Renal Effects of Melatonin Trial in Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

— REM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04336566
• Other study ID #: 10584
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: May 13, 2020

Study information

• Verified date: July 2020
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a prospective, double blinded, randomized, controlled pilot study to determine if there is any correlation between melatonin administration and proteinuria.

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 information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 13, 2020
• Est. primary completion date: May 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Melatonin
Melatonin 5mg
• Placebo
Comparable Good Neighbor Pharmacy placebo tablet

Locations

Country	Name	City	State
United States	University of Oklahoma School of Community Medicine	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

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