Covid 19 Clinical Trials

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.

NCT04482673 COVID-19 Vitamin D Deficiency Respiratory Viral Infection Drug: Daily Vitamin D3 Drug: Daily placebo Drug: Bolus vitamin D3 Drug: Bolus placebo

MeSH:Infection Communicable Diseases Vitamin D Deficiency Virus Diseases

HPO:Low levels of vitamin D

Primary Outcomes

Description: metabolite of vitamin D

Measure: Change in total circulating 25(OH)D concentration

Time: monthly in COVID-19 negative participants through study completion for 1 year

Description: metabolite of vitamin D

Measure: Change in total circulating 25(OH)D concentration in COVID-19 positives

Time: baseline, 2 and 4 weeks, then months 3, 6, 9 and 12 in COVID-19 positive participants

Description: The presence or absent of SARS-CoV-2 antibody will be measured at baseline, 3, 6, 9 and 12 months.

Measure: Change in SARS-CoV-2 antibody titers

Time: every 3 months up to 12 months

Secondary Outcomes

Description: At baseline, 3, 6, 9 and 12 months, inflammatory cytokines will be measured in participant plasma samples. Cytokines to be measured are Interferon-gamma (IFN-g), Interleukin-1beta (IL-1B), IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, IL-13, and Tumor Necrosis Factor-alpha (TNFa). Values of these cytokines at baseline will compared to those at 3, 6, 9, and 12 months

Measure: 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

Time: baseline and every 3 months up to 12 months

Description: COVID-19 positive participants or if COVID-19 negatives develop respiratory symptoms will complete this respiratory survey daily for 2 weeks

Measure: Respiratory symptoms

Time: daily for 2 weeks

Description: Inventory of signs and symptoms of rhino/sinusitis. These signs include sneezing, running nose, cough, dizziness, fatigue, and sense of smell. Each sign is rated on a scale of 0 to 5, with 0 indicating not problem, for instance 1 indicating mild problem, 4 indicating severe problem and 5 indicating problem as bad as it can be.

Measure: Signs and symptoms of rhino/sinusitis

Time: Baseline then 3, 6, 9 and 12 months in negatives and daily for 2 weeks in positives

Description: Dietary intake assessment

Measure: NCI Dietary Intake

Time: baseline then at 6 and 12 months

Description: Survey of participant health problems

Measure: Charlson Comorbidity survey

Time: baseline then at 6 and 12 months

Description: Assessment of physical activity of each participant

Measure: Paffenberger Physical Activity Assessment

Time: Baseline then at 6 and 12 months

Description: Each participant will complete the Perceived Stress Scale Questionnaire (PSS) to assess their perceived stress. Assessments are base on a scale of 0 to 4, with 0 indicating "never" and 4 indicating "very often"

Measure: Perceived stress

Time: monthly for 1 year

Description: Each participant will complete the and Pandemic Stress Index Questionnaire (PSI) to assess their perceived stress cause by the pandemic. Assessments are base on a scale of 0 to 6, with 0 indicating "not at all" and 5 indicating "extremely," and 6 indicating "decline to answer."

Measure: Pandemic stress

Time: monthly for 1 year

Description: Personality characteristics of each participant

Measure: NEO-Personality Inventory

Time: baseline visit

Description: A health assessment will be completed by each participant monthly for 1year. This health. This is for information on health status only and not for comparative assessment.

Measure: GrassrootsHealth Monthly Health assessment

Time: baseline, 6, and 12 months

Related HPO nodes (Using clinical trials)

HP:0100512: Low levels of vitamin D

Genes 8

OCRL ACOX2 FARSB GPR35 RPL11 MST1 TCF4 RPS10

Protein Mutations 0

SNP 4

rs10766197 rs1790349 rs2060793 rs4588

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Covid 19 Research using Clinical Trials (Home Page)

Bolus placeboWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation

Correlated Drug Terms (5)

Correlated MeSH Terms (4)

Correlated HPO Terms (1)

Clinical Trials

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