Back to resultsTrial of Adjunctive Vitamin D in Tuberculosis Treatment
Primary Purpose
Tuberculosis, Pulmonary
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Cholecalciferol
Migliol Placebo Oil
Sponsored by
About this trial
This is an interventional treatment trial for Tuberculosis, Pulmonary
Eligibility 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
Sites / Locations
- Whipps Cross University Hospital NHS Trust
- Newham University Hospital NHS Trust
- London Chest Hospital
- Homerton University Hospital NHS Foundation Trust
Outcomes
Primary Outcome Measures
Time to sputum culture conversion
Secondary Outcome Measures
Rate of bacillary kill
2-month culture conversion rate
Time to sputum smear conversion
Weight change
Radiographic response
Full Information
NCT ID
NCT00419068
First Posted
January 5, 2007
Last Updated
September 29, 2009
Sponsor
Barts & The London NHS Trust
Collaborators
British Lung Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00419068
Brief Title
Trial of Adjunctive Vitamin D in Tuberculosis Treatment
Official Title
Trial of Adjunctive Vitamin D in Tuberculosis Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Barts & The London NHS Trust
Collaborators
British Lung Foundation
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether vitamin D enhances response to standard antibiotic treatment for pulmonary tuberculosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, Pulmonary
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
146 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Intervention Type
Drug
Intervention Name(s)
Migliol Placebo Oil
Primary Outcome Measure Information:
Title
Time to sputum culture conversion
Secondary Outcome Measure Information:
Title
Rate of bacillary kill
Title
2-month culture conversion rate
Title
Time to sputum smear conversion
Title
Weight change
Title
Radiographic response
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian R Martineau, MRCP
Organizational Affiliation
Queen Mary University of London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher J Griffiths, FRCP FRCGP D Phil
Organizational Affiliation
Queen Mary University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Whipps Cross University Hospital NHS Trust
City
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Newham University Hospital NHS Trust
City
London
ZIP/Postal Code
E13 8SL
Country
United Kingdom
Facility Name
London Chest Hospital
City
London
ZIP/Postal Code
E2 9JX
Country
United Kingdom
Facility Name
Homerton University Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
E9 6SR
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
21215445
Citation
Martineau AR, Timms PM, Bothamley GH, Hanifa Y, Islam K, Claxton AP, Packe GE, Moore-Gillon JC, Darmalingam M, Davidson RN, Milburn HJ, Baker LV, Barker RD, Woodward NJ, Venton TR, Barnes KE, Mullett CJ, Coussens AK, Rutterford CM, Mein CA, Davies GR, Wilkinson RJ, Nikolayevskyy V, Drobniewski FA, Eldridge SM, Griffiths CJ. High-dose vitamin D(3) during intensive-phase antimicrobial treatment of pulmonary tuberculosis: a double-blind randomised controlled trial. Lancet. 2011 Jan 15;377(9761):242-50. doi: 10.1016/S0140-6736(10)61889-2. Epub 2011 Jan 5.
Results Reference
derived
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Trial of Adjunctive Vitamin D in Tuberculosis Treatment
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