Home Parenteral NutritionPhase 4NCT02796833
Comparison of Two Intravenous Lipid Emulsions in Home Parenteral Nutrition Patients
A Phase 4 study testing SMOFlipid20% in people with Home Parenteral Nutrition, run by Johane Allard at 1 site in Canada.
Trial summary
Total Parenteral Nutrition (TPN) is a way of feeding a person intravenously, and is required when the gastrointestinal tract is not able to function properly. TPN contains carbohydrates, protein, and fat and lipids. It also contains minerals and vitamins. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Home Parenteral Nutrition
- What is being tested?
- SMOFlipid20%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to Dec 2019
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent form (ICF) to participate before any study related procedures are performed
- Adult over the age of 18
- Both males and females
- Clinically stable for at least 4 weeks with no acute medical co-morbidities
- Patients on a stable Intralipid HPN regimen for 6 months and expected to require long-term PN for at least 13 more months
Who cannot join
- Subjects not already on Intralipid PN Inability to give informed consent Alcohol or drug abuse Pregnant and lactating women
- Clinical instability such as the following:
- Acute pulmonary edema
- Decompensated heart failure
- Decompensated chronic liver disease
- Severe post-traumatic conditions
Show all 14Show fewer
- Uncontrolled diabetes mellitus
- Acute myocardial infarction
- Acute stroke
- Acute thromboembolism
- Metabolic acidosis
- Sepsis
- Hypotonic dehydration
- Coagulopathy with prolonged aPTT or INR Elevated triglyceride level: more than 4.5 mmol/L Active malignancy with life expectancy less than one year Subjects who are hypersensitive or allergic to the product ingredients of SMOF or Intralipid, including soybean oil, peanuts, fish oil, and egg as well as allergy to peanuts.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto General Hospital, University Health Network
Toronto, Ontario
About this study
Official title: A Randomized Controlled Trial Comparing Two Commercially Available Lipid Emulsions in Patients Receiving Home Parenteral Nutrition - SMOF Versus Intralipid
Total Parenteral Nutrition (TPN) is a way of feeding a person intravenously, and is required when the gastrointestinal tract is not able to function properly. TPN contains carbohydrates, protein, and fat and lipids. It also contains minerals and vitamins. The lipid that is currently used at the University Health Network home TPN program is Intralipid20%, which is based on Soybean oil, contains polyunsaturated fats and is a good source of energy and essential fatty acids, including omega 3 and 6 fatty acids, which needed by the body. However, long term use on Intralipid20% has been shown to have negative effects on antioxidant status, inflammation, liver, and the immune system.
SMOFlipid20% is a lipid emulsion that has been designed to maximize the ratio of omega 3 to omega 6 fatty acids, in an effort to avoid potentially harmful effects associated with Intralipid20%. In previous studies, it has been shown that SMOFlipid20% is safe and has positive benefits on the liver enzymes. There are no studies so far which follow patient who is on SMOFlipid20% long term. The investigators hope to show that with long term use of SMOFlipid20% is better for liver function compared to Intralipid20%.
Read the detailed description
A prospective double-blind, crossover, randomized clinical trial of 13 months duration per participant to compare between 2 commercially available lipid emulsion, Intralipid vs SMOF, in patient receiving home parenteral nutrition (HPN). All subjects are stable HPN patients who receive Intralipid as lipid emulsion in their solutions. The subjects will be randomized to two groups. One group will receive Intralipid for 6 months, followed by 28 days of wash-out period, and then will receive SMOF for 6 months. Another groups will receive SMOF in first 6 months, followed by 28 days of wash-out period, then will receive Intralipid for 6 months. During wash-out period for both groups, the patients will receive Intralipid as standard lipid emulsion. Each patient will have 4 clinic visits at Toronto General Hospital for clinical interview, nutritional measurements, routine blood tests, and special blood tests at baseline then at 6, 7, 13 months. Also, the patients will be asked to have routine blood tests after month 3 and month 9. The patients will fill the food record which will be collected later after completion of each period, month 6 and 13 of the study. The investigators will be calling patients during both periods to check compliance and update on their condition including the adverse events.
- Conditions
- Home Parenteral Nutrition
- Being tested
- SMOFlipid20%
- Keywords
- Home parenteral nutrition, Liver injury, Intravenous Lipid Emulsions, Catheter-related infections, Safety
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMOFlipid20%Drug
| Study group | Role | What they receive |
|---|---|---|
| SMOF/Intralipid | Other | Patients that are randomized to receive for the first 6 months SMOF as a lipid emulsion in their PN, and for the next 6 month (after 28 days of active washout on Intralipid) Intralipid, which is the standard lipid emulsion used in the hospital. SMOF is approved by Health Canada.
The parenteral nutrition bags are compounded individually for each patient based on their specific needs. Receives: Drug: SMOFlipid20% |
| Intralipid/SMOF | Other | Patients that are randomized to receive Intralipid, which is the standard lipid emulsion used in the hospital for the first 6 months, and for the next 6 month (after 28 days of active washout on Intralipid) SMOF as a lipid emulsion in their PN. SMOF is approved by Health Canada.The parenteral nutrition bags are compounded individually for each patient based on their specific needs. Receives: Drug: SMOFlipid20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in alanine transaminase (ALT)
Measured: baseline 1, 6 months, baseline 2 (7 mo), 13 months
Secondary outcomes (5)
changes in liver function tests (total and conjugated bilirubin, ALP, AST, GGT)
Measured: baseline 1, 6 months, baseline 2 (7 mo), 13 months
rate of infections (central line and other) per 1000 catheter days
Measured: baseline 1, 6 months, baseline 2 (7 mo), 13 months
antibiotic days for acute infections
Measured: baseline 1, 6 months, baseline 2 (7 mo), 13 months
number of hospitalizations for the past 6 months
Measured: baseline 1, 6 months, 13 months
number of catheter changes for the past 6 months
Measured: baseline 1, 6 months, 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Home Parenteral NutritionStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johane Allard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Johane Allard, University Health Network, Toronto
- Investigators
- Johane Allard, MD, FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796833
- Sponsor's protocol ID
- 14-8537-A
- Status last verified
- Mar 2020
- First submitted
- 7 Jun 2016
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Clermont-Dejean NM, Schwenger KJP, Arca C, Somlaw N, Alhanaee A, Hortencio TDR, Jin J, Jung H, Lou W, Ma D, Allard JP. Comparing mixed oil to soybean oil lipid emulsion in patients on home parenteral nutrition: a pilot prospective double-blind, crossover, randomized trial. Pilot Feasibility Stud. 2023 Apr 20;9(1):64. doi: 10.1186/s40814-023-01295-1.
PubMed 37081524
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Two Commercially Available Lipid Emulsions in Patients Receiving Home Parenteral Nutrition - SMOF Versus Intralipid
- ClinicalTrials.gov ID
- NCT02796833
- Acronym / sponsor ID
- 14-8537-A
- Conditions
- Home Parenteral Nutrition
- Keywords
- Home parenteral nutrition, Liver injury, Intravenous Lipid Emulsions, Catheter-related infections, Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Johane AllardUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 13 Jun 2016 (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.
Total Parenteral Nutrition (TPN) is a way of feeding a person intravenously, and is required when the gastrointestinal tract is not able to function properly. TPN contains carbohydrates, protein, and fat and lipids. It also contains minerals and vitamins. The lipid that is currently used at the University Health Network home TPN program is Intralipid20%, which is based on Soybean oil, contains polyunsaturated fats and is a good source of energy and essential fatty acids, including omega 3 and 6 fatty acids, which needed by the body. However, long term use on Intralipid20% has been shown to have negative effects on antioxidant status, inflammation, liver, and the immune system.
SMOFlipid20% is a lipid emulsion that has been designed to maximize the ratio of omega 3 to omega 6 fatty acids, in an effort to avoid potentially harmful effects associated with Intralipid20%. In previous studies, it has been shown that SMOFlipid20% is safe and has positive benefits on the liver enzymes. There are no studies so far which follow patient who is on SMOFlipid20% long term. The investigators hope to show that with long term use of SMOFlipid20% is better for liver function compared to Intralipid20%.
Detailed description
A prospective double-blind, crossover, randomized clinical trial of 13 months duration per participant to compare between 2 commercially available lipid emulsion, Intralipid vs SMOF, in patient receiving home parenteral nutrition (HPN). All subjects are stable HPN patients who receive Intralipid as lipid emulsion in their solutions. The subjects will be randomized to two groups. One group will receive Intralipid for 6 months, followed by 28 days of wash-out period, and then will receive SMOF for 6 months. Another groups will receive SMOF in first 6 months, followed by 28 days of wash-out period, then will receive Intralipid for 6 months. During wash-out period for both groups, the patients will receive Intralipid as standard lipid emulsion. Each patient will have 4 clinic visits at Toronto General Hospital for clinical interview, nutritional measurements, routine blood tests, and special blood tests at baseline then at 6, 7, 13 months. Also, the patients will be asked to have routine blood tests after month 3 and month 9. The patients will fill the food record which will be collected later after completion of each period, month 6 and 13 of the study. The investigators will be calling patients during both periods to check compliance and update on their condition including the adverse events.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMOF/Intralipid | Other | Drug: SMOFlipid20%Patients that are randomized to receive for the first 6 months SMOF as a lipid emulsion in their PN, and for the next 6 month (after 28 days of active washout on Intralipid) Intralipid, which is the standard lipid emulsion used in the hospital. SMOF is approved by Health Canada. The parenteral nutrition bags are compounded individually for each patient based on their specific needs. |
| Intralipid/SMOF | Other | Drug: SMOFlipid20%Patients that are randomized to receive Intralipid, which is the standard lipid emulsion used in the hospital for the first 6 months, and for the next 6 month (after 28 days of active washout on Intralipid) SMOF as a lipid emulsion in their PN. SMOF is approved by Health Canada.The parenteral nutrition bags are compounded individually for each patient based on their specific needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed and dated informed consent form (ICF) to participate before any study related procedures are performed
- Adult over the age of 18
- Both males and females
- Clinically stable for at least 4 weeks with no acute medical co-morbidities
- Patients on a stable Intralipid HPN regimen for 6 months and expected to require long-term PN for at least 13 more months
Key exclusion criteria (14 listed)
- Subjects not already on Intralipid PN Inability to give informed consent Alcohol or drug abuse Pregnant and lactating women
- Acute pulmonary edema
- Decompensated heart failure
- Decompensated chronic liver disease
- Severe post-traumatic conditions
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 |
|---|---|---|
| SMOFlipid20% | Drug | Intralipid/SMOF, SMOF/Intralipid |
Primary outcome
change in alanine transaminase (ALT)
Time frame: baseline 1, 6 months, baseline 2 (7 mo), 13 months
5 secondary outcomes
changes in liver function tests (total and conjugated bilirubin, ALP, AST, GGT)
Time frame: baseline 1, 6 months, baseline 2 (7 mo), 13 months
rate of infections (central line and other) per 1000 catheter days
Time frame: baseline 1, 6 months, baseline 2 (7 mo), 13 months
antibiotic days for acute infections
Time frame: baseline 1, 6 months, baseline 2 (7 mo), 13 months
number of hospitalizations for the past 6 months
Time frame: baseline 1, 6 months, 13 months
number of catheter changes for the past 6 months
Time frame: baseline 1, 6 months, 13 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Derived from this study: PubMed 37081524Clermont-Dejean NM, Schwenger KJP, Arca C, Somlaw N, Alhanaee A, Hortencio TDR, Jin J, Jung H, Lou W, Ma D, Allard JP. Comparing mixed oil to soybean oil lipid emulsion in patients on home parenteral nutrition: a pilot prospective double-blind, crossover, randomized trial. Pilot Feasibility Stud. 2023 Apr 20;9(1):64. doi: 10.1186/s40814-023-01295-1.
- Individual participant dataSharing planned: No
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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.
Johane Allard, MD, FRCPC principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SMOFlipid20% in people with Home Parenteral Nutrition, run by Johane Allard at 1 site 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 5 inclusion and 14 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: finished, as of the sponsor's last update on 24 Mar 2020. 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in alanine transaminase (ALT) (time frame: baseline 1, 6 months, baseline 2 (7 mo), 13 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 NCT02796833, which also lists 1 linked publication.
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 24 Mar 2020.