Assessment of Serum Vitamin D Status and Its Association With Disease Severity and Mortality Risk Among Critically Ill Children With Acute Respiratory Infections: A Cross-Sectional Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Prevalence of Vitamin D Deficiency among critically ill children with acute respiratory infections.
Study Overview
Brief Summary
Acute respiratory infections (ARIs) are among the leading causes of hospitalization, morbidity, and mortality in children worldwide, particularly among critically ill patients admitted to pediatric intensive care units (PICUs). Vitamin D has an important role not only in bone metabolism but also in regulation of innate and adaptive immune responses, especially within the respiratory tract. Recent evidence suggests that vitamin D deficiency may be associated with increased susceptibility to respiratory infections, greater disease severity, prolonged hospitalization, and higher mortality rates in critically ill children.
This observational cross-sectional study aims to assess serum vitamin D status among critically ill children admitted to the PICU with acute respiratory infections and to evaluate the relationship between vitamin D levels, severity of respiratory illness, and risk of mortality. The study will include pediatric patients aged 1 month to 16 years admitted to the Pediatric Intensive Care Unit of Assiut University Children's Hospital.
Clinical evaluation and laboratory investigations, including serum 25-hydroxyvitamin D levels, serum calcium, and alkaline phosphatase, will be performed within the first 24 hours of admission. Severity of respiratory distress will be assessed using the Pediatric Respiratory Severity Score (PRESS), while mortality risk will be evaluated using the Pediatric Risk of Mortality Score (PRISM III).
The findings of this study may contribute to better understanding of the role of vitamin D in critically ill children with respiratory infections and may support future strategies for early risk assessment and improved clinical management in pediatric intensive care settings.
Detailed Description
Acute respiratory infections remain a major global health problem and are a leading cause of morbidity and mortality among pediatric populations, particularly in low- and middle-income countries. Critically ill children admitted to pediatric intensive care units (PICUs) with severe respiratory infections are at increased risk of complications, prolonged hospitalization, and mortality. Identifying modifiable risk factors associated with disease severity and poor outcomes is therefore of significant clinical importance.
Vitamin D is a fat-soluble steroid hormone traditionally recognized for its role in calcium and phosphorus homeostasis and skeletal development. However, increasing evidence has demonstrated that vitamin D also has immunomodulatory functions through its effects on innate and adaptive immunity. Vitamin D receptors are expressed in immune cells, including macrophages and respiratory epithelial cells, supporting its role in host defense against respiratory pathogens.
Recent studies have suggested an association between vitamin D deficiency and increased susceptibility to acute respiratory infections, sepsis, and adverse outcomes in critically ill children. Nevertheless, available evidence remains inconsistent, and data from pediatric intensive care populations in Egypt and similar settings are limited.
This cross-sectional observational study will be conducted at the Pediatric Intensive Care Unit of Assiut University Children's Hospital. The study will include children aged 1 month to 16 years admitted with acute respiratory infections. Patients with chronic illnesses affecting vitamin D metabolism, severe immunodeficiency, congenital heart disease, malnutrition, rickets, or recent vitamin D supplementation will be excluded.
At PICU admission, all eligible participants will undergo detailed history taking, complete clinical examination, and laboratory investigations. Serum 25-hydroxyvitamin D [25(OH)D] levels will be measured within the first 24 hours of admission as the standard indicator of vitamin D status. Vitamin D levels will be categorized according to international clinical practice guidelines into deficiency, insufficiency, sufficiency, and toxicity.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Month to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children aged between 1 month and 12 years.
- •Admitted to the PICU with a primary diagnosis of acute respiratory infection.
- •Diagnosis confirmed by clinical symptoms and radiological evidence.
Exclusion Criteria
- •Children with known chronic bone diseases or metabolic disorders.
- •Patients receiving vitamin D supplementation prior to admission.
- •Patients with chronic renal or hepatic failure.
Arms & Interventions
Critically Ill Children With Acute Respiratory Infections
This cohort includes pediatric patients aged 1 month to 16 years admitted to the Pediatric Intensive Care Unit (PICU) with acute respiratory infections. Participants will undergo clinical evaluation and laboratory assessment, including measurement of serum 25-hydroxyvitamin D levels within the first 24 hours of admission. Disease severity will be assessed using the Pediatric Respiratory Severity Score (PRESS), and mortality risk will be evaluated using the Pediatric Risk of Mortality Score (PRISM III). No interventions will be assigned as part of the study protocol.
Intervention: Serum 25-Hydroxyvitamin D Assessment (Diagnostic Test)
Outcomes
Primary Outcomes
Prevalence of Vitamin D Deficiency among critically ill children with acute respiratory infections.
Time Frame: Within the first 24 hours of admission to the Pediatric Intensive Care Unit (PICU).
This measure evaluates the baseline vitamin D status of pediatric patients admitted to the PICU with acute respiratory infections. Vitamin D status is determined by measuring serum 25-hydroxyvitamin D \[25(OH)D\] levels. According to the Endocrine Society guidelines, deficiency is defined as levels \<20 ng/mL.
Secondary Outcomes
- Association between Vitamin D and Severity of ARI(Within the first 24 hours of PICU admission.)
- Association between Vitamin D and Risk of Mortality(Within the first 24 hours of PICU admission.)
Investigators
Mohamed Ali Hassan Mohamed
Assistant Lecturer
Assiut University