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.

Study Overview

• Status: Not yet recruiting
• Conditions: Covid19
• Intervention / Treatment: Dietary supplement: Vitamin A supplement

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Seyede Sedigheh Hamzavi, MD; Phone Number: 00989173626692; Email: s.hamzavi55@yahoo.com
• Study Contact Backup: Name: Seyede Maryam Abdollahzadeh, PhD; Phone Number: 00989173202131; Email: maryamabdh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants receiving standard treatment alone.
Experimental: Vitamin A; Participants receiving standard treatment with an additional vitamin A supplementation.	Dietary supplement: Vitamin A supplement; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within 28 days from end of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	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.	on the day of the particular organ involvement
complete blood count (CBC)/diff	Complete blood count with differential	before and within 3 days from end of intervention
Prothrombin time (PT)	Prothrombin time	before and within 3 days from end of intervention
Partial thromboplastin time (PTT)	Partial thromboplastin time	before and within 3 days from end of intervention
International normalised ratio (INR)	International normalised ratio	before and within 3 days from end of intervention
fibrinogen	fibrinogen	before and within 3 days from end of intervention
troponin	troponin	before and within 3 days from end of intervention
Aspartate transaminase (AST)	Aspartate transaminase	before and within 3 days from end of intervention
Alanine transaminase (ALT)	Alanine transaminase	before and within 3 days from end of intervention
Blood urea nitrogen (BUN)	Blood urea nitrogen	before and within 3 days from end of intervention
Cr	Creatinine	before and within 3 days from end of intervention
Erythrocyte sedimentation rate (ESR)	Erythrocyte sedimentation rate	before and within 3 days from end of intervention
C-reactive protein (CRP)	C-reactive protein	before and within 3 days from end of intervention
Lactate dehydrogenase (LDH)	Lactate dehydrogenase	before and within 3 days from end of intervention
D-dimer	D-dimer	before and within 3 days from end of intervention
ferritin	ferritin	before and within 3 days from end of intervention
procalcitonin	procalcitonin	before and within 3 days from end of intervention
vitamin A concentration	vitamin A concentration	before and within 3 days from end of intervention

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences
• Investigators: Principal Investigator: Seyede Sedigheh Hamzavi, MD, Professor Alborzi Clinical Microbiology Research Center, Shiraz University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): June 21, 2021
• Primary Completion (Anticipated): November 21, 2021
• Study Completion (Anticipated): December 19, 2021

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 13, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: pediatrics; inflammation; vitamin A
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin A
• Other Study ID Numbers: 99-01-14-23475

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No