NCT04385940

Vitamin D and COVID-19 Management

Completed Phase 3 Last updated 23 January 2025

What this trial tests

Phase 3 trial testing Ddrops® products, 50,000 IU, Oral in COVID-19 in 11 participants. Completed in 2 July 2024.

Timeline

19 March 2021

Primary endpoint
2 July 2024

2 July 2024

Quick facts

Lead sponsor	University of Alberta
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	11
Start date	19 March 2021
Primary completion	2 July 2024
Estimated completion	2 July 2024
Sites	1 location across Canada

Drugs / interventions tested

• Ddrops® products, 50,000 IU, Oral
• Vitamin D3 (cholecalciferol) — full drug profile →

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

University of Alberta

Who can join

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

Sponsor's own description

A novel coronavirus disease 2019 (COVID-19) outbreak is a global dramatic pandemic that is immeasurably impacting the communities. Due to lack of data, symptomatic management is used for COVID-19 infection including oxygen therapy and mechanical ventilation for those with severe infection. Considering immunomodulatory, anti-inflammatory anti-fibrotic and anti-oxidant actions of vitamin D, it's safety and ease of administration, as well as direct effects of vitamin D on immune cell proliferation and activity, pulmonary ACE2 expression and reducing surface tension, evaluation of vitamin D supplementation as an adjuvant therapeutic intervention could be of substantial clinical and economic significance. High prevalence of vitamin D deficiency in elderly, smokers, patients with chronic diseases and excess uptake by adipose tissue in obesity make investigations of its role as a secondary therapeutic agent in COVID-19 conceivable. It should be necessary to monitor serum 25(OH)D levels in all inpatient and outpatient populations with COVID-19 to identify the importance of maintaining or promptly increasing circulating levels of 25(OH)D into the optimal range of 100-150 nmol/L.

The aim of this study is to conduct a double blind, randomized, controlled three weeks clinical trial on the efficacy of vitamin D (daily low dose versus weekly high dose) in COVID-19 patients in order to determine the relationship between baseline vitamin D deficiency and clinical characteristics and to asses patients' response to vitamin D supplementation in week three and determine its association with disease progression and recovery.

Subjects who are randomized to high-dose will be asked to take 50,000 IU for two times during the first week and one dose over second and third weeks to quickly raise their serum levels. Subjects in the low-dose arm will take vitamin D 1000 IU daily for three weeks.

Publications & conference data

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

1. 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
2. COVID-19: Characteristics and Therapeutics.
   Chilamakuri R, Agarwal S. · · 2021 · cited 192× · PMID 33494237 · DOI 10.3390/cells10020206
3. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
4. Perspective: Vitamin D deficiency and COVID-19 severity - plausibly linked by latitude, ethnicity, impacts on cytokines, ACE2 and thrombosis.
   Rhodes JM, Subramanian S, Laird E, Griffin G, et al · · 2021 · cited 152× · PMID 32613681 · DOI 10.1111/joim.13149
5. Oxidative Stress and Inflammation in COVID-19-Associated Sepsis: The Potential Role of Anti-Oxidant Therapy in Avoiding Disease Progression.
   Beltrán-García J, Osca-Verdegal R, Pallardó FV, Ferreres J, et al · · 2020 · cited 103× · PMID 33003552 · DOI 10.3390/antiox9100936
6. 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
7. Multi-omics-based identification of SARS-CoV-2 infection biology and candidate drugs against COVID-19.
   Barh D, Tiwari S, Weener ME, Azevedo V, et al · · 2020 · cited 57× · PMID 33131530 · DOI 10.1016/j.compbiomed.2020.104051
8. Acute Respiratory Distress Syndrome and COVID-19: A Literature Review.
   Hussain M, Khurram Syed S, Fatima M, Shaukat S, et al · · 2021 · cited 38× · PMID 34992415 · DOI 10.2147/jir.s334043