Melatonin and DNA Damage Study

Study Overview
=================
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.

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.

Official Title
-----------------
Melatonin, Nightshift Work and DNA Damage (MEND) Study

Conditions
-----------------
Sleep Quality, DNA Damage Repair Deficiency, Oxidative Stress

Intervention / Treatment
-----------------
* Dietary Supplement: Melatonin
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin<br> | Dietary Supplement: Melatonin<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melatonin, Sleep quality, DNA Damage, Lipid peroxidation, Nightshift worker