Trial of Adjunctive Vitamin D in Tuberculosis Treatment
NCT ID: NCT00419068
Last Updated: 2009-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
146 participants
INTERVENTIONAL
2007-01-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Cholecalciferol
Migliol Placebo Oil
Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older.
* Written informed consent to participate.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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British Lung Foundation
OTHER
Barts & The London NHS Trust
OTHER
Principal Investigators
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Adrian R Martineau, MRCP
Role: PRINCIPAL_INVESTIGATOR
Queen Mary University of London
Christopher J Griffiths, FRCP FRCGP D Phil
Role: PRINCIPAL_INVESTIGATOR
Queen Mary University of London
Locations
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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
Countries
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References
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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.
Other Identifiers
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EudraCT no: 2005-003562-42
Identifier Type: -
Identifier Source: secondary_id
REC ref: 06/Q0605/83
Identifier Type: -
Identifier Source: secondary_id
2005-003562-42
Identifier Type: -
Identifier Source: org_study_id