Vitamin D DeficiencyNCT03639584
Prevalence of Deficiency of Vitamin D in Critically Ill Patients
An observational study of Vitamin D Deficiency and Critical Illness, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Vitamin D has been shown to related to clinical outcomes in critically ill patients. The object of this study is to investigate the prevalence of Vitamin D deficiency in critically ill patients with various length of ICU stay . Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Vitamin D Deficiency, Critical Illness
- How many people
- 662 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Aug 2018to 30 Nov 2020
- Phase
- Observational
- 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
Study population: This is a multi-center, cross-sectional study involving four medical center in Taipei, Taiwan, which are National Taiwan University Hospital (NTUH), Far Eastern Memorial Hospital (FEMH), MacKay Memorial Hospital (MMH), and Taipei Medical University Hospital (TMUH). The target population is all the ICU patients, divided into four groups according to the length of ICU stay. The serum level of vit D, ICU event such as infection, ventilator dependency is to be recorded.
Who may be able to join
- All ICU patients
Who cannot join
- 1, Less than 20 years 2, BMI < 18 kg/m^2 3, Had large dose vit D within previous four weeks (over 3000 IU per day) 4, ICU admission within previous three months 5, Have disease affecting vit D level, calcium metabolism, bone metabolism such as parathyroid disease, Rickets, liver cirrhosis child C 6, Communication difficulty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Prevalence of Deficiency of Vitamin D in Critically Ill Patients and Its Effects on the Prognosis
Vitamin D has been shown to related to clinical outcomes in critically ill patients. The object of this study is to investigate the prevalence of Vitamin D deficiency in critically ill patients with various length of ICU stay .
Read the detailed description
Studies have revealed that the serum level of 25-hydroxyvitamin D, as known as calcidiol, is low in critically ill patients. The prevalence ranges from 26 to 82%. 25-hydroxyvitamin D deficiency is associated with longer ICU stay, higher medical cost and higher death rate in septic patients. 25-hydroxyvitamin D is a kind of hormone related to bone and mineral metabolism. Moreover, the receptors were found in almost all cells, and it is related to immune system, cytokine release, cellular proliferation and differentiation, angiogenesis, and muscular energy. The main source is skin metabolism triggered by sunshine and food consumption. It is subsequently converted to calcifediol in the liver and then calcitriol in the kidney (the active form). Its serum level is regulated by parathyroid hormone and serum calcium and phosphate. The critically ill patients are deprived of sunshine, suffered from poor nutrition support, impaired liver and kidney function, higher rate of consumption, and are under higher risk of deficiency. Nowadays, the studies about 25-hydroxyvitamin D in ICU patients were conducted mostly in Europe and America. There is no large-scale study in Taiwan or Asia. A randomized controlled study from Austria has shown large dose supply in patients with 25-hydroxyvitamin D deficiency could decrease the mortality.
The object of this multi-center study is to investigate the prevalence of 25-hydroxyvitamin D deficiency, the risk factors and the correlation with outcomes. The results could be a step-stone for future randomized controlled studies.
- Conditions
- Vitamin D Deficiency, Critical Illness
- Keywords
- Vitamin D Deficiency, Critical Illness
- Medical subject headings
- Vitamin D Deficiency, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients admitted to ICU less than 48 hours and the anticipated stay is less than 5 days. Take blood sample on the day of enrollment. | |
| Group 2 | Patients admitted to ICU less than 48 hours and the anticipated stay is longer than 5 days. Take blood sample on the day of enrollment, 7th, 14th, 21st, and 28th. Stop blood sample once exit. | |
| Group 3 | Patients admitted to ICU 3~7 days. Take blood sample on the day of enrollment. | |
| Group 4 | Patients admitted to ICU 8~14 days. Take blood sample on the day of enrollment. | |
| Group 5 | Patients admitted to ICU 15~28 days. Take blood sample on the day of enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of Vitamin D deficiency
Investigate the prevalence of vitamin D deficiency among groups
Measured: 1 day at enrollment
Secondary outcomes (5)
Difference of mortality on 28th and 90th day in group 2
Compare the mortality of 28th and 90th day of patients with vitamin D deficiency and patients without vitamin D deficiency in group 2
Measured: 90 days
Difference of mortality on 28th and 90th day in group 3, 4, and 5
Compare the mortality of 28th and 90th day of patients with vitamin D deficiency and patients without vitamin D deficiency in group 3, 4, and 5
Measured: 90 days
Serial changes of serum vitamin D levels in group 2
investigate the serum vitamin D levels at different time points in group 2
Measured: 28 days
Difference of 28-day ventialtor-free days
Compare the 28-day ventialtor-free days of patients with vitamin D deficiency and patients without vitamin D deficiency for all groups
Measured: 28 days
Difference of 28-day ICU-free days
Compare the 28-day ICU-free days of patients with vitamin D deficiency and patients without vitamin D deficiency for all groups
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start23 Aug 2018
- Primary completion30 Jul 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 662 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chung-Wei Chen, MD, Principal investigator, Far Eastern Memorial HospitalLi-Kuo Kuo, MD, Principal investigator, Mackay Memorial HospitalKuo-Ching Yuan, MD, Principal investigator, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639584
- Sponsor's protocol ID
- 201805087RINB
- Status last verified
- Apr 2021
- First submitted
- 14 Aug 2018
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kuo YT, Kuo LK, Chen CW, Yuan KC, Fu CH, Chiu CT, Yeh YC, Liu JH, Shih MC. Score-based prediction model for severe vitamin D deficiency in patients with critical illness: development and validation. Crit Care. 2022 Dec 21;26(1):394. doi: 10.1186/s13054-022-04274-9.
PubMed 36544226
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Prevalence of Deficiency of Vitamin D in Critically Ill Patients and Its Effects on the Prognosis
- ClinicalTrials.gov ID
- NCT03639584
- Acronym / sponsor ID
- 201805087RINB
- Conditions
- Vitamin D Deficiency, Critical Illness
- Keywords
- Vitamin D Deficiency, Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 662 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 21 Aug 2018 (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.
Vitamin D has been shown to related to clinical outcomes in critically ill patients. The object of this study is to investigate the prevalence of Vitamin D deficiency in critically ill patients with various length of ICU stay .
Detailed description
Studies have revealed that the serum level of 25-hydroxyvitamin D, as known as calcidiol, is low in critically ill patients. The prevalence ranges from 26 to 82%. 25-hydroxyvitamin D deficiency is associated with longer ICU stay, higher medical cost and higher death rate in septic patients. 25-hydroxyvitamin D is a kind of hormone related to bone and mineral metabolism. Moreover, the receptors were found in almost all cells, and it is related to immune system, cytokine release, cellular proliferation and differentiation, angiogenesis, and muscular energy. The main source is skin metabolism triggered by sunshine and food consumption. It is subsequently converted to calcifediol in the liver and then calcitriol in the kidney (the active form). Its serum level is regulated by parathyroid hormone and serum calcium and phosphate. The critically ill patients are deprived of sunshine, suffered from poor nutrition support, impaired liver and kidney function, higher rate of consumption, and are under higher risk of deficiency. Nowadays, the studies about 25-hydroxyvitamin D in ICU patients were conducted mostly in Europe and America. There is no large-scale study in Taiwan or Asia. A randomized controlled study from Austria has shown large dose supply in patients with 25-hydroxyvitamin D deficiency could decrease the mortality.
The object of this multi-center study is to investigate the prevalence of 25-hydroxyvitamin D deficiency, the risk factors and the correlation with outcomes. The results could be a step-stone for future randomized controlled studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients admitted to ICU less than 48 hours and the anticipated stay is less than 5 days. Take blood sample on the day of enrollment. |
| Group 2 | – | –Patients admitted to ICU less than 48 hours and the anticipated stay is longer than 5 days. Take blood sample on the day of enrollment, 7th, 14th, 21st, and 28th. Stop blood sample once exit. |
| Group 3 | – | –Patients admitted to ICU 3~7 days. Take blood sample on the day of enrollment. |
| Group 4 | – | –Patients admitted to ICU 8~14 days. Take blood sample on the day of enrollment. |
| Group 5 | – | –Patients admitted to ICU 15~28 days. Take blood sample on the day of enrollment. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a multi-center, cross-sectional study involving four medical center in Taipei, Taiwan, which are National Taiwan University Hospital (NTUH), Far Eastern Memorial Hospital (FEMH), MacKay Memorial Hospital (MMH), and Taipei Medical University Hospital (TMUH). The target population is all the ICU patients, divided into four groups according to the length of ICU stay. The serum level of vit D, ICU event such as infection, ventilator dependency is to be recorded.
Key inclusion criteria (1 listed)
- All ICU patients
Key exclusion criteria (1 listed)
- 1, Less than 20 years 2, BMI < 18 kg/m^2 3, Had large dose vit D within previous four weeks (over 3000 IU per day) 4, ICU admission within previous three months 5, Have disease affecting vit D level, calcium metabolism, bone metabolism such as parathyroid disease, Rickets, liver cirrhosis child C 6, Communication difficulty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The prevalence of Vitamin D deficiency
Time frame: 1 day at enrollment
Investigate the prevalence of vitamin D deficiency among groups
5 secondary outcomes
Difference of mortality on 28th and 90th day in group 2
Time frame: 90 days
Difference of mortality on 28th and 90th day in group 3, 4, and 5
Time frame: 90 days
Serial changes of serum vitamin D levels in group 2
Time frame: 28 days
Difference of 28-day ventialtor-free days
Time frame: 28 days
Difference of 28-day ICU-free days
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Derived from this study: PubMed 36544226Kuo YT, Kuo LK, Chen CW, Yuan KC, Fu CH, Chiu CT, Yeh YC, Liu JH, Shih MC. Score-based prediction model for severe vitamin D deficiency in patients with critical illness: development and validation. Crit Care. 2022 Dec 21;26(1):394. doi: 10.1186/s13054-022-04274-9.
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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.
Chung-Wei Chen, MD principal investigator
Far Eastern Memorial Hospital
Li-Kuo Kuo, MD principal investigator
Mackay Memorial Hospital
Kuo-Ching Yuan, MD principal investigator
Taipei Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency and Critical Illness, 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 1 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: finished, as of the sponsor's last update on 22 Apr 2021. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of Vitamin D deficiency (time frame: 1 day at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03639584, which also lists 1 linked publication.
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 22 Apr 2021.