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

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ClinicalTrials.gov Identifier: NCT02452177
Recruitment Status : Unknown
Verified May 2015 by Shengxian Fan, Jinling Hospital, China.
Recruitment status was:  Recruiting
First Posted : May 22, 2015
Last Update Posted : May 22, 2015
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Shengxian Fan, Jinling Hospital, China

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.

Condition or disease Intervention/treatment Phase
Liver Disease Drug: Vitamin D Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Preventive and Reversional Effect of Vitamin D on Parenteral Nutrition Associated Liver Disease: Clinical Observation and Experimental Study
Study Start Date : May 2015
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Vitamin D
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 Comparator: Placebo



Primary Outcome Measures :
  1. liver function [ Time Frame: two months ]
    Serum aspartate aminotransferase, alanine aminotransferase (ALT), gamma glutamyl transferase (GGT), triglyceride, very low density lipoprotein (VLDL), and bilirubin (total, direct, and indirect) were analyzed



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02452177


Contacts
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Contact: Shengxian Fan, M.D. +86 15861808332 fanshengxian66@126.com

Locations
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China, Jiangsu
Jinling Hospital Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Yousheng Li, M.D., Ph.D.    +86 25 80860137    liyousheng6666@126.com   
Sponsors and Collaborators
Shengxian Fan
National Natural Science Foundation of China

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Responsible Party: Shengxian Fan, M.D., Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT02452177     History of Changes
Other Study ID Numbers: Jinling Hospital
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015

Keywords provided by Shengxian Fan, Jinling Hospital, China:
parenteral nutrition associated liver disease
vitamin D
short bowel syndrome
farnesoid X receptor
cholestasis

Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents