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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Renal Effects of Melatonin Trial in Chronic Kidney Disease

NCT04336566

Chronic Kidney Diseases

COMPLETED NA

The Effects of Melatonin on Cardiovascular and Bone Metabolism Markers in Peritoneal Dialysis Patients

NCT06096558

Peritoneal Dialysis

UNKNOWN NA

Impact of Vitamin D Therapies on Chronic Kidney Disease

NCT01222234

Chronic Kidney Disease (CKD) End-stage Renal Disease (ESRD)

COMPLETED NA

Sucrosomial Iron on Insomnia in Non-dialysis Chronic Kidney Disease Patients With Iron Deficiency Anemia

NCT06279429

CKD Sleep Disorder

RECRUITING NA

Exploring the Mechanisms of Indoxyl Sulfate Production by Oral Tryptophan Challenge Test

NCT04117191

Healthy Chronic Kidney Diseases

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

End Stage Renal Disease Chronic Kidney Disease Sleep Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo controlled

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

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type DRUG

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

Melatonin

comparison of melatonin 1mg or melatonin 3mg

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Melatonin

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes