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Vitamin D for COVID-19
Phase 3
Waitlist Available
Led By Aldo Montano-Loza, MD, MSc, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with COVID-19:
≥ 17 years old
Must not have
Patients with sarcoidosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and day 21
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial will help determine if vitamin D supplementation could be an effective adjuvant therapeutic intervention for COVID-19.
Who is the study for?
This trial is for COVID-19 patients aged 17 or older, of any sex. It's not suitable for individuals with dementia, mental health needs, substance dependencies, pregnant women, sarcoidosis, hypercalcemia, learning disabilities or known intolerance to vitamin D.
What is being tested?
The study tests if high-dose (50,000 IU twice in the first week and once in the second and third weeks) versus low-dose (1,000 IU daily for three weeks) Vitamin D3 can help manage COVID-19. It's a double-blind trial where neither doctors nor participants know who gets which dose.
What are the potential side effects?
Potential side effects may include high calcium levels in the blood due to excessive vitamin D intake. This could lead to confusion, bone pain and kidney problems among others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently diagnosed with COVID-19.
Select...
I am 17 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with sarcoidosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and day 21
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and day 21
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Symptoms recovery
Secondary study objectives
Blood C-reactive protein (CRP)
Blood Ferritin
Blood Lymphocyte count
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: High dose vitamin DExperimental Treatment1 Intervention
Ddrops® products,Vitamin D3, 50,000 IU, Oral
Group II: Low dose vitamin DActive Control1 Intervention
Vitamin D3 1000IU
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
939 Previous Clinical Trials
433,901 Total Patients Enrolled
Aldo Montano-Loza, MD, MSc, PhDPrincipal InvestigatorUniversity of Alberta
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic or intolerant to Vitamin D.You have mental health concerns that require treatment.My gender does not affect my eligibility.You have a problem with alcohol or drug addiction.I am currently diagnosed with COVID-19.You have a condition that makes it difficult for you to learn.I have been diagnosed with sarcoidosis.You have dementia (a condition that affects your memory and thinking ability).I am 17 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: High dose vitamin D
- Group 2: Low dose vitamin D
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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