Comparison Between Effect of Vitamin D Versus Dexmedetomidine in Patients with Head Trauma Using Interleukin 6

Comparison Between the Neuroprotective Effect of Vitamin D Versus Dexmedetomidine in Patients with Traumatic Brain Injury Using Interleukin 6 As Inflammatory Marker

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06565338

Enrollment

Registered

2024-08-21

Start date

2021-04-25

Completion date

2024-02-05

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Brief summary

in this study the investigators compare between the neuroprotective effect of vitamin d versus dexmedetomidine in patients with traumatic brain injury using interleukin 6 as inflammatory biomarker

Detailed description

patients with moderate head trauma (GCS 8-12) within first 24 hours were randomly divided into 2 groups, first group received 100,000 IU of vitamin D was given IM & the other group received dexmedetomidine 0.4 mic/kg as loading dose then 0.25 mic/kg/hr as maintainence dose for 5 days detecting APATCHE at admission and following up of vital signs (HR & NIBP) & investigations (CBC & RFT& ABG & ESR& CRP & IL-6) & GCS and GOS for 5 days.

Interventions

DRUGDexmedetomidine

drug

DRUGVitamin D3

drug

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

* Both Gender. * Age (18-50) * GCS (8-12) * Pt with traumatic brain insult who not indicated surgical intervention

Exclusion criteria

* Prior severe disability. * Isolated brain system lesions. * History of underlying neurologic, metabolic or psychiatric disorders. * Alcohol or drug abuse. * Pregnancy. * Patients with intracranial hemorrhage who indicated surgical evacuation. * Multisystem life-threatening trauma. * GCS \> 12 & \<8. * Vitamin d deficiency.

Design outcomes

Primary

Measure	Time frame	Description
The primary endpoint aims to measure the inflammatory markers level:	5 days	1- IL-6 in the unit of (pg/mL).
Primary outcome measure	5 days	2- ESR in the unit of(mm/hr).

Secondary

Measure	Time frame	Description
The secondary endpoints aim to compare ICU stay, morbidity and mortality in both groups:	3 months	1- ICU stay (no. Of days)
Secondary outcome measure	3 month	2- Glascow outcome scale (1-5) : that determine morbidity and mortality (units on scale from 1 to 5 with better scale towards 5 and worse towards 1)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026