An interventional study of Vitamin D and Omega DHA / EPA in Covid19, sponsored by Hospital de la Soledad. Withdrawn at 1 site in Mexico. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by Hospital de la Soledad · Not applicable, Interventional, and Other
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.
7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.
Browse COVID-19 studies →This is the only study on the registry with Hospital de la Soledad as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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:
Vitamin D of F1 Omega 3 of F2 Vitamins B, C, Zinc of F3 \[60 days\]
Dietary Supplement: Vitamin D · Dietary Supplement: Omega DHA / EPA · Dietary Supplement: Vitamin C, Vitamin B complex and Zinc Acetate
Vitamin D of F1 Omega 3 of F2 Placebo of F3 \[60 days\]
Dietary Supplement: Vitamin D · Dietary Supplement: Omega DHA / EPA
Vitamin D of F1 Placebo of F2 Vitamins B, C, Zinc of F3 \[60 days\]
Dietary Supplement: Vitamin D · Dietary Supplement: Vitamin C, Vitamin B complex and Zinc Acetate
Vitamin D of F1 Placebo of F2 Placebo of F3 \[60 days\]
Dietary Supplement: Vitamin D
Placebo of F1 Omega 3 of F2 Vitamins B, C, Zinc of F3 \[60 days\]
Dietary Supplement: Omega DHA / EPA · Dietary Supplement: Vitamin C, Vitamin B complex and Zinc Acetate
Placebo of F1 Omega 3 of F2 Placebo of F3 \[60 days\]
Dietary Supplement: Omega DHA / EPA
Placebo of F1 Placebo of F2 Vitamins B, C, Zinc of F3 \[60 days\]
Dietary Supplement: Vitamin C, Vitamin B complex and Zinc Acetate
Placebo of F1 Placebo of F2 Placebo of F3 \[60 days\]
Other: Placebo
Daily 4000 IU Vitamin D for 60 days
Daily 1000mg Omega DHA/EPA for 60 days
Drug pages: Ascorbic Acid · 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)
Placebo
Covid infection rate (PREVENT Trial only)
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.
Time frame: 30 and 60 days
Incidence of severe outcome (TREAT Trial only)
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.
Time frame: 1.a. 1-30 days; 1.b. 30-60; 1.c. 30 days to ~November 2021; 1.d. 60 days to ~ November 2021
Incidence of hospitalization and death (PREVENT Trial only)
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.
Time frame: 1-10 months
Length of hospitalization and death after discharge (TREAT Trial only)
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.
Time frame: 2.a. 1-30 days; 2.b. 1 day(s) to ~November 2021, 2.c. 30 days to ~November 2021
Changes in HbA1c (PREVENT Trial only)
Change in HbA1c at 1 month and 2 months
Time frame: 1-30; 1-60 days
Change in diabetes status (PREVENT Trial only)
Change in diabetes status at 1 month and 2 months
Time frame: 1-30; 1-60 days
Change in weight (PREVENT Trial only)
Change in weight at 1 month and 2 months
Time frame: 1-30; 1-60 days
Incidence of COVID -19 symptoms at 1 month and 2 months (PREVENT Trial only)
\[If available\] Incidence of COVID -19 symptoms at 1 month and 2 months
Time frame: 1-30; 1-60 days
Incidence of hospital readmission (PREVENT Trial only)
\[If available\] Incidence of COVID -19 symptoms at 1 month and 2 months with follow-up to \~November 2021
Time frame: 1-30; 1-60 days; 1 day to ~November 2021
Incidence of ICU admission (PREVENT Trial only)
\[If available\] Incidence of ICU admission (PREVENT Trial only)
Time frame: 1-30; 1-60 days; 1 day to ~November 2021
Incidence of intubation (PREVENT Trial only)
\[If available\] Incidence of intubation (PREVENT Trial only)
Time frame: 1-30; 1-60 days; 1 day to ~November 2021
Incidence of Vaccination (PREVENT Trial only)
\[If available\] Incidence of vaccination
Time frame: 1-30; 1-60 days; 1 day to ~November 2021
Change in HbA1c at 1 month and 2 months (TREAT Trial only)
\[If available\] Change in HbA1c at 1 month and 2 months.
Time frame: 1-30 days and 1-60 days
Change in diabetes status at 1 month and 2 months (TREAT Trial only)
\[If available\] Change in diabetes status at 1 month and 2 months.
Time frame: 1-30 days and 1-60 days
Change in weight at 1 month and 2 months (TREAT Trial only)
\[If available\] Change in weight at 1 month and 2 months
Time frame: 1-30 days and 1-60 days
Incidence of COVID -19 symptoms at 1 month and 2 months (TREAT Trial only)
\[If available\] Incidence of COVID -19 symptoms at 1 month and 2 months.
Time frame: 1-30 days and 1-60 days
Incidence of depression (TREAT Trial only)
\[If available\] Incidence of depression
Time frame: ~1-60 days
Incidence of vaccination (TREAT Trial only)
\[If available\] Incidence of vaccination
Time frame: 1-30; 1-60 days; 1 day to ~November 2021
Incidence of vaccine hesitancy (TREAT Trial only)
\[If available\] Incidence of vaccine hesitancy
Time frame: ~1-60 days
ICU readmission (TREAT Trial only)
\[If available\] ICU readmission
Time frame: 1-30; 1-60 days; 1 day to ~November 2021
Incidence of Intubation (upon readmission) (TREAT Trial only)
\[If available\] Incidence of Intubation
Time frame: 1-30; 1-60 days; 1 day to ~November 2021
Ran from Jan 2021 to primary completion in Dec 2021, 11 months.
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Studies of the drugs tested here: Vitamin D · Ascorbic Acid · Zinc Acetate