Vitamin D to resolve inflammation after tuberculosis (ResolveD-TB)V5.1
Research type
Research Study
Full title
Vitamin D3 to enhance resolution of residual pulmonary inflammation in patients completing antituberculosis treatment (ResolveD-TB): a proof-of-concept intervention study
IRAS ID
209158
Contact name
Adrian Martineau
Contact email
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
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. We propose to investigate
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 we 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 our 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.REC name
London - Stanmore Research Ethics Committee
REC reference
16/LO/1805
Date of REC Opinion
9 Nov 2016
REC opinion
Further Information Favourable Opinion