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Completed

NCT Number: NCT03945955

Melatonin and DNA Damage 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.

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Key information

Conditions

Sleep Quality DNA Damage Repair Deficiency Dyssomnias Mental Disorders Nervous System Diseases Oxidative Stress Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

BC Cancer Research Center

Vancouver, British Columbia, V5Z 1L3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Eligibility criteria included: 1) living and working in the Greater Vancouver area; 2) being between the ages of 18 and 50; 3) having a body mass index (BMI) between 18.5 and 30 kg/m2; 4) working at least two consecutive night shifts per week (≥7 hours per night ending no earlier than 06:00) for at least six months; 5) sleeping, on average, six hours during day sleep periods; 6) not currently using marijuana or illicit drugs; 7) no personal history of sleep disorders, hormone disorders, seizure disorders, or chronic medical conditions (e.g., cancer, diabetes, kidney disease, liver disease, asthma, cardiovascular disease, and infectious disease); 8) not currently pregnant or currently breast feeding; 9) no trans-meridian travel within fours weeks of data collection; and 10) not currently using melatonin supplements.

Treatment and study plan

melatonin

Dietary Supplement

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

Other

Placebo

Primary outcomes

  1. Oxidative DNA damage repair capacity

    Time frame: During day sleep and during night work at baseline and one month

    Measured as urinary concentration of 8-hydroxydeoxyguanosine (ng/mg-Creatinine) between baseline and one month as measured using liquid chromatography tandem mass spectrometry

  2. Sleep duration

    Time frame: During day sleep at baseline and one month

    Measured sleep duration (total minutes asleep) using wrist-based actigraphy device

  3. Karolinska Sleepiness Scale

    Time frame: During night shift work at baseline and one month

    Self-reported level of sleepiness on 9 point scale

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Melatonin Supplementation and Oxidative DNA Damage Repair Capacity Among Night Shift Workers: a Randomized Placebo-controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 10, 2019
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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