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

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01922999
• Other study ID #: Melatonin
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: August 7, 2013
• Last updated: January 23, 2017
• Start date: December 2012
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Southeast Renal Research Institute
• Contact: James A Tumlin, MD
• Phone: 423-826-8003
• Email: jamestumlinmd[@]nephassociates.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Disease
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Parasomnias
• Renal Insufficiency, Chronic
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Drug:
• Melatonin
patients will receive placebo, 1mg melatonin or 3mg melatonin

Locations

Country	Name	City	State
United States	Southeast Renal Research Institute	Chattanooga	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Southeast Renal Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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