Covid19
Conditions
Keywords
Covid19, Nutritional supplements, Vitamin B, Vitamin C, Elemental Zinc, Cytokine storm, Vitamin D, Vitamin B Complex, Omega 3
Brief 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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTVitamin D
Daily 4000 IU Vitamin D for 60 days
DIETARY_SUPPLEMENTOmega DHA / EPA
Daily 1000mg Omega DHA/EPA for 60 days
DIETARY_SUPPLEMENTVitamin C, Vitamin B complex and Zinc Acetate
Combination 1000 mg Vitamin C, Vitamin B complex\*\* and Zinc Acetate, 100 mg/day for 60 days \*\*(Vitamin B complex components: B12=1 mg; B6=50 mg; B9=2.5 mg; B1=100 mg; B2=100 mg; B3=14 mg; B7=50 mg)
OTHERPlacebo
Placebo
Sponsors
Hospital de la Soledad
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Double-blind randomized, placebo-controlled double blinded 2x2x2 factorial trials (includes 2 trials: treatment cohort and prevention cohort) of the following oral supplementation treatments for up to 60 days per person: Factorial 1 (F1): 4000 IU Vitamin D vs placebo Factorial 2 (F2): 1000mg Omega DHA/EPA vs. placebo Factorial 3 (F3): Combination 1000 mg Vitamin C, Vitamin B complex\*\* and Zinc Acetate, 100 mg/day vs. placebo \*\*(Vitamin B complex components: B12=1 mg; B6=50 mg; B9=2.5 mg; B1
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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 \<=5 days of symptom onset; and satisfying one of these risk factors: \>=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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Covid infection rate (PREVENT Trial only) | 30 and 60 days | 1.a. Incidence of positive PCR at \ 1 month and \ 2 months; 1.b. Incidence of symptomatic positive PCR and asymptomatic positive PCR at 1 month and 2 months. |
| Incidence of severe outcome (TREAT Trial only) | 1.a. 1-30 days; 1.b. 30-60; 1.c. 30 days to ~November 2021; 1.d. 60 days to ~ November 2021 | 1.a. Incidence of severe outcome (mortality or ICU admission or intubation) up to 30 days. 1.b. Incidence of severe outcome (mortality or ICU admission or intubation) from 30-60 days. 1.c. Incidence of severe outcome (mortality or ICU admission or intubation), from 30 days to \ November 2021. 1.d. Incidence of severe outcome (mortality or ICU admission or intubation), from 60 days to \ November 2021. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hospitalization and death (PREVENT Trial only) | 1-10 months | 2.a. Incidence of hospitalization, follow-up to \ November 2021. 2.b. Incidence of severe outcome (mortality or ICU admission or intubation), follow-up to \ November 2021. 2.c. Incidence of death, follow-up to \ November 2021. |
| Length of hospitalization and death after discharge (TREAT Trial only) | 2.a. 1-30 days; 2.b. 1 day(s) to ~November 2021, 2.c. 30 days to ~November 2021 | 2.a. Length of hospitalization for admissions less than 30 days from baseline versus for admissions after 30 days from baseline. 2.b. \[If available\] Incidence of hospital readmission after discharge, follow-up to \ November 2021. 2.c. Incidence of death after discharge, follow-up to \ November 2021. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hospital readmission (PREVENT Trial only) | 1-30; 1-60 days; 1 day to ~November 2021 | \[If available\] Incidence of COVID -19 symptoms at 1 month and 2 months with follow-up to \ November 2021 |
| Incidence of ICU admission (PREVENT Trial only) | 1-30; 1-60 days; 1 day to ~November 2021 | \[If available\] Incidence of ICU admission (PREVENT Trial only) |
| Incidence of intubation (PREVENT Trial only) | 1-30; 1-60 days; 1 day to ~November 2021 | \[If available\] Incidence of intubation (PREVENT Trial only) |
| Incidence of Vaccination (PREVENT Trial only) | 1-30; 1-60 days; 1 day to ~November 2021 | \[If available\] Incidence of vaccination |
| Change in HbA1c at 1 month and 2 months (TREAT Trial only) | 1-30 days and 1-60 days | \[If available\] Change in HbA1c at 1 month and 2 months. |
| Change in diabetes status at 1 month and 2 months (TREAT Trial only) | 1-30 days and 1-60 days | \[If available\] Change in diabetes status at 1 month and 2 months. |
| Changes in HbA1c (PREVENT Trial only) | 1-30; 1-60 days | Change in HbA1c at 1 month and 2 months |
| Incidence of COVID -19 symptoms at 1 month and 2 months (TREAT Trial only) | 1-30 days and 1-60 days | \[If available\] Incidence of COVID -19 symptoms at 1 month and 2 months. |
| Incidence of depression (TREAT Trial only) | ~1-60 days | \[If available\] Incidence of depression |
| Incidence of vaccination (TREAT Trial only) | 1-30; 1-60 days; 1 day to ~November 2021 | \[If available\] Incidence of vaccination |
| Incidence of vaccine hesitancy (TREAT Trial only) | ~1-60 days | \[If available\] Incidence of vaccine hesitancy |
| ICU readmission (TREAT Trial only) | 1-30; 1-60 days; 1 day to ~November 2021 | \[If available\] ICU readmission |
| Incidence of Intubation (upon readmission) (TREAT Trial only) | 1-30; 1-60 days; 1 day to ~November 2021 | \[If available\] Incidence of Intubation |
| Change in weight at 1 month and 2 months (TREAT Trial only) | 1-30 days and 1-60 days | \[If available\] Change in weight at 1 month and 2 months |
| Change in diabetes status (PREVENT Trial only) | 1-30; 1-60 days | Change in diabetes status at 1 month and 2 months |
| Change in weight (PREVENT Trial only) | 1-30; 1-60 days | Change in weight at 1 month and 2 months |
| Incidence of COVID -19 symptoms at 1 month and 2 months (PREVENT Trial only) | 1-30; 1-60 days | \[If available\] Incidence of COVID -19 symptoms at 1 month and 2 months |
Countries
Mexico
Outcome results
None listed