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- Title
Therapeutic high-dose vitamin D for vitamin D-deficient severe COVID-19 disease: randomized, double-blind, placebo-controlled study (SHADE-S).
- Authors
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; Soni, Vaishali
- 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 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.
- Subjects
INDIA; 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
- Publication
Journal of Public Health, 2024, Vol 46, Issue 2, p256
- ISSN
1741-3842
- Publication type
Article
- DOI
10.1093/pubmed/fdae007