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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 below
Select...
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 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

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 more

Awards & 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
942 Previous Clinical Trials
434,397 Total Patients Enrolled
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
Coronavirus Research Study Groups: High dose vitamin D, Low dose vitamin D
Coronavirus 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
~3 spots leftby Dec 2025
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