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

NCT04920760 | Unknown Phase 2

• 1 other identifier: 99-01-14-23475
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Covid19

Keywords

vitamin A; inflammation; pediatrics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• length of hospital stay

  on the day of hospital discharge

• length of pediatric intensive care unit (PICU) stay

  on the day of PICU discharge

• length of intubation

  on the day of extubation

• length of mechanical ventilation

  the weaning time of mechanical ventilation

• multiple organ involvement

  on the day of the particular organ involvement

Study Arms (2)

Control

NO INTERVENTION

Participants receiving standard treatment alone.

Vitamin A

EXPERIMENTAL

Participants receiving standard treatment with an additional vitamin A supplementation.

Dietary Supplement: Vitamin A supplement

Interventions

Vitamin A supplement DIETARY_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).

Vitamin A

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \) 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.

You may not qualify if:

• \) mildly infected with SARS-COV-2 virus, and 2) pregnancy or lactation.

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

MeSH Terms

Conditions

COVID-19; Inflammation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Seyede Sedigheh Hamzavi, MD

  Professor Alborzi Clinical Microbiology Research Center, Shiraz University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyede Sedigheh Hamzavi, MD

CONTACT

00989173626692; s.hamzavi55@yahoo.com

Seyede Maryam Abdollahzadeh, PhD

CONTACT

00989173202131; maryamabdh@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants, laboratory technicians, and statisticians will be blinded to the study arm allocation. Investigators and the ICU medical staff, however, will be unblinded due to the nature of intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 10, 2021
• Study Start: June 21, 2021
• Primary Completion: November 21, 2021
• Study Completion: December 19, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share