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Acute Respiratory InfectionsVITD-ARINCT06547749

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

An observational study of Acute Respiratory Infections and Critical Illness in Children, run by Assiut University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 1 month to 16 years
What is being tested?
Serum 25-Hydroxyvitamin D Assessment
How many people
63 participants
Where
1 siteEgypt
Study dates
Jun 2026to Apr 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 16 years
  • All sexes
  • No healthy volunteers
  • Child

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Azza Eltyeb, Professor contact

0 1006863277

azeltyeb@aun.eud.eg

Egypt1 site
  • Assiut university

    Asyut

    Assiut University, 08822080150

Other trials in Egypt

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Serum 25-Hydroxyvitamin D Assessment
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
Medical subject headings
Vitamin D Deficiency, Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Serum 25-Hydroxyvitamin D AssessmentDiagnostic test

    Also called Serum Vitamin D Measurement, 25(OH)D Testing

    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.

Study groups in NCT06547749
Study groupRoleWhat they receive
Critically Ill Children With Acute Respiratory InfectionsThis 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.
Receives: Diagnostic Test: Serum 25-Hydroxyvitamin D Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within the first 24 hours of admission to the Pediatric Intensive Care Unit (PICU).

Secondary outcomes (2)
  1. Association between Vitamin D and Severity of ARI

    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.

    Measured: Within the first 24 hours of PICU admission.

  2. Association between Vitamin D and Risk of Mortality

    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.

    Measured: Within the first 24 hours of PICU admission.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study startJun 2026 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06547749
Sponsor's protocol ID
VITD01
Acronym
VITD-ARI
Status last verified
May 2026
First submitted
2 Aug 2024
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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

  • Gunes N, Cam H. An observational study of serum vitamin D status in critically ill children admitted to the pediatric intensive care unit. Arch Med Sci. 2022 Oct 6;21(2):471-477. doi: 10.5114/aoms/155137. eCollection 2025.

    PubMed 40395895
  • 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

  • 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.

    PubMed 40693518
  • 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.

    PubMed 8706448
  • 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.

    PubMed 35406098
  • 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.

    PubMed 39585042
  • 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.

    PubMed 21646368
  • 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.

    PubMed 26955214

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Respiratory Infections and Critical Illness in Children, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mohamed Ali (01284871896, abo.alimai.123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06547749, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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