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

• Status: Active, not recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prof. Dr. Jörg Leuppi
• Treatments: Cholecalciferol; Ergocalciferols; Pharmaceutical Solutions; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Informed Consent as documented by signature

• Hospitalized Patient

• Ongoing COVID-19 infection

• Vitamin D deficiency defined as a serum 25-hydroxyvitamin D concentration ≤ 50nmol/l( ≤20ng/ml)

• > 18 years of age

Exclusion Criteria:

• Known hypersensitivity to one of the used products of vitamin D or indigents in the drug's composition

• Active malignancy

• Hypercalcemia

• Granulomatous disease such as sarcoidosis

• History of renal stones within the past year

• Pregnancy/breastfeeding, as evaluated through screening,

• Previous enrollment into the current study,

• Enrollment of the investigator, his/her family members, employees and other dependent persons,