Trial of Adjunctive Vitamin D in Tuberculosis Treatment

Phase 3

Completed

• Conditions: Tuberculosis, Pulmonary

• Registration Number: NCT00419068
• Lead Sponsor: Barts & The London NHS Trust

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-05
• Study First Submitted QC: 2007-01-05
• Study First Posted: 2007-01-08
• Status Verified: 2009-09
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Last Update Submitted: 2009-09-29
• Last Update Posted: 2009-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• Suspected smear positive pulmonary tuberculosis.
• Age 18 years or older.
• Written informed consent to participate.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to sputum culture conversion

Secondary Outcome Measures

Name	Time	Method
Rate of bacillary kill
2-month culture conversion rate
Time to sputum smear conversion
Weight change
Radiographic response

Trial Locations

Locations (4)

Whipps Cross University Hospital NHS Trust; 🇬🇧 London, United Kingdom

Newham University Hospital NHS Trust; 🇬🇧 London, United Kingdom

London Chest Hospital; 🇬🇧 London, United Kingdom

Homerton University Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom