Covid19CoVITNCT04751669
Efficacy of a Dietary Supplementation in Reducing Hospital Admissions for COVID-19. Randomized Clinical Trial
A study testing Vitamin and trace elements in people with Covid19, run by Fundació Institut Germans Trias i Pujol at 1 site in Spain.
Trial summary
A double-blind, placebo-controlled, randomized clinical trial to assess efficacy of micronutrient dietary supplementation in reducing hospital admissions for COVID-19 and incidence of Long Covid. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Covid19
- What is being tested?
- Vitamin and trace elements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 1 siteSpain
- Study dates
- 9 Aug 2021to 26 Oct 2023
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent Form signed.
- Patients with symptoms compatible with COVID-19: cough and fever who not fulfil criteria of hospitalization and will be in outpatient care.
- Positive polymerase chain reaction (PCR) or transcription-mediated amplification (TMA) test or rapid antigen test for severe acute respiratory syndrome Corona Virus-2 (SARS-CoV-2) or diagnostic test available.
- Age ≥ 18 years
- Availability to meet the requirements of the protocol.
Who cannot join
- Intake of any micronutrient supplement during the month prior to inclusion.
- Patients fulfilling hospitalization criteria.
- Previous allergies to the micronutrient components and excipients.
- Age ≥ 90 years with any comorbidity (diabetes, hypertension, obesity, heart disease, respiratory disease)
- Participation in other research that requires experimental intervention (does not include observational studies) in the previous month before signing the informed consent form.
- Detection by the researcher of lack of knowledge or willingness to participate and comply with all the requirements of the protocol.
- Any other findings that at the discretion of the researcher may compromise protocol performance or significantly influence the interpretation or results of the effects of the nutritional supplement
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
About this study
Official title: Efficacy of Micronutrient Dietary Supplementation in Reducing Hospital Admissions for COVID-19: A Double-blind, Placebo-controlled, Randomized Clinical Trial
A double-blind, placebo-controlled, randomized clinical trial to assess efficacy of micronutrient dietary supplementation in reducing hospital admissions for COVID-19 and incidence of Long Covid.
We want to assess the need for hospital admission for severe acute respiratory syndrome Corona Virus-2 (SARS-CoV-2) infection in outpatients diagnosed of COVID-19 disease, taking a micronutrient supplementation for 14 days. The outcome Will be measured within 1 month after beginning the study treatment. The patients will be followed-up for a period of 180 days for the incidence of Long Covid
Read the detailed description
- Type of study/ Design: Randomized, double-blind, placebo-controlled clinical trial.
- Sponsor: Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol / Hospital Universitari Germans Trias i Pujol ( IGTP / HUGTIP)
- Title of the clinical trial: Efficacy of micronutrient dietary supplementation in reducing hospital admissions for COVID-19 and Long Covid: A double-blind, placebo-controlled, randomized clinical trial.
- Protocol code: CoVIT Clinical Trial
- NºClinicaltrials.gov: Pending
- Coordinating researcher: Dra. Teresa-Maria Tomasa-Irriguible.
- Recruiting Center: Germans Trias i Pujol University Hospital (HUGTIP)
- Ethical Committee for clinical Investigation (CEI): Germans Trias i Pujol University Hospital CEI.
- Monitoring: Clinical Research Associate at UPIC (Unitat Polivalent d'Investigació Clínica) Clinical Trial Unit- IGTP
- Study treatments: Dietary supplement with micronutrients and Placebo
- Test phase: Not applicable.
- Main objective: Evaluation of the effectiveness of supplementation with a dietary supplement to improve the need for hospital admission for SARS-CoV-2 infection, and incidence of Long Covid.
- Study pathology: COVID-19.
- Main variable: The need for hospital admission of SARS-CoV-2 documented infection and the incidence of Long Covid
- Study population and total number of patients: Patients of the health system of the Northern Metropolitan Area of Catalan Health Institution with symptoms compatible with SARS-CoV-2 infection. A total of 300 people (150 treated with dietary supplement and 150 with placebo).
- Duration of treatment: 14 days.
- Patients follow-up: 180 days
- Conditions
- Covid19
- Being tested
- Vitamin and trace elements, Placebo
- Keywords
- Dietary Supplement
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin and trace elementsDietary supplement
Dietary supplement oral route, once a day, during 14 days
PlaceboDietary supplement
Dietary supplement (placebo) oral route, once a day, during 14 days
| Study group | Role | What they receive |
|---|---|---|
| Micronutrient dietary supplement effervescent tablet | Experimental | Tablet containing:
* Retinol (Vitamin A) 700 mcg
* Cholecalciferol (Vitamin D3) 10 mcg
* Alpha-Tocopherol (Vitamin E) 45 mg
* Ascorbic acid (vitamin C) 1000 mg
* Pyridoxine (Vitamin B6) 6.5 mg
* Cyanocobalamin (Vitamin B12) 9.6 mg
* Folic acid 400 mg
* Iron 5 mg
* Zinc 10 mg
* Selenium 110 mg
* Copper 0.9 mg
* Excipients Receives: Dietary Supplement: Vitamin and trace elements |
| Placebo dietary supplement effervescent tablet | Placebo comparator | Effervescent tablet with only the excipients.
* Sucralose 13 mg
* Sodium Chloride 20 mg
* Potassium Acesulfam 22.5 mg
* Orange P 55 mg
* Sodium Carbonate 70 mg
* Betacarotene 100 mg
* Malic Acid 800 mg
* Citric Acid 960 mg
* Sodium bicarbonate 1,000 mg
* Isomalt 1,459.50 mg Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for hospital admission
The need for hospitalization of documented SARS-CoV-2 infection (positive polymerase chain reaction or transcription-mediated amplification test or antigen test or positive serology or diagnostic test available) over the course of the disease
Measured: From baseline to 1 month after beginning the study treatment
Incidence of Long Covid.
Incidence of long Covid or symptoms persistence following World Health Organization definition
Measured: 6 months after beginning the study treatment
Secondary outcomes (35)
Micronutrient basal status (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid
Evaluation of micronutrient status prior to the nutritional supplement administration (in ng/mL)
Measured: Within day 1 at study inclusion
Micronutrient basal status (Vitamin B12)
Evaluation of micronutrient status prior to the nutritional supplement administration in pg/mL
Measured: Within day 1 at study inclusion
Micronutrient basal status (Iron, Zinc and Copper )
Evaluation of micronutrient status prior to the nutritional supplement administration in mcg/dL
Measured: Within day 1 at study inclusion
Micronutrient basal status (Vitamin A and Vitamin E)
Evaluation of micronutrient status prior to the nutritional supplement administration in mg/L
Measured: Within day 1 at study inclusion
Micronutrient basal status (Selenium )
Evaluation of micronutrient status prior to the nutritional supplement administration in mcg/L
Measured: Within day 1 at study inclusion
Micronutrient basal status (Vitamin C)
Evaluation of micronutrient status prior to the nutritional supplement administration in mg/dL
Measured: Within day 1 at study inclusion
Micronutrient status at hospital admission (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid)
Evaluation of micronutrient status in patients requiring hospitalization in ng/mL
Measured: Within the first day of hospital admission
Micronutrient status at hospital admission ( Vitamin B12)
Evaluation of micronutrient status in patients requiring hospitalization in pg/mL
Measured: Within the first day of hospital admission
Micronutrient status at hospital admission (Iron, Zinc and Copper)
Evaluation of micronutrient status in patients requiring hospitalization in mcg/dL
Measured: Within the first day of hospital admission
Micronutrient status at hospital admission (Vitamin A and Vitamin E)
Evaluation of micronutrient status in patients requiring hospitalization in mg/L
Measured: Within the first day of hospital admission
Micronutrient status at hospital admission (Selenium)
Evaluation of micronutrient status in patients requiring hospitalization in mcg/L
Measured: Within the first day of hospital admission
Micronutrient status at hospital admission (Vitamin C)
Evaluation of micronutrient status in patients requiring hospitalization in mg/dL
Measured: Within the first day of hospital admission
Micronutrient status at end of study (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid)
Evaluation of micronutrient status after the study treatment in ng/mL
Measured: Within 90 days of the study treatment ending
Micronutrient status at end of study (Vitamin B12)
Evaluation of micronutrient status after the study treatment in pg/mL
Measured: Within 90 days of the study treatment ending
Micronutrient status at end of study (Iron, Zinc, and Copper)
Evaluation of micronutrient status after the study treatment in mcg/dL
Measured: Within 90 days of the study treatment ending
Micronutrient status at end of study (Vitamin A and Vitamin E)
Evaluation of micronutrient status after the study treatment in mg/L
Measured: Within 90 days of the study treatment ending
Micronutrient status at end of study (Selenium)
Evaluation of micronutrient status after the study treatment in mcg/L
Measured: Within 90 days of the study treatment ending
Micronutrient status at end of study (Vitamin C)
Evaluation of micronutrient status after the study treatment in mg/dL
Measured: Within 90 days of the study treatment ending
Inflammatory parameters
Evaluation of C-Reactive Protein, InterLeukin-6 and D-dimer progression during the clinical course of SARS-CoV-2 infection in outpatients
Measured: From baseline to 30 days of the study treatment ending
Thromboembolic disease
Evaluation of thromboembolic disease developed during the clinical course of SARS-CoV-2 infection
Measured: From baseline to 30 days of the study treatment ending
Oxygen supplementation
Assess the need for oxygen therapy during the clinical course of the infection
Measured: From baseline to the study follow-up period: Maximum 3 months
High-Flow oxygen supplementation
The need for high-flow oxygen therapy during the clinical course of infection
Measured: From baseline to the study follow-up period: Maximum 3 months
Invasive mechanical ventilation
The cumulative incidence of mechanical ventilation requirement for SARS-CoV-2 infection documented
Measured: From baseline to the study follow-up period: Maximum 3 months
Tracheostomy
The need for tracheostomy during the clinical course of SARS-CoV-2 infection
Measured: From baseline to the study follow-up period: Maximum 3 months
Renal replacement
The need for renal replacement therapies during the clinical course of SARS-CoV-2 infection
Measured: From baseline to the study follow-up period: Maximum 3 months
Death
The cumulative incidence of death from SARS-CoV-2 infection is documented
Measured: From baseline to the study follow-up period: Maximum 3 months
Intensive Care Unit Admission
The cumulative incidence of admission to intensive care for SARS-CoV-2 infection documented
Measured: From baseline to the study follow-up period: Maximum 3 months
Cumulative hospital admission
The cumulative incidence of hospital admission for a documented SARS-CoV-2 infection
Measured: From baseline to the study follow-up period: Maximum 3 months
Hospitalization needs (days)
Number of days hospitalized for a SARS-CoV-2 documented infection
Measured: From baseline to the study follow-up period: Maximum 3 months
Survival
Survival
Measured: From baseline to the study follow-up period: Maximum 3 months
Adverse events
Adverse events
Measured: From baseline to the study follow-up period: Maximum 3 months
Serious Adverse Events
Serious adverse events (hospital admissions and mortality)
Measured: From baseline to the study follow-up period: Maximum 3 months
Persistence (or not) of Covid-19 Clinical Symptoms (directly asking patient for peristence of Neurologic, Psicologic, Digestive, Cardiovascular, Respiratory and Osteomuscular Symptoms).
Assess the Post-Covid19 Persistent Symptoms, directly asking patient for Symptoms at the moment of an On site visit at Day 90 and at thelephonic contact on Day 180.
Questionnaire to the patient to asess persistent symptoms on the following areas:
Neurologic: Montreal Cognitive Assessment (Mo-CA-BLIND) and Persistent cefalea Psicologic: Anxiety, depression, sleep and mood transtorns Digestive: dispepsia, diarrea, constipation Cardiovascular: tachicardia, arrhythmia, acute mycardial infarction and Ictus Respiratory: dispnea, chest pain Osteomuscular: astenia, artralgia and myalgia and other symptoms expressed by the patient.
Measured: From baseline to the study follow-up period: Maximum 6 months.
Cognitive status
Assess the Post-Covid19 cognitive status with MoCA-Blind test.
Measured: At baseline and at Day 180.
EQ-5D
Assess the evolution of quality of life during the study.
EQ-5D-5L quality of life questionnaire will be administered
Measured: At baseline and at Day 180.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start9 Aug 2021
- Primary completion26 Oct 2023
- Study completion26 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blind, placebo-controlled, randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Institut Germans Trias i Pujol
- Sponsor type
- University, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital
- Responsible party
- Sponsor
- Investigators
- Teresa M Tomasa-Irriguible, MD-PhD, Principal investigator, Hospital Germans Trias i Pujol- Intensive Care Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751669
- Sponsor's protocol ID
- CoVIT Clinical Trial
- Acronym
- CoVIT
- Status last verified
- Mar 2024
- First submitted
- 11 Feb 2021
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shakoor H, Feehan J, Al Dhaheri AS, Cheikh Ismail L, Ali HI, Alhebshi SH, Apostolopoulos V, Stojanovska L. Role of vitamin D supplementation in aging patients with COVID-19. Maturitas. 2021 Oct;152:63-65. doi: 10.1016/j.maturitas.2021.03.006. Epub 2021 Mar 16. No abstract available.
PubMed 33757717
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Micronutrient Dietary Supplementation in Reducing Hospital Admissions for COVID-19: A Double-blind, Placebo-controlled, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04751669
- Acronym / sponsor ID
- CoVIT / CoVIT Clinical Trial
- Conditions
- Covid19
- Keywords
- Dietary Supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Fundació Institut Germans Trias i PujolUniversity, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 12 Feb 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.
A double-blind, placebo-controlled, randomized clinical trial to assess efficacy of micronutrient dietary supplementation in reducing hospital admissions for COVID-19 and incidence of Long Covid.
We want to assess the need for hospital admission for severe acute respiratory syndrome Corona Virus-2 (SARS-CoV-2) infection in outpatients diagnosed of COVID-19 disease, taking a micronutrient supplementation for 14 days. The outcome Will be measured within 1 month after beginning the study treatment. The patients will be followed-up for a period of 180 days for the incidence of Long Covid
Detailed description
- Type of study/ Design: Randomized, double-blind, placebo-controlled clinical trial.
- Sponsor: Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol / Hospital Universitari Germans Trias i Pujol ( IGTP / HUGTIP)
- Title of the clinical trial: Efficacy of micronutrient dietary supplementation in reducing hospital admissions for COVID-19 and Long Covid: A double-blind, placebo-controlled, randomized clinical trial.
- Protocol code: CoVIT Clinical Trial
- NºClinicaltrials.gov: Pending
- Coordinating researcher: Dra. Teresa-Maria Tomasa-Irriguible.
- Recruiting Center: Germans Trias i Pujol University Hospital (HUGTIP)
- Ethical Committee for clinical Investigation (CEI): Germans Trias i Pujol University Hospital CEI.
- Monitoring: Clinical Research Associate at UPIC (Unitat Polivalent d'Investigació Clínica) Clinical Trial Unit- IGTP
- Study treatments: Dietary supplement with micronutrients and Placebo
- Test phase: Not applicable.
- Main objective: Evaluation of the effectiveness of supplementation with a dietary supplement to improve the need for hospital admission for SARS-CoV-2 infection, and incidence of Long Covid.
- Study pathology: COVID-19.
- Main variable: The need for hospital admission of SARS-CoV-2 documented infection and the incidence of Long Covid
- Study population and total number of patients: Patients of the health system of the Northern Metropolitan Area of Catalan Health Institution with symptoms compatible with SARS-CoV-2 infection. A total of 300 people (150 treated with dietary supplement and 150 with placebo).
- Duration of treatment: 14 days.
- Patients follow-up: 180 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind, placebo-controlled, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Micronutrient dietary supplement effervescent tablet | Experimental | Dietary Supplement: Vitamin and trace elementsTablet containing: * Retinol (Vitamin A) 700 mcg * Cholecalciferol (Vitamin D3) 10 mcg * Alpha-Tocopherol (Vitamin E) 45 mg * Ascorbic acid (vitamin C) 1000 mg * Pyridoxine (Vitamin B6) 6.5 mg * Cyanocobalamin (Vitamin B12) 9.6 mg * Folic acid 400 mg * Iron 5 mg * Zinc 10 mg * Selenium 110 mg * Copper 0.9 mg * Excipients |
| Placebo dietary supplement effervescent tablet | Placebo comparator | Dietary Supplement: PlaceboEffervescent tablet with only the excipients. * Sucralose 13 mg * Sodium Chloride 20 mg * Potassium Acesulfam 22.5 mg * Orange P 55 mg * Sodium Carbonate 70 mg * Betacarotene 100 mg * Malic Acid 800 mg * Citric Acid 960 mg * Sodium bicarbonate 1,000 mg * Isomalt 1,459.50 mg |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed Consent Form signed.
- Patients with symptoms compatible with COVID-19: cough and fever who not fulfil criteria of hospitalization and will be in outpatient care.
- Positive polymerase chain reaction (PCR) or transcription-mediated amplification (TMA) test or rapid antigen test for severe acute respiratory syndrome Corona Virus-2 (SARS-CoV-2) or diagnostic test available.
- Age ≥ 18 years
- Availability to meet the requirements of the protocol.
Key exclusion criteria (8 listed)
- Intake of any micronutrient supplement during the month prior to inclusion.
- Patients fulfilling hospitalization criteria.
- Previous allergies to the micronutrient components and excipients.
- Age ≥ 90 years with any comorbidity (diabetes, hypertension, obesity, heart disease, respiratory disease)
- Participation in other research that requires experimental intervention (does not include observational studies) in the previous month before signing the informed consent form.
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 and trace elementsDietary supplement oral route, once a day, during 14 days | Dietary supplement | Micronutrient dietary supplement effervescent tablet |
| PlaceboDietary supplement (placebo) oral route, once a day, during 14 days | Dietary supplement | Placebo dietary supplement effervescent tablet |
Primary outcome
Need for hospital admission
Time frame: From baseline to 1 month after beginning the study treatment
The need for hospitalization of documented SARS-CoV-2 infection (positive polymerase chain reaction or transcription-mediated amplification test or antigen test or positive serology or diagnostic test available) over the course of the disease
Incidence of Long Covid.
Time frame: 6 months after beginning the study treatment
Incidence of long Covid or symptoms persistence following World Health Organization definition
35 secondary outcomes
Micronutrient basal status (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid
Time frame: Within day 1 at study inclusion
Micronutrient basal status (Vitamin B12)
Time frame: Within day 1 at study inclusion
Micronutrient basal status (Iron, Zinc and Copper )
Time frame: Within day 1 at study inclusion
Micronutrient basal status (Vitamin A and Vitamin E)
Time frame: Within day 1 at study inclusion
Micronutrient basal status (Selenium )
Time frame: Within day 1 at study inclusion
Micronutrient basal status (Vitamin C)
Time frame: Within day 1 at study inclusion
Micronutrient status at hospital admission (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid)
Time frame: Within the first day of hospital admission
Micronutrient status at hospital admission ( Vitamin B12)
Time frame: Within the first day of hospital admission
Micronutrient status at hospital admission (Iron, Zinc and Copper)
Time frame: Within the first day of hospital admission
Micronutrient status at hospital admission (Vitamin A and Vitamin E)
Time frame: Within the first day of hospital admission
Micronutrient status at hospital admission (Selenium)
Time frame: Within the first day of hospital admission
Micronutrient status at hospital admission (Vitamin C)
Time frame: Within the first day of hospital admission
Micronutrient status at end of study (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid)
Time frame: Within 90 days of the study treatment ending
Micronutrient status at end of study (Vitamin B12)
Time frame: Within 90 days of the study treatment ending
Micronutrient status at end of study (Iron, Zinc, and Copper)
Time frame: Within 90 days of the study treatment ending
Micronutrient status at end of study (Vitamin A and Vitamin E)
Time frame: Within 90 days of the study treatment ending
Micronutrient status at end of study (Selenium)
Time frame: Within 90 days of the study treatment ending
Micronutrient status at end of study (Vitamin C)
Time frame: Within 90 days of the study treatment ending
Inflammatory parameters
Time frame: From baseline to 30 days of the study treatment ending
Thromboembolic disease
Time frame: From baseline to 30 days of the study treatment ending
Oxygen supplementation
Time frame: From baseline to the study follow-up period: Maximum 3 months
High-Flow oxygen supplementation
Time frame: From baseline to the study follow-up period: Maximum 3 months
Invasive mechanical ventilation
Time frame: From baseline to the study follow-up period: Maximum 3 months
Tracheostomy
Time frame: From baseline to the study follow-up period: Maximum 3 months
Renal replacement
Time frame: From baseline to the study follow-up period: Maximum 3 months
Death
Time frame: From baseline to the study follow-up period: Maximum 3 months
Intensive Care Unit Admission
Time frame: From baseline to the study follow-up period: Maximum 3 months
Cumulative hospital admission
Time frame: From baseline to the study follow-up period: Maximum 3 months
Hospitalization needs (days)
Time frame: From baseline to the study follow-up period: Maximum 3 months
Survival
Time frame: From baseline to the study follow-up period: Maximum 3 months
Adverse events
Time frame: From baseline to the study follow-up period: Maximum 3 months
Serious Adverse Events
Time frame: From baseline to the study follow-up period: Maximum 3 months
Persistence (or not) of Covid-19 Clinical Symptoms (directly asking patient for peristence of Neurologic, Psicologic, Digestive, Cardiovascular, Respiratory and Osteomuscular Symptoms).
Time frame: From baseline to the study follow-up period: Maximum 6 months.
Cognitive status
Time frame: At baseline and at Day 180.
EQ-5D
Time frame: At baseline and at Day 180.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Derived from this study: PubMed 33757717Shakoor H, Feehan J, Al Dhaheri AS, Cheikh Ismail L, Ali HI, Alhebshi SH, Apostolopoulos V, Stojanovska L. Role of vitamin D supplementation in aging patients with COVID-19. Maturitas. 2021 Oct;152:63-65. doi: 10.1016/j.maturitas.2021.03.006. Epub 2021 Mar 16. No abstract available.
- Individual participant dataSharing planned: No
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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.
Teresa M Tomasa-Irriguible, MD-PhD principal investigator
Hospital Germans Trias i Pujol- Intensive Care Unit
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 and trace elements in people with Covid19, run by Fundació Institut Germans Trias i Pujol at 1 site in Spain.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 25 Mar 2024. 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 Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Need for hospital admission (time frame: From baseline to 1 month after beginning the study treatment). 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 NCT04751669, which also lists 1 linked publication.
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 25 Mar 2024.