Single 600,000 IU dose of nanoemulsion Vitamin D is safe and effective to fight COVID, even if delay until enter ICU – RCT

Created June 2024

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

J Public Health (Oxf) . 2024 May 29;46(2):256-266. doi: 10.1093/pubmed/fdae007. PDF behind pay wall and in DeepDyve

Ajay Singh 1, Ashu Rastogi 2, Goverdhan Dutt Puri 1, Venkata Ganesh 1, Naveen Bal Naik 1, Kamal Kajal 1, Shubhkarman Kahlon 1, Shiv Lal Soni 1, Narender Kaloria 1, Kulbhushan Saini 1, Amarjyoti Hazarika 1, Varun Mahajan 1, Karan Singla 1, Sanjay Bhadada 2, Vaishali Soni 3

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.