The Role of Vitamin D in Mitigating COVID-19 Infection Severity: Focusing on Reducing Health Disparities in South Carolina

Who is this study for? Healthy adult volunteers over age 50
What treatments are being studied? Vitamin D3
Status: Active_not_recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: t
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⁃ 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.

Locations
United States
South Carolina
Medical University of South Carolina
Charleston
Time Frame
Start Date: 2020-07-31
Completion Date: 2023-12-31
Participants
Target number of participants: 95
Treatments
Experimental: COVID-19 Negative Active Treatment
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.
Placebo_comparator: COVID-19 Negative Placebo
Participants in this arm would receive placebo for 12 months. All participants will receive a multivitamin containing 800 IU vitamin D3/day.
Experimental: COVID-19 Positive Active Treatment
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.
Placebo_comparator: COVID-19 Positive Placebo
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.
Authors
Jeffrey Korte, Carol L Wagner
Sponsors
Leads: Medical University of South Carolina
Collaborators: Grassroots Health Nutrition Institute, ZRT Laboratory

This content was sourced from clinicaltrials.gov