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

The Effect of Vitamin A Supplementation on Disease Improvement of Children With Moderate to Severe COVID-19.

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.

The current phase II, prospective, single-center, single-blinded, randomized placebo-controlled trial, will compare the standard care alone (as the control arm) or in combination with ˝vitamin A supplementation˝ (as the intervention arm) with an allocation ratio of 1:1 in a parallel-group design.

Participants, laboratory technicians, and statisticians will be blinded to the study arm allocation. Investigators and the ICU medical staff, however, will be unblinded due to the nature of intervention.

The supplementation protocol will be the additional care established by World Health Organization (WHO) and the United Nations International Children ʹs Fund (UNICEF) for measles (1998)(i.e. of 200,000 IU, or 50,000-100,000 IU for children > 1 or for infants of < 1 year of age, respectively).

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.

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

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

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

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

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

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.