Vitamin D, Omega-3, and Combination Vitamins B, C and Zinc Supplementation for the Treatment and Prevention of COVID-19 (NUTROVID)

Hospital de la Soledad

Status: Withdrawn

Conditions: Covid19

Treatments: Dietary Supplement: Vitamin C, Vitamin B complex and Zinc Acetate; Dietary Supplement: Vitamin D; Other: Placebo; Dietary Supplement: Omega DHA / EPA

Study type: Interventional

Funder types: Other

Identifiers

NCT04828538

102020

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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0 participants in 8 patient groups, including a placebo group

1 - Vitamin D, Omega 3, Vitamins B, C, Zinc

Active Comparator group

Description:

Vitamin D of F1 Omega 3 of F2 Vitamins B, C, Zinc of F3 \[60 days\]

Treatment:

Dietary Supplement: Vitamin D

Dietary Supplement: Vitamin C, Vitamin B complex and Zinc Acetate

Dietary Supplement: Omega DHA / EPA

2 - Vitamin D, Omega 3

Active Comparator group

Description:

Vitamin D of F1 Omega 3 of F2 Placebo of F3 \[60 days\]

Treatment:

Dietary Supplement: Vitamin D

Dietary Supplement: Omega DHA / EPA

3 - Vitamin D, Vitamins B, C, Zinc

Active Comparator group

Description:

Vitamin D of F1 Placebo of F2 Vitamins B, C, Zinc of F3 \[60 days\]

Treatment:

Dietary Supplement: Vitamin D

Dietary Supplement: Vitamin C, Vitamin B complex and Zinc Acetate

4 - Vitamin D

Active Comparator group

Description:

Vitamin D of F1 Placebo of F2 Placebo of F3 \[60 days\]

Treatment:

Dietary Supplement: Vitamin D

5 - Omega 3, Vitamins B, C, Zinc,

Active Comparator group

Description:

Placebo of F1 Omega 3 of F2 Vitamins B, C, Zinc of F3 \[60 days\]

Treatment:

Dietary Supplement: Vitamin C, Vitamin B complex and Zinc Acetate

Dietary Supplement: Omega DHA / EPA

6 - Omega 3

Active Comparator group

Description:

Placebo of F1 Omega 3 of F2 Placebo of F3 \[60 days\]

Treatment:

Dietary Supplement: Omega DHA / EPA

7 - Vitamins B, C, Zinc

Active Comparator group

Description:

Placebo of F1 Placebo of F2 Vitamins B, C, Zinc of F3 \[60 days\]

Treatment:

Dietary Supplement: Vitamin C, Vitamin B complex and Zinc Acetate

8 - No Interventions

Placebo Comparator group

Description:

Placebo of F1 Placebo of F2 Placebo of F3 \[60 days\]

Treatment:

Other: Placebo