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

NCT02452177 | Unknown DMC

• 1 other identifier: Jinling Hospital
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Disease

Keywords

parenteral nutrition associated liver disease; vitamin D; short bowel syndrome; farnesoid X receptor; cholestasis

Outcome Measures

Primary Outcomes (1)

• liver function

  Serum aspartate aminotransferase, alanine aminotransferase (ALT), gamma glutamyl transferase (GGT), triglyceride, very low density lipoprotein (VLDL), and bilirubin (total, direct, and indirect) were analyzed

  two months

Study Arms (2)

Vitamin D

EXPERIMENTAL

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

Drug: Vitamin D

Placebo

PLACEBO COMPARATOR

Interventions

Vitamin D DRUG

Vitamin D

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shengxian Fan: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, 210002, China

RECRUITING

MeSH Terms

Conditions

Liver Diseases; Short Bowel Syndrome; Cholestasis

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Digestive System Diseases; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bile Duct Diseases; Biliary Tract Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Shengxian Fan, M.D.

CONTACT

+86 15861808332; fanshengxian66@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: May 16, 2015
• First Posted: May 22, 2015
• Study Start: May 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: February 1, 2016
• Last Updated: May 22, 2015

Record last verified: 2015-05

Locations

CN (1)