Although the novel SARS-CoV-2 virus (COVD-19) is classified as an acute respiratory infection, emerging data show that morbidity and mortality are driven by disseminated intravascular coagulopathy. Untreated CAC leads to microangiopathic thromboses, causing multiple systems organ failure and consuming enormous healthcare resources. Identifying strategies to prevent CAC are therefore crucial to reducing COVID-19 hospitalization rates. The pathogenesis of CAC is unknown, but there are major overlaps between severe COVID-19 and vitamin D insufficiency (VDI). We hypothesize that VDI is a major underlying contributor to CAC. Preliminary data from severe COVID-19 patients in New Orleans support this hypothesis. The purpose of the proposed multi-center, prospective, randomized controlled trial is to test the hypothesis that low-risk, early treatment with aspirin and vitamin D in COVID-19 can mitigate the prothrombotic state and reduce hospitalization rates.

NCT04363840

Conditions

1. COVID
2. Vitamin D Deficiency
3. Coagulopathy
4. Disseminated Intravascular Coagulation

Interventions

1. Drug: Aspirin 81 mg
2. Dietary Supplement: Vitamin D

MeSH:Disseminated Intravascular Coagulation Vitamin D Deficiency

HPO:Disseminated intravascular coagulation Low levels of vitamin D

The 2019 novel coronavirus disease (COVID-2019) pandemic is an enormous health issue of worldwide scale. Prevention and/or treatment with a widely-available and already-licensed product such as vitamin D (cholecalciferol) could have a large impact on healthcare worldwide. Given ethnic variation in vitamin D production, this could help to address the discrepancies in how people of different ethnicities are affected by COVID-19. There are currently no published studies analysing either individual-level evidence on the effect of vitamin D status on COVID-19 outcomes, or any prospective studies planning on following-up patients with reference to vitamin D and COVID-19 infection. The study will have 2 arms. Arm 1 will recruit patients hospitalised with COVID-19. Vitamin D levels will be measured in these patients and compared with outcome measures of COVID-19 severity. In Arm 2, patients will be recruited prospectively from local general practices (GPs) with measurement of vitamin D levels at enrolment. They will be followed up after 6 months to determine whether baseline vitamin D levels correspond with developing COVID-19. Data will be collected from a mixture of patient medical records, electronic patient records, laboratory data and from patients themselves. Data in Arm 1 will be analysed with a combination of linear and logistic regression, as appropriate, and with adjustment for covariates. Data in Arm 2 will be analysed as a case-control study, with adjustment for covariates. The primary objectives are to determine whether vitamin D levels affect outcomes in COVID-19 infection and whether vitamin D deficiency is associated with increased risk.

NCT04386044

Conditions

1. COVID-19
2. Vitamin D Deficiency

MeSH:Vitamin D Deficiency

HPO:Low levels of vitamin D

In this prospective observational study we aim to study the association of vitamin D deficiency with adverse clinical outcomes in patients infected with Coronavirus disease 2019

NCT04403932

Conditions

1. Coronavirus Disease 2019 (COVID-19)

MeSH:Coronavirus Infections Vitamin D Deficiency

HPO:Low levels of vitamin D

This study will measure vitamin D levels in adults with COVID 19. Participants with low levels of vitamin D will be entered into an open label trial of supplementation with vitamin D.

NCT04407286

Conditions

1. Covid 19
2. Vitamin D Deficiency

Interventions

1. Dietary Supplement: Vitamin D3

MeSH:Vitamin D Deficiency

HPO:Low levels of vitamin D

Zinc d vitamin and b12 serum levels in covid-19 positive pregnants will be compared in terms of patients' responses to computed tomography and treatment.

NCT04407572

Conditions

1. COVID
2. Zinc Deficiency
3. Vitamin D Deficiency

Interventions

1. Other: Serum zinc, vitamin d vitamin b12 levels .

MeSH:Vitamin D Deficiency

HPO:Low levels of vitamin D

This study is intended to address whether oral daily vitamin D supplementation reduces infection with SARS-CoV-2 in healthy young adults. The primary aim of the study is to demonstrate a reduction in 'silent' seroconversion rates, consistent with asymptomatic transmission of SARS-CoV-2, in a young healthy adult population following 24 weeks of taking oral vitamin D supplemented at a dose of 1000 I.U. daily, versus matching placebo. The secondary aims of this study are to explore: 1. Any effect on symptomatic illness. 2. The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults. 3. The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time. 4. Where salivary Immunoglobulin A (IgA) may be used to provide an alternative/ complementary serological method 5. The effect (if any) of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs and iii) gender.

NCT04476680

Conditions

1. SARS-CoV Infection
2. Vitamin D Deficiency
3. Covid19
4. Acute Respiratory Tract Infection

Interventions

1. Dietary Supplement: Vitamin D 1000 IU
2. Drug: Placebo

MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Vitamin D Deficiency Asymptomatic Infections

HPO:Low levels of vitamin D Respiratory tract infection

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

Conditions

1. COVID-19
2. Vitamin D Deficiency
3. Respiratory Viral Infection

Interventions

1. Drug: Daily Vitamin D3
2. Drug: Daily placebo
3. Drug: Bolus vitamin D3
4. Drug: Bolus placebo

MeSH:Infection Communicable Diseases Virus Diseases Vitamin D Deficiency

HPO:Low levels of vitamin D

The world is currently facing a pandemic with the coronavirus (SARS-CoV-2) which leads to the disease of COVID-19. Risk factors for a poor outcome of COVID-19 have so far been identified as older age and co-morbidity including chronic respiratory conditions such as chronic obstructive pulmonary disease (COPD) and current smoking status. Previous studies found, that vitamin D deficiency is more prevalent among patients with these risk factors. There are observational studies reporting independent associations between low serum concentrations of 25-hydroxyvitamin D (the major circulating vitamin D metabolite) and susceptibility to acute respiratory tract infection. Vitamin D substitution in patients with COVID-19 who show a vitamin D deficiency should therefore be investigated for efficacy and safety. The study is designed as a randomized, placebo-controlled, double blind study. The objective of the study is to test the hypothesis that patients with vitamin D deficiency suffering from COVID-19 treated under standardized conditions in hospital will recover faster when additionally treated with a single high dose of vitamin D compared to standard treatment only.

NCT04525820

Conditions

1. Covid19
2. Vitamin D Deficiency
3. Corona Virus Infection
4. ARDS
5. Coronavirus
6. SARS-CoV Infection

Interventions

1. Drug: Single high dose vitamin D
2. Drug: Placebo
3. Drug: Treatment as usual vitamin D

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Vitamin D Deficiency

HPO:Low levels of vitamin D