1. Therapeutic high-dose vitamin D for vitamin D-deficient severe COVID-19 disease: randomized, double-blind, placebo-controlled study (SHADE-S).
- Author
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Singh, Ajay, Rastogi, Ashu, Puri, Goverdhan Dutt, Ganesh, Venkata, Naik, Naveen Bal, Kajal, Kamal, Kahlon, Shubhkarman, Soni, Shiv Lal, Kaloria, Narender, Saini, Kulbhushan, Hazarika, Amarjyoti, Mahajan, Varun, Singla, Karan, Bhadada, Sanjay, and Soni, Vaishali
- Subjects
VITAMIN D deficiency ,PATIENT safety ,DIPHOSPHONATES ,MULTIPLE organ failure ,STATISTICAL sampling ,BLIND experiment ,POLYMERASE chain reaction ,MULTIPLE regression analysis ,TREATMENT effectiveness ,RANDOMIZED controlled trials ,DESCRIPTIVE statistics ,HOSPITAL mortality ,TERTIARY care ,DIURETICS ,CALCITONIN ,CHOLECALCIFEROL ,DRUG efficacy ,ARTIFICIAL respiration ,CONFIDENCE intervals ,OXYGEN consumption ,DATA analysis software ,SURVIVAL analysis (Biometry) ,COVID-19 ,DIETARY supplements ,IMMUNOMODULATORS ,SARS-CoV-2 ,C-reactive protein ,GLUCOCORTICOIDS ,PROPORTIONAL hazards models - Abstract
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 PaO
2 /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. [ABSTRACT FROM AUTHOR]- Published
- 2024
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