Sleep QualityPhase 4NCT03945955
Melatonin and DNA Damage Study
A Phase 4 study testing Melatonin in people with Sleep Quality and DNA Damage Repair Deficiency, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, DNA Damage Repair Deficiency, Oxidative Stress
- What is being tested?
- Melatonin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2022to 1 Nov 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Melatonin Supplementation and Oxidative DNA Damage Repair Capacity Among Night Shift Workers: a Randomized Placebo-controlled Trial
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.
Read the 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.
- Being tested
- Melatonin, Placebo
- Keywords
- Melatonin, Sleep quality, DNA Damage, Lipid peroxidation, Nightshift worker
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDietary 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.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | Not described Receives: Dietary Supplement: Melatonin |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: During day sleep at baseline and one month
Karolinska Sleepiness Scale
Self-reported level of sleepiness on 9 point scale
Measured: During night shift work at baseline and one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start1 Jun 2022
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parveen Bhatti, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945955
- Sponsor's protocol ID
- H19-00780
- Status last verified
- Aug 2024
- First submitted
- 30 Apr 2019
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28652381Mirick 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.
PubMed 23563887Bhatti 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.
PubMed 24399070
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin Supplementation and Oxidative DNA Damage Repair Capacity Among Night Shift Workers: a Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03945955
- Acronym / sponsor ID
- H19-00780
- Keywords
- Melatonin, Sleep quality, DNA Damage, Lipid peroxidation, Nightshift worker
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Dietary Supplement: Melatonin |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninParticipants 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. | Dietary supplement | Melatonin |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Oxidative DNA damage repair capacity
Time frame: During day sleep and during night work at baseline and one month
Measured as urinary concentration of 8-hydroxydeoxyguanosine (ng/mg-Creatinine) between baseline and one month as measured using liquid chromatography tandem mass spectrometry
Sleep duration
Time frame: During day sleep at baseline and one month
Measured sleep duration (total minutes asleep) using wrist-based actigraphy device
Karolinska Sleepiness Scale
Time frame: During night shift work at baseline and one month
Self-reported level of sleepiness on 9 point scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Results publication: PubMed 28652381Bhatti 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.
- Results publication: PubMed 23563887Mirick 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.
- Results publication: PubMed 24399070Bhatti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Melatonin in people with Sleep Quality and DNA Damage Repair Deficiency, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidative DNA damage repair capacity (time frame: During day sleep and during night work at baseline and one month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03945955, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.