The pharmacogenetics of vitamin D response in tuberculosis

• Research type

  Research Study

• Full title

  The pharmacogenetics of vitamin D response in tuberculosis

• IRAS ID

  62636

• Contact name

  Alice Wood

• Sponsor organisation

  University of Birmingham

• Eudract number

  2010-023189-27

• ISRCTN Number

  n/a

• Research summary

  Tuberculosis (TB) is caused by Mycobacterium tuberculosis (MTb) and is the leading cause of death among curable infectious diseases worldwide. The potential role of Vitamin D supplementation in the treatment of tuberculosis will be studied.The majority of vitamin D in the circulation is bound to Vitamin D Binding protein (DBP, also known as Gc-Globulin), which has effects on the immune system independent of vitamin D carriage.Variations in DBP may be relevant in'susceptibility or resistance to tuberculosis.If successful the therapy may result in more swift resolution of disease, hence decreasing patient morbidity during the illness. The patients will be drawn from adults with a microbiologically confirmed diagnosis of tuberculosis infection at University Hospitals Birmingham (UHB) n's Trest and Heartlan's Hospital, which is part of Heart of England n's Trest.patients, having had their Vitamin D levels checked, will be recruited in Week 0.The severity of TB will be assessed using a validated TB score, and the degree of lung disease radiologically.Blood will be taken for measurement of Vitamin D Binding Protein (DBP) and extraction of DNA.All subjects will receive 100000units of vitamin D3 orally at the baseline visit.Follow up visits will occur at 8, 16 and 24 weeks, and at each visit the TB score recorded and vitamin D level checked. Blood will also be collected formserum DBP measurement.At the visits at 8 and 16 weeks another dose of 100000units of vitamin D3 will be administered as before. Safety measurements of calcium will also be taken.We hope to demonstrate a statistically significant difference in magnitude of vitamin D change post supplementation according to genotype, together with a change in TB outcome which is predicted by this interaction.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  10/H1211/53

• Date of REC Opinion

  7 Dec 2010

• REC opinion

  Favourable Opinion