Bolus vitamin D3 for Coronavirus

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Coronavirus+8 MoreBolus vitamin D3 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether vitamin D supplementation can help reduce the severity of COVID-19 symptoms and the body's inflammatory response to the virus.

Eligible Conditions
  • Coronavirus
  • Vitamin D Deficiency
  • Viral Respiratory Infection

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

3 Primary · 10 Secondary · Reporting Duration: baseline, 2 and 4 weeks, then months 3, 6, 9 and 12 in COVID-19 positive participants

Month 12
Signs and symptoms of rhino/sinusitis
Month 12
Paffenberger Physical Activity Assessment
Month 12
Change in inflammatory cytokine concentration (10 cytokine panel Elisa: Interferon (INF)-gamma, Interleukin (IL)-1beta, IL-2, IL-3, IL-4, IL-6, IL-8, IL-10, IL-13, Tumor Necrosis Factor (TNF)-alpha
Month 12
Charlson Comorbidity survey
NCI Dietary Intake
baseline visit
NEO-Personality Inventory
Month 3
Change in total circulating 25(OH)D concentration in COVID-19 positives
Month 12
GrassrootsHealth Monthly Health assessment
daily for 2 weeks
Respiratory symptoms
Month 12
Change in SARS-CoV-2 antibody titers
monthly for 1 year
Pandemic stress
Perceived stress
Year 1
Change in total circulating 25(OH)D concentration

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

4 Treatment Groups

COVID-19 Negative Active Treatment
1 of 4
COVID-19 Positive Active Treatment
1 of 4
COVID-19 Negative Placebo
1 of 4
COVID-19 Positive Placebo
1 of 4

Experimental Treatment

Non-Treatment Group

140 Total Participants · 4 Treatment Groups

Primary Treatment: Bolus vitamin D3 · Has Placebo Group · Phase 4

COVID-19 Negative Active Treatment
Drug
Experimental Group · 1 Intervention: Daily Vitamin D3 · Intervention Types: Drug
COVID-19 Positive Active TreatmentExperimental Group · 2 Interventions: Bolus vitamin D3, Daily Vitamin D3 · Intervention Types: Drug, Drug
COVID-19 Negative Placebo
Drug
PlaceboComparator Group · 1 Intervention: Daily placebo · Intervention Types: Drug
COVID-19 Positive PlaceboPlaceboComparator Group · 2 Interventions: Bolus placebo, Daily placebo · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 2 and 4 weeks, then months 3, 6, 9 and 12 in covid-19 positive participants

Who is running the clinical trial?

Grassroots Health Nutrition InstituteUNKNOWN
Medical University of South CarolinaLead Sponsor
837 Previous Clinical Trials
5,378,450 Total Patients Enrolled
ZRT LaboratoryOTHER
1 Previous Clinical Trials
220 Total Patients Enrolled
Carol L Wagner, MDPrincipal InvestigatorMedical University of South Carolina
2 Previous Clinical Trials
906 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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