Trial of Adjunctive Vitamin D in Tuberculosis Treatment

This study has been completed.
Sponsor:
Collaborator:
British Lung Foundation
Information provided by:
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT00419068
First received: January 5, 2007
Last updated: September 29, 2009
Last verified: September 2009
  Purpose

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


Condition Intervention Phase
Tuberculosis, Pulmonary
Drug: Cholecalciferol
Drug: Migliol Placebo Oil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Trial of Adjunctive Vitamin D in Tuberculosis Treatment

Resource links provided by NLM:


Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:
  • Time to sputum culture conversion

Secondary Outcome Measures:
  • Rate of bacillary kill
  • 2-month culture conversion rate
  • Time to sputum smear conversion
  • Weight change
  • Radiographic response

Estimated Enrollment: 146
Study Start Date: January 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419068

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

No publications provided by Barts & The London NHS Trust

Additional 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
Study First Received: January 5, 2007
Last Updated: September 29, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on April 17, 2014