Plain English Summary
Not provided at time of registration
Trial website
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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19179490
Publication citations
-
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.