Prevention of relapse in drug sensitive pulmonary tuberculosis patients with and without vitamin D3 supplementation: A double blinded randomized control clinical trial.
Journal
PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081
Informations de publication
Date de publication:
2023
2023
Historique:
received:
08
08
2022
accepted:
09
02
2023
medline:
3
4
2023
entrez:
30
3
2023
pubmed:
31
3
2023
Statut:
epublish
Résumé
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. 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. 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. 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. CTRI/2021/02/030977 (ICMR, Clinical trial registry-India).
Sections du résumé
BACKGROUND
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).
Identifiants
pubmed: 36996065
doi: 10.1371/journal.pone.0272682
pii: PONE-D-22-20832
pmc: PMC10062618
doi:
Substances chimiques
Cholecalciferol
1C6V77QF41
Vitamin D
1406-16-2
Vitamins
0
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e0272682Informations de copyright
Copyright: © 2023 Sinha et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Déclaration de conflit d'intérêts
The authors have declared that no competing interests exist.
Références
Braz J Infect Dis. 2006 Dec;10(6):374-9
pubmed: 17420908
Lancet Infect Dis. 2015 May;15(5):528-34
pubmed: 25863562
Thorax. 2007 Nov;62(11):1003-7
pubmed: 17526677
Am J Respir Crit Care Med. 2019 Mar 15;199(6):784-794
pubmed: 30252496
N Engl J Med. 2020 Jul 23;383(4):359-368
pubmed: 32706534
Nutrients. 2014 Feb 21;6(2):729-75
pubmed: 24566435
BMJ. 2022 Sep 7;378:e071230
pubmed: 36215226
Scientifica (Cairo). 2014;2014:903680
pubmed: 25101194
Syst Rev. 2021 May 26;10(1):157
pubmed: 34039420
Front Immunol. 2022 Sep 12;13:937476
pubmed: 36172344
J Clin Diagn Res. 2014 May;8(5):OC01-3
pubmed: 24995216
Infect Drug Resist. 2019 Jul 22;12:2251-2257
pubmed: 31413602
BMC Pulm Med. 2018 Jun 28;18(1):108
pubmed: 29954353
J Thorac Dis. 2017 Mar;9(3):E301-E303
pubmed: 28449528
Chin Med J (Engl). 2019 Dec 20;132(24):2950-2959
pubmed: 31833904
Am J Respir Crit Care Med. 2009 May 1;179(9):843-50
pubmed: 19179490
Proc Nutr Soc. 2012 Feb;71(1):84-9
pubmed: 22123447
Respir Res. 2020 Aug 26;21(1):223
pubmed: 32847532
J Cell Biochem. 2003 Feb 1;88(2):296-307
pubmed: 12520530
Eur Respir J. 2019 Mar 7;53(3):
pubmed: 30728208
Am J Clin Nutr. 2015 Nov;102(5):1059-69
pubmed: 26399865
AIMS Microbiol. 2020 Mar 13;6(1):65-74
pubmed: 32226915