Short term, high-dose vitamin D supplementation for COVID-19 disease: a randomised, placebo-controlled, study (SHADE study)
Rastogi A, Bhansali A, Khare N, Suri V, Yaddanapudi N, Sachdeva N, Puri GD, Malhotra P
Postgraduate medical journal · 216 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2020-11-12 · Postgrad Med J · vol. 98 · número 1156 · págs. 87–90
- Editorial
- Oxford University Press
- Citado
- 317 citas · más que el 100% de estudios similares · 36.1× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 24 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY-NC
- Áreas de investigación
- Vitamin D Research Studies · COVID-19 Clinical Research Studies · SARS-CoV-2 and COVID-19 Research
- Palabras clave
- vitamin D supplementation, vitamin D3, COVID-19 pandemic, SARS-CoV-2, vitamin D deficiency, 25-hydroxyvitamin D, viral clearance, asymptomatic infection, inflammatory markers, D-dimer, ferritin, procalcitonin, fibrinogen, C-reactive protein, immunomodulation
- MeSH
- humans, vitamin d deficiency, cholecalciferol, vitamin d, c-reactive protein, fibrinogen, fibrin fibrinogen degradation products, rna, viral, dietary supplements, adult, middle aged, female, male, ferritins, biomarkers, procalcitonin, covid-19, sars-cov-2, covid-19 drug treatment
8 autores
- Ashu Rastogi🇮🇳Post Graduate Institute of Medical Education and Research
- Anil Kumar Bhansali🇮🇳Post Graduate Institute of Medical Education and Research
- Niranjan Khare🇮🇳Post Graduate Institute of Medical Education and Research
- Vikas Suri🇮🇳Post Graduate Institute of Medical Education and Research
- Lakshmi Narayana Yaddanapudi🇮🇳Post Graduate Institute of Medical Education and Research
- Naresh Kumar Sachdeva🇮🇳Post Graduate Institute of Medical Education and Research
- Goverdhan Dutt Puri🇮🇳Post Graduate Institute of Medical Education and Research
- Pankaj Malhotra🇮🇳 · autor de correspondenciaPost Graduate Institute of Medical Education and Research
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Vitamin D has an immunomodulatory role but the effect of therapeutic vitamin D supplementation in SARS-CoV-2 infection is not known.
Aim
Effect of high dose, oral cholecalciferol supplementation on SARS-CoV-2 viral clearance.
Design
Randomised, placebo-controlled.
Participants
Asymptomatic or mildly symptomatic SARS-CoV-2 RNA positive vitamin D deficient (25(OH)D<20 ng/ml) individuals.
Intervention
Participants 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 measure
Proportion of patients with SARS-CoV-2 RNA negative before day-21 and change in inflammatory markers.
Results
Forty 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.
Conclusion
Greater 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 number
NCT04459247.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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