Renal Effects of Melatonin Trial in Chronic Kidney Disease | NCT04336566

Studies
Renal Effects of Melatonin Trial in Chronic Kidney Disease

NCT04336566

Sponsor

University of Oklahoma

Status

Completed

Last Update Posted

Aug 3, 2020Actual

Enrollment

31Actual

Phase

Not Applicable

Conditions

Chronic Kidney Diseases

Interventions

Melatonin
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2019Actual

Primary Completion Date

May 13, 2020Actual

Completion Date

May 13, 2020Actual

First Submitted Date

Mar 16, 2020

First Submission Date that Met QC Criteria

Apr 6, 2020

First Posted Date

Apr 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2020

Last Update Posted Date

Aug 3, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Melatonin	Dietary Supplement	Melatonin 5mg	Melatonin
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Surveys including Pittsburgh Sleep Quality Index (PSQI) questionnaire	Scale 0-21, higher scores indicate worse sleep quality	6 months
Sodium levels	electrolyte in blood

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Krishna M Baradhi, MD	OUHSC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Oklahoma School of Community Medicine		Tulsa	Oklahoma	74135	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008550	Melatonin

Ancestor Terms

ID	Term
D014363	Tryptamines
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided