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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Olive oil-based intravenous lipid emulsion in pediatric patients undergoing bone marrow transplantation: a short-term
Corina Hartman1, Elisheva Ben-Artzi, Drora Berkowitz
1Institute of Gastroenterology, Nutrition, and Liver Diseases, Schneider Children's Medical Center of Israel, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. corinahartman@gmail.com
Insights
Olive oil-based (OO) lipid emulsions are safe for pediatric bone marrow transplant (BMT) patients needing parenteral nutrition (PN). This study found OO emulsions well-tolerated, maintaining essential fatty acids and improving lipid profiles during BMT supportive care.
Area of Science:
- Pediatric Hematology/Oncology
- Clinical Nutrition
- Lipid Metabolism
Background:
- Parenteral nutrition (PN) is crucial for pediatric bone marrow transplantation (BMT) patients.
- Assessing lipid emulsion safety and metabolic impact in this vulnerable population is essential.
Purpose of the Study:
- To compare the short-term safety and metabolic effects of an olive oil-based (OO) lipid emulsion versus a medium-chain/long-chain (MCT/LCT) triglyceride (M/L) emulsion in pediatric BMT.
- Evaluate clinical and laboratory parameters, plasma fatty acids, vitamin E, and peroxidation status.
Main Methods:
- Prospective randomized study of 28 pediatric BMT patients (age 1-18) requiring PN for ≥14 days.
- Patients received either OO or M/L lipid emulsions within their PN regimen.
- Data collected at baseline and after 14 days included clinical parameters, lab tests, fatty acid profiles, vitamin E, and peroxidation markers.
Main Results:
- No significant differences in hematological parameters, liver enzymes, vitamin levels, peroxidation status, or engraftment between groups.
- The OO group showed increased oleic, linoleic, and arachidonic acids, with similar omega-3 levels compared to the M/L group.
- Significant decrease in cholesterol levels observed in the OO group after 14 days of PN.
Conclusions:
- Olive oil-based (OO) lipid emulsion is safe and well-tolerated in pediatric BMT patients receiving PN.
- OO emulsions effectively maintain essential fatty acids and peroxidation status.
- Short-term use of OO intravenous lipid emulsions supports a favorable plasma lipid profile in pediatric BMT patients.
Background & Aims:
Parenteral nutrition (PN) is an important component of the supportive care of children undergoing bone marrow transplantation (BMT). The study aimed to assess short-term safety and metabolic effects of an olive oil-based (OO) lipid emulsion compared with a MCT/LCT (M/L) emulsion in the clinical setting of pediatric BMT.
Methods:
Twenty-eight pediatric BMT patients (age 1-18 years) expected to need PN support for at least 2 weeks, were prospectively enrolled and randomly assigned to receive either OO or M/L lipid emulsions within PN. Clinical and routine laboratory parameters, plasma fatty acids profile, vitamin E and peroxidation status were recorded at baseline and after 14 days of PN.
Results:
No significant differences were found for hematological parameters, liver enzymes, vitamins, plasma peroxidation status, percentage and time to engraftment. Taking into consideration the baseline fatty acids levels, the OO group showed higher oleic acid (p=0.012), linoleic (p=0.012) and arachidonic acid (p=0.002) enrichment but similar eicosapentanoic and docosahexanoic acids levels compared to the M/L group at day 14. Cholesterol levels decreased significantly in the OO group after 14 days on PN (p=0.017).
Conclusions:
OO lipid emulsion was well tolerated, maintained essential fatty acids and peroxidation status, and generated a favorable plasma lipid profile. In this study short-term use of OO intravenous lipid emulsions was safe in children who needed PN support during BMT.
