Effects of Vitamin D Supplementation on Antimycobacterial Immunity

• Sponsor: Barts & The London NHS Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT00157066
• Collaborator: Imperial College London (Other), University of Cape Town (Other), Newham Chest Clinic, London E7 8QP, UK (Other), Northwick Park Hospital, Harrow, UK (Other), Department of Clinical Biochemistry, Homerton Hospital, London E9 6SR, UK (Other), Environmental Health Department, London Borough of Newham, London E15 4SF, UK (Other), Wellcome Trust (Other)
• Enrollment: 230
• Location: 1
• Duration (Months): 45
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Official Title: Effects of Vitamin D Supplementation on Antimycobacterial Immunity: A Randomised Trial
• Study Start Date: Dec 1, 2002
• Study Completion Date: Sep 1, 2006

Outcome Measures

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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• Adult

• Tuberculosis (TB) contact or TB patient

Exclusion Criteria:

• Pregnancy

• Breastfeeding

• Hyperparathyroidism

• Sarcoidosis

• Renal failure

• HIV infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00157066
• Other Study ID Numbers: AM1
• First Posted: Sep 12, 2005
• Last Update Posted: Jan 8, 2007
• Last Verified: Jan 1, 2007

• Keywords provided by , ,: Latent tuberculosis infection; Active tuberculosis infection
• Additional relevant MeSH terms: Tuberculosis; Ergocalciferols; Vitamin D

Study Results

No Results Posted as of Jan 8, 2007