Status:
COMPLETED
Trial of Adjunctive Vitamin D in Tuberculosis Treatment
Lead Sponsor:
Barts & The London NHS Trust
Collaborating Sponsors:
British Lung Foundation
Conditions:
Tuberculosis, Pulmonary
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether vitamin D enhances response to standard antibiotic treatment for pulmonary tuberculosis.
Eligibility Criteria
Inclusion
- Suspected smear positive pulmonary tuberculosis.
- Age 18 years or older.
- Written informed consent to participate.
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT00419068
Start Date
January 1 2007
End Date
September 1 2009
Last Update
September 30 2009
Active Locations (4)
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1
Whipps Cross University Hospital NHS Trust
London, United Kingdom, E11 1NR
2
Newham University Hospital NHS Trust
London, United Kingdom, E13 8SL
3
London Chest Hospital
London, United Kingdom, E2 9JX
4
Homerton University Hospital NHS Foundation Trust
London, United Kingdom, E9 6SR