Renal Effects of Melatonin Trial in Chronic Kidney Disease

NCT ID: NCT04336566

Last Updated: 2020-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-05-13

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Participant, care provider, data manager/monitor, principle investigator all blinded

Study Groups

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Melatonin

5mg dose of melatonin manufactured by Good Neighbor Pharmacy

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type DIETARY_SUPPLEMENT

Melatonin 5mg

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Comparable Good Neighbor Pharmacy placebo tablet

Interventions

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Melatonin

Melatonin 5mg

Intervention Type DIETARY_SUPPLEMENT

Placebo

Comparable Good Neighbor Pharmacy placebo tablet

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Krishna M Baradhi, MD

Role: PRINCIPAL_INVESTIGATOR

OUHSC

Locations

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University of Oklahoma School of Community Medicine

Tulsa, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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10584

Identifier Type: -

Identifier Source: org_study_id

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