A single-oral bolus of 100,000 IU of cholecalciferol at hospital admission did not improve outcomes in the COVID-19 disease: the COVID-VIT-D-a randomised multicentre international clinical trial.

BACKGROUND: Vitamin D status has been implicated in COVID-19 disease. The objective of the COVID-VIT-D trial was to investigate if an oral bolus of cholecalciferol (100,000 IU) administered at hospital admission influences the outcomes of moderate-severe COVID-19 disease. In the same cohort, the association between baseline serum calcidiol levels with the same outcomes was also analysed. METHODS: The COVID-VIT-D is a multicentre, international, randomised, open label, clinical trial conducted throughout 1 year. Patients older than 18 years with moderate-severe COVID-19 disease requiring hospitalisation were included. At admission, patients were randomised 1:1 to receive a single oral bolus of cholecalciferol (n=274) or nothing (n=269). Patients were followed from admission to discharge or death. Length of hospitalisation, admission to intensive care unit (ICU) and mortality were assessed. RESULTS: In the randomised trial, comorbidities, biomarkers, symptoms and drugs used did not differ between groups. Median serum calcidiol in the cholecalciferol and control groups were 17.0 vs. 16.1 ng/mL at admission and 29.0 vs. 16.4 ng/mL at discharge, respectively. The median length of hospitalisation (10.0 [95%CI 9.0-10.5] vs. 9.5 [95%CI 9.0-10.5] days), admission to ICU (17.2% [95%CI 13.0-22.3] vs. 16.4% [95%CI 12.3-21.4]) and death rate (8.0% [95%CI 5.2-12.1] vs. 5.6% [95%CI 3.3-9.2]) did not differ between the cholecalciferol and control group. In the cohort analyses, the highest serum calcidiol category at admission (>25ng/mL) was associated with lower percentage of pulmonary involvement and better outcomes. CONCLUSIONS: The randomised clinical trial showed the administration of an oral bolus of 100,000 IU of cholecalciferol at hospital admission did not improve the outcomes of the COVID-19 disease. A cohort analysis showed that serum calcidiol at hospital admission was associated with outcomes. TRIAL REGISTRATION: COVID-VIT-D trial was authorised by the Spanish Agency for Medicines and Health products (AEMPS) and registered in European Union Drug Regulating Authorities Clinical Trials (EudraCT 2020-002274-28) and in ClinicalTrials.gov ( NCT04552951 ).

La enfermedad periodontal se asocia con aumento de PCR en pacientes en hemodiálisis crónica / Periodontal disease associated with an increased CRP in Chronic hemodialysis patients

Introducción: La enfermedad periodontal (EP),primera causa de pérdida dentaria en el adulto, comprende un conjunto de lesiones de etiología infecciosa que pueden causar inflamación crónica. Objetivo: Establecer el estado de salud oral, particularmente periodontal, en una población en hemodiálisis crónica (HDC). Métodos: Se trata de un estudio descriptivo de corte transversal en pacientes en HDC. El examen oral fue realizado por un profesional odontólogo en la unidad de diálisis, simultáneamente con la determinación de Proteína C Reactiva (PCR). Se tabularon datos demográficos, etiología diabética y no diabética, tabaquismo, índice de masa corporal, uso de eritropoyetina, cobertura de salud. Los pacientes se dividieron en con EP y sin EP. Resultados: Participaron 65 pacientes, 67,6% hombres, 13,8 % diabéticos, edad media 60,6+16.5, tiempo medio en HDC (en meses) 60,8+53.5. En 41 pacientes (63,1%) se diagnosticó EP, sólo 5 tuvieron un examen dental normal; presentaron caries 8 pacientes (12%), prótesis 12 (18,5%) ( completa superior e inferior 5, completa superior o inferior 3, parciales 4), restos radiculares 19 (29,2%), ausencia de piezas o movilidad dentarias 9 (14%). El grupo con EP vs sin EP presentó PCR 13,6+12,8 vs 7,81+6,5 (valor normal <6mgr/dl), Edad media 58,7+18 vs 63,9+13; tiempo en HDC 60,8+59 vs 57,3+47 respectivamente. Las diferencias fueron estadísticamente significativas sólo con respecto a la PCR (p=0,037). Conclusiones:La prevalencia de patología odontológica fue alta, con franco predominio de la EP. El grupo con EP tuvo significativamente mayor PCR, como marcador de inflamación. La EP es una causa prevenible y tratable de inflamación crónica que debería incluirse en la evaluación al ingreso a HDC.

Introduction: Periodontal disease (PD), the main cause of tooth loss in adults, comprises a series of conditions of infectious etiology that can produce chronic inflammation. Objective: To determine the oral, particularly periodontal,health condition in chronic hemodialysis (CHD) patients. Methods: This is a descriptive, crosssectional study in CHD patients. The oral examination was performed by a certified odontologist in the dialysis unit, together with a C-reactive protein (CRP) assessment. Demographic data, diabetic and non-diabetic etiology, smoking, body mass index, erythropoietin use and health coverage information has been provided in tabulated form. Patients were divided into PD and non-PD groups. Results: 65 patients took part: 67.6% were male, 13.8 % diabetic, mean age of 60.6+16.5, mean time on CHD 60.8+53.5. Forty one patients were diagnosed with PD (63.1%), only 5 had a normal oral examination; 8 patientshad caries (12%), 12 had prosthesis (18.5%) (5 with complete superior and inferior, 3 with complete superior or inferior, 4 with partial prosthesis), 19 presented radicular remains (29.2%), 9 had pieces missing or dental motility (14%). The PD group vs. the non-PD group showed a CRP 13.6+12.8 vs. 7.81+6.5, a mean age of 58.7+18 vs. 63.9+13; a time on CHD of 60.8+59 vs. 57.3+47, respectively. Differences were only statistically significant in connection with the CRP (p=0.037). Conclusions: The prevalence of dental pathologies was high, with a notorious predominance of PD. The PD group had a significantly higher CRP, as inflammation marker. PD is a preventable and treatable cause of chronic disease which should be included in the starting CHD assessment.