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Trial of Adjunctive Vitamin D in Tuberculosis Treatment

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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

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

Condition or disease Intervention/treatment Phase
Tuberculosis, Pulmonary Drug: Cholecalciferol Drug: Migliol Placebo Oil Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Trial of Adjunctive Vitamin D in Tuberculosis Treatment
Study Start Date : January 2007
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Time to sputum culture conversion

Secondary Outcome Measures :
  1. Rate of bacillary kill
  2. 2-month culture conversion rate
  3. Time to sputum smear conversion
  4. Weight change
  5. Radiographic response


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00419068


Locations
United Kingdom
Whipps Cross University Hospital NHS Trust
London, United Kingdom, E11 1NR
Newham University Hospital NHS Trust
London, United Kingdom, E13 8SL
London Chest Hospital
London, United Kingdom, E2 9JX
Homerton University Hospital NHS Foundation Trust
London, United Kingdom, E9 6SR
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

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
First Posted: January 8, 2007    Key Record Dates
Last Update Posted: September 30, 2009
Last Verified: September 2009

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
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents