Vitamin D, Omega-3, and Combination Vitamins B, C and Zinc Supplementation for the Treatment and Prevention of COVID-19
NCT ID: NCT04828538
Last Updated: 2022-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-01-01
2021-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
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
OTHER
DOUBLE
Study Groups
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1 - Vitamin D, Omega 3, Vitamins B, C, Zinc
Vitamin D of F1 Omega 3 of F2 Vitamins B, C, Zinc of F3
\[60 days\]
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)
2 - Vitamin D, Omega 3
Vitamin D of F1 Omega 3 of F2 Placebo of F3
\[60 days\]
Vitamin D
Daily 4000 IU Vitamin D for 60 days
Omega DHA / EPA
Daily 1000mg Omega DHA/EPA for 60 days
3 - Vitamin D, Vitamins B, C, Zinc
Vitamin D of F1 Placebo of F2 Vitamins B, C, Zinc of F3
\[60 days\]
Vitamin D
Daily 4000 IU Vitamin D 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)
4 - Vitamin D
Vitamin D of F1 Placebo of F2 Placebo of F3
\[60 days\]
Vitamin D
Daily 4000 IU Vitamin D for 60 days
5 - Omega 3, Vitamins B, C, Zinc,
Placebo of F1 Omega 3 of F2 Vitamins B, C, Zinc of F3
\[60 days\]
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)
6 - Omega 3
Placebo of F1 Omega 3 of F2 Placebo of F3
\[60 days\]
Omega DHA / EPA
Daily 1000mg Omega DHA/EPA for 60 days
7 - Vitamins B, C, Zinc
Placebo of F1 Placebo of F2 Vitamins B, C, Zinc of F3
\[60 days\]
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)
8 - No Interventions
Placebo of F1 Placebo of F2 Placebo of F3
\[60 days\]
Placebo
Placebo
Interventions
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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)
Placebo
Placebo
Eligibility Criteria
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Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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Hospital de la Soledad
OTHER_GOV
Responsible Party
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A Yáñez Admin
On-site Principal Investigator
Principal Investigators
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José Yañez
Role: PRINCIPAL_INVESTIGATOR
General Hospital Soledad
Locations
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Hospital de Soledad
San Luis Potosí City, San Luis Potosí, Mexico
Countries
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References
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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.
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.
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.
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.
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.
Singh M, Das RR. Zinc for the common cold. Cochrane Database Syst Rev. 2013 Jun 18;(6):CD001364. doi: 10.1002/14651858.CD001364.pub4.
Other Identifiers
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102020
Identifier Type: -
Identifier Source: org_study_id
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