Vitamin D and COVID-19 Management

NCT04385940 | Completed Phase 3

• 1 other identifier: Pro00100606
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Symptoms recovery

  Number of Participants whose symptoms recovered over three weeks

  Time from onset of intervention to day 21

Secondary Outcomes (12)

• Hospitalization

  Between diagnosis and day 21

• Blood white blood cell count (WBC)

  At day 0 before starting intervention and day 21 of intervention

• Duration of mechanical ventilation

  Between diagnosis and day 21

• Duration of hospitalization

  Between diagnosis and day 21

• Intensive care unit (ICU) admission

  Between diagnosis and day 21

Study Arms (2)

High dose vitamin D

EXPERIMENTAL

Ddrops® products,Vitamin D3, 50,000 IU, Oral

Dietary Supplement: Ddrops® products, 50,000 IU, Oral

Low dose vitamin D

ACTIVE COMPARATOR

Vitamin D3 1000IU

Dietary Supplement: Vitamin D3

Interventions

Ddrops® products, 50,000 IU, Oral DIETARY_SUPPLEMENT

Vitamin D3

High dose vitamin D

Vitamin D3 DIETARY_SUPPLEMENT

Vitamin D3 1000IU

Low dose vitamin D

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with COVID-19:
• ≥ 17 years old
• Both sexes

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location

MeSH Terms

Conditions

COVID-19

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Aldo Montano-Loza, MD, MSc, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 13, 2020
• Study Start: March 19, 2021
• Primary Completion: July 2, 2024
• Study Completion: July 2, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

CA (1)