A Phase 4 interventional study of Daily Vitamin D3 and Daily placebo in COVID-19, Vitamin D Deficiency and Respiratory Viral Infection, sponsored by Medical University of South Carolina. Active, not recruiting at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-24.
Sponsored by Medical University of South Carolina · Phase 4, Interventional, and Prevention
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.
Vitamin D (vitD) deficiency is more prevalent among African Americans and Latinx and in the elderly who have low exposure to sunlight. African Americans and nursing home residents who contract SARS-CoV-2, the novel virus that first appeared in Wuhan, China, and who develop the disease designated COVID-19 experience a much worse clinical outcome than other groups. Some have speculated that low vitD status could exacerbate COVID-19 infection, especially if the viral infection reaches the lower respiratory tract.
Sufficient vitD may help to improve the pulmonary immune response to the virus, reduce the dangerous cytokine storm, and lessen surfactant dysregulation, potentially preventing or ameliorating the acute syndrome. To maximize the benefits of vitD on host response to SARS-CoV-2, prophylactic supplementation to ensure sufficiency before COVID-19 would be the preferable public health option. Yet, vitD supplementation during acute infection may also improve overall clinical outcome in some infected patients. It is a relatively inexpensive therapy that has a large safety profile when given in doses of 4000-6000 international units/day to adults.
To date, there is no effective cure or preventive vaccine for COVID-19. Given the risk of disease and death, any intervention that reduces the morbidity and mortality from COVID-19 would be of immense value. We hypothesize that achieving and sustaining vitD sufficiency through dietary supplementation will result in improved immune function and a decrease in COVID-19 incidence and symptomatology. Importantly, this objective will address the significant health disparity of vitD deficiency among black, Latina and the elderly. We further hypothesize that those individuals with a circulating 25(OH)D of ≥40 ng/mL will have less severe COVID-19 symptoms, particularly among higher risk populations. We will compare the effectiveness of higher dose vitD vs. standard of care dosing.To test these hypotheses, we propose the following Aims:
In the prevention arm of this project (Aim 1), individuals at higher risk ≥50 years of age who test negative for COVID-19 at MUSC/its affiliate hospitals, and agree to daily vitD supplementation for a 12-month period, with vitD status measured monthly will be randomized to placebo or prescribed vitD (6000 IU/day) to achieve a total circulating 25(OH) concentration of ≥40-60 ng/mL. We will compare study groups regarding subsequent infection with COVID-19, severity of symptoms, need and duration of hospitalization (LOS), admission to the ICU, need for ventilatory support, and mortality, along with return to baseline activities and/or work, as a function of age, BMI, and other recognized COVID-19 risk factors. In the mitigation arm of this project (Aim 2), non-hospitalized individuals ≥50 years of age who test COVID-19 positive will be randomized to placebo or a bolus of oral vitD (20,000 IU X 3 days) followed by 6000 IU vitD/day, and we will compare study groups on measures of disease severity as in Aim 1. All participants in both Aims 1 and 2 will receive a daily multivitamin (MVI) containing 800 IU VitD for the 12-month period.
Following the completion of these Aims, we will be able to answer the following questions:
The long-term impact of these studies will influence public policy regarding more widespread vitD supplementation is a means of reducing the severity of COVID-19. Given its low cost and the ease with which widespread supplementation could be instituted, oral vitD supplementation may represent a rapid and inexpensive means by which to reduce both the COVID-19 incidence and severity.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 95 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
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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.
Exclusion Criteria:
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.
Drug: Daily Vitamin D3
Participants in this arm would receive placebo for 12 months. All participants will receive a multivitamin containing 800 IU vitamin D3/day.
Drug: Daily placebo
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.
Drug: Daily Vitamin D3 · Drug: Bolus vitamin D3
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.
Drug: Daily placebo · Drug: Bolus placebo
6000 IU vitamin D3 daily
Also known as: Daily cholecalciferol
Placebo daily
Bolus 20,000 IU vitamin D3 daily for 3 days
Also known as: Bolus cholecalciferol
Bolus placebo daily for 3 days
Change in total circulating 25(OH)D concentration
metabolite of vitamin D
Time frame: monthly in COVID-19 negative participants through study completion for 1 year
Change in total circulating 25(OH)D concentration in COVID-19 positives
metabolite of vitamin D
Time frame: baseline, 2 and 4 weeks, then months 3, 6, 9 and 12 in COVID-19 positive participants
Change in SARS-CoV-2 antibody titers
The presence or absent of SARS-CoV-2 antibody will be measured at baseline, 3, 6, 9 and 12 months.
Time frame: every 3 months up to 12 months
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
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
Time frame: baseline and every 3 months up to 12 months
Respiratory symptoms
COVID-19 positive participants or if COVID-19 negatives develop respiratory symptoms will complete this respiratory survey daily for 2 weeks
Time frame: daily for 2 weeks
Signs and symptoms of rhino/sinusitis
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.
Time frame: Baseline then 3, 6, 9 and 12 months in negatives and daily for 2 weeks in positives
NCI Dietary Intake
Dietary intake assessment
Time frame: baseline then at 6 and 12 months
Charlson Comorbidity survey
Survey of participant health problems
Time frame: baseline then at 6 and 12 months
Paffenberger Physical Activity Assessment
Assessment of physical activity of each participant
Time frame: Baseline then at 6 and 12 months
Perceived stress
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"
Time frame: monthly for 1 year
Pandemic stress
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."
Time frame: monthly for 1 year
NEO-Personality Inventory
Personality characteristics of each participant
Time frame: baseline visit
GrassrootsHealth Monthly Health assessment
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.
Time frame: baseline, 6, and 12 months
Plan to share: No
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