Serum Vitamin D Status in Critically Ill Children With Acute Respiratory Infections (VITD-ARI)

May 5, 2026 updated by: Mohamed Ali Hassan Mohamed, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Severity of respiratory illness will be evaluated using the Pediatric Respiratory Severity Score (PRESS), a validated clinical scoring system for respiratory distress in children. Mortality risk will be assessed using the Pediatric Risk of Mortality Score (PRISM III), which incorporates physiological and laboratory parameters obtained during the first 24 hours of PICU admission.

The primary outcome of the study is the prevalence of vitamin D deficiency among critically ill children with acute respiratory infections. Secondary outcomes include the association between serum vitamin D levels and both respiratory disease severity and mortality risk.

Data will be statistically analyzed using SPSS software. Appropriate statistical tests will be selected according to the type and distribution of data, and statistical significance will be considered at p < 0.05.

This study may provide important insights into the clinical significance of vitamin D deficiency in critically ill pediatric patients and may support future preventive and therapeutic strategies aimed at improving outcomes in children with severe respiratory infections.

Study Type

Observational

Enrollment (Estimated)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Asyut, Egypt
        • Assiut University
        • Contact:
          • Assiut University
          • Phone Number: 08822080150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study involves pediatric patients admitted to the Pediatric Intensive Care Unit (PICU) at a tertiary care hospital who meet the diagnostic criteria for acute respiratory infections.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: Serum 25-Hydroxyvitamin D Assessment
Blood samples will be collected within the first 24 hours of admission to the Pediatric Intensive Care Unit (PICU) to measure serum 25-hydroxyvitamin D [25(OH)D] levels, which is the standard biomarker used to assess vitamin D status. The measured vitamin D levels will be analyzed in relation to the severity of acute respiratory infections using the Pediatric Respiratory Severity Score (PRESS) and the risk of mortality using the Pediatric Risk of Mortality Score (PRISM III). No therapeutic intervention or vitamin D supplementation will be administered as part of the study protocol.
Other Names:
  • Serum Vitamin D Measurement
  • 25(OH)D Testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within the first 24 hours of admission to the Pediatric Intensive Care Unit (PICU).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between Vitamin D and Severity of ARI
Time Frame: Within the first 24 hours of PICU admission.
Analysis of the relationship between serum vitamin D levels and the severity of acute respiratory infections (ARI) as measured by the Pediatric Respiratory Severity Score (PRESS). The PRESS score (0-5) categorizes distress as mild, moderate, or severe.
Within the first 24 hours of PICU admission.
Association between Vitamin D and Risk of Mortality
Time Frame: Within the first 24 hours of PICU admission.
Analysis of the relationship between serum vitamin D levels and the risk of mortality as assessed by the Pediatric Risk of Mortality score (PRISM III). This score is based on 17 physiological variables.
Within the first 24 hours of PICU admission.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

August 6, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VITD01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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