Effects of Vitamin D Supplementation on Antimycobacterial Immunity

January 5, 2007 updated by: Barts & The London NHS Trust

Effects of Vitamin D Supplementation on Antimycobacterial Immunity: A Randomised Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, E7 8QP
        • Tuberculosis Clinic, Newham Chest Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult
  • Tuberculosis (TB) contact or TB patient

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding
  • Hyperparathyroidism
  • Sarcoidosis
  • Renal failure
  • HIV infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bacillus Calmette-Guerin (BCG) lux whole blood assay

Secondary Outcome Measures

Outcome Measure
Antigen-stimulated whole blood interferon gamma production

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barts & The London NHS Trust

Collaborators

Imperial College London
Wellcome Trust
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

Investigators

  • Principal Investigator: Adrian R Martineau, B Med Sci, MBBS, DTM&H, MRCP, Centre for Health Sciences, Barts and The London, QMUL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Study Completion

September 1, 2006

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

January 8, 2007

Last Update Submitted That Met QC Criteria

January 5, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AM1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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