Melatonin in Smoke-induced Vascular Injury
Condition: Smoking; Vascular System Injuries
MeSH terms: Vascular System Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): non-smoker oral placebo; non-smoker oral melatonin; smoker oral placebo; smoker oral melatonin
Intervention type(s): Other; Drug; Other; Drug
Intervention description(s): Participants oral placebo last 2 weeks.; Participants oral melatonin 3 mg/day last 2 weeks.; Participants oral placebo last 2 weeks.; Participants oral melatonin 3 mg/day last 2 weeks.
Other intervention name(s): placebo; Melatonin; placebo; melatonin
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: smoking; melatonin; vascular injury