- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03945955
Melatonin and DNA Damage Study
May 8, 2019 updated by: Parveen Bhatti, University of British Columbia
Melatonin, Nightshift Work and DNA Damage (MEND) Study
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.
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Parveen Bhatti, PhD
- Phone Number: 604-675-8055
- Email: pbhatti@bccrc.ca
Study Contact Backup
- Name: Maryam Darvishian, PhD
- Phone Number: 604-675-8070
- Email: mdarvishian@bccrc.ca
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-40 years of age;
- Live in Vancouver, Burnaby, New Westminster or Richmond;
- 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;
- Sleep at least 6 hours each day after completing a night shift
Exclusion Criteria:
- Currently using any tobacco or marijuana products or illicit drugs;
- Typically drink more than two alcoholic beverages on a work day;
- 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.)
- Currently pregnant;
- Currently breast feeding;
- 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;
- Have been diagnosed or are suspected to have circadian or sleep disorders (e.g sleep apnea, narcolepsy);
- Currently using melatonin supplements.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
Placebo
|
EXPERIMENTAL: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline oxidative DNA damage repair capacity at one month
Time Frame: During day sleep and during night work at baseline and 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
|
Change from baseline lipid peroxidation at one month
Time Frame: During day sleep and during night work at baseline and 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
|
Change from baseline in sleep duration at one month
Time Frame: During day sleep at baseline and 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
July 1, 2019
Primary Completion (ANTICIPATED)
July 1, 2020
Study Completion (ANTICIPATED)
September 1, 2020
Study Registration Dates
First Submitted
April 30, 2019
First Submitted That Met QC Criteria
May 8, 2019
First Posted (ACTUAL)
May 10, 2019
Study Record Updates
Last Update Posted (ACTUAL)
May 10, 2019
Last Update Submitted That Met QC Criteria
May 8, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H19-00780
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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