Clinical Trial of Phenylbutyrate and Vitamin D in Tuberculosis (TB)
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
Vitamin D exerts its effects via the Vitamin D Receptor (VDR) present in activated
macrophages and induces expression and release of the cathelicidin, LL-37, a human
antimicrobial peptide involved in killing of MTB. We aimed to investigate whether treatment
of newly diagnosed pulmonary TB patients for 2 months with adjunctive PBA and vitamin D
(Cholecalciferol) in combination with standard DOTS therapy (i) can improve response to
standard short course TB therapy towards a rapid recovery; (ii) can induce expression of
LL-37 in macrophages; (iii) can enhance killing capacity of macrophages isolated from TB
patients infected in vitro with MTB; and (iv) does not evoke any adverse effects.
Phase:
Phase 2
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators:
Karolinska Institutet National Institute of Diseases of the Chest and Hospital National Tuberculosis Reference Laboratory, National Institute of Diseases of Chest and Hospital (NIDCH), Dhaka, Bangladesh University of Iceland
Treatments:
4-phenylbutyric acid Cholecalciferol Ergocalciferols Vitamin D Vitamins