Clinical trial NCT04920760: Vitamin A Supplementation in Children With Moderate to Severe COVID-19
Official title: The Effect of Vitamin A Supplementation on Disease Improvement of Children With Moderate to Severe COVID-19.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Covid19
Keywords: vitamin A
inflammation
pediatrics
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 28-day mortality rate
timeFrame: within 28 days from end of intervention
Secondary outcomes:
measure: length of hospital stay
timeFrame: on the day of hospital discharge
measure: length of pediatric intensive care unit (PICU) stay
timeFrame: on the day of PICU discharge
measure: length of intubation
timeFrame: on the day of extubation
measure: length of mechanical ventilation
timeFrame: the weaning time of mechanical ventilation
measure: multiple organ involvement
timeFrame: on the day of the particular organ involvement
measure: complete blood count (CBC)/diff
timeFrame: before and within 3 days from end of intervention
measure: Prothrombin time (PT)
timeFrame: before and within 3 days from end of intervention
measure: Partial thromboplastin time (PTT)
timeFrame: before and within 3 days from end of intervention
measure: International normalised ratio (INR)
timeFrame: before and within 3 days from end of intervention
measure: fibrinogen
timeFrame: before and within 3 days from end of intervention
measure: troponin
timeFrame: before and within 3 days from end of intervention
measure: Aspartate transaminase (AST)
timeFrame: before and within 3 days from end of intervention
measure: Alanine transaminase (ALT)
timeFrame: before and within 3 days from end of intervention
measure: Blood urea nitrogen (BUN)
timeFrame: before and within 3 days from end of intervention
measure: Cr
timeFrame: before and within 3 days from end of intervention
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: before and within 3 days from end of intervention
measure: C-reactive protein (CRP)
timeFrame: before and within 3 days from end of intervention
measure: Lactate dehydrogenase (LDH)
timeFrame: before and within 3 days from end of intervention
measure: D-dimer
timeFrame: before and within 3 days from end of intervention
measure: ferritin
timeFrame: before and within 3 days from end of intervention
measure: procalcitonin
timeFrame: before and within 3 days from end of intervention
measure: vitamin A concentration
timeFrame: before and within 3 days from end of intervention
Other outcomes:
Locations:
Study officials:
affiliation: Professor Alborzi Clinical Microbiology Research Center, Shiraz University of Medical Sciences
name: Seyede Sedigheh Hamzavi, MD
role: PRINCIPAL_INVESTIGATOR
References: