Clinical trial NCT00419068: Trial of Adjunctive Vitamin D in Tuberculosis Treatment
Official title: Trial of Adjunctive Vitamin D in Tuberculosis Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tuberculosis, Pulmonary
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: British Lung Foundation
First posted: 2007-01-08
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Time to sputum culture conversion
Secondary outcomes:
measure: Rate of bacillary kill
measure: 2-month culture conversion rate
measure: Time to sputum smear conversion
measure: Weight change
measure: Radiographic response
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Whipps Cross University Hospital NHS Trust
city: London
country: United Kingdom
facility: Newham University Hospital NHS Trust
city: London
country: United Kingdom
facility: London Chest Hospital
city: London
country: United Kingdom
facility: Homerton University Hospital NHS Foundation Trust
Study officials:
affiliation: Queen Mary University of London
name: Adrian R Martineau, MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen Mary University of London
name: Christopher J Griffiths, FRCP FRCGP D Phil
role: PRINCIPAL_INVESTIGATOR
References:
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.