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Melatonin in Smoke-induced Vascular Injury

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ClinicalTrials.gov Identifier: NCT02591238
Recruitment Status : Completed
First Posted : October 29, 2015
Results First Posted : March 3, 2016
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Smoking Vascular System Injuries Other: non-smoker oral placebo Drug: non-smoker oral melatonin Other: smoker oral placebo Drug: smoker oral melatonin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Protective Effect of Melatonin on Smoke-induced Vascular Injury in Human
Study Start Date : June 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Placebo Comparator: non-smoker + placebo
non-smoker oral placebo
Other: non-smoker oral placebo
Participants oral placebo last 2 weeks.
Other Name: placebo

Active Comparator: non-smoker + melatonin
non-smoker oral melatonin
Drug: non-smoker oral melatonin
Participants oral melatonin 3 mg/day last 2 weeks.
Other Name: Melatonin

Placebo Comparator: smoker + placebo
smoker oral placebo
Other: smoker oral placebo
Participants oral placebo last 2 weeks.
Other Name: placebo

Active Comparator: smoker + melatonin
smoker oral melatonin
Drug: smoker oral melatonin
Participants oral melatonin 3 mg/day last 2 weeks.
Other Name: melatonin




Primary Outcome Measures :
  1. Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Fbg. [ Time Frame: Three months ]
  2. Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Glu. [ Time Frame: Three months. ]
  3. Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of FFA. [ Time Frame: Three months. ]
  4. Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of TC. [ Time Frame: Three months. ]
  5. Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of TG. [ Time Frame: Three months. ]
  6. Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of LDL-C. [ Time Frame: Three months. ]


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Ages Eligible for Study:   25 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy smokers:must above 10 cigarettes per day, at least 1 year
  • Healthy non-smokers

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02591238


Locations
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China, Beijing
PekingUMCH
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Changwei Liu, MD Peking Union Medical College Hospital

Publications of Results:

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02591238     History of Changes
Other Study ID Numbers: 81470585
First Posted: October 29, 2015    Key Record Dates
Results First Posted: March 3, 2016
Last Update Posted: March 3, 2016
Last Verified: June 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The cycle of the experiment is long, and it is a part of the experiment.

Keywords provided by Peking Union Medical College Hospital:
smoking
melatonin
vascular injury

Additional relevant MeSH terms:
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Wounds and Injuries
Vascular System Injuries
Vascular Diseases
Cardiovascular Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants