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Effects of Vitamin D Supplementation on Antimycobacterial Immunity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00157066
First Posted: September 12, 2005
Last Update Posted: January 8, 2007
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.
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
  Purpose
The purpose of this study is to determine how vitamin D supplementation (ergocalciferol) affects the immune response to mycobacterial infection.

Condition Intervention
Tuberculosis Drug: Ergocalciferol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Effects of Vitamin D Supplementation on Antimycobacterial Immunity: A Randomised Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Bacillus Calmette-Guerin (BCG) lux whole blood assay

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

Estimated Enrollment: 230
Study Start Date: December 2002
Estimated Study Completion Date: September 2006
  Eligibility

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
Criteria

Inclusion Criteria:

  • Adult
  • Tuberculosis (TB) contact or TB patient

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding
  • Hyperparathyroidism
  • Sarcoidosis
  • Renal failure
  • HIV infection
  Contacts and Locations
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
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
Principal Investigator: Adrian R Martineau, B Med Sci, MBBS, DTM&H, MRCP Centre for Health Sciences, Barts and The London, QMUL
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00157066     History of Changes
Other Study ID Numbers: AM1
First Submitted: September 8, 2005
First Posted: September 12, 2005
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:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vitamin D
Ergocalciferols
Anti-Bacterial Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Anti-Infective Agents