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A randomised placebo controlled double blind clinical trial of vitamin D in the treatment of tuberculosis
ISRCTN ISRCTN35212132
DOI 10.1186/ISRCTN35212132
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised placebo controlled double blind clinical trial of vitamin D in the treatment of tuberculosis
Scientific title
Acronym TBD
Serial number at source N/A
Study hypothesis Vitamin D plays an important role in the immune system, and may help the host in combatting active infection with Mycobacterium Tuberculosis.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Guinea-Bissau
Disease/condition/study domain Tuberculosis
Participants - inclusion criteria Adult patients diagnosed with tuberculosis (smear positive and smear negative) living in the field site study area
Participants - exclusion criteria None. Withdrawal if signs of hypercalcaemia or allergy to vitamin D.
Anticipated start date 01/11/2003
Anticipated end date 31/12/2005
Status of trial Completed
Patient information material
Target number of participants 500
Interventions 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).
Primary outcome measure(s) Clinical status (time to cure by sputum clearance, weight gain, clinical score) after treatment
Secondary outcome measure(s) Mortality
Sources of funding 1. Danish Research Council for Development Research (Denmark) (ref: 91163) - project expenses
2. University of Aarhus (Denmark) - salary of lead principal investigator
3. Crinex Pharmaceuticals (France) - free cholecalciferol and placebo
Trial website http://www.indepth-network.org/dss_site_profiles/bandim.pdf
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19179490
Contact name Dr  Christian  Wejse
  Address Bandim Health Project
Apartado 861
  City/town Bissau Codex
  Zip/Postcode 1004
  Country Guinea-Bissau
  Tel +245 255543
  Fax +245 201672
  Email wejse@hotmail.com
Sponsor Bandim Health Project (Guinea-Bissau)
  Address Apartado 861
  City/town Bissau Codex
  Zip/Postcode 1004
  Country Guinea-Bissau
  Tel +245 201489
  Fax +245 201672
  Email psb@mail.gtelecom.gw
Date applied 13/04/2004
Last edited 11/02/2009
Date ISRCTN assigned 21/05/2004
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