Short term, high-dose vitamin D supplementation for COVID-19 disease: a randomised, placebo-controlled, study (SHADE study)

Comment: From day one, the medical and regulatory response strategy to Covid-19 has focused on the use of non-medical measures such as masks and lockdowns, and later vaccines. In no way was treatment of the infected with existing drugs or prevention used to improve immune function. This is a lack of assistance from the authorities and a failure of the medical profession in general. Like influenza, Covid-19 is a seasonal illness that is triggered, among other things, by a reduction in the natural immune function in the airways and by vitamin D3 deficiency. In this double-blind study, this immune-boosting effect of vitamin D was documented and quantified in people without previous illnesses. The inflammation levels in infected people fell faster with the help of D3.

Background: Vitamin D plays an immunomodulatory role, but the effect of therapeutic vitamin D supplementation in SARS-CoV-2 infection is unknown.

Objective: Effect of high-dose, oral cholecalciferol supplementation on viral clearance of SARS-CoV-2.

Design: Randomized, placebo controlled.

Participants: Asymptomatic or mildly symptomatic SARS-CoV-2 RNA positive individuals with vitamin D deficiency (25(OH)D < 20 ng/mL).

Intervention: Participants were randomized to receive cholecalciferol (oral nano-liquid droplets) 60,000 IU daily for 7 days with a therapeutic goal of 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 determined on 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 regularly.

Outcome measurement: 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 randomly assigned to the intervention (n = 16) or control (n = 24) groups. 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 groups, respectively. 10 of 16 patients were able to reach 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 groups, respectively]. 10 (62.5%) participants in the intervention arm and 5 (20.8%) participants in the control arm (p<0.018) became SARS-CoV-2 RNA negative. Fibrinogen levels decreased significantly with cholecalciferol supplementation, in contrast to other inflammatory biomarkers (difference between groups 0.70 ng/mL; P=0.007).

Conclusion: A greater proportion of vitamin D-deficient individuals with SARS-CoV-2 infection became SARS-CoV-2 RNA negative with a significant decrease in fibrinogen with high-dose cholecalciferol supplementation.

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