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0 0.5 1 1.5 2+ ICU admission 86% Improvement Relative Risk Oxygen therapy 7% Karonova et al. NCT05166005 Vitamin D RCT LATE TREATMENT Is late treatment with vitamin D beneficial for COVID-19? RCT 110 patients in Russia (November 2020 - March 2021) Lower ICU admission with vitamin D (not stat. sig., p=0.11) Karonova et al., Nutrients, doi:10.3390/nu14132602 Favors vitamin D Favors control
Effect of Cholecalciferol Supplementation on the Clinical Features and Inflammatory Markers in Hospitalized COVID-19 Patients: A Randomized, Open-Label, Single-Center Study
Karonova et al., Nutrients, doi:10.3390/nu14132602, NCT05166005 (history)
Karonova et al., Effect of Cholecalciferol Supplementation on the Clinical Features and Inflammatory Markers in Hospitalized.., Nutrients, doi:10.3390/nu14132602, NCT05166005
Jun 2022   Source   PDF  
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RCT with 56 cholecalciferol and 54 control hospitalized patients with vitamin D insufficiency or deficiency in Russia, showing positive effects on immune status. The median age in the treatment group was 7 years lower and deficiency was less common, while baseline treatment group CT lung involvement and supplemental oxygen use was higher in the treatment group. Treatment increased vitamin D levels and neutrophil and lymphocyte counts, decreased CRP levels, and was associated with a decrease in CD38++CD27 transitional and CD27−CD38+ mature naive B cells and an increase in CD27−CD38− DN B cells.
risk of ICU admission, 85.9% lower, RR 0.14, p = 0.11, treatment 0 of 56 (0.0%), control 3 of 54 (5.6%), NNT 18, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 9.
risk of oxygen therapy, 7.0% lower, RR 0.93, p = 0.85, treatment 27 of 56 (48.2%), control 28 of 54 (51.9%), NNT 27, baseline oxygen supplementation was higher in the treatment group, 38 vs. 32, day 9.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Karonova et al., 23 Jun 2022, Randomized Controlled Trial, Russia, peer-reviewed, 12 authors, study period 30 November, 2020 - 20 March, 2021, dosage 50,000IU days 1, 8, trial NCT05166005 (history).
Contact: (corresponding author),,,,,,,,,,,
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This PaperVitamin DAll
Abstract: nutrients Article Effect of Cholecalciferol Supplementation on the Clinical Features and Inflammatory Markers in Hospitalized COVID-19 Patients: A Randomized, Open-Label, Single-Center Study Tatiana L. Karonova 1, *, Ksenia A. Golovatyuk 1 , Igor V. Kudryavtsev 1,2 , Alena T. Chernikova 1 , Arina A. Mikhaylova 1 , Arthur D. Aquino 1 , Daria I. Lagutina 1 , Ekaterina K. Zaikova 1 , Olga V. Kalinina 1 , Alexey S. Golovkin 1 , William B. Grant 3 and Evgeny V. Shlyakhto 1 1 2 3 * Citation: Karonova, T.L.; Golovatyuk, K.A.; Kudryavtsev, I.V.; Chernikova, A.T.; Mikhaylova, A.A.; Aquino, A.D.; Lagutina, D.I.; Zaikova, E.K.; Kalinina, O.V.; Golovkin, A.S.; et al. Effect of Cholecalciferol Supplementation on the Clinical Features and Inflammatory Markers in Hospitalized COVID-19 Patients: A Randomized, Open-Label, Single-Center Study. Nutrients 2022, 14, 2602. nu14132602 Academic Editor: Sara Baldassano Received: 31 May 2022 Accepted: 21 June 2022 Published: 23 June 2022 Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in Almazov National Medical Research Centre, 197341 Saint Petersburg, Russia; (K.A.G.); (I.V.K.); (A.T.C.); (A.A.M.); (A.D.A.); (D.I.L.); (E.K.Z.); (O.V.K.); (A.S.G.); (E.V.S.) Institute of Experimental Medicine, 197376 Saint Petersburg, Russia Sunlight, Nutrition, and Health Research Center, P.O. Box 641603, San Francisco, CA 94164-1603, USA; Correspondence: Abstract: Recent studies showed that a low 25-hydroxyvitamin D (25(OH)D) level was associated with a higher risk of morbidity and severe course of COVID-19. Our study aimed to evaluate the effects of cholecalciferol supplementation on the clinical features and inflammatory markers in patients with COVID-19. A serum 25(OH)D level was determined in 311 COVID-19 patients. Among them, 129 patients were then randomized into two groups with similar concomitant medication. Group I (n = 56) received a bolus of cholecalciferol at a dose of 50,000 IU on the first and the eighth days of hospitalization. Patients from Group II (n = 54) did not receive the supplementation. We found significant differences between groups with the preferential increase in serum 25(OH)D level and ∆ 25(OH)D in Group I on the ninth day of hospitalization (p < 0.001). The serum 25(OH)D level on the ninth day was negatively associated with the number of bed days (r = −0.23, p = 0.006); we did not observe other clinical benefits in patients receiving an oral bolus of cholecalciferol. Moreover, in Group I, neutrophil and lymphocyte counts were significantly higher (p = 0.04; p = 0.02), while the C-reactive protein level was significantly lower on the ninth day of hospitalization (p = 0.02). Patients with supplementation of 100,000 IU of cholecalciferol, compared to those without supplementation, showed a decrease in the frequencies of CD38++CD27 transitional and CD27−CD38+ mature naive B cells (p = 0.006 and p = 0.02) and an increase in the level of CD27−CD38− DN B cells (p = 0.02). Thus, the rise in serum 25(OH)D level caused by vitamin D supplementation in vitamin D insufficient and deficient patients may positively affect immune status and hence the course of COVID-19. Keywords: COVID-19;..
Late treatment
is less effective
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