Skip to main content
OpenTrials
Completed

NCT Number: NCT04385940

Vitamin D and COVID-19 Management

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

About this study

In-patients

  • Determine the frequency of low serum Vit D levels (<50 nmol/L) in COVID-19 patients.
  • Determine the relationship between baseline vitamin D status and disease severity, laboratory biochemical tests of white blood cell count (WBC), C-reactive protein (CRP), lymphocyte count, leukocytes counts and neutrophil-lymphocyte-ratio (NLR), lactate dehydrogenase, IL-6, IL-1beta, TNF-alpha platelet count, albumin, and serum ferritin, required hospitalization and intensive care unit (ICU) admission.
  • Asses patients' initial response to vitamin D supplementation in week one and determine its association with disease progression and recovery.
  • Compare disease severity and progression, laboratory biochemical tests of white blood cell count (WBC), C-reactive protein (CRP), lymphocyte count, lactate dehydrogenase, IL-6, IL-1beta, TNF-alpha, platelet count, albumin, and serum ferritin, hospital admission and length of stay, duration of mechanical ventilation, hospital mortality and respiratory failure differ between the early responder and non-responder groups.

Out-patients

  • Determine the frequency of low serum Vit D levels (<50 nmol/L) in COVID-19 patients.
  • Determine the relationship between baseline vitamin D deficiency and clinical characteristics.
  • Asses patients' response to vitamin D supplementation in week three and determine its association with disease progression and recovery

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with COVID-19:

  • ≥ 17 years old
  • Both sexes

Exclusion criteria

  • Patients with dementia, learning disability, mental health needs and alcohol or drug dependency, pregnant women will be excluded.
  • Patients with sarcoidosis, hypercalcemia, known vitamin D intolerance

Treatment and study plan

Ddrops® products, 50,000 IU, Oral

Dietary Supplement

Vitamin D3

Vitamin D3

Dietary Supplement

Vitamin D3 1000IU

Primary outcomes

  1. Symptoms recovery

    Time frame: Time from onset of intervention to day 21

    Number of Participants whose symptoms recovered over three weeks

Secondary outcomes

  1. Hospitalization

    Time frame: Between diagnosis and day 21

    Number of patients who required hospitalization

  2. Blood white blood cell count (WBC)

    Time frame: At day 0 before starting intervention and day 21 of intervention

    x 109/L

  3. Duration of mechanical ventilation

    Time frame: Between diagnosis and day 21

    If patients required mechanical ventilation at any time after diagnosis

  4. Duration of hospitalization

    Time frame: Between diagnosis and day 21

    Length of stay in hospital (days)

  5. Intensive care unit (ICU) admission

    Time frame: Between diagnosis and day 21

    Number of patients who required ICU

  6. Duration of ICU stay

    Time frame: Between diagnosis and day 21

    Length of stay in ICU

  7. Blood C-reactive protein (CRP)

    Time frame: Baseline and day 21

    mg/L

  8. Blood Lymphocyte count

    Time frame: Baseline and day 21

    number of lymphocytes in 1 microliter (µL) of blood

  9. Blood Ferritin

    Time frame: Baseline and day 21

    ng/mL

  10. Blood platelet count

    Time frame: Baseline and day 21

    platelets per microliter of blood

  11. Blood interleukin-6 (IL-6)

    Time frame: Baseline and day 21

    pg/mL

  12. Blood Tumor Necrosis Factor alpha (TNF)

    Time frame: Baseline and day 21

    pg/ml

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

Improving Vitamin D Status in the Management of COVID-19

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 13, 2020
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.