“Effect of calcifediol treatment and best available therapy versus best available therapy on intensive care unit admission and mortality among patients hospitalized for COVID-19: A pilot randomized clinical study”

Castillo, Marta Entrenas; Costa, Luis Manuel Entrenas; Barrios, José Manuel Vaquero; Díaz, J.F.; López‐Miranda, José; Bouillon, Roger; Gómez, José Manuel

doi:10.1016/j.jsbmb.2020.105751

Cited by 599 publications

(586 citation statements)

References 42 publications

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“…Finally, hypovitaminosis D was found to be associated with greater COVID-19 mortality risk (incident relative risk 1.56 with p < 0.001 if vitamin D deficiency; p = 0.404 after adjustment) [14]. These results support that enhancing serum 25(OH)D concentration may improve the prognosis of COVID-19, as demonstrated by a pilot controlled trial reporting that the administration of calcifediol versus no calcifediol reduced the need for ICU treatment in 76 hospitalized participants with COVID-19 also receiving best available therapy (mean age, 53 years; 40.8% women) [15]. Following these preliminary findings, larger interventional studies dedicated to COVID-19 with groups properly matched are warranted for investigating the role of vitamin D supplementation on COVID-19 outcomes.…”

Section: Discussionsupporting

confidence: 60%

Vitamin D Supplementation Associated to Better Survival in Hospitalized Frail Elderly COVID-19 Patients: The GERIA-COVID Quasi-Experimental Study

Annweiler

Corvaisier

Gautier³

et al. 2020

Nutrients

235

255

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Background. The objective of this quasi-experimental study was to determine whether bolus vitamin D supplementation taken either regularly over the preceding year or after the diagnosis of COVID-19 was effective in improving survival among hospitalized frail elderly COVID-19 patients. Methods. Seventy-seven patients consecutively hospitalized for COVID-19 in a geriatric unit were included. Intervention groups were participants regularly supplemented with vitamin D over the preceding year (Group 1), and those supplemented with vitamin D after COVID-19 diagnosis (Group 2). The comparator group involved participants having received no vitamin D supplements (Group 3). Outcomes were 14-day mortality and highest (worst) score on the ordinal scale for clinical improvement (OSCI) measured during COVID-19 acute phase. Potential confounders were age, gender, functional abilities, undernutrition, cancer, hypertension, cardiomyopathy, glycated hemoglobin, number of acute health issues at admission, hospital use of antibiotics, corticosteroids, and pharmacological treatments of respiratory disorders. Results. The three groups (n = 77; mean ± SD, 88 ± 5years; 49% women) were similar at baseline (except for woman proportion, p = 0.02), as were the treatments used for COVID-19. In Group 1 (n = 29), 93.1% of COVID-19 participants survived at day 14, compared to 81.2% survivors in Group 2 (n = 16) (p = 0.33) and 68.7% survivors in Group 3 (n = 32) (p = 0.02). While considering Group 3 as reference (hazard ratio (HR) = 1), the fully-adjusted HR for 14-day mortality was HR = 0.07 (p = 0.017) for Group 1 and HR = 0.37 (p = 0.28) for Group 2. Group 1 had longer survival time than Group 3 (log-rank p = 0.015), although there was no difference between Groups 2 and 3 (log-rank p = 0.32). Group 1, but not Group 2 (p = 0.40), was associated with lower risk of OSCI score ≥5 compared to Group 3 (odds ratio = 0.08, p= 0.03). Conclusions. Regular bolus vitamin D supplementation was associated with less severe COVID-19 and better survival in frail elderly.

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Section: Discussionsupporting

confidence: 60%

Vitamin D Supplementation Associated to Better Survival in Hospitalized Frail Elderly COVID-19 Patients: The GERIA-COVID Quasi-Experimental Study

Annweiler

Corvaisier

Gautier³

et al. 2020

Nutrients

235

255

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“…This equates to an odds ratio of 0.03 for ICU admission in the calcifediol group, even after adjustment for pre-existing diabetes and high blood pressure. In simple terms, these pilot data suggest a 25-30-fold reduced risk of ICU admission amongst patients who received the calcifediol intervention [35].…”

Section: Intervention Studies Showing Reduced Disease Severity and Rementioning

confidence: 81%

Vitamin D and SARS-CoV-2 infection—evolution of evidence supporting clinical practice and policy development

et al. 2020

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“…8 An intervention study with calcifediol noticed a reduction in requirement for intensive care among hospitalised patients for COVID19. 9 However, vitamin D levels were neither available at baseline nor during follow up in the study. It is noticed that those receiving vitamin D supplementation have fewer respiratory tract infections.…”

Section: Introductionmentioning

confidence: 99%

Short term, high-dose vitamin D supplementation for COVID-19 disease: a randomised, placebo-controlled, study (SHADE study)

Bhansali

Khare

Suri

et al. 2020

Postgraduate Medical Journal

272

285

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BackgroundVitamin D has an immunomodulatory role but the effect of therapeutic vitamin D supplementation in SARS-CoV-2 infection is not known.AimEffect of high dose, oral cholecalciferol supplementation on SARS-CoV-2 viral clearance.DesignRandomised, placebo-controlled.ParticipantsAsymptomatic or mildly symptomatic SARS-CoV-2 RNA positive vitamin D deficient (25(OH)D<20 ng/ml) individuals.InterventionParticipants were randomised to receive daily 60 000 IU of cholecalciferol (oral nano-liquid droplets) for 7 days with therapeutic target 25(OH)D>50 ng/ml (intervention group) or placebo (control group). Patients requiring invasive ventilation or with significant comorbidities were excluded. 25(OH)D levels were assessed at day 7, and cholecalciferol supplementation was continued for those with 25(OH)D <50 ng/ml in the intervention arm. SARS-CoV-2 RNA and inflammatory markers fibrinogen, D-dimer, procalcitonin and (CRP), ferritin were measured periodically.Outcome measureProportion of patients with SARS-CoV-2 RNA negative before day-21 and change in inflammatory markers.ResultsForty SARS-CoV-2 RNA positive individuals were randomised to intervention (n=16) or control (n=24) group. Baseline serum 25(OH)D was 8.6 (7.1 to 13.1) and 9.54 (8.1 to 12.5) ng/ml (p=0.730), in the intervention and control group, respectively. 10 out of 16 patients could achieve 25(OH)D>50 ng/ml by day-7 and another two by day-14 [day-14 25(OH)D levels 51.7 (48.9 to 59.5) ng/ml and 15.2 (12.7 to 19.5) ng/ml (p<0.001) in intervention and control group, respectively]. 10 (62.5%) participants in the intervention group and 5 (20.8%) participants in the control arm (p<0.018) became SARS-CoV-2 RNA negative. Fibrinogen levels significantly decreased with cholecalciferol supplementation (intergroup difference 0.70 ng/ml; P=0.007) unlike other inflammatory biomarkers.ConclusionGreater proportion of vitamin D-deficient individuals with SARS-CoV-2 infection turned SARS-CoV-2 RNA negative with a significant decrease in fibrinogen on high-dose cholecalciferol supplementation.Trial register numberNCT04459247.

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“Effect of calcifediol treatment and best available therapy versus best available therapy on intensive care unit admission and mortality among patients hospitalized for COVID-19: A pilot randomized clinical study”

Cited by 599 publications

References 42 publications

Vitamin D Supplementation Associated to Better Survival in Hospitalized Frail Elderly COVID-19 Patients: The GERIA-COVID Quasi-Experimental Study

Vitamin D Supplementation Associated to Better Survival in Hospitalized Frail Elderly COVID-19 Patients: The GERIA-COVID Quasi-Experimental Study

Vitamin D and SARS-CoV-2 infection—evolution of evidence supporting clinical practice and policy development

Short term, high-dose vitamin D supplementation for COVID-19 disease: a randomised, placebo-controlled, study (SHADE study)

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