Melatonin and DNA Damage Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-11-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Sleep Quality DNA Damage Repair Deficiency Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Melatonin

Group Type EXPERIMENTAL

Melatonin

Intervention Type 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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes