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

NCT04525820 | Completed

• 1 other identifier: 2020-01401
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Covid19; Vitamin D Deficiency; ARDS; Corona Virus; High dose vitamin D

Outcome Measures

Primary Outcomes (1)

• Length of hospitalization

  Overall duration of the hospitalization from day of admission until the day of discharge or fatality

  Administration to Discharge from hospital care (mean duration is between 14 and 22 days for Patients with COVID 19)

Secondary Outcomes (5)

• Need of intensive care

  Until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)

• Lenght of the Intensive Care Treatment

  Until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)

• Overall mortality

  During the length of hospitalisation (mean duration is between 14 and 22 days for Patients with COVID-19)

• Development of vitamin D levels

  Day 1 (Baseline) and Day 7 after the first administration of the high dose vitamin D or the placebo and at discharge (mean hospital stay is between 14 and 22 days for Patients with COVID-19)

• Development of sepsis

  During the length of hospitalization (mean duration is between 14 and 22 days for Patients with COVID-19)

Other Outcomes (10)

• Complications due to COVID-19

  During the length of hospitalization (mean duration is between 14 and 22 days for Patients with COVID-19)

• Blood pressure (BP)

  Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)

• Heart rate

  Daily until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)

Study Arms (2)

High Dose Vitamin D

EXPERIMENTAL

Patient will receive a single high dose of vitamin D (140'000) in addition to daily 800 IU of vitamin D. The medication be administered orally

Drug: Single high dose vitamin D; Drug: Treatment as usual vitamin D

Placebo

PLACEBO COMPARATOR

Patient will receive a single dose of placebo, orally administered and then treatment as usual (daily 800 IU of vitamin D, orally administered)

Drug: Placebo; Drug: Treatment as usual vitamin D

Interventions

Single high dose vitamin D DRUG

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

Also known as: VITAMIN D3 oil 500 IU/drop

High Dose Vitamin D

Placebo DRUG

Patient receives a single dose of a placebo solution

Also known as: Oily placebo solution

Placebo

Treatment as usual vitamin D DRUG

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

Also known as: Vitamin D3 solution 4000 IU/ml

High Dose Vitamin D; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Prof. Dr. Jörg Leuppi: lead

Study Sites (2)

Cantonal Hospital Baselland Liestal

Liestal, Basel-Landschaft, 4410, Switzerland

Location

Cantonal Hospital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9001, Switzerland

Location

Related Publications (1)

• Jaun F, Boesing M, Luthi-Corridori G, Abig K, Makhdoomi A, Bloch N, Lins C, Raess A, Grillmayr V, Haas P, Schuetz P, Gabutti L, Muser J, Leuppi-Taegtmeyer AB, Giezendanner S, Brandle M, Leuppi JD. High-dose vitamin D substitution in patients with COVID-19: study protocol for a randomized, double-blind, placebo-controlled, multi-center study-VitCov Trial. Trials. 2022 Feb 4;23(1):114. doi: 10.1186/s13063-022-06016-2.

  PMID: 35120577 DERIVED

MeSH Terms

Conditions

COVID-19; Vitamin D Deficiency; Coronavirus Infections; Severe Acute Respiratory Syndrome

Interventions

Single Person; Vitamin D; Cholecalciferol; Therapeutics

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Officials

• Jörg D Leuppi, Professor

  Cantonal Hosptal, Baselland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The blinding is performed by the hospital pharmacy of the university hospital of Basel. They will provide us with packed and labeled study medication and placebo. They will provide us with medication packages for each patient which includes either high dose vitamin D and the standard medication or the placebo and the standard medication.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, Medical University Clinic, Principal Investigator

Model Details: one group receives a single high dose of vitamin D in addition to treatment as usual (TAU) the other group receives a single dose of placebo in addition to TAU

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 25, 2020
• Study Start: December 15, 2020
• Primary Completion: August 30, 2021
• Study Completion: November 30, 2021
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)