Condition category
Infections and Infestations
Date applied
13/04/2004
Date assigned
21/05/2004
Last edited
11/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.indepth-network.org/dss_site_profiles/bandim.pdf

Contact information

Type

Scientific

Primary contact

Dr Christian Wejse

ORCID ID

Contact details

Bandim Health Project
Apartado 861
Bissau Codex
1004
Guinea-Bissau
+245 255543
wejse@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

TBD

Study hypothesis

Vitamin D plays an important role in the immune system, and may help the host in combatting active infection with Mycobacterium Tuberculosis.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Tuberculosis

Intervention

100,000 IU cholecalciferol or placebo in drinkable ampoule at diagnosis, 5 months and 8 months clinical follow up (i.e. total 300,000 IU).

Intervention type

Supplement

Phase

Not Applicable

Drug names

Vitamin D

Primary outcome measures

Clinical status (time to cure by sputum clearance, weight gain, clinical score) after treatment

Secondary outcome measures

Mortality

Overall trial start date

01/11/2003

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients diagnosed with tuberculosis (smear positive and smear negative) living in the field site study area

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

None. Withdrawal if signs of hypercalcaemia or allergy to vitamin D.

Recruitment start date

01/11/2003

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Guinea-Bissau

Trial participating centre

Bandim Health Project
Bissau Codex
1004
Guinea-Bissau

Sponsor information

Organisation

Bandim Health Project (Guinea-Bissau)

Sponsor details

Apartado 861
Bissau Codex
1004
Guinea-Bissau
+245 201489
psb@mail.gtelecom.gw

Sponsor type

Not defined

Website

Funders

Funder type

Industry

Funder name

Danish Research Council for Development Research (Denmark) (ref: 91163) - project expenses

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Aarhus (Denmark) - salary of lead principal investigator

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Crinex Pharmaceuticals (France) - free cholecalciferol and placebo

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19179490

Publication citations

  1. Results

    Wejse C, Gomes VF, Rabna P, Gustafson P, Aaby P, Lisse IM, Andersen PL, Glerup H, Sodemann M, Vitamin D as supplementary treatment for tuberculosis: a double-blind, randomized, placebo-controlled trial., Am. J. Respir. Crit. Care Med., 2009, 179, 9, 843-850, doi: 10.1164/rccm.200804-567OC.

Additional files

Editorial Notes