Ignite Creation Date:
2024-05-06 @ 8:29 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391437
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2024-04-23
Brief Title:
Prevalence Of Vitamin A Deficiency In Critically Ill Children With Sepsis And Its Association With Clinical Outcomes
Sponsor:
Benha University
Organization:
Benha University
Study Overview
Official Title:
Prevalence Of Vitamin A Deficiency In Critically Ill Children With Sepsis And Its Association With Clinical Outcomes
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 346 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
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 346 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None