Therapeutic high-dose vitamin D for vitamin D-deficient severe COVID-19 disease: randomized, double-blind, placebo-controlled study (SHADE-S).

BACKGROUND: efficacy of therapeutic cholecalciferol supplementation for severe COVID-19 is sparingly studied. OBJECTIVE: effect of single high-dose cholecalciferol supplementation on sequential organ failure assessment (SOFA) score in moderate-to-severe COVID-19. METHODS: participants with moderate to severe COVID-19 with PaO2/FiO2 ratio < 200 were randomized to 0.6 million IU cholecalciferol oral (intervention) or placebo. OUTCOMES: primary outcome was change in Day 7 SOFA score and pre-specified secondary outcomes were SOFA and 28-day all-cause mortality. RESULTS: in all, 90 patients (45 each group) were included for intention-to-treat analysis. 25(OH)D3 levels were 12 (10-16) and 13 (12-18) ng/ml (P = 0.06) at baseline; and 60 (55-65) ng/ml and 4 (1-7) ng/ml by Day 7 in vitamin D and placebo groups, respectively. The SOFA score on Day 7 was better in the vitamin D group [3 (95% CI, 2-5) versus 5 (95% CI, 3-7), P = 0.01, intergroup difference - 2 (95% CI, -4 to -0.01); r = 0.4]. A lower all-cause 28-day mortality [24% compared to 44% (P = 0.046)] was observed with vitamin D. CONCLUSIONS: single high-dose oral cholecalciferol supplementation on ICU admission can improve SOFA score at Day 7 and reduce in-hospital mortality in vitamin D-deficient COVID-19. ClinicalTrials.gov  id: NCT04952857 registered dated 7 July 2021. What is already known on this topic-vitamin D has immunomodulatory role. Observational and isolated intervention studies show some benefit in COVID-19. Targeted therapeutic vitamin D supplementation improve outcomes in severe COVID-19 is not studied in RCTs. What this study adds-high-dose vitamin D supplementation (0.6 Million IU) to increase 25(OH)D > 50 ng/ml is safe and reduces sequential organ failure assessment score, in-hospital mortality in moderate to severe COVID-19. How this study might affect research, practice or policy-vitamin D supplementation in vitamin D-deficient patients with severe COVID-19 is useful may be practiced.

The effects of short-term relaxation therapy on indices of heart rate variability and blood pressure in young adults.

PURPOSE: Assessment of short-term practice of relaxation therapy on autonomic and cardiovascular functions in first-year medical students. DESIGN: Case-control, interventional study. SETTING: Medical college laboratory. SUBJECTS: Sixty-seven medical students, divided into two groups: study group (n = 35) and control group (n = 32). INTERVENTION: Study group subjects practiced relaxation therapy (shavasana with a soothing background music) daily 1 hour for 6 weeks. Control group did not practice relaxation techniques. MEASURES: Cardiovascular parameters and spectral indices of heart rate variability (HRV) were recorded before and after the 6-week practice of relaxation therapy. ANALYSIS: The data between the groups and the data before and after practice of relaxation techniques were analyzed by one-way analysis of variance and Student t-test. In the study group, prediction of low-frequency to high-frequency ratio (LF-HF) of HRV, the marker of sympathovagal balance, to blood pressure (BP) status was assessed by logistic regression. RESULTS: In the study group, there was significant reduction in heart rate (p = .0001), systolic (p = .0010) and diastolic (p = .0021) pressure, and rate pressure product (p < .0001), and improvement in HRV indices, following 6 weeks of relaxation therapy. As determined by regression model, prediction of LF-HF to BP status was more significant (odds ratio, 2.7; p = .009) after practice of relaxation therapy. There was no significant alteration in these parameters in control subjects. CONCLUSION: Short-term practice of relaxation therapy can improve autonomic balance and promote cardiovascular health of medical students. Sympathovagal balance is directly linked to BP status in these individuals.