Back to resultsRenal Effects of Melatonin Trial in Chronic Kidney Disease (REM)
Primary Purpose
Chronic Kidney Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Melatonin
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Kidney Diseases focused on measuring Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria:
- Are between ages 18 and up with chronic kidney disease (CKD) I-III (stage 3 kidney disease, kidney dysfunction)
- Random urine microalbumin of 30 mcg or greater (protein in the urine)
- Have ability to complete a sleep survey
- Currently not on melatonin therapy.
Exclusion Criteria:
- End Stage Renal Disease
- CKD Stage IV (stage 4 with severe kidney dysfunction)
- Severe liver disease
- Chronic dialysis therapy
Sites / Locations
- University of Oklahoma School of Community Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Melatonin
Placebo
Arm Description
5mg dose of melatonin manufactured by Good Neighbor Pharmacy
Good Neighbor Pharmacy placebo tablet that looks the same without active ingredient
Outcomes
Primary Outcome Measures
Change in Albuminuria
protein in urine
Secondary Outcome Measures
Surveys including Pittsburgh Sleep Quality Index (PSQI) questionnaire
Scale 0-21, higher scores indicate worse sleep quality
Sodium levels
electrolyte in blood
Urinalysis
To asses electrolyte and protein levels
Creatinine levels
serum blood
Blood Urea Nitrogen (BUN) levels
Blood Urea Nitrogen
Potassium levels
mineral in blood
Bicarbonate levels
base found in blood
Chloride levels
electrolyte in blood
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04336566
Brief Title
Renal Effects of Melatonin Trial in Chronic Kidney Disease
Acronym
REM
Official Title
Renal Function in Chronic Kidney Disease and the Effect of Exogenous Melatonin Administration (REM TRIAL)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
May 13, 2020 (Actual)
Study Completion Date
May 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This will be a prospective, double blinded, randomized, controlled pilot study to determine if there is any correlation between melatonin administration and proteinuria.
Detailed Description
Investigators plan to enroll up to 100 eligible participants in this pilot trial with 50 participants randomized to receive melatonin and 50 patients randomized to receive a placebo. Participants will be randomized on a rolling basis; meaning, once participants agree to enroll in the study, the participant will be placed randomly into either group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
Chronic Kidney Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participant, care provider, data manager/monitor, principle investigator all blinded
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Melatonin
Arm Type
Active Comparator
Arm Description
5mg dose of melatonin manufactured by Good Neighbor Pharmacy
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Good Neighbor Pharmacy placebo tablet that looks the same without active ingredient
Intervention Type
Dietary Supplement
Intervention Name(s)
Melatonin
Intervention Description
Melatonin 5mg
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Comparable Good Neighbor Pharmacy placebo tablet
Primary Outcome Measure Information:
Title
Change in Albuminuria
Description
protein in urine
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Surveys including Pittsburgh Sleep Quality Index (PSQI) questionnaire
Description
Scale 0-21, higher scores indicate worse sleep quality
Time Frame
6 months
Title
Sodium levels
Description
electrolyte in blood
Time Frame
6 months
Title
Urinalysis
Description
To asses electrolyte and protein levels
Time Frame
6 months
Title
Creatinine levels
Description
serum blood
Time Frame
6 months
Title
Blood Urea Nitrogen (BUN) levels
Description
Blood Urea Nitrogen
Time Frame
6 months
Title
Potassium levels
Description
mineral in blood
Time Frame
6 months
Title
Bicarbonate levels
Description
base found in blood
Time Frame
6 months
Title
Chloride levels
Description
electrolyte in blood
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Are between ages 18 and up with chronic kidney disease (CKD) I-III (stage 3 kidney disease, kidney dysfunction)
Random urine microalbumin of 30 mcg or greater (protein in the urine)
Have ability to complete a sleep survey
Currently not on melatonin therapy.
Exclusion Criteria:
End Stage Renal Disease
CKD Stage IV (stage 4 with severe kidney dysfunction)
Severe liver disease
Chronic dialysis therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krishna M Baradhi, MD
Organizational Affiliation
OUHSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma School of Community Medicine
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Renal Effects of Melatonin Trial in Chronic Kidney Disease
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