Renal Effects of Melatonin Trial in Chronic Kidney Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Renal Function in Chronic Kidney Disease and the Effect of Exogenous Melatonin Administration (REM TRIAL)

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Dietary Supplement: Melatonin
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Melatonin<br>5mg dose of melatonin manufactured by Good Neighbor Pharmacy | Dietary Supplement: Melatonin<br>* Melatonin 5mg<br>|
| Placebo Comparator: Placebo<br>Good Neighbor Pharmacy placebo tablet that looks the same without active ingredient | Dietary Supplement: Placebo<br>* Comparable Good Neighbor Pharmacy placebo tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Albuminuria | protein in urine | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surveys including Pittsburgh Sleep Quality Index (PSQI) questionnaire | Scale 0-21, higher scores indicate worse sleep quality | 6 months | 
| Sodium levels | electrolyte in blood | 6 months | 
| Urinalysis | To asses electrolyte and protein levels | 6 months | 
| Creatinine levels | serum blood | 6 months | 
| Blood Urea Nitrogen (BUN) levels | Blood Urea Nitrogen | 6 months | 
| Potassium levels | mineral in blood | 6 months | 
| Bicarbonate levels | base found in blood | 6 months | 
| Chloride levels | electrolyte in blood | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Kidney Disease