Melatonin and DNA Damage Study

Oxidative Stress Clinical Trial

Official title:

Melatonin, Nightshift Work and DNA Damage (MEND) Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03945955
• Other study ID #: H19-00780
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 2019
• Est. completion date: September 2020

Study information

• Verified date: May 2019
• Source: University of British Columbia
• Contact: Parveen Bhatti, PhD
• Phone: 604-675-8055
• Email: pbhatti[@]bccrc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: September 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. 18-40 years of age;

2. Live in Vancouver, Burnaby, New Westminster or Richmond;

3. Primarily work nightshifts of 7 or more hours in duration that end no earlier than 6 am at least 3 nights per week over the past 6 months or more;

4. Sleep at least 6 hours each day after completing a night shift

Exclusion Criteria:

1. Currently using any tobacco or marijuana products or illicit drugs;

2. Typically drink more than two alcoholic beverages on a work day;

3. Have personal history of hypertension, hypercholesterolemia, low blood sugar, migraines, hormonal disorders, seizures disorders, depression or chronic medical condition (e.g. cancer, diabetes, kidney disease, liver disease, asthma, cardiovascular disease, infectious disease etc.)

4. Currently pregnant;

5. Currently breast feeding;

6. Have traveled across more than one time zone in the past 4 weeks or are planning to travel across more than one time zone during participation in the study;

7. Have been diagnosed or are suspected to have circadian or sleep disorders (e.g sleep apnea, narcolepsy);

8. Currently using melatonin supplements.

Related Conditions & MeSH terms

• DNA Damage Repair Deficiency
• Oxidative Stress
• Sleep Quality

Intervention

Dietary Supplement:
• 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.

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline oxidative DNA damage repair capacity at one month	Measured as difference in the 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
Primary	Change from baseline lipid peroxidation at one month	Measured as difference in the concentration of urinary 8-isoprostane (ng/mg-Creatinine) between baseline and one month using liquid chromatography tandem mass spectrometry	During day sleep and during night work at baseline and one month
Primary	Change from baseline in sleep duration at one month	Measured as difference in sleep duration (total minutes asleep) using wrist-based actigraphy device between baseline and one month	During day sleep at baseline and one month