Different Doses of Oral Melatonin Supplements in Chronic Kidney Disease (CKD)-Associated Sleep Disorders

A Randomized, Prospective, Double Blind, Placebo-Controlled Trial of Two Different Doses of Oral Melatonin Supplements in Chronic Kidney Disease (CKD)-Associated Sleep Disorders

The study will evaluate the safety and efficacy of melatonin supplementation in CKD and ESRD patients with 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.

Study Overview

• Status: Unknown
• Conditions: Sleep Disorder; End Stage Renal Disease; Chronic Kidney Disease
• Intervention / Treatment: Drug: Melatonin

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 53
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Chattanooga, Tennessee, United States, 37408
      • Recruiting
      • Southeast Renal Research Institute
      • Principal Investigator: James A Tumlin, MD
      • Contact: James A Tumlin, MD; Phone Number: 423-826-8003; Email: jamestumlinmd@nephassociates.com
      • Contact: Jeremy Whitson; Phone Number: 423-826-8003; Email: jeremywhitson@nephassociates.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient age > 18 and <85 years of age
2. Patients with CKD or ESRD with eGFR < 30 mls/min
3. If receiving hemodialysis, patients must be on treatment > 3 months
4. Normal healthy controls must be without a known history of CKD and be willing to have formal PSG test and plasma melatonin measurements

Exclusion Criteria:

1. Patients receiving outpatient hemodialysis for < 3 months
2. Patients with estimated GFR by Cockcroft Gault > 30 mls/min
3. Patients receiving beta blocker therapy within one month of randomization
4. Patients receiving Nifedipine therapy within one month randomization
5. Patients on peritoneal dialysis
6. Patient with chronic home oxygen supplementation
7. Patients receiving chronic home CPAP therapy
8. Patients actively receiving outpatient sleep medications
9. Patients with diabetic gastroparesis unresponsive to medication
10. Patients with known pregnancy or unwilling to use contraception during the course of the study
11. Patients with a functioning renal allograft
12. Patient currently receiving long-term immunosuppressive therapy. Patients receiving low dose prednisone (10mg or less per day) will not be excluded from this trial
13. Unable to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Placebo controlled; comparison of placebo controlled to 1mg melatonin or 3mg melatonin	Drug: Melatonin; patients will receive placebo, 1mg melatonin or 3mg melatonin
Active Comparator: Melatonin; comparison of melatonin 1mg or melatonin 3mg	Drug: Melatonin; patients will receive placebo, 1mg melatonin or 3mg melatonin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Objective	Patients taking melatonin supplement, 1mg or 3mg daily, compared to placebo controlled group will be compared to see who group achieved a 25% reduction in sleep latency or 25% increase in total sleep time at the end of 60 days. Using the Pittsburg Sleep Quality Index (PSQI) questionnaire as the index to measure quality of sleep and sleep patterns. Study will also use Polysomnography testing that will record duration of sleep patterns.	Compare sleep duration at the end of 60 days

Collaborators and Investigators

• Sponsor: Southeast Renal Research Institute
• Investigators: Principal Investigator: James A Tumlin, MD, Southeast Renal Research Institute

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: August 7, 2013
• First Submitted That Met QC Criteria: August 12, 2013
• First Posted (Estimate): August 14, 2013

Study Record Updates

• Last Update Posted (Estimate): January 24, 2017
• Last Update Submitted That Met QC Criteria: January 23, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Urologic Diseases; Neurologic Manifestations; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Sleep Wake Disorders; Parasomnias; Kidney Failure, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: Melatonin