COVID-19Phase 3NCT04385940
Vitamin D and COVID-19 Management
A Phase 3 study testing Ddrops® products, 50,000 IU, Oral and Vitamin D3 in people with COVID-19, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Ddrops® products, 50,000 IU, Oral and Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 19 Mar 2021to 2 Jul 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with COVID-19:
- ≥ 17 years old
- Both sexes
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Vitamin D Status in the Management of COVID-19
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.
Read the 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
- Conditions
- COVID-19
- Being tested
- Ddrops® products, 50,000 IU, Oral, Vitamin D3
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ddrops® products, 50,000 IU, OralDietary supplement
Vitamin D3
Vitamin D3Dietary supplement
Vitamin D3 1000IU
| Study group | Role | What they receive |
|---|---|---|
| High dose vitamin D | Experimental | Ddrops® products,Vitamin D3, 50,000 IU, Oral Receives: Dietary Supplement: Ddrops® products, 50,000 IU, Oral |
| Low dose vitamin D | Active comparator | Vitamin D3 1000IU Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms recovery
Number of Participants whose symptoms recovered over three weeks
Measured: Time from onset of intervention to day 21
Secondary outcomes (12)
Hospitalization
Number of patients who required hospitalization
Measured: Between diagnosis and day 21
Blood white blood cell count (WBC)
x 109/L
Measured: At day 0 before starting intervention and day 21 of intervention
Duration of mechanical ventilation
If patients required mechanical ventilation at any time after diagnosis
Measured: Between diagnosis and day 21
Duration of hospitalization
Length of stay in hospital (days)
Measured: Between diagnosis and day 21
Intensive care unit (ICU) admission
Number of patients who required ICU
Measured: Between diagnosis and day 21
Duration of ICU stay
Length of stay in ICU
Measured: Between diagnosis and day 21
Blood C-reactive protein (CRP)
mg/L
Measured: Baseline and day 21
Blood Lymphocyte count
number of lymphocytes in 1 microliter (µL) of blood
Measured: Baseline and day 21
Blood Ferritin
ng/mL
Measured: Baseline and day 21
Blood platelet count
platelets per microliter of blood
Measured: Baseline and day 21
Blood interleukin-6 (IL-6)
pg/mL
Measured: Baseline and day 21
Blood Tumor Necrosis Factor alpha (TNF)
pg/ml
Measured: Baseline and day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start19 Mar 2021
- Primary completion2 Jul 2024
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aldo Montano-Loza, MD, MSc, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385940
- Sponsor's protocol ID
- Pro00100606
- Status last verified
- Jan 2025
- First submitted
- 8 May 2020
- Last updated
- 23 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Vitamin D Status in the Management of COVID-19
- ClinicalTrials.gov ID
- NCT04385940
- Acronym / sponsor ID
- Pro00100606
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose vitamin D | Experimental | Dietary Supplement: Ddrops® products, 50,000 IU, OralDdrops® products,Vitamin D3, 50,000 IU, Oral |
| Low dose vitamin D | Active comparator | Dietary Supplement: Vitamin D3Vitamin D3 1000IU |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 17 years old
- Both sexes
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ddrops® products, 50,000 IU, OralVitamin D3 | Dietary supplement | High dose vitamin D |
| Vitamin D3Vitamin D3 1000IU | Dietary supplement | Low dose vitamin D |
Primary outcome
Symptoms recovery
Time frame: Time from onset of intervention to day 21
Number of Participants whose symptoms recovered over three weeks
12 secondary outcomes
Hospitalization
Time frame: Between diagnosis and day 21
Blood white blood cell count (WBC)
Time frame: At day 0 before starting intervention and day 21 of intervention
Duration of mechanical ventilation
Time frame: Between diagnosis and day 21
Duration of hospitalization
Time frame: Between diagnosis and day 21
Intensive care unit (ICU) admission
Time frame: Between diagnosis and day 21
Duration of ICU stay
Time frame: Between diagnosis and day 21
Blood C-reactive protein (CRP)
Time frame: Baseline and day 21
Blood Lymphocyte count
Time frame: Baseline and day 21
Blood Ferritin
Time frame: Baseline and day 21
Blood platelet count
Time frame: Baseline and day 21
Blood interleukin-6 (IL-6)
Time frame: Baseline and day 21
Blood Tumor Necrosis Factor alpha (TNF)
Time frame: Baseline and day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for COVID-19
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Not yet recruitingPhase 3
Dapagliflozin for Long COVID Syndrome
COVID - 19, Long COVID Syndrome
RecruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruitingObservational study
Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aldo Montano-Loza, MD, MSc, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ddrops® products, 50,000 IU, Oral and Vitamin D3 in people with COVID-19, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms recovery (time frame: Time from onset of intervention to day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.