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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

Study Description
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Brief Summary:
The purpose of this study is to determine how vitamin D supplementation (ergocalciferol) affects the immune response to mycobacterial infection.

Condition or disease Intervention/treatment Phase
Tuberculosis Drug: Ergocalciferol Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Effects of Vitamin D Supplementation on Antimycobacterial Immunity: A Randomised Trial
Study Start Date : December 2002
Study Completion Date : September 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Bacillus Calmette-Guerin (BCG) lux whole blood assay

Secondary Outcome Measures :
  1. Antigen-stimulated whole blood interferon gamma production

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Adult
  • Tuberculosis (TB) contact or TB patient

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding
  • Hyperparathyroidism
  • Sarcoidosis
  • Renal failure
  • HIV infection
Contacts and Locations
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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): NCT00157066


Locations
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United Kingdom
Tuberculosis Clinic, Newham Chest Clinic
London, United Kingdom, E7 8QP
Sponsors and Collaborators
Barts & The London NHS Trust
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
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Principal Investigator: Adrian R Martineau, B Med Sci, MBBS, DTM&H, MRCP Centre for Health Sciences, Barts and The London, QMUL
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00157066    
Other Study ID Numbers: AM1
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 8, 2007
Last Verified: January 2007
Keywords provided by Barts & The London NHS Trust:
Latent tuberculosis infection
Active tuberculosis infection
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
 Ergocalciferols
Vitamin D
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Bone Density Conservation Agents