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

NCT05244018 | Completed Phase 4

• 1 other identifier: FMASU MS 47/ 2022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1(Treatment group)

ACTIVE COMPARATOR

Drug: Vitamin D3 tablets

Group 2(Control group)

ACTIVE COMPARATOR

Drug: Vitamin D tablets

Interventions

Vitamin D3 tablets DRUG

Vitamin D3 tablets 50,000 IU units

Group 1(Treatment group)

Vitamin D tablets DRUG

Vitamin D tablets 5000 units as daily requirements

Group 2(Control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain-Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Sepsis

Interventions

Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: January 29, 2022
• First Posted: February 17, 2022
• Study Start: March 1, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: November 7, 2022

Record last verified: 2022-11

Locations

EG (1)