NCT06547749

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
19mo left

Started Dec 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

August 2, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

August 2, 2024

Last Update Submit

September 20, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Hospital length of stay

    How long the patient will stay in Hospital

    Baseline

  • Ventilator free day

    How long is the free days

    Baseline

Eligibility Criteria

Age1 Month - 16 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

pediatric patients admitted in PICU with respiratory disease

You may qualify if:

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

You may not qualify if:

  • Patients admitted in PICU due to causes rather than respiratory disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 35792343BACKGROUND
  • 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.

    PMID: 36653058BACKGROUND
  • 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.

    PMID: 27419080BACKGROUND
  • 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.

    PMID: 33280208BACKGROUND
  • 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.

    PMID: 21118827BACKGROUND

Central Study Contacts

Azza Eltyeb, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
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

December 1, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

September 23, 2025

Record last verified: 2025-09