Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04482673
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-24
First Post:
2020-07-01
Brief Title:
Vitamin D Supplementation in the Prevention and Mitigation of COVID-19 Infection
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
The Role of Vitamin D in Mitigating COVID-19 Infection Severity Focusing on Reducing Health Disparities in South Carolina
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VitD-COVID19
Brief 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 bodys 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 D3day 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 20000 IUday for 3 days followed by high dose 6000 IU vitamin Dday vs standard of care for 12 months All participants will receive a multivitamin containing vitamin D
Detailed Description:
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 unitsday 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 25OHD of 40 ngmL 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 dosingTo test these hypotheses we propose the following Aims
1 Focusing on prevention this Aim will test whether achieving vitD sufficiency as defined by total circulating 25OHD 40-60 ngmL in individuals at risk for deficiency will improve clinical outcomes in those who subsequently develop COVID-19
2 Focusing on vitD as mitigation therapy this Aim will evaluate the effectiveness of bolus dosing followed by daily vitD supplementation in achieving the target 25OHD range of 40-60 ngmL in those individuals testing positive for COVID-19 at MUSCaffiliated hospital facilities but do not require admission to a hospital outpatient and will examine whether achieving this target range is associated with less severe COVID-19 and differences in inflammatory cytokine profiles
In the prevention arm of this project Aim 1 individuals at higher risk 50 years of age who test negative for COVID-19 at MUSCits 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 IUday to achieve a total circulating 25OH concentration of 40-60 ngmL 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 andor 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 20000 IU X 3 days followed by 6000 IU vitDday 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
1 Are individuals with vitD deficiency more likely to be diagnosed with COVID-19 infection
2 Does being vitD replete make a person more likely to have asymptomatic COVID-19
3 Does vitD sufficiency status account for why African Americans Latina and the elderly more likely to experience complications related to COVID-19
4 Is vitD deficiency in COVID-19 positive outpatients associated with increased severity of symptoms and differences in inflammatory cytokine profiles that is mitigated by bolus and then sustained vitD supplementation
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
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 unitsday 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 25OHD of 40 ngmL 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 dosingTo test these hypotheses we propose the following Aims
1 Focusing on prevention this Aim will test whether achieving vitD sufficiency as defined by total circulating 25OHD 40-60 ngmL in individuals at risk for deficiency will improve clinical outcomes in those who subsequently develop COVID-19
2 Focusing on vitD as mitigation therapy this Aim will evaluate the effectiveness of bolus dosing followed by daily vitD supplementation in achieving the target 25OHD range of 40-60 ngmL in those individuals testing positive for COVID-19 at MUSCaffiliated hospital facilities but do not require admission to a hospital outpatient and will examine whether achieving this target range is associated with less severe COVID-19 and differences in inflammatory cytokine profiles
In the prevention arm of this project Aim 1 individuals at higher risk 50 years of age who test negative for COVID-19 at MUSCits 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 IUday to achieve a total circulating 25OH concentration of 40-60 ngmL 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 andor 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 20000 IU X 3 days followed by 6000 IU vitDday 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
1 Are individuals with vitD deficiency more likely to be diagnosed with COVID-19 infection
2 Does being vitD replete make a person more likely to have asymptomatic COVID-19
3 Does vitD sufficiency status account for why African Americans Latina and the elderly more likely to experience complications related to COVID-19
4 Is vitD deficiency in COVID-19 positive outpatients associated with increased severity of symptoms and differences in inflammatory cytokine profiles that is mitigated by bolus and then sustained vitD supplementation
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None