NCT04336566

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2020

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2020

Enrollment Period

11 months

First QC Date

March 16, 2020

Last Update Submit

July 30, 2020

Conditions

Chronic Kidney Diseases

Keywords

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Change in Albuminuria

    protein in urine

    6 months

Secondary Outcomes (8)

  • Surveys including Pittsburgh Sleep Quality Index (PSQI) questionnaire

    6 months

  • Sodium levels

    6 months

  • Urinalysis

    6 months

  • Creatinine levels

    6 months

  • Blood Urea Nitrogen (BUN) levels

    6 months

  • +3 more secondary outcomes

Study Arms (2)

Melatonin

ACTIVE COMPARATOR

5mg dose of melatonin manufactured by Good Neighbor Pharmacy

Dietary Supplement: Melatonin

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

MelatoninDIETARY_SUPPLEMENT

Melatonin 5mg

Melatonin
PlaceboDIETARY_SUPPLEMENT

Comparable Good Neighbor Pharmacy placebo tablet

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • End Stage Renal Disease
  • CKD Stage IV (stage 4 with severe kidney dysfunction)
  • Severe liver disease
  • Chronic dialysis therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma School of Community Medicine

Tulsa, Oklahoma, 74135, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Krishna M Baradhi, MD

    OUHSC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participant, care provider, data manager/monitor, principle investigator all blinded
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2020

First Posted

April 7, 2020

Study Start

July 1, 2019

Primary Completion

May 13, 2020

Study Completion

May 13, 2020

Last Updated

August 3, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)