Melatonin and DNA Damage Study

Sponsor

University of British Columbia (Other)

Overall Status

Unknown status

CT.gov ID

NCT03945955

Collaborator

(none)

Enrollment

Arms

14.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This research aims to determine if melatonin supplementation, through improvements in sleep quality, increases the ability to repair oxidative DNA damage and reduce lipid peroxidation levels among nightshift workers.

Condition or Disease	Intervention/Treatment	Phase
Sleep Quality DNA Damage Repair Deficiency Oxidative Stress	Dietary Supplement: Melatonin Other: Placebo	Phase 4

Detailed Description

Administering a 3 mg melatonin supplement to nightshift workers prior to day sleep may significantly improve their oxidative DNA damage repair capacity and reduce the occurrence of lipid peroxidation [measured as increased excretion of urinary 8-hydroxydeoxyguanosine (8-OH-dG) and decreased excretion of urinary 8-isoprostane, respectively] through improvements in sleep quality (measured via actigraphy) and melatonin's direct antioxidative properties.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Melatonin, Nightshift Work and DNA Damage (MEND) Study

Anticipated Study Start Date :

Jul 1, 2019

Anticipated Primary Completion Date :

Jul 1, 2020

Anticipated Study Completion Date :

Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Melatonin	Dietary Supplement: Melatonin Participants will be randomized into two groups (Group A and Group B). Group A will initially be treated with 3 mg melatonin supplements over a 4-week period while Group B will initially receive placebo supplements over a 4-week period. After a 4-week washout period, Group A will receive placebo supplements while Group B will receive 3 mg melatonin supplements.
Placebo Comparator: Placebo	Other: Placebo Placebo

Arm

Intervention/Treatment

Experimental: Melatonin

Dietary Supplement: Melatonin

Participants will be randomized into two groups (Group A and Group B). Group A will initially be treated with 3 mg melatonin supplements over a 4-week period while Group B will initially receive placebo supplements over a 4-week period. After a 4-week washout period, Group A will receive placebo supplements while Group B will receive 3 mg melatonin supplements.

Placebo Comparator: Placebo

Other: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Change from baseline oxidative DNA damage repair capacity at one month [During day sleep and during night work at baseline and one month]
Measured as difference in the urinary concentration of 8-hydroxydeoxyguanosine (ng/mg-Creatinine) between baseline and one month as measured using liquid chromatography tandem mass spectrometry
Change from baseline lipid peroxidation at one month [During day sleep and during night work at baseline and one month]
Measured as difference in the concentration of urinary 8-isoprostane (ng/mg-Creatinine) between baseline and one month using liquid chromatography tandem mass spectrometry
Change from baseline in sleep duration at one month [During day sleep at baseline and one month]
Measured as difference in sleep duration (total minutes asleep) using wrist-based actigraphy device between baseline and one month

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18-40 years of age;
Live in Vancouver, Burnaby, New Westminster or Richmond;
Primarily work nightshifts of 7 or more hours in duration that end no earlier than 6 am at least 3 nights per week over the past 6 months or more;
Sleep at least 6 hours each day after completing a night shift

Exclusion Criteria:

Currently using any tobacco or marijuana products or illicit drugs;
Typically drink more than two alcoholic beverages on a work day;
Have personal history of hypertension, hypercholesterolemia, low blood sugar, migraines, hormonal disorders, seizures disorders, depression or chronic medical condition (e.g. cancer, diabetes, kidney disease, liver disease, asthma, cardiovascular disease, infectious disease etc.)
Currently pregnant;
Currently breast feeding;
Have traveled across more than one time zone in the past 4 weeks or are planning to travel across more than one time zone during participation in the study;
Have been diagnosed or are suspected to have circadian or sleep disorders (e.g sleep apnea, narcolepsy);
Currently using melatonin supplements.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of British Columbia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Parveen Bhatti, Scientific Director, Cancer Prevention, BC Cancer Research Centre, University of British Columbia

ClinicalTrials.gov Identifier:

NCT03945955

Other Study ID Numbers:

H19-00780

First Posted:

May 10, 2019

Last Update Posted:

May 10, 2019

Last Verified:

May 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Parveen Bhatti, Scientific Director, Cancer Prevention, BC Cancer Research Centre, University of British Columbia

Melatonin, Sleep quality, DNA Damage, Lipid peroxidation, Nightshift worker

Additional relevant MeSH terms:

Melatonin

Study Results

No Results Posted as of May 10, 2019