Comparison of Two Intravenous Lipid Emulsions in Home Parenteral Nutrition Patients

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.

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.