
2) Instable angina pectoris, heart failure NYHA class IV
3) Pregnancy
4) Current use of melatonin of known allergy of melatonin
5) Participation in other medication/drug research within a month before inclusion
6)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) improvement of vitality (dimension quality of life) by 15 points (RAND SF 36)<br /><br>2) improvement general health by 15 points (dimension quality of life, RAND SF<br /><br>36)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Change in biochemical parameters<br /><br>2) Change in ProBNP<br /><br>3) Change in nutritonal status<br /><br>4) Change in use of medication<br /><br>5) Change in preload</p><br>