Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Southeast Renal Research Institute
Information provided by (Responsible Party):
Southeast Renal Research Institute Identifier:
First received: August 7, 2013
Last updated: May 13, 2014
Last verified: May 2014

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.

Condition Intervention
End Stage Renal Disease
Chronic Kidney Disease
Sleep Disorder
Drug: Melatonin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Prospective, Double Blind, Placebo-Controlled Trial of Two Different Doses of Oral Melatonin Supplements in Chronic Kidney Disease (CKD)-Associated Sleep Disorders

Resource links provided by NLM:

Further study details as provided by Southeast Renal Research Institute:

Primary Outcome Measures:
  • Primary Objective [ Time Frame: Compare sleep duration at the end of 60 days ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 53
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01922999

Contact: James A Tumlin, MD 423-826-8003
Contact: Jeremy Whitson 423-826-8003

United States, Tennessee
Southeast Renal Research Institute Recruiting
Chattanooga, Tennessee, United States, 37408
Contact: James A Tumlin, MD    423-826-8003   
Contact: Jeremy Whitson    423-826-8003   
Principal Investigator: James A Tumlin, MD         
Sponsors and Collaborators
Southeast Renal Research Institute
Principal Investigator: James A Tumlin, MD Southeast Renal Research Institute
  More Information

No publications provided

Responsible Party: Southeast Renal Research Institute Identifier: NCT01922999     History of Changes
Other Study ID Numbers: Melatonin
Study First Received: August 7, 2013
Last Updated: May 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sleep Disorders
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Renal Insufficiency
Signs and Symptoms
Urologic Diseases
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses processed this record on November 20, 2014