Status:
COMPLETED
Efficacy of a Dietary Supplementation in Reducing Hospital Admissions for COVID-19. Randomized Clinical Trial
Lead Sponsor:
Fundació Institut Germans Trias i Pujol
Collaborating Sponsors:
Germans Trias i Pujol Hospital
Conditions:
Covid19
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief 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. We ...
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 T...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
August 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2023
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT04751669
Start Date
August 9 2021
End Date
October 26 2023
Last Update
March 25 2024
Active Locations (1)
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1
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916