REsCue trial: Randomized controlled clinical trial with extended-release calcifediol in symptomatic COVID-19 outpatients
| Autor: | Charles W. Bishop, Akhtar Ashfaq, Joel Z. Melnick, Enrique Vazquez-Escarpanter, Jonathan A. Fialkow, Stephen A. Strugnell, John Choe, Kamyar Kalantar-Zadeh, Noah C. Federman, David Ng, John S. Adams |
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| Rok vydání: | 2023 |
| Předmět: |
Adult
Male Nutrition and Dietetics Nutrition & Dietetics Endocrinology Diabetes and Metabolism Clinical Trials and Supportive Activities COVID-19 Outpatient Evaluation of treatments and therapeutic interventions Vitamin D Deficiency Medical and Health Sciences Treatment Outcome Double-Blind Method Clinical Research 6.1 Pharmaceuticals Outpatients Humans Female Extended-release Vitamin D Extended -release Calcifediol |
| Zdroj: | Nutrition. 107:111899 |
| ISSN: | 0899-9007 |
| DOI: | 10.1016/j.nut.2022.111899 |
| Popis: | ObjectivesThis 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.MethodsCOVID-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).ResultsIn 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.ConclusionERC 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. |
| Databáze: | OpenAIRE |
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