High doses of vitamin D3 in a sub-group of COVID-19 patients who participated in CARED clinical study

Abstract

Background: Previously, we evaluated angiotensin levels and the cytokine profile in patients with mild COVID-19 and treated with high doses of vitamin D3 (ClinicalTrials.gov NCT04411446). Unfortunately, this treatment did not improve the protective components.Objectives: To perform a sub-study excluding old and obese patients as possible confounders. Methods: From the initial 16 patients, we excluded those with BMI greater than 40 and those older than 70 and were randomized to a single oral dose of 500,000 IU vitamin D3 (n=7) or placebo (n=4). Ang II and Ang-(1-7) levels were determined by radioimmunoassay and interleukins (ILs) 1, 6, 8, and 10 and TNF-α by ELISA before and after treatment. Parallel, serum 25-OH vitamin D concentrations was measured by a chemiluminescence immunoassay.Results: We verified a trend to the highest reduction in pro-inflammatory ILs and protective markers of Ang-(1-7) and Ang-(1-7)/Ang II ratio in the vitamin D3 treated group.Conclusions: High-dose vitamin D3 supplementation in mild to moderate COVID-19-positive patients with plasma vitamin D levels within the normal range -even eliminating obesity and ageing- did not cause significant changes in clinical aspects.