The effect of Vitamin-K1 and Colchicine on Vascular Calcification Activity in subjects with Diabetes Mellitus (ViKCoVaC): A double-blind 2x2 factorial randomized controlled trial
| العنوان: | The effect of Vitamin-K1 and Colchicine on Vascular Calcification Activity in subjects with Diabetes Mellitus (ViKCoVaC): A double-blind 2x2 factorial randomized controlled trial |
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| المؤلفون: | Seng Khee Gan, Roslyn J. Francis, Gerald F. Watts, Joshua R. Lewis, William Macdonald, Alistair Vickery, Michael Phillips, Gerard T. Chew, Carl Schultz, Sing Ching Lee, Jamie W Bellinge |
| المصدر: | Journal of Nuclear Cardiology. 29:1855-1866 |
| بيانات النشر: | Springer Science and Business Media LLC, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | medicine.medical_specialty, business.industry, Type 2 diabetes, 030204 cardiovascular system & hematology, medicine.disease, Placebo, Gastroenterology, 030218 nuclear medicine & medical imaging, law.invention, 03 medical and health sciences, chemistry.chemical_compound, Arterial calcification, 0302 clinical medicine, chemistry, Randomized controlled trial, law, Diabetes mellitus, Internal medicine, Medicine, Colchicine, Radiology, Nuclear Medicine and imaging, Cardiology and Cardiovascular Medicine, business, Adverse effect, Calcification |
| الوصف: | There is currently no treatment for attenuating progression of arterial calcification. 18F-sodium fluoride positron emission tomography (18F-NaF PET) locates regions of calcification activity. We tested whether vitamin-K1 or colchicine affected arterial calcification activity. 154 patients with diabetes mellitus and coronary calcification, as detected using computed tomography (CT), were randomized to one of four treatment groups (placebo/placebo, vitamin-K1 [10 mg/day]/placebo, colchicine [0.5 mg/day]/placebo, vitamin-K1 [10 mg/day]/ colchicine [0.5 mg/day]) in a double-blind, placebo-controlled 2x2 factorial trial of three months duration. Change in coronary calcification activity was estimated as a change in coronary maximum tissue-to-background ratio (TBRmax) on 18F-NaF PET. 149 subjects completed follow-up (vitamin-K1: placebo = 73:76 and colchicine: placebo = 73:76). Neither vitamin-K1 nor colchicine had a statistically significant effect on the coronary TBRmax compared with placebo (mean difference for treatment groups 0·00 ± 0·16 and 0·01 ± 0·17, respectively, p > 0.05). There were no serious adverse effects reported with colchicine or vitamin-K1. In patients with type 2 diabetes, neither vitamin-K1 nor colchicine significantly decreases coronary calcification activity, as estimated by 18F-NaF PET, over a period of 3 months. Clinical trial registration: ACTRN12616000024448. |
| تدمد: | 1532-6551 1071-3581 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_________::42453e20b80449847ccbd8cfc20f7db0Test https://doi.org/10.1007/s12350-021-02589-8Test |
| حقوق: | CLOSED |
| رقم الانضمام: | edsair.doi...........42453e20b80449847ccbd8cfc20f7db0 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15326551 10713581 |
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