Liver Transplant DisorderNCT04111146
Effect of 25-OH-vitamin D3 on the Liver Transplant Recipients
An observational study of Liver Transplant Disorder, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The low vitamin D3 levels and malnutrition before liver transplantation showed an increase in the length of stay in ICU and hospital. Although several factors may influence the clinical outcomes of patients with liver transplantation, low vitamin D3 levels showed an independent risk factor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant Disorder
- How many people
- 219 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2017to 30 Jun 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients received liver transplantation from June 2017 to November 2017
Who may be able to join
- The patients who admitted to intensive care unit (ICU) after liver transplantation were studied
Who cannot join
- Patients who didn't have preoperative vitamin D level
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Effect of Preoperative Level of 25-OH-vitamin D3 on the Liver Transplant Recipients
The low vitamin D3 levels and malnutrition before liver transplantation showed an increase in the length of stay in ICU and hospital. Although several factors may influence the clinical outcomes of patients with liver transplantation, low vitamin D3 levels showed an independent risk factor. It is necessary to prospectively analyze the effect of vitamin D supplements on clinical outcomes in liver transplant recipients.
Read the detailed description
Purpose: Vitamin D deficiency is common in patients of chronic liver disease and has been associated with infection and mortality. The aim of this study is to determine whether preoperative vitamin D levels affect clinical outcomes after liver transplantation.
Methods : This was a single-center retrospective study. Between June and November 2017, a total of 219 patients underwent liver transplantation. The primary outcome was the relationship between serum 25-OH-vitamin D3 level before liver transplantation and length of stay in the intensive care unit (ICU). Secondary outcomes included the duration of normalization of inflammatory marker, such as white blood cell count (WBC) \& C-reactive protein (CRP) after liver transplantation, new infection rates, rejection rates, the length of hospital stay and mortality among vitamin D level.
- Conditions
- Liver Transplant Disorder
- Keywords
- vitamin D, liver transplant, hospital stay
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 |
|---|---|---|
| 1 | Liver transplant patients with severe vitamin D deficiency (<10ng/ml) | |
| 2 | Liver transplant patients with vitamin D insufficiency (10-20ng/ml) | |
| 3 | Liver transplant patients with normal vitamin D status (>20ng/ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital stay after liver transplant
compared with each group
Measured: 6 months
Secondary outcomes (3)
duration of normalization of CRP, WBC
compared with each group
Measured: 6 months
Length of ICU stay
compared with each group
Measured: 6 months
New infection rate
compared with each group
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Jun 2017
- Primary completion30 Nov 2017
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant DisorderStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Retrospective
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suk-Kyung, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111146
- Sponsor's protocol ID
- AsanMC-vitamin D
- Status last verified
- Sep 2019
- First submitted
- 29 Sep 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Finkelmeier F, Kronenberger B, Koberle V, Bojunga J, Zeuzem S, Trojan J, Piiper A, Waidmann O. Severe 25-hydroxyvitamin D deficiency identifies a poor prognosis in patients with hepatocellular carcinoma - a prospective cohort study. Aliment Pharmacol Ther. 2014 May;39(10):1204-12. doi: 10.1111/apt.12731. Epub 2014 Mar 29.
PubMed 24684435Finkelmeier F, Kronenberger B, Zeuzem S, Piiper A, Waidmann O. Low 25-Hydroxyvitamin D Levels Are Associated with Infections and Mortality in Patients with Cirrhosis. PLoS One. 2015 Jun 29;10(6):e0132119. doi: 10.1371/journal.pone.0132119. eCollection 2015.
PubMed 26121590Grant C. A vitamin D protocol post-liver transplantation. J Am Assoc Nurse Pract. 2017 Nov;29(11):658-666. doi: 10.1002/2327-6924.12503. Epub 2017 Aug 25.
PubMed 28840965Zhou Q, Li L, Chen Y, Zhang J, Zhong L, Peng Z, Xing T. Vitamin D supplementation could reduce the risk of acute cellular rejection and infection in vitamin D deficient liver allograft recipients. Int Immunopharmacol. 2019 Oct;75:105811. doi: 10.1016/j.intimp.2019.105811. Epub 2019 Aug 15.
PubMed 31422183
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effect of Preoperative Level of 25-OH-vitamin D3 on the Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT04111146
- Acronym / sponsor ID
- AsanMC-vitamin D
- Conditions
- Liver Transplant Disorder
- Keywords
- vitamin D, liver transplant, hospital stay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 1 Oct 2019 (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.
The low vitamin D3 levels and malnutrition before liver transplantation showed an increase in the length of stay in ICU and hospital. Although several factors may influence the clinical outcomes of patients with liver transplantation, low vitamin D3 levels showed an independent risk factor. It is necessary to prospectively analyze the effect of vitamin D supplements on clinical outcomes in liver transplant recipients.
Detailed description
Purpose: Vitamin D deficiency is common in patients of chronic liver disease and has been associated with infection and mortality. The aim of this study is to determine whether preoperative vitamin D levels affect clinical outcomes after liver transplantation.
Methods : This was a single-center retrospective study. Between June and November 2017, a total of 219 patients underwent liver transplantation. The primary outcome was the relationship between serum 25-OH-vitamin D3 level before liver transplantation and length of stay in the intensive care unit (ICU). Secondary outcomes included the duration of normalization of inflammatory marker, such as white blood cell count (WBC) \& C-reactive protein (CRP) after liver transplantation, new infection rates, rejection rates, the length of hospital stay and mortality among vitamin D level.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Liver transplant patients with severe vitamin D deficiency (<10ng/ml) |
| 2 | – | –Liver transplant patients with vitamin D insufficiency (10-20ng/ml) |
| 3 | – | –Liver transplant patients with normal vitamin D status (>20ng/ml) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients received liver transplantation from June 2017 to November 2017
Key inclusion criteria (1 listed)
- The patients who admitted to intensive care unit (ICU) after liver transplantation were studied
Key exclusion criteria (1 listed)
- Patients who didn't have preoperative vitamin D level
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
Hospital stay after liver transplant
Time frame: 6 months
compared with each group
3 secondary outcomes
duration of normalization of CRP, WBC
Time frame: 6 months
Length of ICU stay
Time frame: 6 months
New infection rate
Time frame: 6 months
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 1 Oct 2019.
- Results publication: PubMed 24684435Finkelmeier F, Kronenberger B, Koberle V, Bojunga J, Zeuzem S, Trojan J, Piiper A, Waidmann O. Severe 25-hydroxyvitamin D deficiency identifies a poor prognosis in patients with hepatocellular carcinoma - a prospective cohort study. Aliment Pharmacol Ther. 2014 May;39(10):1204-12. doi: 10.1111/apt.12731. Epub 2014 Mar 29.
- Results publication: PubMed 26121590Finkelmeier F, Kronenberger B, Zeuzem S, Piiper A, Waidmann O. Low 25-Hydroxyvitamin D Levels Are Associated with Infections and Mortality in Patients with Cirrhosis. PLoS One. 2015 Jun 29;10(6):e0132119. doi: 10.1371/journal.pone.0132119. eCollection 2015.
- Results publication: PubMed 28840965Grant C. A vitamin D protocol post-liver transplantation. J Am Assoc Nurse Pract. 2017 Nov;29(11):658-666. doi: 10.1002/2327-6924.12503. Epub 2017 Aug 25.
- Results publication: PubMed 31422183Zhou Q, Li L, Chen Y, Zhang J, Zhong L, Peng Z, Xing T. Vitamin D supplementation could reduce the risk of acute cellular rejection and infection in vitamin D deficient liver allograft recipients. Int Immunopharmacol. 2019 Oct;75:105811. doi: 10.1016/j.intimp.2019.105811. Epub 2019 Aug 15.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Liver Transplant Disorder, run by Asan Medical Center at 1 site in South Korea.
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 1 Oct 2019. 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 South Korea. 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?
Hospital stay after liver transplant (time frame: 6 months). 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 NCT04111146, which also lists 4 linked publications.
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 1 Oct 2019.