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

Primary Purpose

Sepsis

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin D3 tablets
Vitamin D tablets
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ain-Shams University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1(Treatment group)

Group 2(Control group)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 29, 2022
Last Updated
November 3, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05244018
Brief Title
Outcome of High Dose Vitamin D on Prognosis of Sepsis Requiring Mechanical Ventilation
Official Title
Outcome of High Dose Vitamin D on Prognosis of Sepsis Requiring Mechanical Ventilation; A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1(Treatment group)
Arm Type
Active Comparator
Arm Title
Group 2(Control group)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Vitamin D3 tablets
Intervention Description
Vitamin D3 tablets 50,000 IU units
Intervention Type
Drug
Intervention Name(s)
Vitamin D tablets
Intervention Description
Vitamin D tablets 5000 units as daily requirements
Primary Outcome Measure Information:
Title
Change in procalcitonin level (ng/ml) and antimicrobial peptide cathelicidin (LL37) (ng/ml) level at day 7.
Description
Change in procalcitonin level (ng/ml) and antimicrobial peptide cathelicidin (LL37) (ng/ml) level at day 7.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Ain-Shams University Hospitals
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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

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