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

Take Home Message

In this 40 person randomized, placebo-controlled  study in India a greater proportion of vitamin D-deficient individuals with mildly symptomatic COVID-19 infections tested COVID-19 negative within 21 days when given high-dose (60,000 IU daily for 7 days) vitamin D3 supplementation compared to those who were not given vitamin D supplementation. This suggests that vitamin D levels may help to reduce transmission rates of individuals who may be contagious.

 

Results

  • The median 25(OH)D level at Day 14 in the intervention group was 129.3 nmol/L with a median increase of 106 nmol/L and in the control group was 38 nmol/L with a median increase of 12.8 nmol/L.
  • 5% participants in the vitamin D intervention group achieved COVID-19 negativity within 21 days compared to 20.8% participants in the control group (this was a significant difference).
  • A significant decrease in fibrinogen was observed in the intervention group compared to the control group. No significant differences in other inflammatory markers were observed.

Who

Forty asymptomatic or mildly symptomatic COVID-19 PCR positive and vitamin D-deficient individuals with no co-morbidities who were admitted to a hospital in north India between June 15, 2020 and August 30, 2020.

Things to Keep in Mind

  • Only 16 mildly symptomatic and asymptomatic individuals who had no comorbidities were enrolled in the intervention arm of the study, which limits the generalizability of the results to moderate or severe cases of COVID-19.
  • The placebo used in the study was not exactly matched with regards to the taste and consistency to the vitamin D3 treatment.
  • The dose of vitamin D3 used in the present study is high compared to conventional treatment and warrants a close follow-up to look for vitamin D toxicity.

 

Author’s Conclusions

High-dose, oral vitamin D supplementation to augment 25(OH)D to >125 nmol/L helped to achieve COVID-19 RNA negativity in a greater proportion of vitamin

D-deficient individuals with asymptomatic or mild COVID-19 infection within 21 days. Testing negative faster may help to decrease transmission rates in highly contagious individuals.

Study Design

  • Randomized-placebo controlled study.
  • Sixteen patients testing positive for COVID-19 with vitamin D deficiency defined as 25(OH)D level <50 nmol/L were randomized to receive daily 60,000 IU of vitamin D3 (5 ml oral solution) for 7 days (intervention group) with the aim to achieve a 25(OH)D level of >125 nmol/L by Day 7. Average age was 50.0 years (range 36-51 years), 62.5% were women and baseline median serum 25(OH)D was 21.5 (range= 17.7-32.7) nmol/L.
  • Twenty-four patients with vitamin D deficiency defined as 25(OH)D level <50 nmol/L were randomized to receive a placebo of 5 ml distilled water for 7 days (control group). Average age was 47.5 years (range=39.3-49.2 years), 41.7% were women and baseline median serum 25(OH)D was 23.8 (range=20.2-31.2) nmol/L.
  • The primary outcome measure was the proportion of participants who tested negative for COVID-19 by PCR (confirmed twice at a 24-hour interval) in the two groups before Day 21.
  • A secondary outcome measure was the change in the level of inflammatory markers (D-dimer, fibrinogen, C-reactive protein and procalcitonin) with treatment.

Reference

Rastogi A, Bhansali A, Khare N, Suri V, Yaddanapudi N, Sachdeva N, Puri GD, Malhotra P. Short term, high-dose vitamin D supplementation for COVID-19 disease: a randomised, placebo-controlled, study (SHADE study). Postgrad Med J. 2020 Nov 12:postgradmedj-2020-139065. doi: 10.1136/postgradmedj-2020-139065. Epub ahead of print. PMID: 33184146

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