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

NCT04751669 | Completed DMC

• 1 other identifier: CoVIT Clinical Trial
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

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 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

Conditions

Covid19

Keywords

Dietary Supplement

Outcome Measures

Primary Outcomes (2)

• 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

  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

  6 months after beginning the study treatment

Secondary Outcomes (35)

• Micronutrient basal status (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid

  Within day 1 at study inclusion

• Micronutrient basal status (Vitamin B12)

  Within day 1 at study inclusion

• Micronutrient basal status (Iron, Zinc and Copper )

  Within day 1 at study inclusion

• Micronutrient basal status (Vitamin A and Vitamin E)

  Within day 1 at study inclusion

• Micronutrient basal status (Selenium )

  Within day 1 at study inclusion

Study Arms (2)

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

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

Dietary Supplement: Placebo

Interventions

Vitamin and trace elements DIETARY_SUPPLEMENT

Dietary supplement oral route, once a day, during 14 days

Micronutrient dietary supplement effervescent tablet

Placebo DIETARY_SUPPLEMENT

Dietary supplement (placebo) oral route, once a day, during 14 days

Placebo dietary supplement effervescent tablet

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundació Institut Germans Trias i Pujol: lead
• Germans Trias i Pujol Hospital: collaborator

Study Sites (1)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Related Publications (1)

• 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.

  PMID: 33757717 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Vitamins; Trace Elements

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Elements; Inorganic Chemicals

Study Officials

• Teresa M Tomasa-Irriguible, MD-PhD

  Hospital Germans Trias i Pujol- Intensive Care Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo tablets with the same external aspect than the dietary supplement, the same administration route, containing only the excipients
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A double-blind, placebo-controlled, randomized clinical trial

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 12, 2021
• Study Start: August 9, 2021
• Primary Completion: October 26, 2023
• Study Completion: October 26, 2023
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)