Clinical Outcomes Of Mega-dosage Supplementations Of Cholecalciferol In Critically Ill Patients With Sepsis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, Cholecalciferol.
- Who it may be relevant to
- Registry conditions: Critically Ill, Sepsis, Mortality Rate, Critical Care. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Placebo
Enteral supplementation of placebo in 3 consecutive days within 96 hours after ICU admission. - Other Cholecalciferol
Enteral supplementation of 576,000IU/day vitamin D3 in 3 consecutive days within 96 hours after ICU admission
Primary outcome measures
- 30-day Mortality [Time frame: Up to 30 days after intervention]
Secondary outcome measures (3)
- ICU Length of Stay of Survivors [Time frame: Up to 30 days after intervention]
- 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)]
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06447441 · CMMC11302007