This Strategic Research Project is a translational proof-of-concept study that will determine
whether vitamin D3 has potential to prevent recurrent tuberculosis (TB), as indicated by
enhanced resolution of pulmonary inflammation detected using 18F-FDG PET-CT scanning. The
extent of pulmonary inflammation detectable on PET-CT scanning is a validated biomarker that
has previously been shown to predict risk of TB recurrence in patients taking anti-TB
treatment. The investigators propose to explore whether vitamin D3 can enhance resolution of
PET-CT-detectable pulmonary inflammation, on the basis of extensive preliminary data from in
vitro studies and a Phase 2b clinical trial that the investigators have conducted, showing
that high-dose vitamin D3 accelerates resolution of peripheral blood inflammatory responses
in patients with pulmonary TB.
Forty vitamin D-deficient patients who have completed 6 months' TB treatment, but who still
have residual pulmonary inflammation detectable on PET-CT scanning, will be allocated to
receive either an 8-week course of high-dose oral vitamin D3 supplementation or placebo
during the study period. The extent of pulmonary inflammation on PET-CT scanning will be
compared between intervention vs. control groups at 8-week follow-up.
If the study shows a positive result, it will generate valuable proof-of-concept data that
could be used to support an application to conduct a large phase 3 trial of vitamin D
supplementation to prevent TB recurrence.