Trial of Adjunctive Vitamin D in Tuberculosis Treatment

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether vitamin D enhances response to standard antibiotic treatment for pulmonary tuberculosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barts & The London NHS Trust
• Collaborator: British Lung Foundation
• Treatments: Cholecalciferol; Vitamin D

Criteria

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