NCT04525820: VitCov

High Dose Vitamin-D Substitution in Patients With COVID-19: a Randomized Controlled, Multi Center Study

Completed NA Last updated 8 February 2023

What this trial tests

NA trial testing Single high dose vitamin D in Covid19 in 80 participants. Completed in 30 November 2021.

Timeline

15 December 2020

Primary endpoint
30 August 2021

30 November 2021

Quick facts

Lead sponsor	Prof. Dr. Jörg Leuppi
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	80
Start date	15 December 2020
Primary completion	30 August 2021
Estimated completion	30 November 2021
Sites	2 locations across Switzerland

Drugs / interventions tested

• Single high dose vitamin D — full drug profile →
• Placebo
• Treatment as usual vitamin D — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →
• Vitamin D Deficiency — all drugs for Vitamin D Deficiency →
• Corona Virus Infection — all drugs for Corona Virus Infection →
• ARDS — all drugs for ARDS →

Sponsor

Prof. Dr. Jörg Leuppi

Who can join

18 and older, any sex, with Covid19 or Vitamin D Deficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The world is currently facing a pandemic with the coronavirus (SARS-CoV-2) which leads to the disease of COVID-19. Risk factors for a poor outcome of COVID-19 have so far been identified as older age and co-morbidity including chronic respiratory conditions such as chronic obstructive pulmonary disease (COPD) and current smoking status. Previous studies found, that vitamin D deficiency is more prevalent among patients with these risk factors. There are observational studies reporting independent associations between low serum concentrations of 25-hydroxyvitamin D (the major circulating vitamin D metabolite) and susceptibility to acute respiratory tract infection.

Vitamin D substitution in patients with COVID-19 who show a vitamin D deficiency should therefore be investigated for efficacy and safety.

The study is designed as a randomized, placebo-controlled, double blind study. The objective of the study is to test the hypothesis that patients with vitamin D deficiency suffering from COVID-19 treated under standardized conditions in hospital will recover faster when additionally treated with a single high dose of vitamin D compared to standard treatment only.

Publications & conference data

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

1. 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
2. Mitochondrial network dynamics in pulmonary disease: Bridging the gap between inflammation, oxidative stress, and bioenergetics.
   Pokharel MD, Garcia-Flores A, Marciano D, Franco MC, et al · · 2024 · cited 73× · PMID 38295575 · DOI 10.1016/j.redox.2024.103049
3. Involvement of the secosteroid vitamin D in autoimmune rheumatic diseases and COVID-19.
   Cutolo M, Smith V, Paolino S, Gotelli E. · · 2023 · cited 36× · PMID 36977791 · DOI 10.1038/s41584-023-00944-2
4. Role of Neutrophil Extracellular Traps in COVID-19 Progression: An Insight for Effective Treatment.
   Blanch-Ruiz MA, Ortega-Luna R, Gómez-García G, Martínez-Cuesta MÁ, et al · · 2021 · cited 17× · PMID 35052711 · DOI 10.3390/biomedicines10010031
5. High-dose vitamin D substitution in patients with COVID-19: study protocol for a randomized, double-blind, placebo-controlled, multi-center study-VitCov Trial.
   Jaun F, Boesing M, Lüthi-Corridori G, Abig K, et al · · 2022 · cited 16× · PMID 35120577 · DOI 10.1186/s13063-022-06016-2
6. COVID-19 and renin angiotensin aldosterone system: Pathogenesis and therapy.
   Babajani F, Kakavand A, Mohammadi H, Sharifi A, et al · · 2021 · cited 16× · PMID 34869917 · DOI 10.1002/hsr2.440
7. Micronutrient therapy and effective immune response: a promising approach for management of COVID-19.
   Lotfi F, Akbarzadeh-Khiavi M, Lotfi Z, Rahbarnia L, et al · · 2021 · cited 11× · PMID 34160789 · DOI 10.1007/s15010-021-01644-3
8. Effect of Single High Dose Vitamin D Substitution in Hospitalized COVID-19 Patients with Vitamin D Deficiency on Length of Hospital Stay.
   Jaun F, Boesing M, Luethi-Corridori G, Abig K, et al · · 2023 · cited 9× · PMID 37238948 · DOI 10.3390/biomedicines11051277