| Trial ID: | L1029 |
| Source ID: | NCT01922999
|
| Associated Drug: |
Melatonin
|
| Title: |
Different Doses of Oral Melatonin Supplements in Chronic Kidney Disease (CKD)-Associated Sleep Disorders
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease|Chronic Kidney Disease|Sleep Disorder
|
| Interventions: |
DRUG: Melatonin
|
| Outcome Measures: |
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 |
|
| Sponsor/Collaborators: |
Sponsor: Southeast Renal Research Institute
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
53
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-12
|
| Completion Date: |
2017-12
|
| Results First Posted: |
|
| Last Update Posted: |
2017-01-24
|
| Locations: |
Southeast Renal Research Institute, Chattanooga, Tennessee, 37408, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01922999
|
