Effect of 25-OH-vitamin D3 on the Liver Transplant Recipients

NCT04111146 | Completed

• 1 other identifier: AsanMC-vitamin D
• Study Type: observational
• Target: 219
• Locations: 1 country
• Sites: 1

Brief 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. It is necessary to prospectively analyze the effect of vitamin D supplements on clinical outcomes in liver transplant recipients.

Conditions

Liver Transplant Disorder

Keywords

vitamin D; liver transplant; hospital stay

Outcome Measures

Primary Outcomes (1)

• Hospital stay after liver transplant

  compared with each group

  6 months

Secondary Outcomes (3)

• duration of normalization of CRP, WBC

  6 months

• Length of ICU stay

  6 months

• New infection rate

  6 months

Study Arms (3)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients received liver transplantation from June 2017 to November 2017

You may qualify if:

• The patients who admitted to intensive care unit (ICU) after liver transplantation were studied

You may not qualify if:

• Patients who didn't have preoperative vitamin D level

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Hakjae Lee

Seoul, South Korea

Location

Related Publications (4)

• 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.

  PMID: 24684435 RESULT

• Finkelmeier 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.

  PMID: 26121590 RESULT

• Grant 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.

  PMID: 28840965 RESULT

• Zhou 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.

  PMID: 31422183 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 29, 2019
• First Posted: October 1, 2019
• Study Start: June 1, 2017
• Primary Completion: November 30, 2017
• Study Completion: June 30, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)