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

Covid19 Clinical Trial

— NUTROVID  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04828538
• Other study ID #: 102020
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2022
• Source: Hospital de la Soledad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Dietary Supplement:
• Vitamin D
Daily 4000 IU Vitamin D for 60 days
• Omega DHA / EPA
Daily 1000mg Omega DHA/EPA for 60 days
• 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)

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Mexico	Hospital de Soledad	San Luis Potosí	SLP

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de la Soledad

Country where clinical trial is conducted

Mexico, 

References & Publications (6)

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. Review. — View Citation

Entrenas Castillo M, Entrenas Costa LM, Vaquero Barrios JM, Alcalá Díaz JF, López 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. — View Citation

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. — View Citation

Panigrahy D, Gilligan MM, Huang S, Gartung A, Cortés-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. — View Citation

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. — View Citation

Singh M, Das RR. Zinc for the common cold. Cochrane Database Syst Rev. 2013 Jun 18;(6):CD001364. doi: 10.1002/14651858.CD001364.pub4. Review. Update in: Cochrane Database Syst Rev. 2015;(4):CD001364. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in HbA1c (PREVENT Trial only)	Change in HbA1c at 1 month and 2 months	1-30; 1-60 days
Other	Change in diabetes status (PREVENT Trial only)	Change in diabetes status at 1 month and 2 months	1-30; 1-60 days
Other	Change in weight (PREVENT Trial only)	Change in weight at 1 month and 2 months	1-30; 1-60 days
Other	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	1-30; 1-60 days
Other	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	1-30; 1-60 days; 1 day to ~November 2021
Other	Incidence of ICU admission (PREVENT Trial only)	[If available] Incidence of ICU admission (PREVENT Trial only)	1-30; 1-60 days; 1 day to ~November 2021
Other	Incidence of intubation (PREVENT Trial only)	[If available] Incidence of intubation (PREVENT Trial only)	1-30; 1-60 days; 1 day to ~November 2021
Other	Incidence of Vaccination (PREVENT Trial only)	[If available] Incidence of vaccination	1-30; 1-60 days; 1 day to ~November 2021
Other	Change in HbA1c at 1 month and 2 months (TREAT Trial only)	[If available] Change in HbA1c at 1 month and 2 months.	1-30 days and 1-60 days
Other	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.	1-30 days and 1-60 days
Other	Change in weight at 1 month and 2 months (TREAT Trial only)	[If available] Change in weight at 1 month and 2 months	1-30 days and 1-60 days
Other	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.	1-30 days and 1-60 days
Other	Incidence of depression (TREAT Trial only)	[If available] Incidence of depression	~1-60 days
Other	Incidence of vaccination (TREAT Trial only)	[If available] Incidence of vaccination	1-30; 1-60 days; 1 day to ~November 2021
Other	Incidence of vaccine hesitancy (TREAT Trial only)	[If available] Incidence of vaccine hesitancy	~1-60 days
Other	ICU readmission (TREAT Trial only)	[If available] ICU readmission	1-30; 1-60 days; 1 day to ~November 2021
Other	Incidence of Intubation (upon readmission) (TREAT Trial only)	[If available] Incidence of Intubation	1-30; 1-60 days; 1 day to ~November 2021
Primary	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
Primary	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	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.	1-10 months
Secondary	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.	2.a. 1-30 days; 2.b. 1 day(s) to ~November 2021, 2.c. 30 days to ~November 2021