Total Parenteral Nutrition-induced CholestasisPhase 3NCT01565278
Fish Oil for Patients With Liver Disease Due to Parenteral Nutrition
A Phase 3 study testing Soybean oil (Standard treatment) and Soybean oil + Fish oil in people with Total Parenteral Nutrition-induced Cholestasis, run by Johane Allard at 4 sites in Canada.
Trial summary
Patients who are not able to eat normally for a longer time require parenteral nutrition, i.e. they receive liquids and nutrients directly into their veins. This can have many long-term side effects, including liver problems. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Parenteral Nutrition-induced Cholestasis
- What is being tested?
- Soybean oil (Standard treatment) and Soybean oil + Fish oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 4 sitesCanada
- Study dates
- Feb 2012to Aug 2015
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinically stable patients on home TPN with PNALD with persistently elevated bilirubin (>1.5 times > normal) for at least 3 months despite standard treatment with ursodeoxycholic acid (15-30 mg/kg or at least 500 mg/d orally), changes in TPN (reduction to 25 kcal/kg/TPN day with Intralipid 0.25 g/kg) , and antibiotics (Metronidazole 500 mg bid and Ciprofloxacin 500 mg bid)
- male or female,equal or over 18 years of age
- on stable TPN regimen equal or over 3 days/week
- on a stable drug regimen for equal or over 3 months prior to randomization, which will not changed for the study duration if these drugs are ursodeoxycholic acid given for PNALD or others affecting glucose and lipid metabolism
Who cannot join
- Not receiving lipid emulsion as part of TPN
- Allergy to fish, egg , soy, and peanuts
- Liver disease of other etiology (e.g. excessive alcohol intake >20g/d, viral hepatitis, auto-immune or drug-induced, hemochromatosis, alfa 1-antitrypsin deficiency, Wilson's disease)
- Complications of chronic liver disease, such as recurrent variceal bleeding, ascites, encephalopathy or any other reason contraindicating a liver biopsy
- Severe hemorrhagic disorders
- Sepsis - Inflammatory processes
Show all 9Show fewer
- Taking medications that precipitate steatohepatitis (e.g. corticosteroids, methotrexate, or amiodarone)
- Pregnancy, lactation
- Fluid restriction - Omegaven is more dilute than Intralipid.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Foothills Medical Center
Calgary, Alberta, T2N 4Z6
University of Alberta
Edmonton, Alberta, T5H 3V9
University Health Network
Toronto, Ontario, M5G 2N2
St Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: Effect of n-3 Polyunsaturated Fatty Acid Lipid Emulsion on Parenteral Nutrition Associated Liver Disease
Patients who are not able to eat normally for a longer time require parenteral nutrition, i.e. they receive liquids and nutrients directly into their veins. This can have many long-term side effects, including liver problems. This study will examine whether a specific lipid emulsion containing fish oil can improve liver disease in patients on parenteral nutrition. The investigators will compare changes in bilirubin and liver enzymes after 3 months in 10 patients receiving standard lipid emulsion to 10 patients receiving standard lipids + a fish-oil containing emulsion. The investigators will also assess liver histology, the kind of fat, oxidative stress and gene expression in the liver at the beginning and after 6 months of fish-oil. The investigators also want to compare the baseline values from all 20 patients to 20 healthy controls. This will help to explain how fish oil may improve liver disease in patients on parenteral nutrition.
Read the detailed description
Chronic exposure to total parenteral nutrition (TPN) can cause parenteral nutrition associated liver disease (PNALD), a progressive condition that may severely affect the liver and lead to end-stage liver disease. Fish oil has been shown to exert beneficial effects as it favorably alters metabolism and inflammation. It has been used parenterally (Omegaven) in young children with short bowel syndrome and PNALD with encouraging results. In adults it has mostly been used in peri-surgical settings as well as in critically ill patients, again proving its effectiveness.
The goal of this proposal is to show that Omegaven use in home-TPN patients with PNALD and elevated bilirubin despite conventional treatment, is beneficial in improving cholestasis and reducing intrahepatic inflammation. Primary objective is to compare the response to treatment between the Omegaven and the Intralipid group. Secondary objectives are to study the effect of Omegaven supplementation on single liver function tests, liver histology, liver fatty acid composition, liver oxidative stress and gene expression. In addition, the investigators want to compare the baseline values of all 20 patients to 20 healthy controls subjects.
After establishing that the patients' liver disease does not improve with conventional medical treatments for 3 months, as evidenced by repeated blood work at that time, they will all have a liver biopsy done as per diagnostic standards. They will then be randomized to either continue receiving Intralipid (0.25 g/kg/TPN day) or a mixture of Intralipid (0.25 g/kg/TPN day) and Omegaven (0.4 g/kg/TPN day) for a period of 3 months. After that, patients in the Omegaven arm will continue their treatment for 3 more months. Those in the Intralipid arm will be switched over to also receive Omegaven for the following 6 months.
Blood work will be repeated every 3 months after the initiation of the intervention. A repeat liver biopsy will be done in both groups after 6 months.
Main outcome is response to treatment (improvement in liver function tests) after 3 months (comparing Intralipid to Omegaven). In addition, change in liver function tests during the 6 months on Omegaven will be assessed. Lipid peroxidation and oxidative stress, fatty acid composition, and gene expression in the liver will be compared before and after 6 months on Omegaven.
In a second part of the study baseline values from all 20 patients will be compared to 20 healthy controls. Controls will be recruited from the healthy living liver donor transplant program at the University Health Network (UHN). Liver samples will be obtained at the time of hepatectomy for transplantation. The same measurements as for the patient livers will be performed in healthy liver tissue.
Significance: The investigators aim to reveal the beneficial effects of fish oil supplementation in the setting of PNALD. Should this pilot study show improvement in the liver disease with Omegaven, a larger, randomized trial should follow. Comparison with healthy controls will provide further insight into the pathogenesis of PNALD, which to date is not completely understood
- Being tested
- Soybean oil (Standard treatment), Soybean oil + Fish oil
- Keywords
- Parenteral nutrition, fish oil, liver disease, Omegaven, hepatic, liver biopsy, bilirubin
- Medical subject headings
- Hyperphagia, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soybean oil (Standard treatment)Drug
Also called Intralipid
- Standard treatment: Soybean oil based emulsion: 0.25 g/kg/TPN day
Soybean oil + Fish oilDrug
Also called Intralipid, Omegaven
Intralipid+Omegaven: 0.25 g/kg/TPN Intralipid day+0.4 g/kg/TPN Omegaven day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Soybean oil + Fish oil | Experimental | Intralipid (0.25 g/kg/TPN day) + Omegaven (0.4 g/kg/TPN day) for a period of 6 months. Receives: Drug: Soybean oil + Fish oil |
| Soybean oil (Standard treatment) | Active comparator | Standard treatment: Intralipid (0.25 g/kg/TPN day) for a period of 6 months Receives: Drug: Soybean oil (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment at 3 months
Response is defined as improvement of at least one PNALD parameter by 20% or more; PNALD parameters are: ALP, GGT, ALT, total bilirubin Yes/No
Measured: 3 months
Secondary outcomes (6)
Change in total and conjugated bilirubin over time
Measured: 0, 3, 6 months on Omegaven
Changes in liver function test (ALP, AST, GGT) over 6 months
Measured: 0, 3, 6 months on Omegaven
Changes in liver histology between baseline and 6 months on Omegaven
Measured: 0, 6 months on Omegaven
Changes in liver fatty acid composition between baseline and 6 months on Omegaven
Fatty acid composition by gas chromatography
Measured: 0, 6 months on Omegaven
Changes in liver oxidative stress between baseline and 6 months
Lipid peroxides in liver tissue (test-kit)
Measured: 0, 6 months
Changes in hepatic gene expression between baseline and 6 months on Omegaven
Hepatic gene expression (mRNA) by microarray
Measured: 0, 6 months on Omegaven
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: No more eligible patients could be identified.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Total Parenteral Nutrition-induced CholestasisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johane Allard
- Sponsor type
- University, hospital or other
- Collaborators
- ASPEN Rhoads Research Foundation, Fresenius Kabi, University of Alberta, Foothills Medical Centre, St. Boniface Hospital, Hamilton Health Sciences Corporation, St. Paul's Hospital, Canada
- Responsible party
- Sponsor-investigator, Johane Allard, University Health Network, Toronto
- Investigators
- Johane P Allard, MD,FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565278
- Sponsor's protocol ID
- 11-0298-B
- Other IDs
- 151342, 155516, 161875, 169378
- Status last verified
- May 2016
- First submitted
- 26 Mar 2012
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Raman M, Gramlich L, Whittaker S, Allard JP. Canadian home total parenteral nutrition registry: preliminary data on the patient population. Can J Gastroenterol. 2007 Oct;21(10):643-8. doi: 10.1155/2007/217897.
PubMed 17948134Fernandes G, Kaila B, Jeejeebhoy KN, Gramlich L, Armstrong D, Allard JP. Canadian home parenteral nutrition (HPN) registry: validation and patient outcomes. JPEN J Parenter Enteral Nutr. 2012 Jul;36(4):407-14. doi: 10.1177/0148607111434599. Epub 2012 Feb 10.
PubMed 22326909Jurewitsch B, Gardiner G, Naccarato M, Jeejeebhoy KN. Omega-3-enriched lipid emulsion for liver salvage in parenteral nutrition-induced cholestasis in the adult patient. JPEN J Parenter Enteral Nutr. 2011 May;35(3):386-90. doi: 10.1177/0148607110382023.
PubMed 21527601Kelly DA. Intestinal failure-associated liver disease: what do we know today? Gastroenterology. 2006 Feb;130(2 Suppl 1):S70-7. doi: 10.1053/j.gastro.2005.10.066.
PubMed 16473076Guglielmi FW, Boggio-Bertinet D, Federico A, Forte GB, Guglielmi A, Loguercio C, Mazzuoli S, Merli M, Palmo A, Panella C, Pironi L, Francavilla A. Total parenteral nutrition-related gastroenterological complications. Dig Liver Dis. 2006 Sep;38(9):623-42. doi: 10.1016/j.dld.2006.04.002. Epub 2006 Jun 12.
PubMed 16766237Messing B, Joly F. Guidelines for management of home parenteral support in adult chronic intestinal failure patients. Gastroenterology. 2006 Feb;130(2 Suppl 1):S43-51. doi: 10.1053/j.gastro.2005.09.064.
PubMed 16473071Diamond IR, Sterescu A, Pencharz PB, Kim JH, Wales PW. Changing the paradigm: omegaven for the treatment of liver failure in pediatric short bowel syndrome. J Pediatr Gastroenterol Nutr. 2009 Feb;48(2):209-15. doi: 10.1097/MPG.0b013e318182c8f6.
PubMed 19179884Calhoun AW, Sullivan JE. Omegaven for the treatment of parenteral nutrition associated liver disease: a case study. J Ky Med Assoc. 2009 Feb;107(2):55-7.
PubMed 19263944Chung PH, Wong KK, Wong RM, Tsoi NS, Chan KL, Tam PK. Clinical experience in managing pediatric patients with ultra-short bowel syndrome using omega-3 fatty acid. Eur J Pediatr Surg. 2010 Mar;20(2):139-42. doi: 10.1055/s-0029-1238283. Epub 2010 Feb 22.
PubMed 20178080Fallon EM, Le HD, Puder M. Prevention of parenteral nutrition-associated liver disease: role of omega-3 fish oil. Curr Opin Organ Transplant. 2010 Jun;15(3):334-40. doi: 10.1097/mot.0b013e3283394879.
PubMed 20503524
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of n-3 Polyunsaturated Fatty Acid Lipid Emulsion on Parenteral Nutrition Associated Liver Disease
- ClinicalTrials.gov ID
- NCT01565278
- Acronym / sponsor ID
- 11-0298-B
- Keywords
- Parenteral nutrition, fish oil, liver disease, Omegaven, hepatic, liver biopsy, bilirubin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No more eligible patients could be identified.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Johane AllardUniversity, hospital or other
- Collaborators
- ASPEN Rhoads Research Foundation, Fresenius Kabi, University of Alberta, Foothills Medical Centre, St. Boniface Hospital, Hamilton Health Sciences Corporation, St. Paul's Hospital, Canada
- Study start
- Feb 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 28 Mar 2012 (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 are not able to eat normally for a longer time require parenteral nutrition, i.e. they receive liquids and nutrients directly into their veins. This can have many long-term side effects, including liver problems. This study will examine whether a specific lipid emulsion containing fish oil can improve liver disease in patients on parenteral nutrition. The investigators will compare changes in bilirubin and liver enzymes after 3 months in 10 patients receiving standard lipid emulsion to 10 patients receiving standard lipids + a fish-oil containing emulsion. The investigators will also assess liver histology, the kind of fat, oxidative stress and gene expression in the liver at the beginning and after 6 months of fish-oil. The investigators also want to compare the baseline values from all 20 patients to 20 healthy controls. This will help to explain how fish oil may improve liver disease in patients on parenteral nutrition.
Detailed description
Chronic exposure to total parenteral nutrition (TPN) can cause parenteral nutrition associated liver disease (PNALD), a progressive condition that may severely affect the liver and lead to end-stage liver disease. Fish oil has been shown to exert beneficial effects as it favorably alters metabolism and inflammation. It has been used parenterally (Omegaven) in young children with short bowel syndrome and PNALD with encouraging results. In adults it has mostly been used in peri-surgical settings as well as in critically ill patients, again proving its effectiveness.
The goal of this proposal is to show that Omegaven use in home-TPN patients with PNALD and elevated bilirubin despite conventional treatment, is beneficial in improving cholestasis and reducing intrahepatic inflammation. Primary objective is to compare the response to treatment between the Omegaven and the Intralipid group. Secondary objectives are to study the effect of Omegaven supplementation on single liver function tests, liver histology, liver fatty acid composition, liver oxidative stress and gene expression. In addition, the investigators want to compare the baseline values of all 20 patients to 20 healthy controls subjects.
After establishing that the patients' liver disease does not improve with conventional medical treatments for 3 months, as evidenced by repeated blood work at that time, they will all have a liver biopsy done as per diagnostic standards. They will then be randomized to either continue receiving Intralipid (0.25 g/kg/TPN day) or a mixture of Intralipid (0.25 g/kg/TPN day) and Omegaven (0.4 g/kg/TPN day) for a period of 3 months. After that, patients in the Omegaven arm will continue their treatment for 3 more months. Those in the Intralipid arm will be switched over to also receive Omegaven for the following 6 months.
Blood work will be repeated every 3 months after the initiation of the intervention. A repeat liver biopsy will be done in both groups after 6 months.
Main outcome is response to treatment (improvement in liver function tests) after 3 months (comparing Intralipid to Omegaven). In addition, change in liver function tests during the 6 months on Omegaven will be assessed. Lipid peroxidation and oxidative stress, fatty acid composition, and gene expression in the liver will be compared before and after 6 months on Omegaven.
In a second part of the study baseline values from all 20 patients will be compared to 20 healthy controls. Controls will be recruited from the healthy living liver donor transplant program at the University Health Network (UHN). Liver samples will be obtained at the time of hepatectomy for transplantation. The same measurements as for the patient livers will be performed in healthy liver tissue.
Significance: The investigators aim to reveal the beneficial effects of fish oil supplementation in the setting of PNALD. Should this pilot study show improvement in the liver disease with Omegaven, a larger, randomized trial should follow. Comparison with healthy controls will provide further insight into the pathogenesis of PNALD, which to date is not completely understood
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soybean oil + Fish oil | Experimental | Drug: Soybean oil + Fish oilIntralipid (0.25 g/kg/TPN day) + Omegaven (0.4 g/kg/TPN day) for a period of 6 months. |
| Soybean oil (Standard treatment) | Active comparator | Drug: Soybean oil (Standard treatment)Standard treatment: Intralipid (0.25 g/kg/TPN day) for a period of 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinically stable patients on home TPN with PNALD with persistently elevated bilirubin (>1.5 times > normal) for at least 3 months despite standard treatment with ursodeoxycholic acid (15-30 mg/kg or at least 500 mg/d orally), changes in TPN (reduction to 25 kcal/kg/TPN day with Intralipid 0.25 g/kg) , and antibiotics (Metronidazole 500 mg bid and Ciprofloxacin 500 mg bid)
- male or female,equal or over 18 years of age
- on stable TPN regimen equal or over 3 days/week
- on a stable drug regimen for equal or over 3 months prior to randomization, which will not changed for the study duration if these drugs are ursodeoxycholic acid given for PNALD or others affecting glucose and lipid metabolism
Key exclusion criteria (9 listed)
- Not receiving lipid emulsion as part of TPN
- Allergy to fish, egg , soy, and peanuts
- Liver disease of other etiology (e.g. excessive alcohol intake >20g/d, viral hepatitis, auto-immune or drug-induced, hemochromatosis, alfa 1-antitrypsin deficiency, Wilson's disease)
- Complications of chronic liver disease, such as recurrent variceal bleeding, ascites, encephalopathy or any other reason contraindicating a liver biopsy
- Severe hemorrhagic disorders
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 |
|---|---|---|
| Soybean oil (Standard treatment)Also: Intralipid1. Standard treatment: Soybean oil based emulsion: 0.25 g/kg/TPN day | Drug | Soybean oil (Standard treatment) |
| Soybean oil + Fish oilAlso: Intralipid, OmegavenIntralipid+Omegaven: 0.25 g/kg/TPN Intralipid day+0.4 g/kg/TPN Omegaven day for 6 months | Drug | Soybean oil + Fish oil |
Primary outcome
Response to treatment at 3 months
Time frame: 3 months
Response is defined as improvement of at least one PNALD parameter by 20% or more; PNALD parameters are: ALP, GGT, ALT, total bilirubin Yes/No
6 secondary outcomes
Change in total and conjugated bilirubin over time
Time frame: 0, 3, 6 months on Omegaven
Changes in liver function test (ALP, AST, GGT) over 6 months
Time frame: 0, 3, 6 months on Omegaven
Changes in liver histology between baseline and 6 months on Omegaven
Time frame: 0, 6 months on Omegaven
Changes in liver fatty acid composition between baseline and 6 months on Omegaven
Time frame: 0, 6 months on Omegaven
Changes in liver oxidative stress between baseline and 6 months
Time frame: 0, 6 months
Changes in hepatic gene expression between baseline and 6 months on Omegaven
Time frame: 0, 6 months on Omegaven
Results and safety
The study was stopped early (reason given: No more eligible patients could be identified.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Background: PubMed 17948134Raman M, Gramlich L, Whittaker S, Allard JP. Canadian home total parenteral nutrition registry: preliminary data on the patient population. Can J Gastroenterol. 2007 Oct;21(10):643-8. doi: 10.1155/2007/217897.
- Background: PubMed 22326909Fernandes G, Kaila B, Jeejeebhoy KN, Gramlich L, Armstrong D, Allard JP. Canadian home parenteral nutrition (HPN) registry: validation and patient outcomes. JPEN J Parenter Enteral Nutr. 2012 Jul;36(4):407-14. doi: 10.1177/0148607111434599. Epub 2012 Feb 10.
- Background: PubMed 21527601Jurewitsch B, Gardiner G, Naccarato M, Jeejeebhoy KN. Omega-3-enriched lipid emulsion for liver salvage in parenteral nutrition-induced cholestasis in the adult patient. JPEN J Parenter Enteral Nutr. 2011 May;35(3):386-90. doi: 10.1177/0148607110382023.
- Background: PubMed 16473076Kelly DA. Intestinal failure-associated liver disease: what do we know today? Gastroenterology. 2006 Feb;130(2 Suppl 1):S70-7. doi: 10.1053/j.gastro.2005.10.066.
- Background: PubMed 16766237Guglielmi FW, Boggio-Bertinet D, Federico A, Forte GB, Guglielmi A, Loguercio C, Mazzuoli S, Merli M, Palmo A, Panella C, Pironi L, Francavilla A. Total parenteral nutrition-related gastroenterological complications. Dig Liver Dis. 2006 Sep;38(9):623-42. doi: 10.1016/j.dld.2006.04.002. Epub 2006 Jun 12.
- Background: PubMed 16473071Messing B, Joly F. Guidelines for management of home parenteral support in adult chronic intestinal failure patients. Gastroenterology. 2006 Feb;130(2 Suppl 1):S43-51. doi: 10.1053/j.gastro.2005.09.064.
- Background: PubMed 19179884Diamond IR, Sterescu A, Pencharz PB, Kim JH, Wales PW. Changing the paradigm: omegaven for the treatment of liver failure in pediatric short bowel syndrome. J Pediatr Gastroenterol Nutr. 2009 Feb;48(2):209-15. doi: 10.1097/MPG.0b013e318182c8f6.
- Background: PubMed 19263944Calhoun AW, Sullivan JE. Omegaven for the treatment of parenteral nutrition associated liver disease: a case study. J Ky Med Assoc. 2009 Feb;107(2):55-7.
- Background: PubMed 20178080Chung PH, Wong KK, Wong RM, Tsoi NS, Chan KL, Tam PK. Clinical experience in managing pediatric patients with ultra-short bowel syndrome using omega-3 fatty acid. Eur J Pediatr Surg. 2010 Mar;20(2):139-42. doi: 10.1055/s-0029-1238283. Epub 2010 Feb 22.
- Background: PubMed 20503524Fallon EM, Le HD, Puder M. Prevention of parenteral nutrition-associated liver disease: role of omega-3 fish oil. Curr Opin Organ Transplant. 2010 Jun;15(3):334-40. doi: 10.1097/mot.0b013e3283394879.
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.
Johane P Allard, MD,FRCPC principal investigator
University Health Network, Toronto
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Soybean oil (Standard treatment) and Soybean oil + Fish oil in people with Total Parenteral Nutrition-induced Cholestasis, run by Johane Allard at 4 sites in Canada.
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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No more eligible patients could be identified.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to treatment at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01565278, which also lists 10 linked publications.
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 12 May 2016.