Vitamin A Deficiency in ChildrenNCT06391437
Prevalence Of Vitamin A Deficiency In Critically Ill Children With Sepsis And Its Association With Clinical Outcomes
An observational study of Vitamin A Deficiency in Children, run by Benha University at 1 site in Egypt.
Trial summary
Aim of the work is to assess the prevalence of vitamin A deficiency in critically ill children with sepsis and the association between vitamin A deficiency and clinical outcomes Read more about this study
- Who is it for?
- Ages 1 month to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin A Deficiency in Children
- What is being tested?
- Extraction of blood sample
- How many people
- 220 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 31 Mar 2024
- Phase
- Observational
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: This is a prospective study will be conducted from May 2023 to October 2023 in pediatric intensive care unit (PICU) at Benha university Hospital
Who may be able to join
- All pediatric Patients from 29 days to 16 years old who were admitted to the pediatric intensive care unit (PICU) with sepsis as defined by International pediatric sepsis consensus conference will be consecutively recruited in this study.
- Sex- and age-matched approximate-health children without sepsis will be recruited as a control group.
Who cannot join
- - Age > 16 years old.
- - Premature infants and low birth weight infants.
- - Children with underlying organ dysfunction, having received chemotherapy or radiotherapy, hematological malignancies, primary or acquired immunodeficiency.
- - Children who discharged against medical advice with an uncertain prognosis.
Trial locations and contacts
1 site in 1 country.
About this study
Aim of the work is to assess the prevalence of vitamin A deficiency in critically ill children with sepsis and the association between vitamin A deficiency and clinical outcomes
Read the detailed description
Vitamin A plays an essential role in a large number of physiological functions that encompass vision, growth, reproduction, hematopoiesis, and immunity.
Despite major advances in the knowledge of vitamin A biology, its deficiency is still a serious public health problem that affects an estimated 127 million preschool children. In children, vitamin A deficiency results in increased risks of mortality and morbidity from infections, blindness and anemia. Many of these effects can be linked to the immunological functions of vitamin A.
Vitamin A modulates immunity through its active metabolite retinoic acid (RA), which acts on retinoid receptors in various cell types. Studies utilizing various animal models of vitamin A or retinoid receptor deficiency have revealed an integral role for RA in immunity and tolerance.
Retinoic acid (RA) has been reported to promote anti-inflammatory regulatory T cell (Treg) differentiation and inhibit interleukin (IL)-6-induced proinflammatory T helper 17 (Th17) cells, which could balance pro- and anti-inflammatory immunity.
Vitamin A deficiency (VAD ) is associated with adverse health outcomes due to an increased risk of infection in children. VAD could impact immunity at multiple levels, including disturbing the integrity of the gastrointestinal mucosal barrier, decreasing monocyte and natural killer (NK) cell numbers, and impairing the function of macrophages, dendritic cells, and neutrophils.
Sepsis, a life-threatening organ dysfunction caused by a dysregulated host response to infection, contributes to millions of deaths worldwide each year, with a mortality rate of more than 25%. Remarkably, sepsis is a common cause of death in children. The mortality of severe sepsis was reported to be as high as 34.6% in children.
As a public health problem, sepsis has posed a significant burden on extensive health care resources for many years. It is reported as a complicated immune disorder characterized by both a hyperinflammatory immune response in the early stage and immunosuppression in the later stage.
Most deaths from sepsis occur due to opportunistic pathogen superinfections or latent viral reactivation resulting from immunosuppression.
VA is an immunomodulatory, and its deficiency may cause an imbalance between pro- and anti-inflammatory factors and impaired immune function, which are found in sepsis. There is a biological rationale that VAD may be a contributing factor related to poor clinical outcomes in patients with sepsis. Importantly, VAD is highly prevalent in children, especially in preschool children. However, there is limited data regarding the correlation between VAD and sepsis, so we hypothesize that VAD may play an important role in the pathogenesis and progression of sepsis in children.
- Conditions
- Vitamin A Deficiency in Children
- Being tested
- Extraction of blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraction of blood sampleDiagnostic test
Blood samples will be collected from all patients during the first 24 h of admission before enteral nutrition and/ or parenteral nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sex- and age-matched approximate-health children without sepsis will be recruited as a control group. Receives: Diagnostic Test: Extraction of blood sample | |
| Studied group | All pediatric Patients from 29 days to 16 years old who were admitted to the pediatric intensive care unit (PICU) with sepsis as defined by International pediatric sepsis consensus conference will be consecutively recruited in this study. Receives: Diagnostic Test: Extraction of blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of sepsis in pediatric patients with vitamin A deficiency
Severity of sepsis in pediatric patients with vitamin A deficiency
Measured: 1 month
Clinical outcomes in septic pediatric patients with vitamin A deficiency
Length of hospital stay and mortality rate in pediatric patients with vitamin A deficiency
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 May 2023
- Primary completion1 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin A Deficiency in ChildrenStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Mohammed El-Rebigi, MD, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391437
- Sponsor's protocol ID
- RC17-4-2023
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence Of Vitamin A Deficiency In Critically Ill Children With Sepsis And Its Association With Clinical Outcomes
- ClinicalTrials.gov ID
- NCT06391437
- Acronym / sponsor ID
- RC17-4-2023
- Conditions
- Vitamin A Deficiency in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 30 Apr 2024 (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.
Aim of the work is to assess the prevalence of vitamin A deficiency in critically ill children with sepsis and the association between vitamin A deficiency and clinical outcomes
Detailed description
Vitamin A plays an essential role in a large number of physiological functions that encompass vision, growth, reproduction, hematopoiesis, and immunity.
Despite major advances in the knowledge of vitamin A biology, its deficiency is still a serious public health problem that affects an estimated 127 million preschool children. In children, vitamin A deficiency results in increased risks of mortality and morbidity from infections, blindness and anemia. Many of these effects can be linked to the immunological functions of vitamin A.
Vitamin A modulates immunity through its active metabolite retinoic acid (RA), which acts on retinoid receptors in various cell types. Studies utilizing various animal models of vitamin A or retinoid receptor deficiency have revealed an integral role for RA in immunity and tolerance.
Retinoic acid (RA) has been reported to promote anti-inflammatory regulatory T cell (Treg) differentiation and inhibit interleukin (IL)-6-induced proinflammatory T helper 17 (Th17) cells, which could balance pro- and anti-inflammatory immunity.
Vitamin A deficiency (VAD ) is associated with adverse health outcomes due to an increased risk of infection in children. VAD could impact immunity at multiple levels, including disturbing the integrity of the gastrointestinal mucosal barrier, decreasing monocyte and natural killer (NK) cell numbers, and impairing the function of macrophages, dendritic cells, and neutrophils.
Sepsis, a life-threatening organ dysfunction caused by a dysregulated host response to infection, contributes to millions of deaths worldwide each year, with a mortality rate of more than 25%. Remarkably, sepsis is a common cause of death in children. The mortality of severe sepsis was reported to be as high as 34.6% in children.
As a public health problem, sepsis has posed a significant burden on extensive health care resources for many years. It is reported as a complicated immune disorder characterized by both a hyperinflammatory immune response in the early stage and immunosuppression in the later stage.
Most deaths from sepsis occur due to opportunistic pathogen superinfections or latent viral reactivation resulting from immunosuppression.
VA is an immunomodulatory, and its deficiency may cause an imbalance between pro- and anti-inflammatory factors and impaired immune function, which are found in sepsis. There is a biological rationale that VAD may be a contributing factor related to poor clinical outcomes in patients with sepsis. Importantly, VAD is highly prevalent in children, especially in preschool children. However, there is limited data regarding the correlation between VAD and sepsis, so we hypothesize that VAD may play an important role in the pathogenesis and progression of sepsis in children.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Diagnostic Test: Extraction of blood sampleSex- and age-matched approximate-health children without sepsis will be recruited as a control group. |
| Studied group | – | Diagnostic Test: Extraction of blood sampleAll pediatric Patients from 29 days to 16 years old who were admitted to the pediatric intensive care unit (PICU) with sepsis as defined by International pediatric sepsis consensus conference will be consecutively recruited in this study. |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This is a prospective study will be conducted from May 2023 to October 2023 in pediatric intensive care unit (PICU) at Benha university Hospital
Key inclusion criteria (2 listed)
- All pediatric Patients from 29 days to 16 years old who were admitted to the pediatric intensive care unit (PICU) with sepsis as defined by International pediatric sepsis consensus conference will be consecutively recruited in this study.
- Sex- and age-matched approximate-health children without sepsis will be recruited as a control group.
Key exclusion criteria (4 listed)
- - Age > 16 years old.
- - Premature infants and low birth weight infants.
- - Children with underlying organ dysfunction, having received chemotherapy or radiotherapy, hematological malignancies, primary or acquired immunodeficiency.
- - Children who discharged against medical advice with an uncertain prognosis.
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 |
|---|---|---|
| Extraction of blood sampleBlood samples will be collected from all patients during the first 24 h of admission before enteral nutrition and/ or parenteral nutrition. | Diagnostic test | Control group, Studied group |
Primary outcome
Severity of sepsis in pediatric patients with vitamin A deficiency
Time frame: 1 month
Severity of sepsis in pediatric patients with vitamin A deficiency
Clinical outcomes in septic pediatric patients with vitamin A deficiency
Time frame: 1 month
Length of hospital stay and mortality rate in pediatric patients with vitamin A deficiency
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin A Deficiency in Children, run by Benha University at 1 site in Egypt.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of sepsis in pediatric patients with vitamin A deficiency (time frame: 1 month). The study lists 2 primary outcomes in all. 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 30 Apr 2024.