NCT04449718

Vitamin D Supplementation in Patients With COVID-19

Completed NA Last updated 17 November 2020

What this trial tests

NA trial testing Vitamin D in COVID-19 in 240 participants. Completed in 7 October 2020.

Timeline

1 June 2020

Primary endpoint
7 October 2020

7 October 2020

Quick facts

Lead sponsor	University of Sao Paulo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	240
Start date	1 June 2020
Primary completion	7 October 2020
Estimated completion	7 October 2020
Sites	1 location across Brazil

Drugs / interventions tested

• Vitamin D
• Placebo

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

University of Sao Paulo

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Coronavirus disease 2019 (COVID-19) was declared an emergency public health problem by the World Health Organization (WHO) in March 2020. Since then, several initiatives by the medical and scientific community have sought alternatives to treat infected individuals, as well as identifying risk or protective factors for the contamination and prognosis of patients. In this perspective, vitamin D supplementation can improve some important outcomes in critically ill patients, being considered a potent immunomodulatory agent. Vitamin D deficiency is a common outcome in critically ill patients, thus making it a modifiable risk factor with great potential for reducing hospital stay and intensive care and mortality. The investigators speculate that vitamin D supplementation could have therapeutic effects in patients with COVID-19.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of a Single High Dose of Vitamin D3 on Hospital Length of Stay in Patients With Moderate to Severe COVID-19: A Randomized Clinical Trial.
   Murai IH, Fernandes AL, Sales LP, Pinto AJ, et al · · 2021 · cited 364× · PMID 33595634 · DOI 10.1001/jama.2020.26848
2. Immune-boosting role of vitamins D, C, E, zinc, selenium and omega-3 fatty acids: Could they help against COVID-19?
   Shakoor H, Feehan J, Al Dhaheri AS, Ali HI, et al · · 2021 · cited 206× · PMID 33308613 · DOI 10.1016/j.maturitas.2020.08.003
3. Vitamin D supplementation for the treatment of COVID-19: a living systematic review.
   Stroehlein JK, Wallqvist J, Iannizzi C, Mikolajewska A, et al · · 2021 · cited 85× · PMID 34029377 · DOI 10.1002/14651858.cd015043
4. Role of vitamins and minerals as immunity boosters in COVID-19.
   Kumar P, Kumar M, Bedi O, Gupta M, et al · · 2021 · cited 75× · PMID 34110533 · DOI 10.1007/s10787-021-00826-7
5. Association of vitamin D deficiency with COVID-19 infection severity: Systematic review and meta-analysis.
   Wang Z, Joshi A, Leopold K, Jackson S, et al · · 2022 · cited 73× · PMID 34160843 · DOI 10.1111/cen.14540
6. The epigenetic implication in coronavirus infection and therapy.
   Atlante S, Mongelli A, Barbi V, Martelli F, et al · · 2020 · cited 65× · PMID 33087172 · DOI 10.1186/s13148-020-00946-x
7. Zinc, Vitamin D and Vitamin C: Perspectives for COVID-19 With a Focus on Physical Tissue Barrier Integrity.
   Name JJ, Souza ACR, Vasconcelos AR, Prado PS, et al · · 2020 · cited 54× · PMID 33365326 · DOI 10.3389/fnut.2020.606398
8. Micronutrients, Phytochemicals and Mediterranean Diet: A Potential Protective Role against COVID-19 through Modulation of PAF Actions and Metabolism.
   Detopoulou P, Demopoulos CA, Antonopoulou S. · · 2021 · cited 52× · PMID 33573169 · DOI 10.3390/nu13020462