NCT04751669

Efficacy of a Dietary Supplementation in Reducing Hospital Admissions for COVID-19. Randomized Clinical Trial

Efficacy of Micronutrient Dietary Supplementation in Reducing Hospital Admissions for COVID-19: A Double-blind, Placebo-controlled, Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Fundació Institut Germans Trias i Pujol · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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 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

Conditions

• Covid19

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin and trace elements	Dietary supplement oral route, once a day, during 14 days
DIETARY_SUPPLEMENT	Placebo	Dietary supplement (placebo) oral route, once a day, during 14 days

Timeline

• Start date: 2021-08-09
• Primary completion: 2023-10-26
• Completion: 2023-10-26
• First posted: 2021-02-12
• Last updated: 2024-03-25

Locations

1 site across 1 country: Spain