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Effects of Vitamin D Supplementation on Antimycobacterial Immunity

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: NCT00157066
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 8, 2007
Sponsor:
Collaborators:
Imperial College London
University of Cape Town
Newham Chest Clinic, London E7 8QP, UK
Northwick Park Hospital, Harrow, UK
Department of Clinical Biochemistry, Homerton Hospital, London E9 6SR, UK
Environmental Health Department, London Borough of Newham, London E15 4SF, UK
Wellcome Trust
Information provided by:
Barts & The London NHS Trust

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 12, 2005
Last Update Posted Date January 8, 2007
Study Start Date  ICMJE December 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2006)		 Bacillus Calmette-Guerin (BCG) lux whole blood assay
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2005)		 BCG lux whole blood assay
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2005)		 Antigen-stimulated whole blood interferon gamma production
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 Effects of Vitamin D Supplementation on Antimycobacterial Immunity
Official Title  ICMJE Effects of Vitamin D Supplementation on Antimycobacterial Immunity: A Randomised Trial
Brief Summary The purpose of this study is to determine how vitamin D supplementation (ergocalciferol) affects the immune response to mycobacterial infection.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Condition  ICMJE Tuberculosis
Intervention  ICMJE Drug: Ergocalciferol
Study Arms  ICMJE Not Provided
Publications * Martineau AR, Wilkinson RJ, Wilkinson KA, Newton SM, Kampmann B, Hall BM, Packe GE, Davidson RN, Eldridge SM, Maunsell ZJ, Rainbow SJ, Berry JL, Griffiths CJ. A single dose of vitamin D enhances immunity to mycobacteria. Am J Respir Crit Care Med. 2007 Jul 15;176(2):208-13. doi: 10.1164/rccm.200701-007OC. Epub 2007 Apr 26.

*   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
Enrollment  ICMJE
 (submitted: September 8, 2005)		 230
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE September 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult
  • Tuberculosis (TB) contact or TB patient

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding
  • Hyperparathyroidism
  • Sarcoidosis
  • Renal failure
  • HIV infection
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
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 NCT00157066
Other Study ID Numbers  ICMJE AM1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Barts & The London NHS Trust
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Imperial College London
  • University of Cape Town
  • Newham Chest Clinic, London E7 8QP, UK
  • Northwick Park Hospital, Harrow, UK
  • Department of Clinical Biochemistry, Homerton Hospital, London E9 6SR, UK
  • Environmental Health Department, London Borough of Newham, London E15 4SF, UK
  • Wellcome Trust
Investigators  ICMJE
Principal Investigator: Adrian R Martineau, B Med Sci, MBBS, DTM&H, MRCP Centre for Health Sciences, Barts and The London, QMUL
PRS Account Barts & The London NHS Trust
Verification Date January 2007

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