Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03945955
Other study ID # H19-00780
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Completed NCT04136821 - The Long-term Effects of Oceanix™ on Resistance Training Adaptations N/A
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Completed NCT03358524 - Effects of Vitamin E Supplementation on Free Radicals and Fat Level of Obese Adolescence in Jakarta, Indonesia Phase 4
Recruiting NCT05327348 - Effectiveness of IV Vitamin C in Reducing Oxidative Stress Associated With Free Flap Surgery Phase 3
Completed NCT03288623 - The Effects of Dark Chocolate Implementation in Elite Athletes N/A
Completed NCT04419025 - Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease Phase 2
Completed NCT04597983 - Effect of 8-week Intake of 2S-hesperidin on Performance, Body Composition and Biochemicals Markers in Amateur Cyclists N/A
Not yet recruiting NCT06159543 - The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes N/A
Enrolling by invitation NCT03030456 - Whole Body Vibrations on Functional Capacity, Muscular Strength, and Biochemical Profile in Elders N/A
Completed NCT02256254 - SIMOX - Induction of Oxidative Stress Phase 2
Not yet recruiting NCT02202239 - Effect of Induction and Maintenance of Anesthesia With Etomidate on Hemodynamics and Oxidative Stress in Diabetic Patients Phase 4
Recruiting NCT02048592 - Impact of Immunonutrition on the Patients With Cystic Fibrosis Phase 4
Completed NCT01942460 - Ferumoxytol for Iron-Deficiency Anemia in Chronic Kidney Disease and Peritoneal Dialysis Patients Phase 4
Completed NCT02463318 - The Effect of Melatonin on Gene Expression and Activity of the Sirt1 and Its Target Genes Catalase and MnSOD in Multiple Sclerosis Patients and Healthy Subjects N/A
Completed NCT02177383 - Action of Essential Fatty Acids on the Expression of Antioxidant Genes and Athletic Performance N/A
Completed NCT01990391 - Brazil Nut Consumption in Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities N/A
Completed NCT00845130 - Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes N/A
Completed NCT00607893 - Efficacy of Continuous Positive Airway Pressure in Reducing Oxidative Stress in Individuals With Sleep Apnea N/A
Active, not recruiting NCT00247507 - The Effects of Acetylcysteine on Alleviating Damage of Oxidative Stress in Hemodialysis Patients Phase 4