Renal Effects of Melatonin Trial in Chronic Kidney Disease (REM)

University of Oklahoma (OU)

Status: Completed

Conditions: Chronic Kidney Diseases

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT04336566

10584

Details and patient eligibility

About

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

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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31 participants in 2 patient groups, including a placebo group

Melatonin

Active Comparator group

Description:

5mg dose of melatonin manufactured by Good Neighbor Pharmacy

Treatment:

Dietary Supplement: Melatonin

Placebo

Placebo Comparator group

Description:

Good Neighbor Pharmacy placebo tablet that looks the same without active ingredient

Treatment:

Dietary Supplement: Placebo