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

Summary

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.

Conditions

• Covid19
• Vitamin D Deficiency
• Corona Virus Infection
• ARDS
• Coronavirus
• SARS-CoV Infection

Interventions

DRUG

Single high dose vitamin D

Patient receives either one dose orally of 140'000 IU (7 ml) of this drug once as an intervention treatment additionally to TAU or the patient receives 7 ml of the placebo Solution (7 ml) in addition to TAU

DRUG

Placebo

Patient receives a single dose of a placebo solution

DRUG

Treatment as usual vitamin D

Both groups receive the treatment as usual after the single high dose or the placebo which will be 800 IU per day

Sponsors & Collaborators

• Prof. Dr. Jörg Leuppi

  lead OTHER

Principal Investigators

• Jörg D Leuppi, Professor · Cantonal Hosptal, Baselland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-15

Primary Completion

2021-08-30

Completion

2021-11-30

Countries

• Switzerland

Study Locations