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Vitamin D for COVID-19 (VitD-COVID19 Trial)

Phase 4

Waitlist Available

Led By Carol L Wagner, MD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2 and 4 weeks, then months 3, 6, 9 and 12 in covid-19 positive participants

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

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.

Who is the study for?

This trial is for adults aged 50 or older who are getting tested for COVID-19 but aren't hospitalized. They must be able to make their own decisions and not have cognitive impairments. Only those being initially tested for COVID-19 at certain locations can join.

What is being tested?

The study tests if high doses of vitamin D can lessen the severity of COVID-19 symptoms and boost the body's response to the infection. Participants will either receive daily high dose vitamin D, a short-term very high dose if they test positive, or standard care with a multivitamin.

What are the potential side effects?

Possible side effects from taking high doses of vitamin D may include elevated blood calcium levels, digestive discomfort, fatigue, confusion, increased thirst and urination.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 and 4 weeks, then months 3, 6, 9 and 12 in covid-19 positive participants

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2 and 4 weeks, then months 3, 6, 9 and 12 in covid-19 positive participants

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 and 4 weeks, then months 3, 6, 9 and 12 in covid-19 positive participants for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in SARS-CoV-2 antibody titers

Change in total circulating 25(OH)D concentration

Change in total circulating 25(OH)D concentration in COVID-19 positives

Secondary study objectives

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

Charlson Comorbidity survey

GrassrootsHealth Monthly Health assessment

+7 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: COVID-19 Positive Active TreatmentExperimental Treatment2 Interventions

Participants will be randomized to vitamin D3 as a bolus (20,000 IU) per day for 3 days followed by high dose vitamin D (6000 IU) per dayfor 12 months. All participants will receive a multivitamin containing 800 IU vitamin D3/day.

Group II: COVID-19 Negative Active TreatmentExperimental Treatment1 Intervention

Participants will be randomized to vitamin D3 (6000 IU) per day for 12 months. All participants will receive a multivitamin containing 800 IU vitamin D3/day.

Group III: COVID-19 Negative PlaceboPlacebo Group1 Intervention

Participants in this arm would receive placebo for 12 months. All participants will receive a multivitamin containing 800 IU vitamin D3/day.

Group IV: COVID-19 Positive PlaceboPlacebo Group2 Interventions

Participants in this arm would receive placebo as a bolus followed by daily placebo for 12 months. All participants will receive a multivitamin containing 800 IU vitamin D3/day.

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