Melatonin and DNA Damage Study

NCT03945955 | Completed Phase 4

• 1 other identifier: H19-00780
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Quality; DNA Damage Repair Deficiency; Oxidative Stress

Keywords

Melatonin, Sleep quality, DNA Damage, Lipid peroxidation, Nightshift worker

Outcome Measures

Primary Outcomes (3)

• Oxidative DNA damage repair capacity

  Measured as 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

• Sleep duration

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

  During day sleep at baseline and one month

• Karolinska Sleepiness Scale

  Self-reported level of sleepiness on 9 point scale

  During night shift work at baseline and one month

Study Arms (2)

Melatonin

EXPERIMENTAL

Dietary Supplement: Melatonin

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

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.

Melatonin

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Cancer Research Center

Vancouver, British Columbia, V5Z 1L3, Canada

Location

Related Publications (3)

• Bhatti P, Mirick DK, Randolph TW, Gong J, Buchanan DT, Zhang JJ, Davis S. Oxidative DNA damage during night shift work. Occup Environ Med. 2017 Sep;74(9):680-683. doi: 10.1136/oemed-2017-104414. Epub 2017 Jun 26.

  PMID: 28652381 RESULT

• Mirick DK, Bhatti P, Chen C, Nordt F, Stanczyk FZ, Davis S. Night shift work and levels of 6-sulfatoxymelatonin and cortisol in men. Cancer Epidemiol Biomarkers Prev. 2013 Jun;22(6):1079-87. doi: 10.1158/1055-9965.EPI-12-1377. Epub 2013 Apr 5.

  PMID: 23563887 RESULT

• Bhatti P, Mirick DK, Davis S. The impact of chronotype on melatonin levels among shift workers. Occup Environ Med. 2014 Mar;71(3):195-200. doi: 10.1136/oemed-2013-101730. Epub 2014 Jan 7.

  PMID: 24399070 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 10, 2019
• Study Start: June 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)