Clinical trial NCT06547749: Vitamin D Supplementation in Critically Ill Children With Respiratory Disease
Official title: Vitamin D Supplementation in Critically Ill Children With Respiratory Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Vitamin D Supplementation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients admitted in PICU with respiratory disease

Brief summary: To evaluate the role of vitamin D supplementation in critically ill children with respiratory disease regarding their outcome.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hospital length of stay
timeFrame: Baseline
measure: Ventilator free day
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.