Tuberculosis, Pulmonary
Conditions
Brief summary
The purpose of this study is to determine whether vitamin D enhances response to standard antibiotic treatment for pulmonary tuberculosis.
Interventions
DRUGCholecalciferol
DRUGMigliol Placebo Oil
Sponsors
British Lung Foundation
Barts & The London NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Suspected smear positive pulmonary tuberculosis. * Age 18 years or older. * Written informed consent to participate.
Exclusion criteria
* Known intolerance of vitamin D or first-line anti-tuberculous therapy. * Taking antituberculous therapy for more than six days in the six months preceding enrolment. * Taking the following medication in the month preceding enrolment: oral corticosteroid therapy, immunosuppressant therapy or cytotoxic therapy. * Taking the following medication at enrolment: benzothiadiazine derivatives, cardiac glycosides or antituberculous therapy other than rifampicin, isoniazid, pyrazinamide and ethambutol. * Diagnosis of any of the following: sarcoidosis, hyperparathyroidism, nephrolithiasis, pulmonary silicosis, HIV infection, liver failure, renal failure or malignancy * Infection with rifampicin-resistant organism (as demonstrated by rapid molecular testing) * Biochemical disturbance at enrolment: serum corrected calcium \>2.66 mmol/l, serum AST \>120 IU/l, total serum bilirubin \> 40 micromol/l or serum creatinine \> 250 micromol/l * Breastfeeding or pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to sputum culture conversion | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of bacillary kill | — |
| 2-month culture conversion rate | — |
| Time to sputum smear conversion | — |
| Weight change | — |
| Radiographic response | — |
Countries
United Kingdom
Outcome results
None listed