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

NCT01922999 | Unknown Phase 2

• 1 other identifier: Melatonin
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Renal Disease; Chronic Kidney Disease; Sleep Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Placebo controlled

ACTIVE COMPARATOR

comparison of placebo controlled to 1mg melatonin or 3mg melatonin

Drug: Melatonin

Melatonin

ACTIVE COMPARATOR

comparison of melatonin 1mg or melatonin 3mg

Drug: Melatonin

Interventions

Melatonin DRUG

patients will receive placebo, 1mg melatonin or 3mg melatonin

Melatonin; Placebo controlled

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients on peritoneal dialysis
• Patient with chronic home oxygen supplementation
• Patients receiving chronic home CPAP therapy
• Patients actively receiving outpatient sleep medications
• Patients with diabetic gastroparesis unresponsive to medication
• Patients with known pregnancy or unwilling to use contraception during the course of the study
• Patients with a functioning renal allograft
• Patient currently receiving long-term immunosuppressive therapy. Patients receiving low dose prednisone (10mg or less per day) will not be excluded from this trial
• Unable to give informed consent

Sponsors & Collaborators

• Southeast Renal Research Institute: lead

Study Sites (1)

Southeast Renal Research Institute

Chattanooga, Tennessee, 37408, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic; Sleep Wake Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• James A Tumlin, MD

  Southeast Renal Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James A Tumlin, MD

CONTACT

423-826-8003; jamestumlinmd@nephassociates.com

Jeremy Whitson

CONTACT

423-826-8003; jeremywhitson@nephassociates.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 14, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

US (1)