Daily adjunctive therapy with vitamin D₃ and phenylbutyrate supports clinical recovery from pulmonary tuberculosis: a randomized controlled trial in Ethiopia.

ABSTRACT:

Objective

Immunotherapy using vitamin D (vitD₃ ) and phenylbutyrate (PBA) may support standard drug regimens used to treat infectious diseases. We investigated if vitD₃ + PBA enhanced clinical recovery from pulmonary tuberculosis (TB).

Methods

A randomized controlled trial was conducted in Addis Ababa, Ethiopia. Patients with smear-positive or smear-negative TB received daily oral supplementation with 5000 IU vitD₃ and 2 × 500 mg PBA or placebo for 16 weeks, together with 6-month chemotherapy. Primary end-point: reduction of a clinical composite TB score at week 8 compared with baseline using modified intention-to-treat (mITT, n = 348) and per-protocol (n = 296) analyses. Secondary end-points: primary and modified TB scores (week 0, 4, 8, 16,

SUBMITTER: Bekele A 

PROVIDER: S-EPMC6202271 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature