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NCT Number: NCT06447441

Clinical Outcomes Of Mega-dosage Supplementations Of Cholecalciferol In Critically Ill Patients With Sepsis

Non-COVID-19 sepsis (Sepsis) has always been one of the common diseases in critically ill patients. The main treatment strategy is to kill pathogens and mitigate hyperinflammation. One study demonstrated that the supplementation with 576,000 IU cholecalciferol (vitamin D3) as a single dose in critically ill adults in the medical intensive care units (MICUs) can improve clinical outcomes, including acute physiology and chronic health evaluation II score (APACHE II), sequential organ failure assessment score (SOFA), and C-reactive protein (CRP).

It is a three-year, multi-center, prospective, parallel, double-blind, randomized controlled clinical trial for 240 eligible subjects, with administrations of vitamin D3 576,000 IU or placebo every 24 hours for 3 days (72 hours) within 96 hours after intensive care unit (ICU) admission.

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Key information

Conditions

Critically Ill Critical Care Critical Illness Disease Attributes Infections Inflammation Mortality Rate Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Medical subject ≥ 18 years old and diagnosed with sepsis
  • Transferred to the intensive care unit within 24 hours after being diagnosed with sepsis
  • Admitted to the ICU with 40 > APACHE II score ≥ 15.
  • The intensivist anticipates that the subject will stay in the ICU ≥ 7 days.

Exclusion criteria

  • Diseases that affect serum levels of 25(OH)D and calcium, including thyroidectomy, parathyroid disease, rickets, or severe cirrhosis [Child C]
  • Received large doses of vitamin D3 in the past four weeks (> 2000 IU per day or ≥ 10,000 IU in a single dose)
  • Admitted to the ICU with diagnosis of COVID-19
  • AIDS subjects taking immunosuppressants
  • Organ transplant
  • Active cancer
  • Tuberculosis, sarcoidosis, or kidney stones in the past one year
  • Weight < 45 kg or > 90 kg
  • Had been admitted to ICU in the past three months
  • Subject and family members who do not speak the native language
  • Pregnant women

Treatment and study plan

Placebo

Other

Enteral supplementation of placebo in 3 consecutive days within 96 hours after ICU admission.

cholecalciferol

Other

Enteral supplementation of 576,000IU/day vitamin D3 in 3 consecutive days within 96 hours after ICU admission

Other names: vitamin D3

Primary outcomes

  1. 30-day Mortality

    Time frame: Up to 30 days after intervention

    Duration from the day of intervention to subjects died

Secondary outcomes

  1. ICU Length of Stay of Survivors

    Time frame: Up to 30 days after intervention

    Duration from the day of intervention to ICU discharge

  2. iPTH concentration

    Time frame: 12 hours pre-intervention, Day5-6 post-intervention, Day15-16 pre-intervention, Day 29-30 post-intervention (or the day ICU discharge)

  3. calcifediol concentration ( 25(OH)D )

    Time frame: 12 hours pre-intervention, Day5-6 post-intervention, Day15-16 pre-intervention, Day 29-30 post-intervention (or the day ICU discharge)

Study contacts

Contact information is provided by the study sponsor or research team.

Chin Ming Chen, professor

CONTACT

[email protected]

+886 6-2812811 ext. 56689

Jia Wei Lin

CONTACT

[email protected]

+886 6-62812811 ext. 52951

Sponsors and collaborators

Lead sponsor

Chimei Medical Center

Other

Collaborators

  • E-DA Hospital

Registry information

Acronym: MDC-S

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Jun 7, 2024
Registry last updated
Jun 17, 2024

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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