Serum Vitamin D Status in Critically Ill Children With Acute Respiratory Infections

NCT06547749 | Not Yet Recruiting

• 1 other identifier: VITD01
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Acute Respiratory Infections; Critical Illness in Children; Pediatric Respiratory Infections; Respiratory Distress

Keywords

25-hydroxyvitamin D; Vitamin D; Pediatric intensive care unit; PICU; Acute respiratory infection; Critically ill children; Pediatric respiratory severity score; Respiratory infection severity; Pediatric critical care; Mortality risk

Outcome Measures

Primary Outcomes (1)

• Prevalence of Vitamin D Deficiency among critically ill children with acute respiratory infections.

  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 Outcomes (2)

• 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.

Study Arms (1)

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

Interventions

Serum 25-Hydroxyvitamin D Assessment DIAGNOSTIC_TEST

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.

Also known as: Serum Vitamin D Measurement, 25(OH)D Testing

Critically Ill Children With Acute Respiratory Infections

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Children with known chronic bone diseases or metabolic disorders.
• Patients receiving vitamin D supplementation prior to admission.
• Patients with chronic renal or hepatic failure.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Related Publications (10)

• Thokngaen J, Karoonboonyanan W. Pediatric respiratory severity score evaluates disease severity of respiratory tract infection in children. Chulalongkorn Med J. 2019;63(1):Article 7. doi: 10.58837/CHULA.CMJ.63.1.6

  BACKGROUND

• Kangel D, Kıral A. The effect of vitamin D level on the clinical course of the disease in patients with lower respiratory tract infection. Cam Sakura Med J. 2025;5(1):17-24. doi: 10.58519/csmedj.galenos.2025.2025-3-2

  BACKGROUND

• Gunes N, Çam H. An observational study of serum vitamin D status in critically ill children admitted to the pediatric intensive care unit. Arch Med Sci. 2025;21(2):471-477. doi: 10.5114/aoms/155137.

  BACKGROUND

• Chandana HNG, Jyotirmanju CS, Jeniffer NV. Association of vitamin D levels and mortality in critically ill children: a prospective observational study. Lex Localis Journal of Local Self-Government. 2025;23(S6). Available from: https://lexlocalis.org/index.php/LexLocalis/article/view/802821/2956

  BACKGROUND

• Zhang C, Wang D, Zhu C, Lei X, Meng L, Shen C. Halogen-Engineered Copper-Based Materials with Multicolor Emission for Dual-Functional Anticounterfeiting and LED Applications. ACS Appl Mater Interfaces. 2025 Jul 30;17(30):43298-43306. doi: 10.1021/acsami.5c11245. Epub 2025 Jul 22.

  PMID: 40693518 BACKGROUND

• Pollack MM, Patel KM, Ruttimann UE. PRISM III: an updated Pediatric Risk of Mortality score. Crit Care Med. 1996 May;24(5):743-52. doi: 10.1097/00003246-199605000-00004.

  PMID: 8706448 BACKGROUND

• Pludowski P, Takacs I, Boyanov M, Belaya Z, Diaconu CC, Mokhort T, Zherdova N, Rasa I, Payer J, Pilz S. Clinical Practice in the Prevention, Diagnosis and Treatment of Vitamin D Deficiency: A Central and Eastern European Expert Consensus Statement. Nutrients. 2022 Apr 2;14(7):1483. doi: 10.3390/nu14071483.

  PMID: 35406098 BACKGROUND

• Petkova GS, Mineva EN, Botsova VT. Clinical Study of Vitamin D Levels in Hospitalized Children with Acute Respiratory Infections. Pediatr Rep. 2024 Nov 22;16(4):1034-1041. doi: 10.3390/pediatric16040088.

  PMID: 39585042 BACKGROUND

• Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6.

  PMID: 21646368 BACKGROUND

• Gulla KM, Sachdev A. Illness severity and organ dysfunction scoring in Pediatric Intensive Care Unit. Indian J Crit Care Med. 2016 Jan;20(1):27-35. doi: 10.4103/0972-5229.173685.

  PMID: 26955214 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples may be retained for laboratory confirmation only, without genetic analysis

MeSH Terms

Conditions

Vitamin D Deficiency; Dyspnea

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mohamed Ali

CONTACT

01284871896; abo.alimai.123@gmail.com

Azza Eltyeb, Professor

CONTACT

0 1006863277; azeltyeb@aun.eud.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 9, 2024
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)