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Completed

NCT Number: NCT05244018

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain-Shams University Hospitals

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D3 tablets

Drug

Vitamin D3 tablets 50,000 IU units

Vitamin D tablets

Drug

Vitamin D tablets 5000 units as daily requirements

Primary outcomes

  1. Change in procalcitonin level (ng/ml) and antimicrobial peptide cathelicidin (LL37) (ng/ml) level at day 7.

    Time frame: 7 days

    Change in procalcitonin level (ng/ml) and antimicrobial peptide cathelicidin (LL37) (ng/ml) level at day 7.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2022
Registry last updated
Nov 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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