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

Sponsor
Hospital de la Soledad (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04828538
Collaborator
Microclinic International (Other)
1,800
Enrollment
1
Location
8
Arms
10.9
Anticipated Duration (Months)
164.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Dietary Supplement: Vitamin D
  • Dietary Supplement: Omega DHA / EPA
  • Dietary Supplement: Vitamin C, Vitamin B complex and Zinc Acetate
  • Other: Placebo
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1800 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
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; B1Double-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
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Other
Official Title:
Prevent and Treat Double-Blind Factorial Randomized Trials of Daily Oral Vitamin D, Omega 3, and Combination Vitamins B, C and Zinc Supplementation for the Treatment and Prevention of COVID-19
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Nov 30, 2021
Anticipated Study Completion Date :
Nov 30, 2021

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: 1 - Vitamin D, Omega 3, Vitamins B, C, Zinc

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

Dietary Supplement: Vitamin D
Daily 4000 IU Vitamin D for 60 days

Dietary Supplement: Omega DHA / EPA
Daily 1000mg Omega DHA/EPA for 60 days

Dietary Supplement: Vitamin 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)

Active Comparator: 2 - Vitamin D, Omega 3

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

Dietary Supplement: Vitamin D
Daily 4000 IU Vitamin D for 60 days

Dietary Supplement: Omega DHA / EPA
Daily 1000mg Omega DHA/EPA for 60 days

Active Comparator: 3 - Vitamin D, Vitamins B, C, Zinc

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

Dietary Supplement: Vitamin D
Daily 4000 IU Vitamin D for 60 days

Dietary Supplement: Vitamin 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)

Active Comparator: 4 - Vitamin D

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

Dietary Supplement: Vitamin D
Daily 4000 IU Vitamin D for 60 days

Active Comparator: 5 - Omega 3, Vitamins B, C, Zinc,

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

Dietary Supplement: Omega DHA / EPA
Daily 1000mg Omega DHA/EPA for 60 days

Dietary Supplement: Vitamin 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)

Active Comparator: 6 - Omega 3

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

Dietary Supplement: Omega DHA / EPA
Daily 1000mg Omega DHA/EPA for 60 days

Active Comparator: 7 - Vitamins B, C, Zinc

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

Dietary Supplement: Vitamin 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)

Placebo Comparator: 8 - No Interventions

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

Other: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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 Outcome Measures

  1. 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.

  2. 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 Outcome Measures

  1. Changes in HbA1c (PREVENT Trial only) [1-30; 1-60 days]

    Change in HbA1c at 1 month and 2 months

  2. Change in diabetes status (PREVENT Trial only) [1-30; 1-60 days]

    Change in diabetes status at 1 month and 2 months

  3. Change in weight (PREVENT Trial only) [1-30; 1-60 days]

    Change in weight at 1 month and 2 months

  4. 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

  5. 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

  6. 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)

  7. Incidence of intubation (PREVENT Trial only) [1-30; 1-60 days; 1 day to ~November 2021]

    [If available] Incidence of intubation (PREVENT Trial only)

  8. Incidence of Vaccination (PREVENT Trial only) [1-30; 1-60 days; 1 day to ~November 2021]

    [If available] Incidence of vaccination

  9. 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.

  10. 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.

  11. 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

  12. 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.

  13. Incidence of depression (TREAT Trial only) [~1-60 days]

    [If available] Incidence of depression

  14. Incidence of vaccination (TREAT Trial only) [1-30; 1-60 days; 1 day to ~November 2021]

    [If available] Incidence of vaccination

  15. Incidence of vaccine hesitancy (TREAT Trial only) [~1-60 days]

    [If available] Incidence of vaccine hesitancy

  16. ICU readmission (TREAT Trial only) [1-30; 1-60 days; 1 day to ~November 2021]

    [If available] ICU readmission

  17. Incidence of Intubation (upon readmission) (TREAT Trial only) [1-30; 1-60 days; 1 day to ~November 2021]

    [If available] Incidence of Intubation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Hospital de SoledadSan Luis PotosíSLPMexico78435

Sponsors and Collaborators

  • Hospital de la Soledad
  • Microclinic International

Investigators

  • Principal Investigator: Eric Ding, ScD, Federation of American Scientists
  • Principal Investigator: Daniel E Zoughbie, DPhil, Microclinic Social Network Research Group
  • Study Director: Diego Sanchez, MSc, Microclinic Social Network Research Group

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr. Arturo Yanez, On-site Principal Investigator, Hospital de la Soledad
ClinicalTrials.gov Identifier:
NCT04828538
Other Study ID Numbers:
  • MCI102020
First Posted:
Apr 2, 2021
Last Update Posted:
Nov 17, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Arturo Yanez, On-site Principal Investigator, Hospital de la Soledad
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 17, 2021