Background
The role of oral vitamin D3 supplementation for hospitalized patients with COVID-19 remains to be determined. The study was aimed to evaluate whether vitamin D3 supplementation could prevent respiratory worsening among hospitalized patients with COVID-19.
Methods and findings
We designed a multicentre, randomized, double-blind, sequential, placebo-controlled clinical trial. The study was conducted in 17 second and third level hospitals, located in four provinces of Argentina, from 14 August 2020 to 22 June 2021. We enrolled 218 adult patients, hospitalized in general wards with SARS-CoV-2 confirmed infection, mild-to-moderate COVID-19 and risk factors for disease progression. Participants were randomized to a single oral dose of 500 000 IU of vitamin D3 or matching placebo. Randomization ratio was 1:1, with permuted blocks and stratified for study site, diabetes and age (≤60 vs >60 years). The primary outcome was the change in the respiratory Sepsis related Organ Failure Assessment score between baseline and the highest value recorded up to day 7. Secondary outcomes included the length of hospital stay; intensive care unit admission; and in-hospital mortality. Overall, 115 participants were assigned to vitamin D3 and 105 to placebo (mean [SD] age, 59.1 [10.7] years; 103 [47.2%] women). There were no significant differences in the primary outcome between groups (median [IQR] 0.0 [0.0–1.0] vs 0.0 [0.0–1.0], for vitamin D3 and placebo, respectively; p = 0.925). Median [IQR] length of hospital stay was not significantly different between vitamin D3 group (6.0 [4.0–9.0] days) and placebo group (6.0 [4.0–10.0] days; p = 0.632). There were no significant differences for intensive care unit admissions (7.8% vs 10.7%; RR 0.73; 95% CI 0.32 to 1.70; p = 0.622), or in-hospital mortality (4.3% vs 1.9%; RR 2.24; 95% CI 0.44 to 11.29; p = 0.451). There were no significant differences in serious adverse events (vitamin D3 = 14.8%, placebo = 11.7%).
Conclusions
Among hospitalized patients with mild-to-moderate COVID-19 and risk factors, a single high oral dose of vitamin D3 as compared with placebo, did not prevent the respiratory worsening.
Trial registration
ClincicalTrials.gov Identifier: NCT04411446.
Oncologic emergencies have been extensively described and clearly defined. In oncology daily practice, cancer patients seek non-scheduled medical care in situations they perceive as a medical emergency, but which may not be a true emergency. The aim of the study was to identify the main symptoms leading to a non-scheduled consultation (NSC) and their relationship to the type of cancer, and to evaluate whether the diagnosis at discharge of patients admitted as result of a NSC correlates with a true oncologic emergency. This was a prospective observational study. Between July 2002 and April 2003, 365 NSCs were recorded. The most frequent baseline diseases were breast cancer (70), lung cancer (67), gastrointestinal cancer (52), lymphoma (42) and ovarian cancer (22). The most common symptoms for consultation were: fever (84), pain (81), cutaneous manifestations (26), dyspnea (23), bleeding (16) and abdominal distention (16). Overall, 114 of 365 NSCs (31%) resulted in admission. The most frequent symptoms resulting in admission were fever (42), pain (16), dyspnea (11), vomiting (9), neurologic manifestations (7), abdominal distention (6) and anuria (6). At discharge, only 30 patients (26%) admitted after a NSC were diagnosed with a defined oncologic emergency: febrile neutropenia (13), intestinal occlusion (12), obstructive uropathy (4) and abdominal perforation (1). True emergencies were not the most frequent causes of NSC at our institution.
Preliminary open trials performed by the authors and others with Moclobemide, a new MAO-A inhibitor, indicated that the drug has a satisfactory antidepressant activity. In the present double-blind study Moclobemide has been compared to placebo in a group of 34 unipolar psychotic or neurotic depressed patients. The mean daily dose of Moclobemide was 297 mg and treatment lasted from two to four weeks. Drug effectiveness was measured by improvements in the Hamilton Rating Scale for Depression (HRSD), Clinical Global Impression (CGI) and 100 mm Visual Analogue Scale (VAS). The results have shown that the active drug was markedly superior to placebo. The mean total score of HRSD was reduced from 41.7 to 16.5 in 18 pts. treated with Moclobemide and from 36.3 to 29.1 in 16 pts. who received placebo. Self-assessment with VAS showed a mean reduction from 82.7 mm to 42.2 mm and from 84.3 to 70.6 mm respectively. Moderate to marked improvement was observed by the CGI in 15 cases treated with Moclobemide and mild to moderate in 5 cases who received placebo. The treatment was well tolerated.
The study found a high prevalence of vitamin D deficiency in hospitalized cancer patients under active treatment. Many authors have recommended dosing vitamin D levels in this population; normalizing serum levels is difficult.
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