Status:
WITHDRAWN
Vitamin D, Omega-3, and Combination Vitamins B, C and Zinc Supplementation for the Treatment and Prevention of COVID-19
Lead Sponsor:
Hospital de la Soledad
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
NA
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 d...
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 regula...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04828538
Start Date
January 1 2021
End Date
December 31 2021
Last Update
November 8 2022
Active Locations (1)
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1
Hospital de Soledad
San Luis Potosí City, San Luis Potosí, Mexico, 78435