Liver DiseaseNCT02452177
Preventive and Reversional Effect of Vitamin D on Parenteral Nutrition Associated Liver Disease
A study testing Vitamin D in people with Liver Disease, run by Shengxian Fan at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Disease
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital
Nanjing, Jiangsu, 210002
Yousheng Li, M.D., Ph.D., +86 25 80860137, liyousheng6666@126.com
About this study
Official title: Preventive and Reversional Effect of Vitamin D on Parenteral Nutrition Associated Liver Disease: Clinical Observation and Experimental Study
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
- Being tested
- Vitamin D
- Keywords
- parenteral nutrition associated liver disease, vitamin D, short bowel syndrome, farnesoid X receptor, cholestasis
- Medical subject headings
- Liver Diseases, Short Bowel Syndrome, Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Patients in this group were treated with oral vitamin D at a dose of 1200 IU per day for 2 months. Receives: Drug: Vitamin D |
| Placebo | Placebo comparator | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengxian Fan
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Sponsor-investigator, Shengxian Fan, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452177
- Sponsor's protocol ID
- Jinling Hospital
- Status last verified
- May 2015
- First submitted
- 16 May 2015
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive and Reversional Effect of Vitamin D on Parenteral Nutrition Associated Liver Disease: Clinical Observation and Experimental Study
- ClinicalTrials.gov ID
- NCT02452177
- Acronym / sponsor ID
- Jinling Hospital
- Conditions
- Liver Disease
- Keywords
- parenteral nutrition associated liver disease, vitamin D, short bowel syndrome, farnesoid X receptor, cholestasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shengxian FanUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- May 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 22 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Drug: Vitamin DPatients in this group were treated with oral vitamin D at a dose of 1200 IU per day for 2 months. |
| Placebo | Placebo comparator | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D | Drug | Vitamin D |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Liver Disease, run by Shengxian Fan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shengxian Fan, M.D. (+86 15861808332, fanshengxian66@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
liver function (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2015.