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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 below
Select...
I am currently diagnosed with COVID-19.
Select...
I am 17 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and day 21
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and day 21 for reporting.

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 more

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
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

Ddrops® products, 50,000 IU, Oral Clinical Trial Eligibility Overview. Trial Name: NCT04385940 — Phase 3
COVID-19 Research Study Groups: High dose vitamin D, Low dose vitamin D
COVID-19 Clinical Trial 2023: Ddrops® products, 50,000 IU, Oral Highlights & Side Effects. Trial Name: NCT04385940 — Phase 3
Ddrops® products, 50,000 IU, Oral 2023 Treatment Timeline for Medical Study. Trial Name: NCT04385940 — Phase 3

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
~2 spots leftby Oct 2024