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REsCue trial: Randomized controlled clinical trial with extended-release calcifediol in symptomatic COVID-19 outpatients.
Bishop, Charles W; Ashfaq, Akhtar; Melnick, Joel Z; Vazquez-Escarpanter, Enrique; Fialkow, Jonathan A; Strugnell, Stephen A; Choe, John; Kalantar-Zadeh, Kamyar; Federman, Noah C; Ng, David; Adams, John S.
Afiliación
  • Bishop CW; Renal Division, OPKO Health, Miami, FL, USA.
  • Ashfaq A; Renal Division, OPKO Health, Miami, FL, USA.
  • Melnick JZ; SCD Advisor, Evanston, IL, USA.
  • Vazquez-Escarpanter E; Kendall South Medical Center, Miami, FL, USA.
  • Fialkow JA; Baptist Health South Florida, Coral Gables, FL, USA.
  • Strugnell SA; Renal Division, OPKO Health, Miami, FL, USA.
  • Choe J; Renal Division, OPKO Health, Miami, FL, USA.
  • Kalantar-Zadeh K; Division of Nephrology, Hypertension and Kidney Transplantation, University of California Irvine, Orange, CA, USA.
  • Federman NC; Department of Pediatrics, David Geffen School of Medicine, UCLA, Los Angeles, CA, USA.
  • Ng D; WuXi Clinical, Austin, TX, USA.
  • Adams JS; Departments of Orthopaedic Surgery and Molecular, Cell and Developmental Biology, UCLA, Los Angeles, CA, USA.
Nutrition ; 107: 111899, 2023 03.
Article en En | MEDLINE | ID: mdl-36529089
OBJECTIVES: This double-blind randomized controlled trial investigated raising serum 25-hydroxyvitamin D (25D) with extended-release calcifediol (ERC) on time to symptom resolution in patients with mild to moderate COVID-19. METHODS: COVID-19 outpatients received oral ERC (300 mcg on days 1-3 and 60 mcg on days 4-27) or placebo (NCT04551911). Symptoms were self-reported daily. Primary end points were raising 25D to ≥50 ng/mL and decreasing resolution time for five aggregated symptoms (three respiratory). RESULTS: In all, 171 patients were randomized, 160 treated and 134 (65 ERC, 69 placebo) retained. The average age was 43 y (range 18-71), 59% were women. The mean baseline 25D was 37 ± 1 (SE) ng/mL. In the full analysis set (FAS), 81% of patients in the ERC group achieved 25D levels of ≥50 ng/mL versus 15% in the placebo group (P < 0.0001). In the per-protocol (PP) population, mean 25D increased with ERC to 82 ± 4 (SE) ng/mL (P < 0.0001) by day 7; the placebo group trended lower. Symptom resolution time was unchanged in the FAS by ERC (hazard ratio [HR], 0.983; 95% confidence interval [CI], 0.695-1.390; P = 0.922). In the PP population, respiratory symptoms resolved 4 d faster when 25D was elevated above baseline level at both days 7 and 14 (median 6.5 versus 10.5 d; HR, 1.372; 95% CI, 0.945-1.991; P = 0.0962; Wilcoxon P = 0.0386). Symptoms resolved in both treatment groups to a similar extent by study end. Safety concerns including hypercalcemia were absent with ERC treatment. CONCLUSION: ERC safely raised serum 25D to ≥50 ng/mL in outpatients with COVID-19, possibly accelerating resolution of respiratory symptoms and mitigating the risk for pneumonia. These findings warrant further study.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Deficiencia de Vitamina D / COVID-19 Tipo de estudio: Clinical_trials / Diagnostic_studies / Guideline Límite: Adult / Female / Humans / Male Idioma: En Revista: Nutrition Asunto de la revista: CIENCIAS DA NUTRICAO Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Deficiencia de Vitamina D / COVID-19 Tipo de estudio: Clinical_trials / Diagnostic_studies / Guideline Límite: Adult / Female / Humans / Male Idioma: En Revista: Nutrition Asunto de la revista: CIENCIAS DA NUTRICAO Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos