Vitamin D Supplementation in Critically Ill Children With Respiratory Diseases

NCT ID: NCT06547749

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-12-31

Brief Summary

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To evaluate the role of vitamin D supplementation in critically ill children with respiratory diseases regarding their outcome.

Detailed Description

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Vitamin D is involved in the process of immunomodulation, especially in the context of autoimmunity . Vitamin D has multiple pharmacological effects, such as alleviating the inflammatory response, promoting phagocytosis, and inducing lymphocyte proliferation . previous studies have demonstrated that patients with lower serum vitamin D levels had a longer length of hospital stay and might have an independent relationship with the duration of mechanical ventilation (MV) in critically ill children

.

Approved Vitamin D Supplementation Regimens:

The recommended daily allowance (RDA) or adequate intake (AI) suggested by the Institute of Medicine (IOM) and supported by Health Canada are 400 IU for infants and 600 IU for older children.

Approved High-Dose Regimens:

In addition to RDA, the IOM provides a higher age-specific dose called the tolerable upper intake level (UL), which ranges from 1,000 to 4,000 IU.

Conditions

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Vitamin D Supplementation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* All pediatric patients admitted in PICU with respiratory disease with age from 1month to 16 years.

Exclusion Criteria

* Patients admitted in PICU due to causes rather than respiratory disease.
Minimum Eligible Age

1 Month

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ali Hassan Mohamed

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mohamed Ali

Role: CONTACT

01284871896

Azza Eltyeb, Professor

Role: CONTACT

0 1006863277

References

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Triantos C, Aggeletopoulou I, Mantzaris GJ, Mouzaki A. Molecular basis of vitamin D action in inflammatory bowel disease. Autoimmun Rev. 2022 Aug;21(8):103136. doi: 10.1016/j.autrev.2022.103136. Epub 2022 Jul 2.

Reference Type BACKGROUND
PMID: 35792343 (View on PubMed)

Vanichkulbodee A, Romposra M, Inboriboon PC, Trongtrakul K. Effects of vitamin D insufficiency on sepsis severity and risk of hospitalisation in emergency department patients: a cross-sectional study. BMJ Open. 2023 Jan 17;13(1):e064985. doi: 10.1136/bmjopen-2022-064985.

Reference Type BACKGROUND
PMID: 36653058 (View on PubMed)

Han JE, Jones JL, Tangpricha V, Brown MA, Brown LAS, Hao L, Hebbar G, Lee MJ, Liu S, Ziegler TR, Martin GS. High Dose Vitamin D Administration in Ventilated Intensive Care Unit Patients: A Pilot Double Blind Randomized Controlled Trial. J Clin Transl Endocrinol. 2016 Jun;4:59-65. doi: 10.1016/j.jcte.2016.04.004. Epub 2016 May 5.

Reference Type BACKGROUND
PMID: 27419080 (View on PubMed)

He M, Cao T, Wang J, Wang C, Wang Z, Abdelrahim MEA. Vitamin D deficiency relation to sepsis, paediatric risk of mortality III score, need for ventilation support, length of hospital stay, and duration of mechanical ventilation in critically ill children: A meta-analysis. Int J Clin Pract. 2021 Apr;75(4):e13908. doi: 10.1111/ijcp.13908. Epub 2020 Dec 20.

Reference Type BACKGROUND
PMID: 33280208 (View on PubMed)

Ross AC, Manson JE, Abrams SA, Aloia JF, Brannon PM, Clinton SK, Durazo-Arvizu RA, Gallagher JC, Gallo RL, Jones G, Kovacs CS, Mayne ST, Rosen CJ, Shapses SA. The 2011 report on dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know. J Clin Endocrinol Metab. 2011 Jan;96(1):53-8. doi: 10.1210/jc.2010-2704. Epub 2010 Nov 29.

Reference Type BACKGROUND
PMID: 21118827 (View on PubMed)

Other Identifiers

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Vitamin D supplementation

Identifier Type: -

Identifier Source: org_study_id

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