Trial of Adjunctive Vitamin D in Tuberculosis Treatment

Tuberculosis, Pulmonary Clinical Trial

Official title:

Trial of Adjunctive Vitamin D in Tuberculosis Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419068
• Other study ID #: 2005-003562-42
• Secondary ID: EudraCT no: 2005
• Status: Completed
• Phase: Phase 3
• First received: January 5, 2007
• Last updated: September 29, 2009
• Start date: January 2007
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: Barts & The London NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Drug:
• Cholecalciferol

• Migliol Placebo Oil

Locations

Country	Name	City	State
United Kingdom	Homerton University Hospital NHS Foundation Trust	London
United Kingdom	London Chest Hospital	London
United Kingdom	Newham University Hospital NHS Trust	London
United Kingdom	Whipps Cross University Hospital NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Barts & The London NHS Trust	British Lung Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to sputum culture conversion
Secondary	Rate of bacillary kill
Secondary	2-month culture conversion rate
Secondary	Time to sputum smear conversion
Secondary	Weight change
Secondary	Radiographic response