SmokingPhase 4NCT02591238
Melatonin in Smoke-induced Vascular Injury
A Phase 4 study testing non-smoker oral melatonin and smoker oral melatonin in people with Smoking and Vascular System Injuries, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The main purpose of this study was to evaluate the effects of melatonin in the regulation of the vascular injury in smokers through population-based, randomized, double-blind, placebo-controlled trial. Read more about this study
- Who is it for?
- Ages 25 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Vascular System Injuries
- What is being tested?
- non-smoker oral melatonin and smoker oral melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Oct 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy smokers：must above 10 cigarettes per day, at least 1 year
- Healthy non-smokers
Who cannot join
- Cardiovascular disease
- Systolic blood pressure above 140 mm Hg
- Diastolic blood pressure above 90 mmHg
- Psychiatric disorders
- Cancer
- Pregnant
- Lactating
- Taking antipsychotic drugs orally during the 2 weeks of the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Protective Effect of Melatonin on Smoke-induced Vascular Injury in Human
The main purpose of this study was to evaluate the effects of melatonin in the regulation of the vascular injury in smokers through population-based, randomized, double-blind, placebo-controlled trial.
Read the detailed description
Trial title: The protective effect of melatonin on smoke-induced vascular injury in human
Protocol: Investigators recruited eligible Han Chinese participants (aged 25-39) if they had smoking at least 10 cigarettes per day for at least 1 year. Participants excluded if they had undergone cardiovascular disease, or systolic blood pressure above 140 mm Hg, or diastolic blood pressure above 90 mmHg, or psychiatric disorders, or cancer, or pregnant, or lactating, or taking antipsychotic drugs orally during the 2 weeks of the trial. They were randomly divided participants into non-smoking with oral placebo, non-smoking with oral melatonin, smoking with oral placebo, and smoking with oral melatonin. They are oral melatonin 3 mg/day or placebo for 2 weeks. Blood samples (about 3 milliliter) were taken at baseline and after 2 weeks of treatment. Through a series hospital clinical laboratory and related ELISA kits to detect endothelial cell injury in serum markers platelet endothelial cell adhesion molecule-1 (PECAM-1/CD31)， intercellular adhesion molecule-1 (ICAM - 1), vascular cell adhesion molecule-1 (VCAM 1), endothelin-1 (ET-1), endothelial nitric oxide synthase (eNOS), nuclear erythroid 2-related factor 2 (Nrf - 2), NAD(P)H quinone oxidoreductase-1 (NQO-1), catalytic glutamate cysteine ligase (GCLC), heme oxygenase-1 (HO-1), free fatty acid (FFA), total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL), hypersensitive c-reactive protein (hsCRP), fibrinogen (Fbg), and free fatty acids (FFA), through the above vascular endothelial damage index analysis whether melatonin have protective effect against smoke-induced vascular injury. All participants and study investigators were unaware of treatment allocation throughout the trial. This trial is approved by the Ethical Committee of Peking Union Medical College Hospital (No JS-863). All participants completed a questionnaire and signed an informed consent document. Otherwise, they will get appropriate economic compensation. To achieve treatment concealment, melatonin and placebo in appearance and package were identically. Trial associates monitored compliance with the masking procedure throughout the trial. All participants and study investigators were unaware of treatment allocation throughout the study. The randomization codes remained sealed until after data collection and cleaning, and completion of a masked analysis. The study team monitored and classified protocol deviations. Investigators summarized baseline clinical and demographic characteristics with descriptive statistics and then determined by the Univariate Analysis of Variance. All the data analyses were done using statistical software SPSS 20.0.
Expected results: Compared with smoker oral placebo, melatonin 3 mg/day may be alleviate smoke-induced vascular injury.
Consent document: The potential risk, research as a treatment drug of melatonin may delay the metabolism of antipsychotic antipsychotic drug, so when investigators recruit psychiatric disorders or taking antipsychotic drugs orally during the 2 weeks of the trial should exclusion. As a Health care medicine. Melatonin is not suitable for children, so investigators selected recruiting participants under the age of 25 to 39.
The measure to minimize the risk, fully inform the participants and their families the trial's advantages, disadvantages and desired effect. All participants totally agree with the subjects. In this process, at least three or more effective way to get contact with the medical staff or doctor and ensure that those unexpected accident should deserve effective tackle. Examination for every participant before start of the trial to guarantee they comply with the criterion. Our research involves the application of melatonin is through the china food and drug administration (CFDA) approved to ensure its safety (include its chemical composition, structure, content parameters, main raw material and appropriate crowd). All staff is qualified medical professionals to guarantee the safety of all participants.
The potential risks or discomfort, or inconvenience, or benefits for participants: So far, effective of melatonin in human include regulating sleep, anti-tumor, immune regulation, regulating of inflammation and immune and regulating blood lipid metabolism is confirmed. Adverse reactions is slow the delay of antipsychotic drug metabolism (so nearly one month ago and during period of the trial participants should not taking antipsychotic drugs) during the trial. The basic principle during the trial is ensure safety of participants.
The relevant content consultation: Everyone have the right to consultation the research content through telephone: +86 01069152500 (principal investigator) and +86 01069155817(Ethics committee).
The rights of withdrew from the trial: Participate in the trial is completely voluntary. If for any reason, participants not willing to participate in, or do not wish to continue to participate in this trial, will not affect the rights and interests of participants. In addition, participants have the right to withdraw this trial at any time. If participants do not according to the doctor instructions, or for the sake of your health and benefits, the doctor or the researchers may also require participants to quit the trial.
The compensation of research: If the participants have any unexpected accident relation with the trial, the compensation and responsibility will be provided by Peking union medical college hospital.
Privacy protection: The privacy of every participant will be protected. The results of the trial in academic publications will not leak any information to identify your personal identity. Peking union medical college hospital will save everybody's data and guarantee not leak without authorization.
Investigators declare no competing interests.
- Conditions
- Smoking, Vascular System Injuries
- Being tested
- non-smoker oral placebo, non-smoker oral melatonin, smoker oral placebo, smoker oral melatonin
- Keywords
- smoking, melatonin, vascular injury
- Medical subject headings
- Smoking, Vascular System Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-smoker oral placeboOther
Also called placebo
Participants oral placebo last 2 weeks.
non-smoker oral melatoninDrug
Also called Melatonin
Participants oral melatonin 3 mg/day last 2 weeks.
smoker oral placeboOther
Also called placebo
Participants oral placebo last 2 weeks.
smoker oral melatoninDrug
Also called melatonin
Participants oral melatonin 3 mg/day last 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| non-smoker + placebo | Placebo comparator | non-smoker oral placebo Receives: Other: non-smoker oral placebo |
| non-smoker + melatonin | Active comparator | non-smoker oral melatonin Receives: Drug: non-smoker oral melatonin |
| smoker + placebo | Placebo comparator | smoker oral placebo Receives: Other: smoker oral placebo |
| smoker + melatonin | Active comparator | smoker oral melatonin Receives: Drug: smoker oral melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Fbg.
Measured: Three months
Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Glu.
Measured: Three months.
Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of FFA.
Measured: Three months.
Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of TC.
Measured: Three months.
Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of TG.
Measured: Three months.
Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of LDL-C.
Measured: Three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Changwei Liu, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591238
- Sponsor's protocol ID
- 81470585
- Status last verified
- Jun 2015
- First submitted
- 26 Oct 2015
- Last updated
- 3 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: The cycle of the experiment is long, and it is a part of the experiment.
Publications
Yang GH, Li YC, Wang ZQ, Liu B, Ye W, Ni L, Zeng R, Miao SY, Wang LF, Liu CW. Protective effect of melatonin on cigarette smoke-induced restenosis in rat carotid arteries after balloon injury. J Pineal Res. 2014 Nov;57(4):451-8. doi: 10.1111/jpi.12185. Epub 2014 Oct 6.
PubMed 25251422Rodella LF, Filippini F, Bonomini F, Bresciani R, Reiter RJ, Rezzani R. Beneficial effects of melatonin on nicotine-induced vasculopathy. J Pineal Res. 2010 Mar;48(2):126-32. doi: 10.1111/j.1600-079X.2009.00735.x. Epub 2009 Dec 30.
PubMed 20050989Hardeland R, Tan DX, Reiter RJ. Kynuramines, metabolites of melatonin and other indoles: the resurrection of an almost forgotten class of biogenic amines. J Pineal Res. 2009 Sep;47(2):109-126. doi: 10.1111/j.1600-079X.2009.00701.x. Epub 2009 Jul 1.
PubMed 19573038Hautamaki RD, Kobayashi DK, Senior RM, Shapiro SD. Requirement for macrophage elastase for cigarette smoke-induced emphysema in mice. Science. 1997 Sep 26;277(5334):2002-4. doi: 10.1126/science.277.5334.2002.
PubMed 9302297Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.
PubMed 15364185Teo KK, Ounpuu S, Hawken S, Pandey MR, Valentin V, Hunt D, Diaz R, Rashed W, Freeman R, Jiang L, Zhang X, Yusuf S; INTERHEART Study Investigators. Tobacco use and risk of myocardial infarction in 52 countries in the INTERHEART study: a case-control study. Lancet. 2006 Aug 19;368(9536):647-58. doi: 10.1016/S0140-6736(06)69249-0.
PubMed 16920470Pirie K, Peto R, Reeves GK, Green J, Beral V; Million Women Study Collaborators. The 21st century hazards of smoking and benefits of stopping: a prospective study of one million women in the UK. Lancet. 2013 Jan 12;381(9861):133-41. doi: 10.1016/S0140-6736(12)61720-6. Epub 2012 Oct 27.
PubMed 23107252Opie LH. The metabolic vicious cycle in heart failure. Lancet. 2004 Nov 13-19;364(9447):1733-4. doi: 10.1016/S0140-6736(04)17412-6. No abstract available.
PubMed 15541431Bonita R, Magnusson R, Bovet P, Zhao D, Malta DC, Geneau R, Suh I, Thankappan KR, McKee M, Hospedales J, de Courten M, Capewell S, Beaglehole R; Lancet NCD Action Group. Country actions to meet UN commitments on non-communicable diseases: a stepwise approach. Lancet. 2013 Feb 16;381(9866):575-84. doi: 10.1016/S0140-6736(12)61993-X. Epub 2013 Feb 12.
PubMed 23410607Tan DX, Manchester LC, Reiter RJ, Plummer BF, Hardies LJ, Weintraub ST, Vijayalaxmi, Shepherd AM. A novel melatonin metabolite, cyclic 3-hydroxymelatonin: a biomarker of in vivo hydroxyl radical generation. Biochem Biophys Res Commun. 1998 Dec 30;253(3):614-20. doi: 10.1006/bbrc.1998.9826.
PubMed 9918777Reiter RJ, Tan DX, Galano A. Melatonin: exceeding expectations. Physiology (Bethesda). 2014 Sep;29(5):325-33. doi: 10.1152/physiol.00011.2014.
PubMed 25180262Jha P, Ramasundarahettige C, Landsman V, Rostron B, Thun M, Anderson RN, McAfee T, Peto R. 21st-century hazards of smoking and benefits of cessation in the United States. N Engl J Med. 2013 Jan 24;368(4):341-50. doi: 10.1056/NEJMsa1211128.
PubMed 23343063Tan DX, Hardeland R, Manchester LC, Galano A, Reiter RJ. Cyclic-3-hydroxymelatonin (C3HOM), a potent antioxidant, scavenges free radicals and suppresses oxidative reactions. Curr Med Chem. 2014;21(13):1557-65. doi: 10.2174/0929867321666131129113146.
PubMed 24304286Reiter RJ. Melatonin: Lowering the High Price of Free Radicals. News Physiol Sci. 2000 Oct;15:246-250. doi: 10.1152/physiologyonline.2000.15.5.246.
PubMed 11390919Rostron BL, Chang CM, Pechacek TF. Estimation of cigarette smoking-attributable morbidity in the United States. JAMA Intern Med. 2014 Dec;174(12):1922-8. doi: 10.1001/jamainternmed.2014.5219.
PubMed 25317719
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Protective Effect of Melatonin on Smoke-induced Vascular Injury in Human
- ClinicalTrials.gov ID
- NCT02591238
- Acronym / sponsor ID
- 81470585
- Conditions
- Smoking, Vascular System Injuries
- Keywords
- smoking, melatonin, vascular injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Posted 3 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study was to evaluate the effects of melatonin in the regulation of the vascular injury in smokers through population-based, randomized, double-blind, placebo-controlled trial.
Detailed description
Trial title: The protective effect of melatonin on smoke-induced vascular injury in human
Protocol: Investigators recruited eligible Han Chinese participants (aged 25-39) if they had smoking at least 10 cigarettes per day for at least 1 year. Participants excluded if they had undergone cardiovascular disease, or systolic blood pressure above 140 mm Hg, or diastolic blood pressure above 90 mmHg, or psychiatric disorders, or cancer, or pregnant, or lactating, or taking antipsychotic drugs orally during the 2 weeks of the trial. They were randomly divided participants into non-smoking with oral placebo, non-smoking with oral melatonin, smoking with oral placebo, and smoking with oral melatonin. They are oral melatonin 3 mg/day or placebo for 2 weeks. Blood samples (about 3 milliliter) were taken at baseline and after 2 weeks of treatment. Through a series hospital clinical laboratory and related ELISA kits to detect endothelial cell injury in serum markers platelet endothelial cell adhesion molecule-1 (PECAM-1/CD31)， intercellular adhesion molecule-1 (ICAM - 1), vascular cell adhesion molecule-1 (VCAM 1), endothelin-1 (ET-1), endothelial nitric oxide synthase (eNOS), nuclear erythroid 2-related factor 2 (Nrf - 2), NAD(P)H quinone oxidoreductase-1 (NQO-1), catalytic glutamate cysteine ligase (GCLC), heme oxygenase-1 (HO-1), free fatty acid (FFA), total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL), hypersensitive c-reactive protein (hsCRP), fibrinogen (Fbg), and free fatty acids (FFA), through the above vascular endothelial damage index analysis whether melatonin have protective effect against smoke-induced vascular injury. All participants and study investigators were unaware of treatment allocation throughout the trial. This trial is approved by the Ethical Committee of Peking Union Medical College Hospital (No JS-863). All participants completed a questionnaire and signed an informed consent document. Otherwise, they will get appropriate economic compensation. To achieve treatment concealment, melatonin and placebo in appearance and package were identically. Trial associates monitored compliance with the masking procedure throughout the trial. All participants and study investigators were unaware of treatment allocation throughout the study. The randomization codes remained sealed until after data collection and cleaning, and completion of a masked analysis. The study team monitored and classified protocol deviations. Investigators summarized baseline clinical and demographic characteristics with descriptive statistics and then determined by the Univariate Analysis of Variance. All the data analyses were done using statistical software SPSS 20.0.
Expected results: Compared with smoker oral placebo, melatonin 3 mg/day may be alleviate smoke-induced vascular injury.
Consent document: The potential risk, research as a treatment drug of melatonin may delay the metabolism of antipsychotic antipsychotic drug, so when investigators recruit psychiatric disorders or taking antipsychotic drugs orally during the 2 weeks of the trial should exclusion. As a Health care medicine. Melatonin is not suitable for children, so investigators selected recruiting participants under the age of 25 to 39.
The measure to minimize the risk, fully inform the participants and their families the trial's advantages, disadvantages and desired effect. All participants totally agree with the subjects. In this process, at least three or more effective way to get contact with the medical staff or doctor and ensure that those unexpected accident should deserve effective tackle. Examination for every participant before start of the trial to guarantee they comply with the criterion. Our research involves the application of melatonin is through the china food and drug administration (CFDA) approved to ensure its safety (include its chemical composition, structure, content parameters, main raw material and appropriate crowd). All staff is qualified medical professionals to guarantee the safety of all participants.
The potential risks or discomfort, or inconvenience, or benefits for participants: So far, effective of melatonin in human include regulating sleep, anti-tumor, immune regulation, regulating of inflammation and immune and regulating blood lipid metabolism is confirmed. Adverse reactions is slow the delay of antipsychotic drug metabolism (so nearly one month ago and during period of the trial participants should not taking antipsychotic drugs) during the trial. The basic principle during the trial is ensure safety of participants.
The relevant content consultation: Everyone have the right to consultation the research content through telephone: +86 01069152500 (principal investigator) and +86 01069155817(Ethics committee).
The rights of withdrew from the trial: Participate in the trial is completely voluntary. If for any reason, participants not willing to participate in, or do not wish to continue to participate in this trial, will not affect the rights and interests of participants. In addition, participants have the right to withdraw this trial at any time. If participants do not according to the doctor instructions, or for the sake of your health and benefits, the doctor or the researchers may also require participants to quit the trial.
The compensation of research: If the participants have any unexpected accident relation with the trial, the compensation and responsibility will be provided by Peking union medical college hospital.
Privacy protection: The privacy of every participant will be protected. The results of the trial in academic publications will not leak any information to identify your personal identity. Peking union medical college hospital will save everybody's data and guarantee not leak without authorization.
Investigators declare no competing interests.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| non-smoker + placebo | Placebo comparator | Other: non-smoker oral placebonon-smoker oral placebo |
| non-smoker + melatonin | Active comparator | Drug: non-smoker oral melatoninnon-smoker oral melatonin |
| smoker + placebo | Placebo comparator | Other: smoker oral placebosmoker oral placebo |
| smoker + melatonin | Active comparator | Drug: smoker oral melatoninsmoker oral melatonin |
Who may qualify
- Ages
- 25 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy smokers：must above 10 cigarettes per day, at least 1 year
- Healthy non-smokers
Key exclusion criteria (8 listed)
- Cardiovascular disease
- Systolic blood pressure above 140 mm Hg
- Diastolic blood pressure above 90 mmHg
- Psychiatric disorders
- Cancer
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 |
|---|---|---|
| non-smoker oral placeboAlso: placeboParticipants oral placebo last 2 weeks. | Other | non-smoker + placebo |
| non-smoker oral melatoninAlso: MelatoninParticipants oral melatonin 3 mg/day last 2 weeks. | Drug | non-smoker + melatonin |
| smoker oral placeboAlso: placeboParticipants oral placebo last 2 weeks. | Other | smoker + placebo |
| smoker oral melatoninAlso: melatoninParticipants oral melatonin 3 mg/day last 2 weeks. | Drug | smoker + melatonin |
Primary outcome
Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Fbg.
Time frame: Three months
Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Glu.
Time frame: Three months.
Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of FFA.
Time frame: Three months.
Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of TC.
Time frame: Three months.
Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of TG.
Time frame: Three months.
Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of LDL-C.
Time frame: Three months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25251422Yang GH, Li YC, Wang ZQ, Liu B, Ye W, Ni L, Zeng R, Miao SY, Wang LF, Liu CW. Protective effect of melatonin on cigarette smoke-induced restenosis in rat carotid arteries after balloon injury. J Pineal Res. 2014 Nov;57(4):451-8. doi: 10.1111/jpi.12185. Epub 2014 Oct 6.
- Results publication: PubMed 20050989Rodella LF, Filippini F, Bonomini F, Bresciani R, Reiter RJ, Rezzani R. Beneficial effects of melatonin on nicotine-induced vasculopathy. J Pineal Res. 2010 Mar;48(2):126-32. doi: 10.1111/j.1600-079X.2009.00735.x. Epub 2009 Dec 30.
- Results publication: PubMed 19573038Hardeland R, Tan DX, Reiter RJ. Kynuramines, metabolites of melatonin and other indoles: the resurrection of an almost forgotten class of biogenic amines. J Pineal Res. 2009 Sep;47(2):109-126. doi: 10.1111/j.1600-079X.2009.00701.x. Epub 2009 Jul 1.
- Results publication: PubMed 9302297Hautamaki RD, Kobayashi DK, Senior RM, Shapiro SD. Requirement for macrophage elastase for cigarette smoke-induced emphysema in mice. Science. 1997 Sep 26;277(5334):2002-4. doi: 10.1126/science.277.5334.2002.
- Results publication: PubMed 15364185Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.
- Results publication: PubMed 16920470Teo KK, Ounpuu S, Hawken S, Pandey MR, Valentin V, Hunt D, Diaz R, Rashed W, Freeman R, Jiang L, Zhang X, Yusuf S; INTERHEART Study Investigators. Tobacco use and risk of myocardial infarction in 52 countries in the INTERHEART study: a case-control study. Lancet. 2006 Aug 19;368(9536):647-58. doi: 10.1016/S0140-6736(06)69249-0.
- Results publication: PubMed 23107252Pirie K, Peto R, Reeves GK, Green J, Beral V; Million Women Study Collaborators. The 21st century hazards of smoking and benefits of stopping: a prospective study of one million women in the UK. Lancet. 2013 Jan 12;381(9861):133-41. doi: 10.1016/S0140-6736(12)61720-6. Epub 2012 Oct 27.
- Results publication: PubMed 15541431Opie LH. The metabolic vicious cycle in heart failure. Lancet. 2004 Nov 13-19;364(9447):1733-4. doi: 10.1016/S0140-6736(04)17412-6. No abstract available.
- Results publication: PubMed 23410607Bonita R, Magnusson R, Bovet P, Zhao D, Malta DC, Geneau R, Suh I, Thankappan KR, McKee M, Hospedales J, de Courten M, Capewell S, Beaglehole R; Lancet NCD Action Group. Country actions to meet UN commitments on non-communicable diseases: a stepwise approach. Lancet. 2013 Feb 16;381(9866):575-84. doi: 10.1016/S0140-6736(12)61993-X. Epub 2013 Feb 12.
- Results publication: PubMed 9918777Tan DX, Manchester LC, Reiter RJ, Plummer BF, Hardies LJ, Weintraub ST, Vijayalaxmi, Shepherd AM. A novel melatonin metabolite, cyclic 3-hydroxymelatonin: a biomarker of in vivo hydroxyl radical generation. Biochem Biophys Res Commun. 1998 Dec 30;253(3):614-20. doi: 10.1006/bbrc.1998.9826.
- Results publication: PubMed 25180262Reiter RJ, Tan DX, Galano A. Melatonin: exceeding expectations. Physiology (Bethesda). 2014 Sep;29(5):325-33. doi: 10.1152/physiol.00011.2014.
- Results publication: PubMed 23343063Jha P, Ramasundarahettige C, Landsman V, Rostron B, Thun M, Anderson RN, McAfee T, Peto R. 21st-century hazards of smoking and benefits of cessation in the United States. N Engl J Med. 2013 Jan 24;368(4):341-50. doi: 10.1056/NEJMsa1211128.
- Individual participant dataSharing planned: Undecided. The cycle of the experiment is long, and it is a part of the experiment.
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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.
Changwei Liu, MD principal investigator
Peking Union Medical College Hospital
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 non-smoker oral melatonin and smoker oral melatonin in people with Smoking and Vascular System Injuries, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. 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 3 Mar 2016. 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 China. 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?
Yes. Results are posted in the registry (first posted 3 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Fbg. (time frame: Three months). The study lists 6 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 NCT02591238, which also lists 17 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 3 Mar 2016.