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Vitamin D and COVID-19 Management

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Ddrops® products, 50,000 IU, Oral
Vitamin D3
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of AlbertaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High dose vitamin D

Low dose vitamin D

Arm Description

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

Vitamin D3 1000IU

Outcomes

Primary Outcome Measures

Symptoms recovery
Number of Participants whose symptoms recovered over three weeks

Secondary Outcome Measures

Hospitalization
Number of patients who required hospitalization
Blood white blood cell count (WBC)
x 109/L
Duration of mechanical ventilation
If patients required mechanical ventilation at any time after diagnosis
Duration of hospitalization
Length of stay in hospital (days)
Intensive care unit (ICU) admission
Number of patients who required ICU
Duration of ICU stay
Length of stay in ICU
Blood C-reactive protein (CRP)
mg/L
Blood Lymphocyte count
number of lymphocytes in 1 microliter (µL) of blood
Blood Ferritin
ng/mL
Blood platelet count
platelets per microliter of blood
Blood interleukin-6 (IL-6)
pg/mL
Blood Tumor Necrosis Factor alpha (TNF)
pg/ml

Full Information

First Posted
May 8, 2020
Last Updated
April 19, 2023
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT04385940
Brief Title
Vitamin D and COVID-19 Management
Official Title
Improving Vitamin D Status in the Management of COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 19, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High dose vitamin D
Arm Type
Experimental
Arm Description
Ddrops® products,Vitamin D3, 50,000 IU, Oral
Arm Title
Low dose vitamin D
Arm Type
Active Comparator
Arm Description
Vitamin D3 1000IU
Intervention Type
Dietary Supplement
Intervention Name(s)
Ddrops® products, 50,000 IU, Oral
Intervention Description
Vitamin D3
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Intervention Description
Vitamin D3 1000IU
Primary Outcome Measure Information:
Title
Symptoms recovery
Description
Number of Participants whose symptoms recovered over three weeks
Time Frame
Time from onset of intervention to day 21
Secondary Outcome Measure Information:
Title
Hospitalization
Description
Number of patients who required hospitalization
Time Frame
Between diagnosis and day 21
Title
Blood white blood cell count (WBC)
Description
x 109/L
Time Frame
At day 0 before starting intervention and day 21 of intervention
Title
Duration of mechanical ventilation
Description
If patients required mechanical ventilation at any time after diagnosis
Time Frame
Between diagnosis and day 21
Title
Duration of hospitalization
Description
Length of stay in hospital (days)
Time Frame
Between diagnosis and day 21
Title
Intensive care unit (ICU) admission
Description
Number of patients who required ICU
Time Frame
Between diagnosis and day 21
Title
Duration of ICU stay
Description
Length of stay in ICU
Time Frame
Between diagnosis and day 21
Title
Blood C-reactive protein (CRP)
Description
mg/L
Time Frame
Baseline and day 21
Title
Blood Lymphocyte count
Description
number of lymphocytes in 1 microliter (µL) of blood
Time Frame
Baseline and day 21
Title
Blood Ferritin
Description
ng/mL
Time Frame
Baseline and day 21
Title
Blood platelet count
Description
platelets per microliter of blood
Time Frame
Baseline and day 21
Title
Blood interleukin-6 (IL-6)
Description
pg/mL
Time Frame
Baseline and day 21
Title
Blood Tumor Necrosis Factor alpha (TNF)
Description
pg/ml
Time Frame
Baseline and day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aldo Montano-Loza, MD, MSc, PhD
Phone
780 248-1892
Email
montanol@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aldo Montano-Loza, MD, MSc, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2R3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aldo Montano-Loza, MD, MSc, PhD
Phone
780 248-1892
Email
montanol@ualberta.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Vitamin D and COVID-19 Management

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