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Trial of Adjunctive Vitamin D in Tuberculosis Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00419068
Recruitment Status : Completed
First Posted : January 8, 2007
Last Update Posted : September 30, 2009
Sponsor:
Collaborator:
British Lung Foundation
Information provided by:
Barts & The London NHS Trust

Tracking Information
First Submitted Date  ICMJE January 5, 2007
First Posted Date  ICMJE January 8, 2007
Last Update Posted Date September 30, 2009
Study Start Date  ICMJE January 2007
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2007)
Time to sputum culture conversion
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2007)
  • Rate of bacillary kill
  • 2-month culture conversion rate
  • Time to sputum smear conversion
  • Weight change
  • Radiographic response
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Adjunctive Vitamin D in Tuberculosis Treatment
Official Title  ICMJE Trial of Adjunctive Vitamin D in Tuberculosis Treatment
Brief Summary The purpose of this study is to determine whether vitamin D enhances response to standard antibiotic treatment for pulmonary tuberculosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Tuberculosis, Pulmonary
Intervention  ICMJE
  • Drug: Cholecalciferol
  • Drug: Migliol Placebo Oil
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 5, 2007)
146
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00419068
Other Study ID Numbers  ICMJE 2005-003562-42
EudraCT no: 2005-003562-42
REC ref: 06/Q0605/83
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Barts & The London NHS Trust
Collaborators  ICMJE British Lung Foundation
Investigators  ICMJE
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
PRS Account Barts & The London NHS Trust
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP