A randomised placebo controlled double blind clinical trial of vitamin D in the treatment of tuberculosis

ISRCTN	ISRCTN35212132
DOI	https://doi.org/10.1186/ISRCTN35212132
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Christian Wejse
Scientific

Bandim Health Project
Apartado 861
Bissau Codex
1004
Guinea-Bissau

Phone	+245 255543
Email	wejse@hotmail.com

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title
Study acronym	TBD
Study objectives	Vitamin D plays an important role in the immune system, and may help the host in combatting active infection with Mycobacterium Tuberculosis.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Clinical status (time to cure by sputum clearance, weight gain, clinical score) after treatment
Secondary outcome measures	Mortality
Overall study start date	01/11/2003
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	500
Key inclusion criteria	Adult patients diagnosed with tuberculosis (smear positive and smear negative) living in the field site study area
Key exclusion criteria	None. Withdrawal if signs of hypercalcaemia or allergy to vitamin D.
Date of first enrolment	01/11/2003
Date of final enrolment	31/12/2005

Bandim Health Project

Bissau Codex
1004
Guinea-Bissau

Bandim Health Project (Guinea-Bissau)
Not defined

Apartado 861
Bissau Codex
1004
Guinea-Bissau

Industry

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

No information available

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

No information available

Crinex Pharmaceuticals (France) - free cholecalciferol and placebo

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2009		Yes	No