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

NCT04482673 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2023-02-24

No results posted yet for this study

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.

Conditions

  • COVID-19
  • Vitamin D Deficiency
  • Respiratory Viral Infection

Interventions

DRUG

Daily Vitamin D3

6000 IU vitamin D3 daily

DRUG

Daily placebo

Placebo daily

DRUG

Bolus vitamin D3

Bolus 20,000 IU vitamin D3 daily for 3 days

DRUG

Bolus placebo

Bolus placebo daily for 3 days

Sponsors & Collaborators

  • Grassroots Health Nutrition Institute

    collaborator UNKNOWN

  • ZRT Laboratory

    collaborator OTHER

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Carol L Wagner, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-31
Primary Completion
2022-12-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04482673 on ClinicalTrials.gov