Trial of Adjunctive Vitamin D in Tuberculosis Treatment (AdjuVIT) - Trial of Adjunctive Vitamin D in Tuberculosis Treatment (AdjuVIT)

Queen Mary, University of London0 个研究点目标入组 0 人开始时间: 2008年1月11日最近更新: 2020年7月27日

适应症

试验速览

暂无简介。

•Age 18 years or older
•Suspected pulmonary tuberculosis (with or without extrapulmonary tuberculosis) with acid-fast bacilli in a stained sputum smear
•If a woman of child-bearing potential, has negative pregnancy test and agrees to use reliable form of contraception for at least 8 months
•Willing and able to travel to Homerton Hospital TB Clinic for sputum induction if necessary, and contactable by telephone
•Gives written informed consent to participate
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Known intolerance of vitamin D or first-line anti-tuberculous therapy
•Known sarcoidosis, hyperparathyroidism or nephrolithiasis
•Taking benzothiadiazine derivatives or cardiac glycosides
•Specific comorbidity (known malignancy, known liver failure, known renal failure, known pulmonary silicosis, known HIV infection)
•Taking oral corticosteroid therapy, immuno-suppressant therapy or cytotoxic drug in the month preceding enrollment
•Taking antituberculous therapy for more than 7 days in the 6 months preceding enrolment
•Taking antituberculous therapy other than rifampicin, isoniazid, pyrazinamide and ethambutol at time of enrollment
•Infection with rifampicin-resistant organism (as demonstrated by rapid molecular testing)
•Serum corrected calcium >2.66 mmol/l
•Serum AST >3 x ULN
•Total serum bilirubin > 2.5 x ULN
•Serum creatinine > 2 x ULN
•Breastfeeding
•Planned travel out of London area within 8 weeks of enrollment

发起方