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

Primary Purpose

End Stage Renal Disease, Chronic Kidney Disease, Sleep Disorder

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Melatonin

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Southeast Renal Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Placebo controlled

Melatonin

Arm Description

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

comparison of melatonin 1mg or melatonin 3mg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01922999

First Posted

August 7, 2013

Last Updated

January 23, 2017

Sponsor

Southeast Renal Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT01922999

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 2012 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Southeast Renal Research Institute

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease, Chronic Kidney Disease, Sleep Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo controlled

Arm Type

Active Comparator

Arm Description

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

Arm Title

Melatonin

Arm Type

Active Comparator

Arm Description

comparison of melatonin 1mg or melatonin 3mg

Intervention Type

Drug

Intervention Name(s)

Melatonin

Intervention Description

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

Primary Outcome Measure Information:

Title

Primary Objective

Description

Time Frame

Compare sleep duration at the end of 60 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

James A Tumlin, MD

Phone

423-826-8003

jamestumlinmd@nephassociates.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jeremy Whitson

Phone

423-826-8003

jeremywhitson@nephassociates.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James A Tumlin, MD

Organizational Affiliation

Southeast Renal Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Southeast Renal Research Institute

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37408

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

James A Tumlin, MD

Phone

423-826-8003

jamestumlinmd@nephassociates.com

First Name & Middle Initial & Last Name & Degree

Jeremy Whitson

Phone

423-826-8003

jeremywhitson@nephassociates.com

First Name & Middle Initial & Last Name & Degree

James A Tumlin, MD

12. IPD Sharing Statement

Learn more about this trial

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

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