Outcome of High Dose Vitamin D on Prognosis of Sepsis Requiring Mechanical Ventilation

Outcome of High Dose Vitamin D on Prognosis of Sepsis Requiring Mechanical Ventilation; A Randomized Controlled Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05244018

Enrollment

Registered

2022-02-17

Start date

2022-03-01

Completion date

2022-10-31

Last updated

2022-11-07

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

Conditions

Sepsis

Brief summary

There is a high prevalence of vitamin D deficiency in the critically ill patient population, with approximately 60% of patients found to be vitamin D deficient, (25(OH)D concentrations \<20 ng/mL) and an additional 30% of patients being vitamin D insufficient, (25(OH)D = 20-30 ng/mL).Approximately 80% of sepsis/septic shock patients experience respiratory failure and require mechanical ventilation. Furthermore, several studies document that vitamin D deficiency could be associated with poor outcomes in critically ill patient.

Interventions

DRUGVitamin D3 tablets

Vitamin D3 tablets 50,000 IU units

DRUGVitamin D tablets

Vitamin D tablets 5000 units as daily requirements

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosed with sepsis and required mechanical ventilation (MV) within 24 hours from ICU admission. * Expected to require mechanical ventilation for at least 72 hours after study entry.

Exclusion criteria

* Age \<18 years. * inability to obtain informed consent from the patient and/or legally authorized representative. * BMI\> 40. * Pregnant or breastfeeding. * Chronic kidney diseases * Pancreatitis. * Hepatic insufficiency * Cases with coagulopathy * Moribund and not expected to survive 96 hours. * Ongoing shock * History of therapy with high dose vitamin D3 within previous 6 months. * History of disorders associated with hypercalcemia * Cancer as the cause of sepsis. * Subjects undergoing chemotherapy. * Immune compromised patients. * Pneumonia developed \< 48 hours following intubation. * Patients with history of aspiration before intubation. * known allergy to vitamin D.

Design outcomes

Primary

Measure	Time frame	Description
Change in procalcitonin level (ng/ml) and antimicrobial peptide cathelicidin (LL37) (ng/ml) level at day 7.	7 days	Change in procalcitonin level (ng/ml) and antimicrobial peptide cathelicidin (LL37) (ng/ml) level at day 7.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026