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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate how useful vitamin D supplementation is in reducing the severity of COVID-19 symptoms and the body's inflammatory and infection-fighting response to COVID-19. Individuals ≥50 years of age and older who are tested for COVID-19 and negative will be randomized (like flipping a coin) to either daily high dose vitamin D supplementation (6000 IU vitamin D3/day) vs. standard of care. Those individuals ≥50 years of age or older who test positive for COVID-19 at baseline will be randomized to bolus vitamin D (20,000 IU/day for 3 days) followed by high dose (6000 IU vitamin D/day) vs. standard of care for 12 months. All participants will receive a multivitamin containing vitamin D.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborators: Grassroots Health Nutrition Institute; ZRT Laboratory
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Entry Criteria:

---Adults aged 50 years of age or older who presents to MUSC or its affiliate hospitals (or associated testing centers) for COVID-19 testing during the recruitment period is eligible for participation.

Exclusion Criteria:

• Hospitalization at the time of study recruitment.

• Any individual less than 50 years of age. The reason that the participants ≥50 years are being excluded from this study is because those who are ≥50 years have a higher risk of being symptomatic with COVID-19 and have the potential for the greatest benefit. The disease appears to manifest differently in children and its occurrence is quite rare.

• Only those patients tested for COVID-19 initially will be eligible to participate; therefore, anyone wanting to participate in the trial must have had a COVID-19 test prior to enrollment/participation in the study.

• Any individual who is not capable of making independent decisions and who is considered cognitively impaired.