drugset / Trial / NCT02591238
Melatonin in Smoke-induced Vascular Injury
RandomizedParallel-groupDouble-blindPrevention
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.
Timeline
- Start
- 2015-06
- Primary completion
- 2015-07
- Completion
- 2015-10
Publications
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results Reiter RJ, Tan DX, Galano A. Melatonin: exceeding expectations. Physiology (Bethesda). 2014 Sep;29(5):325-33. doi: 10.1152/physiol.00011.2014.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Melatonin | Small molecule | 3 mg | Oral |
Indications
No indication recorded.