Melatonin and DNA Damage Study

Melatonin, Nightshift Work and DNA Damage (MEND) Study

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.

Study Overview

• Status: Unknown
• Conditions: Oxidative Stress; Sleep Quality; DNA Damage Repair Deficiency
• Intervention / Treatment: Other: Placebo; Dietary supplement: Melatonin

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 Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Parveen Bhatti, PhD; Phone Number: 604-675-8055; Email: pbhatti@bccrc.ca
• Study Contact Backup: Name: Maryam Darvishian, PhD; Phone Number: 604-675-8070; Email: mdarvishian@bccrc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18-40 years of age;
2. Live in Vancouver, Burnaby, New Westminster or Richmond;
3. 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;
4. Sleep at least 6 hours each day after completing a night shift

Exclusion Criteria:

1. Currently using any tobacco or marijuana products or illicit drugs;
2. Typically drink more than two alcoholic beverages on a work day;
3. 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.)
4. Currently pregnant;
5. Currently breast feeding;
6. 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;
7. Have been diagnosed or are suspected to have circadian or sleep disorders (e.g sleep apnea, narcolepsy);
8. Currently using melatonin supplements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Other: Placebo; Placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline oxidative DNA damage repair capacity at 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	During day sleep and during night work at baseline and one month
Change from baseline lipid peroxidation at 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	During day sleep and during night work at baseline and one month
Change from baseline in sleep duration at one month	Measured as difference in sleep duration (total minutes asleep) using wrist-based actigraphy device between baseline and one month	During day sleep at baseline and one month

Collaborators and Investigators

• Sponsor: University of British Columbia

Publications and helpful links

General Publications

• Bhatti P, Mirick DK, Randolph TW, Gong J, Buchanan DT, Zhang JJ, Davis S. Oxidative DNA damage during night shift work. Occup Environ Med. 2017 Sep;74(9):680-683. doi: 10.1136/oemed-2017-104414. Epub 2017 Jun 26.
• Mirick DK, Bhatti P, Chen C, Nordt F, Stanczyk FZ, Davis S. Night shift work and levels of 6-sulfatoxymelatonin and cortisol in men. Cancer Epidemiol Biomarkers Prev. 2013 Jun;22(6):1079-87. doi: 10.1158/1055-9965.EPI-12-1377. Epub 2013 Apr 5.
• Bhatti P, Mirick DK, Davis S. The impact of chronotype on melatonin levels among shift workers. Occup Environ Med. 2014 Mar;71(3):195-200. doi: 10.1136/oemed-2013-101730. Epub 2014 Jan 7.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2019
• Primary Completion (ANTICIPATED): July 1, 2020
• Study Completion (ANTICIPATED): September 1, 2020

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (ACTUAL): May 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2019
• Last Update Submitted That Met QC Criteria: May 8, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Melatonin, Sleep quality, DNA Damage, Lipid peroxidation, Nightshift worker
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: H19-00780

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No