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

July 30, 2020 updated by: University of Oklahoma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • University of Oklahoma School of Community Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Krishna M Baradhi, MD, OUHSC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

May 13, 2020

Study Completion (Actual)

May 13, 2020

Study Registration Dates

First Submitted

March 16, 2020

First Submitted That Met QC Criteria

April 6, 2020

First Posted (Actual)

April 7, 2020

Study Record Updates

Last Update Posted (Actual)

August 3, 2020

Last Update Submitted That Met QC Criteria

July 30, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10584

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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