Home Parenteral Nutrition Clinical Trial in Toronto Ontario
NCT02796833
| Phase 4
| Interventional
This study is looking to recruit 50 Participants
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%.
Details for the study
Brief Title
Comparison of Two Intravenous Lipid Emulsions in Home Parenteral Nutrition Patients
Official Title
A Randomized Controlled Trial Comparing Two Commercially Available Lipid Emulsions in Patients Receiving Home Parenteral Nutrition - SMOF Versus Intralipid
Brief Summary
Total Parenteral Nutrition (TPN) is a way of feeding a person intravenously, and is required<br /> when the gastrointestinal tract is not able to function properly. TPN contains carbohydrates,<br /> protein, and fat and lipids. It also contains minerals and vitamins. The lipid that is<br /> currently used at the University Health Network home TPN program is Intralipid20%, which is<br /> based on Soybean oil, contains polyunsaturated fats and is a good source of energy and<br /> essential fatty acids, including omega 3 and 6 fatty acids, which needed by the body.<br /> However, long term use on Intralipid20% has been shown to have negative effects on<br /> antioxidant status, inflammation, liver, and the immune system.<br /><br /> SMOFlipid20% is a lipid emulsion that has been designed to maximize the ratio of omega 3 to<br /> omega 6 fatty acids, in an effort to avoid potentially harmful effects associated with<br /> Intralipid20%. In previous studies, it has been shown that SMOFlipid20% is safe and has<br /> positive benefits on the liver enzymes. There are no studies so far which follow patient who<br /> is on SMOFlipid20% long term. The investigators hope to show that with long term use of<br /> 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 Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
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
- 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.