title: Homocysteine and venous thrombosis: outline of a vitamin intervention trial.
abstract: In the past years several case-control studies established the association of an elevated plasma homocysteine concentration and the risk of venous thromboembolism. It is still unclear if elevated homocysteine concentrations can cause venous thrombosis. The VITRO (VItamins and ThROmbosis) trial is the first multicenter, randomized, double-blind and placebo-controlled study to evaluate the effect of homocysteine-lowering therapy by means of 5 mg folic acid, 0.4 mg vitamin B12 and 50 mg vitamin B6. The study is a secondary prevention trial in 600 patients who suffered from a first episode of idiopathic deep vein thrombosis (DVT) or pulmonary embolism (PE), or both. There will be 300 hyperhomocysteinemic and 300 normohomocysteinemic patients included, all with an objectivated venous thrombosis. The end point is recurrence of venous thrombosis.
authors.affiliation: Department of Haematology, Leyenburg Hospital, The Hague, The Netherlands.
authors.forename: H P
authors.initials: HP
authors.lastname: Willems
authors.forename: M
authors.initials: M
authors.lastname: den Heijer
authors.forename: G M
authors.initials: GM
authors.lastname: Bos
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015897:Comorbidity; D004311:Double-Blind Method; D005260:Female; D005492:Folic Acid / Q000008:administration & dosage / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006710:Homocysteine / Q000097:blood*; D006801:Humans; D020138:Hyperhomocysteinemia / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology* / Q000517:prevention & control; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000097:blood / Q000188:drug therapy / Q000453:epidemiology / Q000517:prevention & control; D011736:Pyridoxine / Q000008:administration & dosage / Q000627:therapeutic use*; D012189:Retrospective Studies; D055502:Secondary Prevention; D019851:Thrombophilia / Q000097:blood / Q000188:drug therapy / Q000453:epidemiology* / Q000209:etiology / Q000517:prevention & control; D013924:Thrombophlebitis / Q000097:blood / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000209:etiology / Q000517:prevention & control; D016896:Treatment Outcome; D014463:Ultrasonography; D020246:Venous Thrombosis / Q000209:etiology / Q000517:prevention & control*; D014805:Vitamin B 12 / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D006710:Homocysteine; D005492:Folic Acid; D011736:Pyridoxine; D014805:Vitamin B 12