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

ConditionsCritically IllSepsisMortality RateCritical Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorChimei Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Other intervention

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

  • Cholecalciferol

    Other intervention

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

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: Vitamin D3 groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

30-day Mortality

Duration from the day of intervention to subjects died

Time frame
Up to 30 days after intervention

Secondary outcomes

1

ICU Length of Stay of Survivors

Duration from the day of intervention to ICU discharge

Time frame
Up to 30 days after intervention
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)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chimei Medical Center

Lead sponsor

E-DA Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: