NCT Number: NCT00419068
Trial of Adjunctive Vitamin D in Tuberculosis Treatment
The purpose of this study is to determine whether vitamin D enhances response to standard antibiotic treatment for pulmonary tuberculosis.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Homerton University Hospital NHS Foundation Trust, London, United Kingdom
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Migliol Placebo Oil
DrugPrimary outcomes
-
Time to sputum culture conversion
Secondary outcomes
-
Rate of bacillary kill
-
2-month culture conversion rate
-
Time to sputum smear conversion
-
Weight change
-
Radiographic response
Sponsors and collaborators
Lead sponsor
Barts & The London NHS Trust
Other
Collaborators
- British Lung Foundation
Registry information
Important dates
- Study start
- 2007
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- Jan 8, 2007
- Registry last updated
- Sep 30, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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