Preventive and Reversional Effect of Vitamin D on Parenteral Nutrition Associated Liver Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patients who accept long-term parenteral nutrition tend to suffer from liver injury. The mechanism for this injury has two possible explanations. The first possible reason is intrinsic toxic effects of parenteral nutrition. The second is the basic pathological condition of intestinal failure which includes infection, bacterial translocation, etc. Cholestasis is the lethal presentation of this kind of liver disease. Farnesoid X receptor (FXR) is a member of ligand-activated nuclear receptor superfamily. FXR serves as a sensor for bile acids and promotes enterohepatic clearance of bile acids by controlling the expression of genes involved in their transport and metabolism. Considering the activation of vitamin D receptor (VDR) by vitamin D can induce FXR-related genes in the liver.The hypothesis of this study is that vitamin D plays a key role in the prevention and reversion of the liver via VDR and/or FXR signaling pathway. Using a mouse cholestasis model based on short bowel syndrome and parenteral nutrition, the researchers will investigate the dynamic change of plasma vitamin D level. Afterward, intravenous supplement of vitamin D was added to this model to demonstrate vitamin D can ameliorate cholestasis. An in vitro system was developed to investigate the importance of FXR signaling pathway in this effect.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04111146

Liver Transplant Disorder

COMPLETED

Vitamin D Levels in Liver Transplantation Recipients Prospective Observational Study

NCT03234218

Liver Transplant Disorder Vitamin D Deficiency

COMPLETED

Effect of Vitamin D on Skeletal Muscle Function and Qol in Patients With Chronic Intestinal Failure/Insufficiency

NCT06283615

Intestinal Failure

COMPLETED NA

Effect on Liver Histology of Vitamin D in Patients With Non-alcoholic Steatohepatitis

NCT01623024

Non.Alcoholic Fatty Liver Disease

UNKNOWN PHASE3

The 'Hidden' Biological Impact of Vitamin D Deficiency: a Biomarker Study; Part 2

NCT02451787

Vitamin D Deficiency

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vitamin D

Patients in this group were treated with oral vitamin D at a dose of 1200 IU per day for 2 months.

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitamin D

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with short bowel syndrome supported by total parenteral nutrition.
* Patients have intestine more than 50cm.
* Requirements of informed consent and assent of participant, parent or legal guardian as applicable consciousness and ability cooperate.

Exclusion Criteria

* Patients have obstruction of biliary tract, infection, autoimmune disease, cancer.
* Patients have intestine less than 50cm.
* A clinically significant laboratory abnormality or a history of significant cardiac, pulmonary, hepatic, or renal disease.
* Female with positive pregnancy.
* Allergy to ursodeoxycholic acid.

Eligible Sex

ALL

Accepts Healthy Volunteers

No