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出境医 / 临床实验 / Melatonin and DNA Damage Study

Melatonin and DNA Damage Study

Study Description
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.

Condition or disease Intervention/treatment Phase
Sleep Quality DNA Damage Repair Deficiency Oxidative Stress Dietary Supplement: Melatonin Other: Placebo Phase 4

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Melatonin, Nightshift Work and DNA Damage (MEND) Study
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : September 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Melatonin 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.
Placebo Comparator: Placebo Other: Placebo
Placebo
Outcome Measures
Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Contacts
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Contact: Parveen Bhatti, PhD 604-675-8055 pbhatti@bccrc.ca
Contact: Maryam Darvishian, PhD 604-675-8070 mdarvishian@bccrc.ca

Sponsors and Collaborators
University of British Columbia
Tracking Information
First Submitted Date  ICMJE April 30, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date May 10, 2019
Estimated Study Start Date  ICMJE July 2019
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Melatonin and DNA Damage Study
Official Title  ICMJE Melatonin, Nightshift Work and DNA Damage (MEND) Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Sleep Quality
  • DNA Damage Repair Deficiency
  • Oxidative Stress
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Melatonin
    Intervention: Dietary Supplement: Melatonin
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 8, 2019) 		36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03945955
Other Study ID Numbers  ICMJE H19-00780
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Parveen Bhatti, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of British Columbia
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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