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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04920760
• Other study ID #: 99-01-14-23475
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 21, 2021
• Est. completion date: December 19, 2021

Study information

• Verified date: June 2021
• Source: Shiraz University of Medical Sciences
• Contact: Seyede Sedigheh Hamzavi, MD
• Phone: 00989173626692
• Email: s.hamzavi55[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 19, 2021
• Est. primary completion date: November 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

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 ?s 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Outcome

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