NCT02591238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
4 months until next milestone

Results Posted

Study results publicly available

March 3, 2016

Completed
Last Updated

March 3, 2016

Status Verified

June 1, 2015

Enrollment Period

1 month

First QC Date

October 26, 2015

Results QC Date

November 23, 2015

Last Update Submit

February 3, 2016

Conditions

SmokingVascular System Injuries

Keywords

smokingmelatoninvascular injury

Outcome Measures

Primary Outcomes (6)

  • Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Fbg.

    Three months

  • Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Glu.

    Three months.

  • Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of FFA.

    Three months.

  • Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of TC.

    Three months.

  • Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of TG.

    Three months.

  • Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of LDL-C.

    Three months.

Study Arms (4)

non-smoker + placebo

PLACEBO COMPARATOR

non-smoker oral placebo

Other: non-smoker oral placebo

non-smoker + melatonin

ACTIVE COMPARATOR

non-smoker oral melatonin

Drug: non-smoker oral melatonin

smoker + placebo

PLACEBO COMPARATOR

smoker oral placebo

Other: smoker oral placebo

smoker + melatonin

ACTIVE COMPARATOR

smoker oral melatonin

Drug: smoker oral melatonin

Interventions

non-smoker oral placeboOTHER

Participants oral placebo last 2 weeks.

Also known as: placebo
non-smoker + placebo
non-smoker oral melatoninDRUG

Participants oral melatonin 3 mg/day last 2 weeks.

Also known as: Melatonin
non-smoker + melatonin
smoker oral placeboOTHER

Participants oral placebo last 2 weeks.

Also known as: placebo
smoker + placebo
smoker oral melatoninDRUG

Participants oral melatonin 3 mg/day last 2 weeks.

Also known as: melatonin
smoker + melatonin

Eligibility Criteria

Age25 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PekingUMCH

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (17)

  • 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.

    PMID: 25251422RESULT

  • Rodella 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.

    PMID: 20050989RESULT

  • Hardeland 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.

    PMID: 19573038RESULT

  • Hautamaki 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.

    PMID: 9302297RESULT

  • Yusuf 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.

    PMID: 15364185RESULT

  • Teo 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.

    PMID: 16920470RESULT

  • Pirie 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.

    PMID: 23107252RESULT

  • Opie 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.

    PMID: 15541431RESULT

  • Bonita 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.

    PMID: 23410607RESULT

  • Tan 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.

    PMID: 9918777RESULT

  • Reiter RJ, Tan DX, Galano A. Melatonin: exceeding expectations. Physiology (Bethesda). 2014 Sep;29(5):325-33. doi: 10.1152/physiol.00011.2014.

    PMID: 25180262RESULT

  • Jha 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.

    PMID: 23343063RESULT

  • Tan 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.

    PMID: 24304286RESULT

  • Reiter 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.

    PMID: 11390919RESULT

  • Rostron 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.

    PMID: 25317719RESULT

  • Bernhard D, Pfister G, Huck CW, Kind M, Salvenmoser W, Bonn GK, Wick G. Disruption of vascular endothelial homeostasis by tobacco smoke: impact on atherosclerosis. FASEB J. 2003 Dec;17(15):2302-4. doi: 10.1096/fj.03-0312fje. Epub 2003 Oct 2.

    PMID: 14525940RESULT

  • Pope CA 3rd, Burnett RT, Krewski D, Jerrett M, Shi Y, Calle EE, Thun MJ. Cardiovascular mortality and exposure to airborne fine particulate matter and cigarette smoke: shape of the exposure-response relationship. Circulation. 2009 Sep 15;120(11):941-8. doi: 10.1161/CIRCULATIONAHA.109.857888. Epub 2009 Aug 31.

    PMID: 19720932RESULT

MeSH Terms

Conditions

SmokingVascular System Injuries

Interventions

Melatonin

Condition Hierarchy (Ancestors)

BehaviorVascular DiseasesCardiovascular DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

Limitations. First, the dose-dependent manner of melatonin should be considered. Second, the duration of smoke exposure and melatonin administration time should be prolonged. Lastly,the levels of melatonin at different time points should be examined.

Results Point of Contact

Title
Prof. Changwei Liu. Director of vascular surgery.
Organization
Peking Union Medical College Hospital.
aresbill@outlook.com
+86 1069152509

Study Officials

  • Changwei Liu, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2015

First Posted

October 29, 2015

Study Start

June 1, 2015

Primary Completion

July 1, 2015

Study Completion

October 1, 2015

Last Updated

March 3, 2016

Results First Posted

March 3, 2016

Record last verified: 2015-06

Locations

CN(1)