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.
, Effect of Cholecalciferol Supplementation on the Clinical Features and Inflammatory Markers in Hospitalized..
, Nutrients, doi:10.3390/nu14132602, NCT05166005
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)
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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
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. https://doi.org/10.3390/
Academic Editor: Sara Baldassano
Received: 31 May 2022
Accepted: 21 June 2022
Published: 23 June 2022
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with regard to jurisdictional claims in
Almazov National Medical Research Centre, 197341 Saint Petersburg, Russia;
email@example.com (K.A.G.); firstname.lastname@example.org (I.V.K.); email@example.com (A.T.C.);
firstname.lastname@example.org (A.A.M.); email@example.com (A.D.A.); firstname.lastname@example.org (D.I.L.);
email@example.com (E.K.Z.); firstname.lastname@example.org (O.V.K.); email@example.com (A.S.G.);
Institute of Experimental Medicine, 197376 Saint Petersburg, Russia
Sunlight, Nutrition, and Health Research Center, P.O. Box 641603, San Francisco, CA 94164-1603, USA;
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.
is less effective
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