Effects of Vitamin D Supplementation on Antimycobacterial... | NCT00157066

Studies
Effects of Vitamin D Supplementation on Antimycobacterial Immunity

NCT00157066

Sponsor

Barts & The London NHS Trust

Status

Completed

Last Update Posted

Jan 8, 2007Estimated

Enrollment

230

Phase

Not Applicable

Conditions

Tuberculosis

Interventions

Ergocalciferol

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2002

Primary Completion Date

Not provided

Completion Date

Sep 2006

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2007

Last Update Posted Date

Jan 8, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Barts & The London NHS TrustOTHER

Collaborators

Name	Class
Imperial College London	OTHER
University of Cape Town	OTHER
Newham Chest Clinic, London E7 8QP, UK	UNKNOWN
Northwick Park Hospital, Harrow, UK

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

230

Name	Type	Description	Arm Group Labels	Other Names
Ergocalciferol	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bacillus Calmette-Guerin (BCG) lux whole blood assay

Secondary Outcomes

Measure	Description	Time Frame
Antigen-stimulated whole blood interferon gamma production

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult
Tuberculosis (TB) contact or TB patient

Exclusion Criteria:

Pregnancy
Breastfeeding
Hyperparathyroidism
Sarcoidosis
Renal failure
HIV infection

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tuberculosis Clinic, Newham Chest Clinic		London		E7 8QP	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17463418	Derived	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. doi: 10.1164/rccm.200701-007OC. Epub 2007 Apr 26.

ID	Term
D014376	Tuberculosis
D055985	Latent Tuberculosis

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds