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

Shiraz University of Medical Sciences

Status and phase: Unknown; Phase 2

Conditions: Covid19

Treatments: Dietary Supplement: Vitamin A supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT04920760

99-01-14-23475

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Control

No Intervention group

Description:

Participants receiving standard treatment alone.

Vitamin A

Experimental group

Description:

Participants receiving standard treatment with an additional vitamin A supplementation.

Treatment:

Dietary Supplement: Vitamin A supplement