Covid19NUTROVIDNCT04828538
Vitamin D, Omega-3, and Combination Vitamins B, C and Zinc Supplementation for the Treatment and Prevention of COVID-19
A study testing Vitamin D, Omega DHA / EPA and Vitamin C, Vitamin B complex and Zinc Acetate in people with Covid19, run by Hospital de la Soledad at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Vitamin D, Omega DHA / EPA and Vitamin C, Vitamin B complex and Zinc Acetate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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).
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Vitamin D, Omega DHA / EPA, Vitamin C, Vitamin B complex and Zinc Acetate, Placebo
- Keywords
- Covid19, Nutritional supplements, Vitamin B, Vitamin C, Elemental Zinc, Cytokine storm, Vitamin D, Vitamin B Complex, Omega 3
- Medical subject headings
- COVID-19, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Daily 4000 IU Vitamin D for 60 days
Omega DHA / EPADietary supplement
Daily 1000mg Omega DHA/EPA for 60 days
Vitamin C, Vitamin B complex and Zinc AcetateDietary 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)
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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] Receives: 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] Receives: 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] Receives: 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] Receives: 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] Receives: 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] Receives: 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] Receives: 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] Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: 1-10 months
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.
Measured: 2.a. 1-30 days; 2.b. 1 day(s) to ~November 2021, 2.c. 30 days to ~November 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: Recruitment failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- 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; B1
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de la Soledad
- Sponsor type
- Other government
- Responsible party
- Principal investigator, A Yáñez Admin, Hospital de la Soledad
- Investigators
- José Yañez, Principal investigator, General Hospital Soledad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828538
- Sponsor's protocol ID
- 102020
- Acronym
- NUTROVID
- Status last verified
- Nov 2022
- First submitted
- 12 Mar 2021
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32603576Boretti 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.
PubMed 32322486Panigrahy 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.
PubMed 32385712Shakoor 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.
PubMed 32829981Entrenas 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.
PubMed 32871238Singh M, Das RR. Zinc for the common cold. Cochrane Database Syst Rev. 2013 Jun 18;(6):CD001364. doi: 10.1002/14651858.CD001364.pub4.
PubMed 23775705
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04828538
- Acronym / sponsor ID
- NUTROVID / 102020
- Conditions
- Covid19
- Keywords
- Covid19, Nutritional supplements, Vitamin B, Vitamin C, Elemental Zinc, Cytokine storm, Vitamin D, Vitamin B Complex
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment failure
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital de la SoledadOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 8
- 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; B1
| Arm | Type | Receives |
|---|---|---|
| 1 - Vitamin D, Omega 3, Vitamins B, C, Zinc | Active comparator | Dietary Supplement: Vitamin D, Dietary Supplement: Omega DHA / EPA, Dietary Supplement: Vitamin C, Vitamin B complex and Zinc AcetateVitamin D of F1 Omega 3 of F2 Vitamins B, C, Zinc of F3 [60 days] |
| 2 - Vitamin D, Omega 3 | Active comparator | Dietary Supplement: Vitamin D, Dietary Supplement: Omega DHA / EPAVitamin D of F1 Omega 3 of F2 Placebo of F3 [60 days] |
| 3 - Vitamin D, Vitamins B, C, Zinc | Active comparator | Dietary Supplement: Vitamin D, Dietary Supplement: Vitamin C, Vitamin B complex and Zinc AcetateVitamin D of F1 Placebo of F2 Vitamins B, C, Zinc of F3 [60 days] |
| 4 - Vitamin D | Active comparator | Dietary Supplement: Vitamin DVitamin D of F1 Placebo of F2 Placebo of F3 [60 days] |
| 5 - Omega 3, Vitamins B, C, Zinc, | Active comparator | Dietary Supplement: Omega DHA / EPA, Dietary Supplement: Vitamin C, Vitamin B complex and Zinc AcetatePlacebo of F1 Omega 3 of F2 Vitamins B, C, Zinc of F3 [60 days] |
| 6 - Omega 3 | Active comparator | Dietary Supplement: Omega DHA / EPAPlacebo of F1 Omega 3 of F2 Placebo of F3 [60 days] |
| 7 - Vitamins B, C, Zinc | Active comparator | Dietary Supplement: Vitamin C, Vitamin B complex and Zinc AcetatePlacebo of F1 Placebo of F2 Vitamins B, C, Zinc of F3 [60 days] |
| 8 - No Interventions | Placebo comparator | Other: PlaceboPlacebo of F1 Placebo of F2 Placebo of F3 [60 days] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DDaily 4000 IU Vitamin D for 60 days | Dietary supplement | 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 / EPADaily 1000mg Omega DHA/EPA for 60 days | Dietary supplement | 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 AcetateCombination 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) | Dietary supplement | 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 |
| PlaceboPlacebo | Other | 8 - No Interventions |
Primary outcome
Covid infection rate (PREVENT Trial only)
Time frame: 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.
Incidence of severe outcome (TREAT Trial only)
Time frame: 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.
2 secondary outcomes
Incidence of hospitalization and death (PREVENT Trial only)
Time frame: 1-10 months
Length of hospitalization and death after discharge (TREAT Trial only)
Time frame: 2.a. 1-30 days; 2.b. 1 day(s) to ~November 2021, 2.c. 30 days to ~November 2021
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Background: PubMed 32603576Laird 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.
- Background: PubMed 32322486Boretti 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.
- Background: PubMed 32385712Panigrahy 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.
- Background: PubMed 32829981Shakoor 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.
- Background: PubMed 32871238Entrenas 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.
- Background: PubMed 23775705Singh M, Das RR. Zinc for the common cold. Cochrane Database Syst Rev. 2013 Jun 18;(6):CD001364. doi: 10.1002/14651858.CD001364.pub4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Yañez principal investigator
General Hospital Soledad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D, Omega DHA / EPA and Vitamin C, Vitamin B complex and Zinc Acetate in people with Covid19, run by Hospital de la Soledad at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Covid infection rate (PREVENT Trial only) (time frame: 30 and 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04828538, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.