Oct. 1, 2023

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

Short term, high-dose vitamin D supplementation for COVID-19 disease: a randomised, placebo-controlled, study (SHADE study)
COVID-19 is a respiratory infection caused by the SARS-CoV-2 virus. A growing number of studies have demonstrated the importance of vitamin D in regulating the immune system and controlling COVID-19 disease severity. Authors of a new study found that vitamin D supplementation shortened SARS-CoV-2 infection in vitamin D-deficient people. Vitamin D is a hormone that affects the expression of many genes important for immune function. Vitamin D deficiency is associated with greater risk of influenza and other respiratory infections. Unfortunately, one 2012 report estimates that approximately half of all people worldwide have vitamin D insufficiency, and 1 billion have vitamin D deficiency, defined as blood levels less than 12 nanograms per milliliter. The study involved 40 adults who had a positive SARS-CoV-2 RNA test; mild or no COVID-19 symptoms; and vitamin D deficiency (blood level less than 20 nanograms per milliliter). The authors assigned 16 study participants to take 60,000 international units of vitamin D3 (cholecalciferol) orally until they reached a blood level greater than 50 nanograms per milliliter. At baseline, the average serum vitamin D level in the treatment group was 8.6 nanograms per milliliter. After two weeks of supplementation, 75 percent of the participants achieved a vitamin D blood level greater than 50 nanograms per milliliter. Those who corrected their deficiency were more likely to clear the virus by day 21 of the study. They also experienced a decrease in serum fibrinogen, a marker of inflammation. The authors concluded that short-term high dose oral vitamin D supplementation is effective in correcting deficiency and promotes the clearance of SARS-CoV-2. They encouraged cholecalciferol supplementation as a way to decrease viral transmission.
Affiliations 

Abstract

Background: Vitamin D has an immunomodulatory role but the effect of therapeutic vitamin D supplementation in SARS-CoV-2 infection is not known.

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

Design: Randomised, placebo-controlled.

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

Intervention: Participants were randomised to receive daily 60 000 IU of cholecalciferol (oral nano-liquid droplets) for 7 days with therapeutic target 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 assessed at 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 periodically.

Outcome measure: 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 randomised to intervention (n=16) or control (n=24) group. 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 group, respectively. 10 out of 16 patients could achieve 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 group, respectively]. 10 (62.5%) participants in the intervention group and 5 (20.8%) participants in the control arm (p<0.018) became SARS-CoV-2 RNA negative. Fibrinogen levels significantly decreased with cholecalciferol supplementation (intergroup difference 0.70 ng/ml; P=0.007) unlike other inflammatory biomarkers.

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

Trial register number: NCT04459247.

Keywords: Diabetes & endocrinology; Infectious diseases; Virology.

© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.

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