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Completed

NCT Number: NCT04336566

Renal Effects of Melatonin Trial in Chronic Kidney Disease

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

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma School of Community Medicine

Tulsa, Oklahoma, 74135, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

melatonin

Dietary Supplement

Melatonin 5mg

Placebo

Dietary Supplement

Comparable Good Neighbor Pharmacy placebo tablet

Primary outcomes

  1. Change in Albuminuria

    Time frame: 6 months

    protein in urine

Secondary outcomes

  1. Surveys including Pittsburgh Sleep Quality Index (PSQI) questionnaire

    Time frame: 6 months

    Scale 0-21, higher scores indicate worse sleep quality

  2. Sodium levels

    Time frame: 6 months

    electrolyte in blood

  3. Urinalysis

    Time frame: 6 months

    To asses electrolyte and protein levels

  4. Creatinine levels

    Time frame: 6 months

    serum blood

  5. Blood Urea Nitrogen (BUN) levels

    Time frame: 6 months

    Blood Urea Nitrogen

  6. Potassium levels

    Time frame: 6 months

    mineral in blood

  7. Bicarbonate levels

    Time frame: 6 months

    base found in blood

  8. Chloride levels

    Time frame: 6 months

    electrolyte in blood

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Acronym: REM

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 7, 2020
Registry last updated
Aug 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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