Vitamin D DeficiencyNCT05449522
Vitamin D for Critically Traumatic Patients
A study testing Vitamin D in people with Vitamin D Deficiency and Major Trauma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Trauma has been an important global public health issue. Yet it is the sixth cause of death in Taiwan, trauma brings great negative impact to national productivity since it presents specifically as the leading cause of death for the population aged below 40 years. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Vitamin D Deficiency, Major Trauma
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2018to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major trauma adult (> 20 years old) with Injury Severity Score equal or higher than 9, who is admitted to ICU
Who cannot join
- Patients with the following conditions:
- Chronic liver disease
- Contraindication to enteral feeds
- Hypercalcemia
- Current use of vitamin D, estrogen, or medications for bone disease
- High risk of hypercalcemia, ex. metastatic cancer, primary hyperparathyroidism, sarcoidosis, multiple myeloma
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Yin-Yi Han, MD, PhD
About this study
Official title: Effects of High Doses of Liquid Vitamin D Supplementation on Clinical Outcomes in Critically Traumatic Patients.
Trauma has been an important global public health issue. Yet it is the sixth cause of death in Taiwan, trauma brings great negative impact to national productivity since it presents specifically as the leading cause of death for the population aged below 40 years. According to the national databank from Formosa Association for the Surgery of Trauma, mortality rate in critically traumatic patients with injury severity score (ISS) ≥ 25 is as high as 23%. Vitamin D, a pleiotropic hormone, regulates directly functions of most organs and immune system. It has been proven that vitamin D insufficiency or deficiency would deteriorate survival of critically ill patients, while supplementation of high-dose vitamin D ameliorates the clinical outcomes. This study investigates whether multiple high doses of vitamin D supplementation in one week can decrease the mortality and morbidity in critically traumatic patients. The serum levels of calcidiol and PTH will be measured on Day 0, Day 3, Day 10, Day 15, Day 30 and Day 60 before and after vitamin D supplementation.
- Conditions
- Vitamin D Deficiency, Major Trauma
- Being tested
- Vitamin D, Placebo
- Keywords
- Vitamin D, Major Trauma
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
High dose of vitamin D with 576,000 IU on the 3rd post-trauma day and 432,000 IU on the 10th post-trauma day (1,008,000 IU in total) is given orally or enterally via a feeding tube
PlaceboDietary supplement
Medium-chain triglyceride (MCT)
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Experimental group will receive 576,000 IU on the 3rd post-trauma day and 432,000 IU on the 10th post-trauma day (1,008,000 IU in total) theoretically to achieve sufficient level of vitamin D. Receives: Dietary Supplement: Vitamin D |
| Control group | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality in ICU
Measured: up to 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start1 May 2018
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yin-Yi Han, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449522
- Sponsor's protocol ID
- 201705002MIPC
- Status last verified
- Aug 2024
- First submitted
- 5 Jul 2022
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Doses of Liquid Vitamin D Supplementation on Clinical Outcomes in Critically Traumatic Patients.
- ClinicalTrials.gov ID
- NCT05449522
- Acronym / sponsor ID
- 201705002MIPC
- Conditions
- Vitamin D Deficiency, Major Trauma
- Keywords
- Vitamin D, Major Trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 8 Jul 2022 (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.
Trauma has been an important global public health issue. Yet it is the sixth cause of death in Taiwan, trauma brings great negative impact to national productivity since it presents specifically as the leading cause of death for the population aged below 40 years. According to the national databank from Formosa Association for the Surgery of Trauma, mortality rate in critically traumatic patients with injury severity score (ISS) ≥ 25 is as high as 23%. Vitamin D, a pleiotropic hormone, regulates directly functions of most organs and immune system. It has been proven that vitamin D insufficiency or deficiency would deteriorate survival of critically ill patients, while supplementation of high-dose vitamin D ameliorates the clinical outcomes. This study investigates whether multiple high doses of vitamin D supplementation in one week can decrease the mortality and morbidity in critically traumatic patients. The serum levels of calcidiol and PTH will be measured on Day 0, Day 3, Day 10, Day 15, Day 30 and Day 60 before and after vitamin D supplementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Dietary Supplement: Vitamin DExperimental group will receive 576,000 IU on the 3rd post-trauma day and 432,000 IU on the 10th post-trauma day (1,008,000 IU in total) theoretically to achieve sufficient level of vitamin D. |
| Control group | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Major trauma adult (> 20 years old) with Injury Severity Score equal or higher than 9, who is admitted to ICU
Key exclusion criteria (6 listed)
- Chronic liver disease
- Contraindication to enteral feeds
- Hypercalcemia
- Current use of vitamin D, estrogen, or medications for bone disease
- High risk of hypercalcemia, ex. metastatic cancer, primary hyperparathyroidism, sarcoidosis, multiple myeloma
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 |
|---|---|---|
| Vitamin DHigh dose of vitamin D with 576,000 IU on the 3rd post-trauma day and 432,000 IU on the 10th post-trauma day (1,008,000 IU in total) is given orally or enterally via a feeding tube | Dietary supplement | Treatment group |
| PlaceboMedium-chain triglyceride (MCT) | Dietary supplement | Control group |
Primary outcome
Mortality
Time frame: up to 3 months after discharge
Mortality in ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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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. This study is not recruiting at the moment.
Yin-Yi Han, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Vitamin D Deficiency and Major Trauma, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yin-Yi Han, MD, PhD (886-972651405, yyhan@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: up to 3 months after discharge). 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 16 Aug 2024.