Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04536831
Status:
COMPLETED
Last Update Posted:
2020-09-03
First Post:
2020-08-21
Brief Title:
The Association of Vitamin D Supplementation With the Outcome in Critically Ill Children
Sponsor:
Dr Mustahsin Khalil
Organization:
King Edward Medical University
Study Overview
Official Title:
The Association of Vitamin D Supplementation With the Outcome in Critically Ill Children
Status:
COMPLETED
Status Verified Date:
2020-08
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:
Vitamin D deficiency is highly prevalent in critically ill adult and pediatric population that causes multiple adverse health outcomes including higher illness severity score increased morbidity and mortality multiple organ dysfunction longer duration of Mechanical ventilation longer duration of Oxygen therapy and increased length of stay LOS in PICU and hospital Vitamin D deficiency is a modifiable risk factor that can be corrected with high dose of vitamin D supplementation to improve the clinical outcome
This study is designed to determine whether random vitamin D supplementation within dose limits improves clinical outcomes in critically ill children
This study is designed to determine whether random vitamin D supplementation within dose limits improves clinical outcomes in critically ill children
Detailed Description:
Vitamin D is known for its role in bone metabolism and calcium haemostasis but it is also required for the optimal functioning of cardiovascular and innate immune systems
As a pleiotropic hormone it has been increasingly implicated in proper functioning of multiple organs its deficiency is associated with cardiovascular diseases asthma cancer multiple sclerosis diabetes and acute lower respiratory tract infections Over one billion people are vitamin D deficient worldwide and in Pakistani population vitamin D deficiency is reported as high as 76 despite abundant sunshine
Beside of ambulatory individuals the patients presenting in intensive care units are also found Vitamin D deficient In adult intensive care settings studies have shown vitamin D deficiency VDD present in 60 of critically ill adult patientsVDD is also very common in pediatric intensive care units PICU worldwide ranging from 30 to 80
Although there is high prevalence of VDD in pediatric and adult population but there is no uniform definition of VDD exists Levels of active metabolite 125OH2D of Vitamin D at tissue level cannot be measured however patients blood level of 25-hydroxy vitamin D is used to know vitamin D stores in the body Patient with serum vitamin D level20ngml is considered to be vitamin D deficient
VDD is associated with clinically poor outcomes like increased duration of mechanical ventilation increased length of hospital stay Sepsis Acute respiratory failure and mortality in critically ill patients
The existing evidences suggest that Vitamin D3 supplementation enhances recovery from influenza recurrent pneumonias and tuberculosis Recently an observational study of adult patients suggested that patients with VDD showed decrease in the odds of all cause-mortality when their Vitamin D status was improved before hospitalization
A randomized study demonstrated that one time bolus dose of oral vitamin D supplementation caused decrease in mortality in a group of patients with severe VDD
A significant literature is available that suggests vitamin D deficiency as a modifiable risk factor in PICU settings The recognized importance of vitamin D to the health of multiple organ systems suggest that rapid normalization could represent a simple inexpensive and safe means of improving outcomes and reducing health care spending
This study is designed to supplement large dose of vitamin D that may lead to fast correction of low vitamin D level in critically ill children and possibility of better clinical outcome If such an association is established by this study routine detection and use of Vitamin D might be recommended for critically ill children admitted to PICU
As a pleiotropic hormone it has been increasingly implicated in proper functioning of multiple organs its deficiency is associated with cardiovascular diseases asthma cancer multiple sclerosis diabetes and acute lower respiratory tract infections Over one billion people are vitamin D deficient worldwide and in Pakistani population vitamin D deficiency is reported as high as 76 despite abundant sunshine
Beside of ambulatory individuals the patients presenting in intensive care units are also found Vitamin D deficient In adult intensive care settings studies have shown vitamin D deficiency VDD present in 60 of critically ill adult patientsVDD is also very common in pediatric intensive care units PICU worldwide ranging from 30 to 80
Although there is high prevalence of VDD in pediatric and adult population but there is no uniform definition of VDD exists Levels of active metabolite 125OH2D of Vitamin D at tissue level cannot be measured however patients blood level of 25-hydroxy vitamin D is used to know vitamin D stores in the body Patient with serum vitamin D level20ngml is considered to be vitamin D deficient
VDD is associated with clinically poor outcomes like increased duration of mechanical ventilation increased length of hospital stay Sepsis Acute respiratory failure and mortality in critically ill patients
The existing evidences suggest that Vitamin D3 supplementation enhances recovery from influenza recurrent pneumonias and tuberculosis Recently an observational study of adult patients suggested that patients with VDD showed decrease in the odds of all cause-mortality when their Vitamin D status was improved before hospitalization
A randomized study demonstrated that one time bolus dose of oral vitamin D supplementation caused decrease in mortality in a group of patients with severe VDD
A significant literature is available that suggests vitamin D deficiency as a modifiable risk factor in PICU settings The recognized importance of vitamin D to the health of multiple organ systems suggest that rapid normalization could represent a simple inexpensive and safe means of improving outcomes and reducing health care spending
This study is designed to supplement large dose of vitamin D that may lead to fast correction of low vitamin D level in critically ill children and possibility of better clinical outcome If such an association is established by this study routine detection and use of Vitamin D might be recommended for critically ill children admitted to PICU
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