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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

VitD-COVID19 Trial 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.Check my eligibility

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.See study design

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.

VitD-COVID19 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

VitD-COVID19 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Grassroots Health Nutrition InstituteUNKNOWN

Medical University of South CarolinaLead Sponsor

932 Previous Clinical Trials

7,394,165 Total Patients Enrolled

6 Trials studying Vitamin D Deficiency

1,637 Patients Enrolled for Vitamin D Deficiency

ZRT LaboratoryOTHER

1 Previous Clinical Trials

220 Total Patients Enrolled

Media Library

Bolus placebo (Placebo) Clinical Trial Eligibility Overview. Trial Name: NCT04482673 — Phase 4

Vitamin D Deficiency Research Study Groups: COVID-19 Negative Placebo, COVID-19 Positive Active Treatment, COVID-19 Positive Placebo, COVID-19 Negative Active Treatment

Vitamin D Deficiency Clinical Trial 2023: Bolus placebo Highlights & Side Effects. Trial Name: NCT04482673 — Phase 4

Bolus placebo (Placebo) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04482673 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks do individuals face when taking Bolus vitamin D3?

"As this is a Phase 4 trial, indicating approval by the relevant regulatory bodies, Bolus Vitamin D3 receives our team's highest safety rating of 3."

Answered by AI

What are the principal aims of this investigation?

"The primary outcome of this clinical trial, assessed approximately monthly over the duration of one year in COVID-19 negative participants, is to note any changes in total circulating 25(OH)D concentration among those with a positive diagnosis. Secondary objectives include completion of the Charlson Comorbidity Survey and GrassrootsHealth Monthly Health Assessment - both designed to provide insight into participant health status rather than comparative assessment. Additionally, an Elisa panel measuring 10 cytokines (INF-gamma, IL-1beta, IL-2 etc.) will be examined at baseline and each month for 12 months to observe if there has been a change in"

Answered by AI

Is this experiment currently open to participants?

"According to the records held on clinicaltrials.gov, this medical study is presently open for enrolment and was first made available at the end of July 2020 with its most recent update taking place in February 2022."

Answered by AI

How many subjects are participating in this experiment?

"Affirmative. Clinicaltrials.gov records confirm that this research trial, which was initially posted on July 31st 2020 is actively looking for participants. 140 volunteers need to be enrolled from 1 medical centre."

Answered by AI

What are the typical medical conditions that Bolus vitamin D3 is employed to address?

"Vitamin D3 is routinely recommended to treat calcium deficiencies, and has been clinically proven beneficial for conditions such as fracture, spine fractures, and post menopausal women."

Answered by AI

What precedent has been established with administration of Bolus vitamin D3 in prior clinical investigations?

"At this time, 33 clinical trials regarding Bolus vitamin D3 are currently underway, 14 of which being in the last phase. Most studies take place in Boston, Massachusetts; however, there are 155 sites running these tests globally."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vitamin D Supplementation in the Prevention and Mitigation of COVID-19 Infection

Carol L. Wagner, MD 2020. "Vitamin D Supplementation in the Prevention and Mitigation of COVID-19 Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04482673.

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