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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05244018
• Other study ID #: FMASU MS 47/ 2022
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Drug:
• Vitamin D3 tablets
Vitamin D3 tablets 50,000 IU units
• Vitamin D tablets
Vitamin D tablets 5000 units as daily requirements

Locations

Country	Name	City	State
Egypt	Ain-Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

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