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Ddrops® products, 50,000 IU, Oral 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and day 21
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Symptoms recovery
Secondary outcome measures
Blood C-reactive protein (CRP)
Blood Ferritin
Blood Lymphocyte count
+9 moreTrial 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
886 Previous Clinical Trials
384,766 Total Patients Enrolled
11 Trials studying COVID-19
4,549 Patients Enrolled for COVID-19
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we currently receiving applications for this research project?
"Yes, the study is currently enrolling patients. The trial was initially posted on March 19th, 2021 and was updated on July 27th, 2022. The study needs 64 participants from 1 location."
Answered by AI
Are Ddrops® products, 50,000 IU, Oral generally well-tolerated by patients?
"Ddrops® products, 50,000 IU, Oral, received a score of 3 for safety. This is due to the product being in Phase 3 trials, which suggests that not only is there some data supporting efficacy, but also that there are multiple rounds of data supporting safety."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
University of Alberta
What portion of applicants met pre-screening criteria?
Did not meet criteria
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