Trial of Adjunctive Vitamin D in Tuberculosis Treatment
This study has been completed.
Sponsor:
Barts & The London NHS Trust
Collaborator:
British Lung Foundation
Information provided by:
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT00419068
First received: January 5, 2007
Last updated: September 29, 2009
Last verified: September 2009
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Purpose
The purpose of this study is to determine whether vitamin D enhances response to standard antibiotic treatment for pulmonary tuberculosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Tuberculosis, Pulmonary |
Drug: Cholecalciferol Drug: Migliol Placebo Oil |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Trial of Adjunctive Vitamin D in Tuberculosis Treatment |
Resource links provided by NLM:
Further study details as provided by Barts & The London NHS Trust:
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
| Estimated Enrollment: | 146 |
| Study Start Date: | January 2007 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419068
Locations
| United Kingdom | |
| Homerton University Hospital NHS Foundation Trust | |
| London, United Kingdom, E9 6SR | |
| London Chest Hospital | |
| London, United Kingdom, E2 9JX | |
| Newham University Hospital NHS Trust | |
| London, United Kingdom, E13 8SL | |
| Whipps Cross University Hospital NHS Trust | |
| London, United Kingdom, E11 1NR | |
Sponsors and Collaborators
Barts & The London NHS Trust
British Lung Foundation
Investigators
| Principal Investigator: | Adrian R Martineau, MRCP | Queen Mary University of London |
| Principal Investigator: | Christopher J Griffiths, FRCP FRCGP D Phil | Queen Mary University of London |
More Information
No publications provided by Barts & The London NHS Trust
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00419068 History of Changes |
| Other Study ID Numbers: | 2005−003562−42, EudraCT no: 2005−003562−42, REC ref: 06/Q0605/83 |
| Study First Received: | January 5, 2007 |
| Last Updated: | September 29, 2009 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Tuberculosis Tuberculosis, Pulmonary Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Cholecalciferol Vitamin D Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 16, 2013