Vitamin A Supplementation in Children With Moderate to Severe COVID-19

Phase 2UnknownNCT04920760

Shiraz University of Medical Sciences60 enrolled

Overview

Severe acute respiratory syndrome (SARS)-like coronavirus 2 (Sars-CoV-2) pandemia is considered to be the current major global health issue. With no specific treatment or vaccine known to be licensed, empowering the immune system to overcome the inflammatory status associated with the late stages of the disease, particularly by anti-inflammatory nutrients, is of great concern. Effective in reducing both the morbidity and mortality of respiratory infections, including measles, vitamin A and its derivatives are reported to enhance the immune system and/or antibody response to virus vaccinations in children, particularly those with vitamin insufficiency. Retinoids are, therefore, proposed as an adjunct therapy in the treatment of COVID-19. The study is aimed to investigate the effects of vitamin A supplementation on disease improvement in pediatric and adolescent patients with either moderate or severe COVID-19 disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Covid19

Interventions

Eligibility

Sex: ALLMin age: 1 MonthMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1\) aged between 1-month to 18-year old (boy or girl), 2) definitive or clinical diagnosis of severe acute respiratory syndrome (SARS)-like coronavirus 2 (SARS-COV-2) infection (by either a positive SARS-COV-2 polymerase chain reaction (PCR) test or a suggestive computed tomography (CT) scan, 3) no history or evidence of cancer or renal, hepatic, endocrine or viral disorders (including HIV/AIDS), 4) no history of supplementation either with vitamin A (VA) or with a multivitamin containing VA within the last 4 months, and 5) not participated in other clinical trials. Exclusion Criteria: * 1\) mildly infected with SARS-COV-2 virus, and 2) pregnancy or lactation.

Outcomes

Primary Outcomes

28-day mortality rate

COVID-19 mortality rate is defined as the number of deaths per 100 pediatric COVID-19 cases 28 days from the date of the intervention.

Time frame: within 28 days from end of intervention

Secondary Outcomes

length of hospital stay

The length of hospital stay is defined as the difference between date of admission and date of discharge of the patient.

Time frame: on the day of hospital discharge

length of pediatric intensive care unit (PICU) stay

The length of PICU stay is defined as the difference between date of PICU admission and date of PICU discharge of the patient.

Time frame: on the day of PICU discharge

length of intubation

The length of intubation is defined as the difference between date of beginning and end of intubation

Time frame: on the day of extubation

length of mechanical ventilation

The length of mechanical ventilation is defined as the difference between date of beginning and end of mechanical ventilation.

Time frame: the weaning time of mechanical ventilation

multiple organ involvement

Multiple organ involvement is defined as one of either hematological, gastrointestinal, neurological, cardiovascular or hepatorenal complications.

Time frame: on the day of the particular organ involvement

complete blood count (CBC)/diff

Complete blood count with differential