Clinical Trial of Phenylbutyrate and Vitamin D in Tuberculosis (TB)

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• Adults, 18-60 years with sputum smear positive pulmonary TB

• New cases only

• Gender, both

• Consent to enroll in the study

Exclusion Criteria:

• Hypercalcaemia (serum calcium > 2.6 mmol/L) identified at baseline

• Taking vitamin D

• Pregnant and lactating

• Any known liver or kidney function abnormality, malignancy