Suspended
A Randomized, Prospective, Double Blind, Placebo-Controlled Trial of Two Different Doses of Oral Melatonin Supplements in Chronic Kidney Disease (CKD)-Associated Sleep Disorders
What is being tested
Melatonin
Drug
Who is being recruted
Urogenital Diseases+15
+ Mental Disorders
+ Chronic Disease
From 18 to 85 Years
+17 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2 & 3
Interventional
Study Start: December 2012
Summary
Principal SponsorSoutheast Renal Research Institute
Study ContactJames A Tumlin, MDMore contacts
Last updated: January 27, 2026Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2012
Actual date on which the first participant was enrolled.The study will look at the safety and efficacy of melatonin supplementation given to patients with chronic kidney disease and end stage renal disease who have sleep disorders to reduce sleep latency times, the number of apnea/hypopneic episodes, and prolong duration in rapid eye movement (REM) sleep in CKD and ESRD patients with sleep disordered breathing.
Official TitleA Randomized, Prospective, Double Blind, Placebo-Controlled Trial of Two Different Doses of Oral Melatonin Supplements in Chronic Kidney Disease (CKD)-Associated Sleep Disorders
Principal SponsorSoutheast Renal Research Institute
Study ContactJames A Tumlin, MDMore contacts
Last updated: January 27, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
53 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Urogenital DiseasesMental DisordersChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesKidney Failure, ChronicNervous System DiseasesNeurologic ManifestationsPathologic ProcessesSigns and SymptomsSleep Wake DisordersPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases
Criteria
4 inclusion criteria required to participate
Patient age > 18 and <85 years of age
Patients with CKD or ESRD with eGFR < 30 mls/min
If receiving hemodialysis, patients must be on treatment > 3 months
Normal healthy controls must be without a known history of CKD and be willing to have formal PSG test and plasma melatonin measurements
13 exclusion criteria prevent from participating
Patients receiving outpatient hemodialysis for < 3 months
Patients with estimated GFR by Cockcroft Gault > 30 mls/min
Patients receiving beta blocker therapy within one month of randomization
Patients receiving Nifedipine therapy within one month randomization
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active Comparatorcomparison of melatonin 1mg or melatonin 3mg
Group II
Active Comparatorcomparison of placebo controlled to 1mg melatonin or 3mg melatonin
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
Southeast Renal Research Institute
Chattanooga, United StatesOpen Southeast Renal Research Institute in Google MapsSuspendedOne Study Center