Vitamin D Supplementation and Clinical Outcomes in Severe COVID-19 Patients—Randomized Controlled Trial
Domazet Bugarin et al.
, Vitamin D Supplementation and Clinical Outcomes in Severe COVID-19 Patients—Randomized Controlled Trial
, Nutrients, doi:10.3390/nu15051234, NCT05384574
Very late stage RCT 155 ICU patients in Croatia with low vitamin D levels, showing no significant differences with 10,000IU cholecalciferol daily. Calcifediol or calcitriol, which avoids several days delay in conversion, may be more successful, especially with this very late stage usage.
The baseline mean age and median WHO scores for the treatment and control groups are both higher than the respective values reported for all patients combined, which is not possible.
The trial was registered after completion in May 2022.
risk of death, 21.0% lower, RR 0.79, p = 0.20, treatment 30 of 75 (40.0%), control 39 of 77 (50.6%), NNT 9.4, day 60.
risk of death, 12.5% lower, RR 0.87, p = 0.61, treatment 23 of 75 (30.7%), control 27 of 77 (35.1%), NNT 23, day 28.
risk of death, 28.9% lower, RR 0.71, p = 0.49, treatment 9 of 75 (12.0%), control 13 of 77 (16.9%), NNT 20, day 14.
WHO score, no change, RR 1.00, p = 0.70, treatment 75, control 77, day 28.
hospitalization time, 5.6% higher, relative time 1.06, p = 0.76, treatment 75, control 77.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Domazet Bugarin et al., 28 Feb 2023, Randomized Controlled Trial, Croatia, peer-reviewed, 9 authors, study period November 2021 - May 2022, dosage 10,000IU days 1-14, trial NCT05384574 (history)
email@example.com (corresponding author).
Vitamin D Supplementation and Clinical Outcomes in Severe
COVID-19 Patients—Randomized Controlled Trial
Josipa Domazet Bugarin 1 , Svjetlana Dosenovic 1 , Darko Ilic 1 , Nikola Delic 1 , Ivana Saric 1 , Ivo Ugrina 2 ,
Sanda Stojanovic Stipic 1 , Bozidar Duplancic 1 and Lenko Saric 1, *
Citation: Domazet Bugarin, J.;
Department of Anesthesiology, Reanimatology and Intensive Care, University Hospital Split,
21000 Split, Croatia
Intellomics Ltd., 21000 Split, Croatia
Abstract: COVID-19 symptoms vary from asymptomatic cases to moderate and severe illness with
patients needing hospitalization and intensive care treatment. Vitamin D is associated with severity
of viral infections and has an immune-modulatory effect in immune response. Observational studies
showed a negative association of low vitamin D levels and COVID-19 severity and mortality outcomes.
In this study, we aimed to determine whether daily supplementation of vitamin D during intensive
care unit (ICU) stay in COVID-19 patients with severe illness affects clinically relevant outcomes.
Patients with COVID-19 disease in need of respiratory support admitted to the ICU were eligible
for inclusion. Patients with low vitamin D levels were randomized into one of two groups: the
intervention group received daily supplementation of vitamin D and the control group did not
receive vitamin D supplementation. In total, 155 patients were randomized: 78 into the intervention
group and 77 into the control group. There was no statistically significant difference in number
of days spent on respiratory support, although the trial was underpowered for the main outcome.
There was no difference in any of the secondary outcomes analyzed between two groups. Our study
suggests no benefit in vitamin D supplementation to patients with severe COVID-19 disease admitted
to the ICU and in need of respiratory support in any of the analyzed outcomes.
Dosenovic, S.; Ilic, D.; Delic, N.; Saric,
I.; Ugrina, I.; Stojanovic Stipic, S.;
Keywords: vitamin D; ICU; COVID-19; respiratory support; mechanical ventilation; ARDS
Duplancic, B.; Saric, L. Vitamin D
Supplementation and Clinical
Outcomes in Severe COVID-19
is less effective
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