Covid19Phase 2NCT04920760
Vitamin A Supplementation in Children With Moderate to Severe COVID-19
A Phase 2 study testing Vitamin A supplement in people with Covid19, run by Shiraz University of Medical Sciences.
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… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Covid19
- What is being tested?
- Vitamin A supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 21 Jun 2021to 19 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 1) mildly infected with SARS-COV-2 virus, and 2) pregnancy or lactation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Covid19
- Being tested
- Vitamin A supplement
- Keywords
- vitamin A, inflammation, pediatrics
- Medical subject headings
- COVID-19, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin A supplementDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants receiving standard treatment alone. |
| Vitamin A | Experimental | Participants receiving standard treatment with an additional vitamin A supplementation. Receives: Dietary Supplement: Vitamin A supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 28 days from end of intervention
Secondary outcomes (22)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: on the day of the particular organ involvement
complete blood count (CBC)/diff
Complete blood count with differential
Measured: before and within 3 days from end of intervention
Prothrombin time (PT)
Prothrombin time
Measured: before and within 3 days from end of intervention
Partial thromboplastin time (PTT)
Partial thromboplastin time
Measured: before and within 3 days from end of intervention
International normalised ratio (INR)
International normalised ratio
Measured: before and within 3 days from end of intervention
fibrinogen
fibrinogen
Measured: before and within 3 days from end of intervention
troponin
troponin
Measured: before and within 3 days from end of intervention
Aspartate transaminase (AST)
Aspartate transaminase
Measured: before and within 3 days from end of intervention
Alanine transaminase (ALT)
Alanine transaminase
Measured: before and within 3 days from end of intervention
Blood urea nitrogen (BUN)
Blood urea nitrogen
Measured: before and within 3 days from end of intervention
Cr
Creatinine
Measured: before and within 3 days from end of intervention
Erythrocyte sedimentation rate (ESR)
Erythrocyte sedimentation rate
Measured: before and within 3 days from end of intervention
C-reactive protein (CRP)
C-reactive protein
Measured: before and within 3 days from end of intervention
Lactate dehydrogenase (LDH)
Lactate dehydrogenase
Measured: before and within 3 days from end of intervention
D-dimer
D-dimer
Measured: before and within 3 days from end of intervention
ferritin
ferritin
Measured: before and within 3 days from end of intervention
procalcitonin
procalcitonin
Measured: before and within 3 days from end of intervention
vitamin A concentration
vitamin A concentration
Measured: before and within 3 days from end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start21 Jun 2021 (estimated)
- Primary completion21 Nov 2021 (estimated)
- Study completion19 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyede Sedigheh Hamzavi, Shiraz University of Medical Sciences
- Investigators
- Seyede Sedigheh Hamzavi, MD, Principal investigator, Professor Alborzi Clinical Microbiology Research Center, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920760
- Sponsor's protocol ID
- 99-01-14-23475
- Status last verified
- Jun 2021
- First submitted
- 9 Jun 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin A Supplementation on Disease Improvement of Children With Moderate to Severe COVID-19.
- ClinicalTrials.gov ID
- NCT04920760
- Acronym / sponsor ID
- 99-01-14-23475
- Conditions
- Covid19
- Keywords
- vitamin A, inflammation, pediatrics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 21 Jun 2021 (estimated)
- Primary completion
- 21 Nov 2021 (estimated)
- Study completion
- 19 Dec 2021 (estimated)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants receiving standard treatment alone. |
| Vitamin A | Experimental | Dietary Supplement: Vitamin A supplementParticipants receiving standard treatment with an additional vitamin A supplementation. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 1) mildly infected with SARS-COV-2 virus, and 2) pregnancy or lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin A supplementThe 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). | Dietary supplement | Vitamin A |
Primary outcome
28-day mortality rate
Time frame: 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.
22 secondary outcomes
length of hospital stay
Time frame: on the day of hospital discharge
length of pediatric intensive care unit (PICU) stay
Time frame: on the day of PICU discharge
length of intubation
Time frame: on the day of extubation
length of mechanical ventilation
Time frame: the weaning time of mechanical ventilation
multiple organ involvement
Time frame: on the day of the particular organ involvement
complete blood count (CBC)/diff
Time frame: before and within 3 days from end of intervention
Prothrombin time (PT)
Time frame: before and within 3 days from end of intervention
Partial thromboplastin time (PTT)
Time frame: before and within 3 days from end of intervention
International normalised ratio (INR)
Time frame: before and within 3 days from end of intervention
fibrinogen
Time frame: before and within 3 days from end of intervention
troponin
Time frame: before and within 3 days from end of intervention
Aspartate transaminase (AST)
Time frame: before and within 3 days from end of intervention
Alanine transaminase (ALT)
Time frame: before and within 3 days from end of intervention
Blood urea nitrogen (BUN)
Time frame: before and within 3 days from end of intervention
Cr
Time frame: before and within 3 days from end of intervention
Erythrocyte sedimentation rate (ESR)
Time frame: before and within 3 days from end of intervention
C-reactive protein (CRP)
Time frame: before and within 3 days from end of intervention
Lactate dehydrogenase (LDH)
Time frame: before and within 3 days from end of intervention
D-dimer
Time frame: before and within 3 days from end of intervention
ferritin
Time frame: before and within 3 days from end of intervention
procalcitonin
Time frame: before and within 3 days from end of intervention
vitamin A concentration
Time frame: before and within 3 days from end of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seyede Sedigheh Hamzavi, MD principal investigator
Professor Alborzi Clinical Microbiology Research Center, Shiraz University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin A supplement in people with Covid19, run by Shiraz University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyede Sedigheh Hamzavi, MD (00989173626692, s.hamzavi55@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality rate (time frame: within 28 days from end of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.