Prevention of relapse in drug sensitive pulmonary tuberculosis patients with and without vitamin D3 supplementation: A double blinded randomized control clinical trial.

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).

Th1/Th2/Th17 Cytokine Profile among Different Stages of COVID-19 Infection.

Aim: To characterize Th1/Th2/Th17 cytokine profile (IL-2, IL-4, IL-6, IL-10, TNF-α, IFN-γ, and IL-17A) among different stages of COVID-19 infection. Methods: This was a cross-sectional study which included six healthy individuals and 68 patients who were admitted with COVID-19 in the Department of Medicine, at All India Institute of Medical Sciences, New Delhi, from July 2020 to September 2020. Patients were categorized into mild, moderate, and severe COVID-19 groups, and serum samples were drawn for the measurement of Th1/Th2/Th17 cytokines (IL-4, IL-6, IL-10, TNF-α, IFN-γ, and IL-17A) which was done by BD™ Cytometric Bead Array. Results: All the cytokines showed dynamic expression in the COVID-19 group, of which only IL-6 was statistically significant. Among the three severity groups of COVID-19, increased severity did not transform into increased cytokine level, with the exception for IL-6, which was statistically significant. Conclusions: In our small sample study, six cytokines expressions were evaluated however most of them were elevated in COVID-19 patients but were not statistically significant except IL-6.

Covid-19 presenting as isolated severe thrombocytopenia in an HIV-lymphoma survivor.

Coronavirus disease has myriad manifestations and can present with predominantly extrapulmonary manifestations. We describe a 50-year-old man, a person living with HIV (PLHA), a non-Hodgkin lymphoma survivor, who presented with isolated severe thrombocytopenia. He was found to have immune-mediated thrombocytopenia, and showed excellent response to intravenous immunoglobulins.