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

NCT ID: NCT05244018

Last Updated: 2022-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-10-31

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.

Conditions

Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1(Treatment group)

Group Type: ACTIVE_COMPARATOR

Vitamin D3 tablets

Intervention Type: DRUG

Vitamin D3 tablets 50,000 IU units

Group 2(Control group)

Group Type: ACTIVE_COMPARATOR

Vitamin D tablets

Intervention Type: DRUG

Vitamin D tablets 5000 units as daily requirements

Interventions

Vitamin D3 tablets

Vitamin D3 tablets 50,000 IU units

Intervention Type: DRUG

Vitamin D tablets

Vitamin D tablets 5000 units as daily requirements

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Dr.Ibrahim Mamdouh Esmat

Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain-Shams University Hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU MS 47/ 2022

Identifier Type: -

Identifier Source: org_study_id