Evaluation of Vitamin A and E Deficiency With Severity of SARS-COV-2 Disease: A Case-Control Study

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT05946499

Collaborator

(none)

Enrollment

Location

8.9

Actual Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Coronavirus disease 2019 (COVID-19) is a novel infectious disease that has been spreading worldwide Coronaviridae study group of the International Committee on taxonomy of viruses (2020). The clinical manifestation of COVID-19 can range from asymptomatic infection to critical illness with severe pneumonia, respiratory failure, and death.

Vitamin A is of special interest in the field of infectious diseases, especially for pulmonary infections. It is crucial for the development of normal lung tissue and tissue repair after injury due to infection. Therefore, it may play a role in recovery after severe COVID-19 pneumonia. Vitamin A has immune regulatory functions and positively affects both the innate and adaptive immune cell response.

The anti-oxidant Vitamin E, and trace element selenium, are major components of anti-oxidant defense. Epidemiological studies demonstrate that deficiencies in, either of these nutrients, alters immune responses and viral pathogenicity.

Data concerning vitamin A and E plasma levels in COVID-19 patients are lacking. Therefore, this study aims at characterizing vitamin A and E plasma levels in COVID-19 and analyzing the association of plasma levels with disease severity and outcome.

Condition or Disease	Intervention/Treatment	Phase
COVID-19

Detailed Description

The aim of the current study is to evaluate the relation of plasma level of Vitamin A and E and their correlation with severity of SARS-COV2 disease.

Study Design

Study Type:

Observational

Actual Enrollment :

90 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Correlation Between Vitamin A and E Deficiency With Severity of SARS-COV2 Disease.

Actual Study Start Date :

Sep 1, 2021

Actual Primary Completion Date :

Apr 30, 2022

Actual Study Completion Date :

May 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Group A 30 ICU-admitted SARS-CoV-2- infected individuals with ARDS or in need of oxygen supplementation
Group B 30 ward-admitted SARS-CoV-2-infected individuals not suffering from ARDS and not in need of oxygen supplementation
Group C 30 sex and age-matched normal individuals

Outcome Measures

Primary Outcome Measures

Correlating between vitamin A and E deficiency and severity of SARS-COV2 [From September 2021 to November 2022]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

COVID-19 positive patients by PCR (polymerase chain reaction) test
Patients aging 18 to 75 years

Exclusion Criteria:

Patients with known immunodeficiency - Patients with known lung diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	balsam Sherif Fahmy	Cairo	None Selected	Egypt	11511

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Balsam Sherif Fahmy, Lecturer, Cairo University

ClinicalTrials.gov Identifier:

NCT05946499

Other Study ID Numbers:

Vitamin A and E in COVID-19

First Posted:

Jul 14, 2023

Last Update Posted:

Jul 14, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Balsam Sherif Fahmy, Lecturer, Cairo University

COVID-19

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jul 14, 2023