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

Southeast Renal Research Institute

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Chronic Kidney Disease; Sleep Disorder; End Stage Renal Disease

Treatments: Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT01922999

Melatonin

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 2 patient groups

Placebo controlled

Active Comparator group

Description:

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

Treatment:

Drug: Melatonin

Melatonin

Active Comparator group

Description:

comparison of melatonin 1mg or melatonin 3mg

Treatment:

Drug: Melatonin