Melatonin and DNA Damage Study

Phase 4

Completed

• Conditions: DNA Damage Repair Deficiency; Sleep Quality; Oxidative Stress
• Interventions: Other: Placebo; Dietary Supplement: Melatonin

• Registration Number: NCT03945955
• Lead Sponsor: University of British Columbia

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-05-08
• Study First Posted: 2019-05-10
• Study Start: 2022-06-01
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Melatonin	Melatonin	-

Primary Outcome Measures

Name	Time	Method
Oxidative DNA damage repair capacity	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
Sleep duration	During day sleep at baseline and one month	Measured sleep duration (total minutes asleep) using wrist-based actigraphy device
Karolinska Sleepiness Scale	During night shift work at baseline and one month	Self-reported level of sleepiness on 9 point scale

Trial Locations

Locations (1)

BC Cancer Research Center; 🇨🇦 Vancouver, British Columbia, Canada