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

NCT04828538 | Withdrawn

• 1 other identifier: 102020
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Covid19; Nutritional supplements; Vitamin B; Vitamin C; Elemental Zinc; Cytokine storm; Vitamin D; Vitamin B Complex; Omega 3

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1.a. 1-30 days; 1.b. 30-60; 1.c. 30 days to ~November 2021; 1.d. 60 days to ~ November 2021

Secondary Outcomes (2)

• Incidence of hospitalization and death (PREVENT Trial only)

  1-10 months

• 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

Other Outcomes (17)

• Changes in HbA1c (PREVENT Trial only)

  1-30; 1-60 days

• Change in diabetes status (PREVENT Trial only)

  1-30; 1-60 days

• Change in weight (PREVENT Trial only)

  1-30; 1-60 days

Study Arms (8)

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

ACTIVE COMPARATOR

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

2 - Vitamin D, Omega 3

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin D; Dietary Supplement: Omega DHA / EPA

3 - Vitamin D, Vitamins B, C, Zinc

ACTIVE COMPARATOR

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

4 - Vitamin D

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin D

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

ACTIVE COMPARATOR

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

6 - Omega 3

ACTIVE COMPARATOR

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

Dietary Supplement: Omega DHA / EPA

7 - Vitamins B, C, Zinc

ACTIVE COMPARATOR

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

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

8 - No Interventions

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Vitamin D DIETARY_SUPPLEMENT

Daily 4000 IU Vitamin D for 60 days

1 - Vitamin D, Omega 3, Vitamins B, C, Zinc; 2 - Vitamin D, Omega 3; 3 - Vitamin D, Vitamins B, C, Zinc; 4 - Vitamin D

Omega DHA / EPA DIETARY_SUPPLEMENT

Daily 1000mg Omega DHA/EPA for 60 days

1 - Vitamin D, Omega 3, Vitamins B, C, Zinc; 2 - Vitamin D, Omega 3; 5 - Omega 3, Vitamins B, C, Zinc,; 6 - Omega 3

Vitamin C, Vitamin B complex and Zinc Acetate DIETARY_SUPPLEMENT

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)

1 - Vitamin D, Omega 3, Vitamins B, C, Zinc; 3 - Vitamin D, Vitamins B, C, Zinc; 5 - Omega 3, Vitamins B, C, Zinc,; 7 - Vitamins B, C, Zinc

Placebo OTHER

Placebo

8 - No Interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de la Soledad: lead

Study Sites (1)

Hospital de Soledad

San Luis Potosí City, San Luis Potosí, 78435, Mexico

Location

Related Publications (6)

• Laird E, Rhodes J, Kenny RA. Vitamin D and Inflammation: Potential Implications for Severity of Covid-19. Ir Med J. 2020 May 7;113(5):81.

  PMID: 32603576 BACKGROUND

• Boretti A, Banik BK. Intravenous vitamin C for reduction of cytokines storm in acute respiratory distress syndrome. PharmaNutrition. 2020 Jun;12:100190. doi: 10.1016/j.phanu.2020.100190. Epub 2020 Apr 21.

  PMID: 32322486 BACKGROUND

• Panigrahy D, Gilligan MM, Huang S, Gartung A, Cortes-Puch I, Sime PJ, Phipps RP, Serhan CN, Hammock BD. Inflammation resolution: a dual-pronged approach to averting cytokine storms in COVID-19? Cancer Metastasis Rev. 2020 Jun;39(2):337-340. doi: 10.1007/s10555-020-09889-4.

  PMID: 32385712 BACKGROUND

• Shakoor H, Feehan J, Mikkelsen K, Al Dhaheri AS, Ali HI, Platat C, Ismail LC, Stojanovska L, Apostolopoulos V. Be well: A potential role for vitamin B in COVID-19. Maturitas. 2021 Feb;144:108-111. doi: 10.1016/j.maturitas.2020.08.007. Epub 2020 Aug 15. No abstract available.

  PMID: 32829981 BACKGROUND

• Entrenas Castillo M, Entrenas Costa LM, Vaquero Barrios JM, Alcala Diaz JF, Lopez Miranda J, Bouillon R, Quesada Gomez JM. "Effect of calcifediol treatment and best available therapy versus best available therapy on intensive care unit admission and mortality among patients hospitalized for COVID-19: A pilot randomized clinical study". J Steroid Biochem Mol Biol. 2020 Oct;203:105751. doi: 10.1016/j.jsbmb.2020.105751. Epub 2020 Aug 29.

  PMID: 32871238 BACKGROUND

• Singh M, Das RR. Zinc for the common cold. Cochrane Database Syst Rev. 2013 Jun 18;(6):CD001364. doi: 10.1002/14651858.CD001364.pub4.

  PMID: 23775705 BACKGROUND

MeSH Terms

Conditions

COVID-19; Cytokine Release Syndrome

Interventions

Vitamin D; Ascorbic Acid; Vitamin B Complex; Zinc Acetate

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Vitamins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Acetic Acid; Acetates

Study Officials

• José Yañez

  General Hospital Soledad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: On-site Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: April 2, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

ME (1)