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Background  Development of new tuberculosis (TB) drugs and alternative treatment strategies are urgently required to control the global spread of TB. Previous results have shown that vitamin D 3  (vitD 3 ) and 4-phenyl butyrate (PBA) are potent inducers of the host defense peptide LL-37 that possess anti-mycobacterial effects.    Objective  To examine if oral adjunctive therapy with 5,000IU vitD 3  or 2x500 mg PBA or PBA+vitD 3  to standard chemotherapy would lead to enhanced recovery in sputum smear-positive pulmonary TB patients.    Methods  Adult TB patients (n = 288) were enrolled in a randomized, double-blind, placebo-controlled trial conducted in Bangladesh. Primary endpoints included proportions of patients with a negative sputum culture at week 4 and reduction in clinical symptoms at week 8. Clinical assessments and sputum smear microscopy were performed weekly up to week 4, fortnightly up to week 12 and at week 24; TB culture was performed at week 0, 4 and 8; concentrations of LL-37 in cells, 25-hydroxyvitamin D 3  (25(OH)D 3 ) in plasma and  ex vivo  bactericidal function of monocyte-derived macrophages (MDM) were determined at week 0, 4, 8, 12 and additionally at week 24 for plasma 25(OH)D 3 .    Results  At week 4, 71% (46/65) of the patients in the PBA+vitD 3 -group ( p  = 0.001) and 61.3% (38/62) in the vitD 3 -group ( p  = 0.032) were culture negative compared to 42.2% (27/64) in the placebo-group. The odds of sputum culture being negative at week 4 was 3.42 times higher in the PBA+vitD 3 -group (p = 0.001) and 2.2 times higher in vitD 3 -group (p = 0.032) compared to placebo. The concentration of LL-37 in MDM was significantly higher in the PBA-group compared to placebo at week 12 ( p  = 0.034). Decline in intracellular  Mtb  growth in MDM was earlier in the PBA-group compared to placebo (log rank 11.38,  p  = 0.01).    Conclusion  Adjunct therapy with PBA+vitD 3  or vitD 3  or PBA to standard short-course therapy demonstrated beneficial effects towards clinical recovery and holds potential for host-directed-therapy in the treatment of TB.    Trial Registration  clinicaltrials.gov  NCT01580007

Significant Effects of Oral Phenylbutyrate and Vitamin D3 Adjunctive Therapy in Pulmonary Tuberculosis: A Randomized Controlled Trial