vitamin d, omega-3, and combination vitamins b, c and zinc supplementation for the treatment and prevention of covid-19

Conditions: Covid19

Summary: the nutrovid factorial trials the purpose of the nutrovid-prevent and nutrovid-treat factorial trials is to determine whether vitamin b complex, vitamin c, and zinc; vitamin d; and omega3, taken at dosages approximating recommended dosages, can reduce the risk of covid-19 infection, hospitalization, mortality.

inadequate vitamin intake is common in mexico. vitamin deficiency is hypothesized as a risk factor for covid-19 infection and severe outcomes. specifically, vitamin d has been hypothesized as a regulator of the inflammatory cytokine response; vitamin c may help reduce the risk of a cytokine storm and support the immune system; vitamin b reduces pro-inflammatory cytokine levels, helps improve respiratory function, reduces hypercoagulability, and promotes endothelial structural integrity; resolvins, derived from omega3s, are a type of specialized pro-resolving lipid autacoid mediators hypothesized to prevent cytokine storms. elemental zinc is hypothesized to inhibit the replication of viruses. the nutrovid-prevent and nutrovid-treat factorial trials are testing the efficacy of these supplements (vitamins b, c, d, zinc, and omega 3) when used over a 60 day period among those who test positive (treat) and negative (prevent) for sars-cov-2 via a pcr test. the nutrovid trials utilize an innovative and cost-efficient approach, leveraging the existing infrastructure of the hospital system in san luis potosí province of mexico. for nutrovid-treat, we aim to enroll \~1,800 adults who have recently tested positive for sars-cov-2 and who have given informed consent. these \~1,800 adult females and males age 18 or older will be enrolled and randomized into the nutrovid treat factorial trial's 2x2x2 arms, in which 50% of the population will have a chance to receive any combination of the 3 supplement formulations; the other 50% will receive the respective placebos. those who test negative will be randomized into the nutrovid-prevent factorial trial's 2x2x2 arms, in which 50% of the population will have a chance to receive any combination of the 3 supplement formulations; the other 50% will receive the respective placebos. for nutrovid-prevent, we also aim to recruit \~1,800 adults, females and males. hospital staff will review medical records for vital events and conduct patient and family follow-up until \~november 2021.

Eligibility criteria:
positive sars-cov-2 test group (target enrollment: n=1,800) nutrovid treat trial: adult men/women recently diagnosed with covid-19 (positive pcr test for sars-cov-2 coronavirus) within \ =50 years old; or diabetic \& \>=40 years old; or obese \& \>=40 years old. negative sars-cov-2 test group (target enrollment: n=1,800) nutrovid prevent trial: adult men/women recently tested negative for covid-19 (negative pcr test for sars-cov-2 coronavirus); and satisfying one of these risk factors: \>=50 years old; or diabetic \& \>=40 years old; or obese \& \>=40 years old. signed informed consent form exclusion criteria: * patients requiring immediate intubation or deemed likely to die within 48 hours. * patients deemed likely for transfer to an icu within 48 hours. * patients currently taking oral corticosteroids for any reason at the time of presentation for care. * patients included in any other interventional trial. * uncontrolled bacterial superinfection. * severe chronic kidney disease (stage 4) or requiring dialysis (i.e. egfr \< 30). * pregnant women or women who are breastfeeding. * immunocompromised patients. * any patient with recent treatment (past 30 days) of immunosuppressive agents including (but not restricted to) dmards, corticosteroids, antibody therapy, intravenous immunoglobulins etc. * patients with acute myocardial infarction.

Keywords: covid19 nutritional supplements vitamin b vitamin c elemental zinc cytokine storm vitamin d vitamin b complex omega 3