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Tuberculosis not treated by monthly 140,000 IU (Vitamin D binding protein problem) – RCT Sept 2017

High-Dose Vitamin D3 during Tuberculosis Treatment in Mongolia. A Randomized Controlled Trial.

Am J Respir Crit Care Med. 2017 Sep 1;196(5):628-637. doi: 10.1164/rccm.201705-0936OC.
Ganmaa D1,2, Munkhzul B3, Fawzi W2, Spiegelman D1,2, Willett WC1,2, Bayasgalan P3, Baasansuren E3, Buyankhishig B3, Oyun-Erdene S3, Jolliffe DA4, Xenakis T4, Bromage S2, Bloom BR2, Martineau AR4.

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RATIONALE:
Existing trials of adjunctive vitamin D in the treatment of pulmonary tuberculosis (PTB) are variously limited by small sample sizes, inadequate dosing regimens, and high baseline vitamin D status among participants. Comprehensive analyses of the effects of genetic variation in the vitamin D pathway on response to vitamin D supplementation are lacking.

OBJECTIVES:
To determine the effect of high-dose vitamin D3 on response to antimicrobial therapy for PTB and to evaluate the influence of single-nucleotide polymorphisms (SNPs) in vitamin D pathway genes on response to adjunctive vitamin D3.

METHODS:
We conducted a clinical trial in 390 adults with PTB in Ulaanbaatar, Mongolia, who were randomized to receive four biweekly doses of 3.5 mg (140,000 IU) vitamin D3 (n = 190) or placebo (n = 200) during intensive-phase antituberculosis treatment.

MEASUREMENTS AND MAIN RESULTS:
The intervention elevated 8-week serum 25-hydroxyvitamin D concentrations (154.5 nmol/L vs. 15.2 nmol/L in active vs. placebo arms, respectively; 95% confidence interval for difference, 125.9-154.7 nmol/L; P < 0.001) but did not influence time to sputum culture conversion overall (adjusted hazard ratio, 1.09; 95% confidence interval, 0.86-1.36; P = 0.48). Adjunctive vitamin D3 accelerated sputum culture conversion in patients with one or more minor alleles for SNPs in genes encoding the vitamin D receptor (rs4334089, rs11568820) and 25-hydroxyvitamin D 1α-hydroxylase (CYP27B1: rs4646536) (adjusted hazard ratio ≥ 1.47; P for interaction ≤ 0.02).

CONCLUSIONS:
Vitamin D3 did not influence time to sputum culture conversion in the study population overall. Effects of the intervention were modified by SNPs in VDR and CYP27B1. Clinical trial registered with www.clinicaltrials.gov (NCT01657656).


Created by admin. Last Modification: Friday June 14, 2019 00:57:27 GMT-0000 by admin. (Version 4)

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12122 TB RCT Bindinf Protein Mongolia.pdf PDF 2019 admin 14 Jun, 2019 00:47 541.85 Kb 136
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