Effects of Vitamin D Supplementation on Antimycobacterial Immunity

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00157066
First received: September 8, 2005
Last updated: January 5, 2007
Last verified: January 2007
  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-Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Adult
  • Tuberculosis (TB) contact or TB patient

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding
  • Hyperparathyroidism
  • Sarcoidosis
  • Renal failure
  • HIV infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: NCT00157066     History of Changes
Other Study ID Numbers: AM1
Study First Received: September 8, 2005
Last Updated: January 5, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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
Anti-Bacterial Agents
Ergocalciferols
Vitamin D
Vitamins
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 21, 2014