Effects of Vitamin D Supplementation on Antimycobacterial Immunity

This study has been completed.

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
Information provided by:	Barts & The London NHS Trust
ClinicalTrials.gov Identifier:	NCT00157066

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

MedlinePlus related topics: Antibiotics Tuberculosis

Drug Information available for: Vitamin D Ergocalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	Effects of Vitamin D Supplementation on Antimycobacterial Immunity: A Randomised Trial

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

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

Publications indexed to this study:

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. Epub 2007 Apr 26.

Study ID Numbers:	AM1
Study First Received:	September 8, 2005
Last Updated:	January 5, 2007
ClinicalTrials.gov Identifier:	NCT00157066
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Barts & The London NHS Trust:

Latent tuberculosis infection
Active tuberculosis infection

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Vitamin D

Ergocalciferols
Mycobacterium Infections
Tuberculosis

Additional relevant MeSH terms:

Growth Substances
Vitamins
Physiological Effects of Drugs
Bone Density Conservation Agents

Micronutrients
Pharmacologic Actions
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 15, 2009