A Phase 3 interventional study of Ddrops® products, 50,000 IU, Oral and Vitamin D3 in COVID-19, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by University of Alberta · Phase 3, Interventional, and Treatment
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.
In-patients
Out-patients
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 11 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with COVID-19:
Exclusion Criteria:
Ddrops® products,Vitamin D3, 50,000 IU, Oral
Dietary Supplement: Ddrops® products, 50,000 IU, Oral
Vitamin D3 1000IU
Dietary Supplement: Vitamin D3
Vitamin D3
Vitamin D3 1000IU
Symptoms recovery
Number of Participants whose symptoms recovered over three weeks
Time frame: Time from onset of intervention to day 21
Hospitalization
Number of patients who required hospitalization
Time frame: Between diagnosis and day 21
Blood white blood cell count (WBC)
x 109/L
Time frame: 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
Time frame: Between diagnosis and day 21
Duration of hospitalization
Length of stay in hospital (days)
Time frame: Between diagnosis and day 21
Intensive care unit (ICU) admission
Number of patients who required ICU
Time frame: Between diagnosis and day 21
Duration of ICU stay
Length of stay in ICU
Time frame: Between diagnosis and day 21
Blood C-reactive protein (CRP)
mg/L
Time frame: Baseline and day 21
Blood Lymphocyte count
number of lymphocytes in 1 microliter (µL) of blood
Time frame: Baseline and day 21
Blood Ferritin
ng/mL
Time frame: Baseline and day 21
Blood platelet count
platelets per microliter of blood
Time frame: Baseline and day 21
Blood interleukin-6 (IL-6)
pg/mL
Time frame: Baseline and day 21
Blood Tumor Necrosis Factor alpha (TNF)
pg/ml
Time frame: Baseline and day 21
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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