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Vitamin D Levels in Liver Transplantation Recipients Prospective Observational Study (D-LIVER-X)

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ClinicalTrials.gov Identifier: NCT03234218
Recruitment Status : Completed
First Posted : July 31, 2017
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Brief Summary:

Interest in vitamin D has seen an unprecedented revival sparked by the finding that vitamin D has pleiotropic effects with an intriguing link to the critically ill patients. The recent VITdAL-ICU RCT found a significant difference in mortality in patients with severe deficiency when high doses of vitamin D supplementation were administered.

Vitamin D deficiency is extremely common in patients with chronic liver disease and/or cirrhosis. It seems to be a marker of severity of the disease, but also a possible contributing factor in determining poor outcomes.

Design of the study: Observational prospective study. Primary variable end point: Vitamin D at baseline, and POD (post-operative day) 1, 3, 7, 28.

Secondary variable end points: ICU length of stay; SAPS 2 and SOFA score at POD 1, 7; Days of mechanical ventilation; Hospital length of stay; Mortality at POD 28; Diagnosed invasive infections; Graft rejection in the first 28 days; Bilirubin and INR at POD 7 and 28.

SAFETY. The patient will not undergo to additional procedure during the study and will be asked for consent to treatment of personal data.

SAMPLE SIZE. Because of the lack of knowledge in this specific cohort no formal sample was calculated beforehand. The sample size will be defined by one-year clinical activity: about 60 consecutive patients.

STATISTICAL ANALYSIS. All statistical analysis and results will be assessed and reported as exploratory analysis. In order to describe the trend over time of the vitamin D levels, descriptive statistics such as mean, median, interquartile range and standard deviation will be evaluated. In addition, 95% confidence intervals for mean and standard deviation will be reported. Comparisons between two temporal observations will be assessed with paired t-test. Any univariate association between factors or covariates, will be explored. Statistical analyses will be done with SAS 9.4,


Condition or disease
Liver Transplant Disorder Vitamin D Deficiency

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 68 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vitamin D Levels in Liver Transplantation Recipients Prospective Observational Study
Actual Study Start Date : September 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D




Primary Outcome Measures :
  1. Describe and explore the level and the trend of vitamin D levels in liver transplantation recipients during the first 28 days after transplantation. [ Time Frame: Preoperative and on the post-operative day 28 ]
    Change of the Vitamin D level during the first 28 days after liver transplantation


Secondary Outcome Measures :
  1. Explore the association between vitamin D level and critical condition; [ Time Frame: Post-operative day 28 ]
    ICU length of stay

  2. Explore the association between pre-transplant vitamin D level and outcome [ Time Frame: Post-operative day 28 ]
    Mortality at Post-Operative Day 28

  3. Explore the association between vitamin D level and graft function [ Time Frame: Post-operative day 28 ]
    Graft rejection in the first 28 days

  4. Explore the association between vitamin d level and incidence of early post-operative infections [ Time Frame: Post.operative day 28 ]
    Diagnosed invasive infections



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study presented in this protocol is the first to focus on vitamin D status in patients undergoing liver transplantation. The primary objective is to study, explore, and describe the level and the trends of vitamin D values over time in liver transplantation recipients in the first days after transplantation, i.e., POD 1, POD 7, and POD 28.

Because of the lack of knowledge on the association between vitamin D levels and outcomes in this specific cohort no formal sample was calculated beforehand.

The sample size will be defined by one-year clinical activity: about 60 consecutive patients undergoing liver transplantation will be enrolled during this period.

Criteria

Inclusion Criteria:

  • All recipients of liver transplantation at Ismett, aged 18 or more

Exclusion Criteria:

  • Lack of informed consent for the treatment of personal data. otherwise all the patients will be included if the accept to sign the informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234218


Locations
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Italy
Ismett
Palermo, Italy, 90133
Sponsors and Collaborators
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Investigators
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Principal Investigator: Gennaro Martucci, MD The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

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Responsible Party: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
ClinicalTrials.gov Identifier: NCT03234218     History of Changes
Other Study ID Numbers: IRRB/12/16
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies:
vitamin D, liver transplantation

Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents