Renal Effects of Melatonin Trial in Chronic Kidney Disease
- Conditions
- Chronic Kidney Diseases
- Registration Number
- NCT04336566
- Lead Sponsor
- University of Oklahoma
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- 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.
- End Stage Renal Disease
- CKD Stage IV (stage 4 with severe kidney dysfunction)
- Severe liver disease
- Chronic dialysis therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in Albuminuria 6 months protein in urine
- Secondary Outcome Measures
Name Time Method Potassium levels 6 months mineral in blood
Urinalysis 6 months To asses electrolyte and protein levels
Surveys including Pittsburgh Sleep Quality Index (PSQI) questionnaire 6 months Scale 0-21, higher scores indicate worse sleep quality
Sodium levels 6 months electrolyte in blood
Bicarbonate levels 6 months base found in blood
Chloride levels 6 months electrolyte in blood
Creatinine levels 6 months serum blood
Blood Urea Nitrogen (BUN) levels 6 months Blood Urea Nitrogen
Trial Locations
- Locations (1)
University of Oklahoma School of Community Medicine
🇺🇸Tulsa, Oklahoma, United States
University of Oklahoma School of Community Medicine🇺🇸Tulsa, Oklahoma, United States