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

Phase 2

• Conditions: Covid19
• Interventions: Dietary Supplement: Vitamin A supplement

• Registration Number: NCT04920760
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-10
• Last Update Submitted: 2021-06-13
• Last Update Posted: 2021-06-18
• Study Start: 2021-06-21
• Primary Completion: 2021-11-21
• Study Completion: 2021-12-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin A	Vitamin A supplement	Participants receiving standard treatment with an additional vitamin A supplementation.

Primary Outcome Measures

Name	Time	Method
28-day mortality rate	within 28 days from end of intervention	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.

Secondary Outcome Measures

Name	Time	Method
Partial thromboplastin time (PTT)	before and within 3 days from end of intervention	Partial thromboplastin time
Alanine transaminase (ALT)	before and within 3 days from end of intervention	Alanine transaminase
Cr	before and within 3 days from end of intervention	Creatinine
C-reactive protein (CRP)	before and within 3 days from end of intervention	C-reactive protein
Prothrombin time (PT)	before and within 3 days from end of intervention	Prothrombin time
Aspartate transaminase (AST)	before and within 3 days from end of intervention	Aspartate transaminase
ferritin	before and within 3 days from end of intervention	ferritin
vitamin A concentration	before and within 3 days from end of intervention	vitamin A concentration
length of hospital stay	on the day of hospital discharge	The length of hospital stay is defined as the difference between date of admission and date of discharge of the patient.
length of intubation	on the day of extubation	The length of intubation is defined as the difference between date of beginning and end of intubation
length of mechanical ventilation	the weaning time of mechanical ventilation	The length of mechanical ventilation is defined as the difference between date of beginning and end of mechanical ventilation.
Lactate dehydrogenase (LDH)	before and within 3 days from end of intervention	Lactate dehydrogenase
procalcitonin	before and within 3 days from end of intervention	procalcitonin
fibrinogen	before and within 3 days from end of intervention	fibrinogen
length of pediatric intensive care unit (PICU) stay	on the day of PICU discharge	The length of PICU stay is defined as the difference between date of PICU admission and date of PICU discharge of the patient.
multiple organ involvement	on the day of the particular organ involvement	Multiple organ involvement is defined as one of either hematological, gastrointestinal, neurological, cardiovascular or hepatorenal complications.
complete blood count (CBC)/diff	before and within 3 days from end of intervention	Complete blood count with differential
International normalised ratio (INR)	before and within 3 days from end of intervention	International normalised ratio
troponin	before and within 3 days from end of intervention	troponin
Blood urea nitrogen (BUN)	before and within 3 days from end of intervention	Blood urea nitrogen
D-dimer	before and within 3 days from end of intervention	D-dimer
Erythrocyte sedimentation rate (ESR)	before and within 3 days from end of intervention	Erythrocyte sedimentation rate