Trial of Adjunctive Vitamin D in Tuberculosis Treatment

Barts & The London NHS Trust

Status and phase: Completed; Phase 3

Conditions: Tuberculosis, Pulmonary

Treatments: Drug: Cholecalciferol; Drug: Migliol Placebo Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT00419068

REC ref: 06/Q0605/83

2005-003562-42

EudraCT no: 2005-003562-42

Details and patient eligibility

About

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

Enrollment: 146 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind