1. Therapeutic high-dose vitamin D for vitamin D-deficient severe COVID-19 disease: randomized, double-blind, placebo-controlled study (SHADE-S).
- Author
-
Singh A, Rastogi A, Puri GD, Ganesh V, Naik NB, Kajal K, Kahlon S, Soni SL, Kaloria N, Saini K, Hazarika A, Mahajan V, Singla K, Bhadada S, and Soni V
- Subjects
- Humans, Male, Female, Double-Blind Method, Middle Aged, Aged, Vitamin D blood, Vitamins therapeutic use, Vitamins administration & dosage, Organ Dysfunction Scores, Dietary Supplements, Coronavirus Infections drug therapy, Coronavirus Infections mortality, COVID-19 Drug Treatment, Pandemics, Adult, Treatment Outcome, Pneumonia, Viral drug therapy, Pneumonia, Viral mortality, Severity of Illness Index, Betacoronavirus, COVID-19 mortality, COVID-19 complications, Vitamin D Deficiency drug therapy, Vitamin D Deficiency complications, SARS-CoV-2, Cholecalciferol administration & dosage, Cholecalciferol therapeutic use
- 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., (© The Author(s) 2024. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2024
- Full Text
- View/download PDF