Critically IllMDC-SNCT06447441
Clinical Outcomes Of Mega-dosage Supplementations Of Cholecalciferol In Critically Ill Patients With Sepsis
A study testing Cholecalciferol in people with Critically Ill and Sepsis, run by Chimei Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Critically Ill, Sepsis, Mortality Rate
- What is being tested?
- Cholecalciferol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Critically Ill, Sepsis, Mortality Rate, Critical Care
- Being tested
- Placebo, Cholecalciferol
- Keywords
- Vitamin D, Cholecalciferol, Sepsis
- Medical subject headings
- Critical Illness, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Enteral supplementation of placebo in 3 consecutive days within 96 hours after ICU admission.
CholecalciferolOther
Also called vitamin D3
Enteral supplementation of 576,000IU/day vitamin D3 in 3 consecutive days within 96 hours after ICU admission
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Enteral supplementation of placebo in 3 days Receives: Other: Placebo |
| Vitamin D3 group | Experimental | Enteral supplementation of 1,728,000 IU vitamin D3 in 3 days Receives: Other: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day Mortality
Duration from the day of intervention to subjects died
Measured: Up to 30 days after intervention
Secondary outcomes (3)
ICU Length of Stay of Survivors
Duration from the day of intervention to ICU discharge
Measured: Up to 30 days after intervention
iPTH concentration
Measured: 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 )
Measured: 12 hours pre-intervention, Day5-6 post-intervention, Day15-16 pre-intervention, Day 29-30 post-intervention (or the day ICU discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chimei Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- E-DA Hospital
- Responsible party
- Principal investigator, Chin-Ming Chen, Chimei Medical Center
- Investigators
- Chin Ming Chen, Principal investigator, Chimei Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447441
- Sponsor's protocol ID
- CMMC11302007
- Acronym
- MDC-S
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes Of Mega-dosage Supplementations Of Cholecalciferol In Critically Ill Patients With Sepsis
- ClinicalTrials.gov ID
- NCT06447441
- Acronym / sponsor ID
- MDC-S / CMMC11302007
- Conditions
- Critically Ill, Sepsis, Mortality Rate, Critical Care
- Keywords
- Vitamin D, Cholecalciferol, Sepsis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Chimei Medical CenterUniversity, hospital or other
- Collaborators
- E-DA Hospital
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboEnteral supplementation of placebo in 3 days |
| Vitamin D3 group | Experimental | Other: CholecalciferolEnteral supplementation of 1,728,000 IU vitamin D3 in 3 days |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboEnteral supplementation of placebo in 3 consecutive days within 96 hours after ICU admission. | Other | Placebo |
| CholecalciferolAlso: vitamin D3Enteral supplementation of 576,000IU/day vitamin D3 in 3 consecutive days within 96 hours after ICU admission | Other | Vitamin D3 group |
Primary outcome
30-day Mortality
Time frame: Up to 30 days after intervention
Duration from the day of intervention to subjects died
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chin Ming Chen principal investigator
Chimei Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol in people with Critically Ill and Sepsis, run by Chimei Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chin Ming Chen, professor (+886 6-2812811 ext. 56689, Chencm3383@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day Mortality (time frame: Up to 30 days after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.