In:
PLOS ONE, Public Library of Science (PLoS), Vol. 18, No. 3 ( 2023-3-30), p. e0272682-
Abstract:
The immunomodulatory effects of vitamin D are widely recognized and a few studies have been conducted to determine its utility in the treatment of tuberculosis, with mixed results. This study was conducted to see if vitamin D supplementation in patients with active pulmonary tuberculosis (PTB) in the Indian population contributed to sputum smear and culture conversion as well as the prevention of relapse. Methods This randomized double-blind placebo-controlled trial was conducted in three sites in India. HIV negative participants aged 15–60 years with sputum smear positive PTB were recruited according to the Revised National Tuberculosis Control Program guidelines and were randomly assigned (1:1) to receive standard anti-tubercular treatment (ATT) with either supplemental dose of oral vitamin D3 (60,000 IU/sachet weekly for first two months, fortnightly for next four months followed by monthly for the next 18 months) or placebo with same schedule. The primary outcome was relapse of PTB and secondary outcomes were time to conversion of sputum smear and sputum culture. Results A total of 846 participants were enrolled between February 1, 2017 to February 27, 2021, and randomly assigned to receive either 60,000 IU vitamin D3 (n = 424) or placebo (n = 422) along with standard ATT. Among the 697 who were cured of PTB, relapse occurred in 14 participants from the vitamin D group and 19 participants from the placebo group (hazard risk ratio 0.68, 95%CI 0.34 to 1.37, log rank p value 0.29). Similarly, no statistically significant difference was seen in time to sputum smear and sputum culture conversion between both groups. Five patients died each in vitamin D and placebo groups, but none of the deaths were attributable to the study intervention. Serum levels of vitamin D were significantly raised in the vitamin D group as compared to the placebo group, with other blood parameters not showing any significant difference between groups. Conclusions The study reveals that vitamin D supplementation does not seem to have any beneficial effect in the treatment of PTB in terms to the prevention of relapse and time to sputum smear and culture conversion. Trial registration CTRI/2021/02/030977 (ICMR, Clinical trial registry-India).
Type of Medium:
Online Resource
ISSN:
1932-6203
DOI:
10.1371/journal.pone.0272682
DOI:
10.1371/journal.pone.0272682.g001
DOI:
10.1371/journal.pone.0272682.g002
DOI:
10.1371/journal.pone.0272682.g003
DOI:
10.1371/journal.pone.0272682.g004
DOI:
10.1371/journal.pone.0272682.g005
DOI:
10.1371/journal.pone.0272682.t001
DOI:
10.1371/journal.pone.0272682.t002
DOI:
10.1371/journal.pone.0272682.t003
DOI:
10.1371/journal.pone.0272682.t004
DOI:
10.1371/journal.pone.0272682.s001
DOI:
10.1371/journal.pone.0272682.s002
Language:
English
Publisher:
Public Library of Science (PLoS)
Publication Date:
2023
detail.hit.zdb_id:
2267670-3
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