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

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05244018

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

13.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis	Drug: Vitamin D3 tablets Drug: Vitamin D tablets	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1(Treatment group)	Drug: Vitamin D3 tablets Vitamin D3 tablets 50,000 IU units
Active Comparator: Group 2(Control group)	Drug: Vitamin D tablets Vitamin D tablets 5000 units as daily requirements

Arm

Intervention/Treatment

Active Comparator: Group 1(Treatment group)

Drug: Vitamin D3 tablets

Vitamin D3 tablets 50,000 IU units

Active Comparator: Group 2(Control group)

Drug: Vitamin D tablets

Vitamin D tablets 5000 units as daily requirements

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain-Shams University Hospitals	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr.Ibrahim Mamdouh Esmat, Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt., Ain Shams University

ClinicalTrials.gov Identifier:

NCT05244018

Other Study ID Numbers: