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

Study acronym: VitD-COVID19
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 140 to confirmed 95 · Completion date: Dec 31, 2022 to Dec 31, 2023 · Site details revisedv5 Show 3 more changesShow less
    • Enrollment target: estimated 140 to confirmed 95
    • Completion date: Dec 31, 2022 to Dec 31, 2023
    • Site details revised
  2. Primary and study completion dates: Dec 31, 2021 to Dec 31, 2022v4
  3. Re-verified, no change to tracked fieldsv3
  4. Primary completion date: Aug 30, 2021 to Dec 31, 2021 Completion date: Dec 30, 2021 to Dec 31, 2021 · Start date changed from estimate of Jul 20, 2020 to Jul 31, 2020v2 Show 2 more changesShow less
    • Completion date: Dec 30, 2021 to Dec 31, 2021
    • Start date changed from estimate of Jul 20, 2020 to Jul 31, 2020
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04482673
Lead Sponsor Medical University of South Carolina
Collaborators: Grassroots Health Nutrition Institute, ZRT Laboratory
Conditions COVID-19, Vitamin D Deficiency, Respiratory Viral Infection
Enrollment 95 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov