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Melatonin and DNA Damage Study

University of British Columbia logo

University of British Columbia

Status and phase

Completed
Phase 4

Conditions

DNA Damage Repair Deficiency
Sleep Quality
Oxidative Stress

Treatments

Other: Placebo
Dietary Supplement: Melatonin

Study type

Interventional

Funder types

Other

Identifiers

NCT03945955
H19-00780

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups, including a placebo group

Melatonin
Experimental group
Treatment:
Dietary Supplement: Melatonin
Placebo
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

1

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Central trial contact

Parveen Bhatti, PhD; Maryam Darvishian, PhD

Data sourced from clinicaltrials.gov

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