Renal Effects of Melatonin Trial in Chronic Kidney Disease

Not Applicable

Completed

• Conditions: Chronic Kidney Diseases
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Melatonin

• 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.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-04-06
• Study First Posted: 2020-04-07
• Primary Completion: 2020-05-13
• Study Completion: 2020-05-13
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Good Neighbor Pharmacy placebo tablet that looks the same without active ingredient
Melatonin	Melatonin	5mg dose of melatonin manufactured by Good Neighbor Pharmacy

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