Safety and efficacy of a lipid emulsion containing a mixture of soybean oil, medium-chain triglycerides, olive oil, and fish oil: a randomised, double-blind clinical trial in premature infants requiring parenteral nutrition
Tomsits E, Pataki M, Tölgyesi A, Fekete G, Rischak K, Szollár L
Journal of pediatric gastroenterology and nutrition · 127 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
- Intake measured by
- Food provided by researchers
Who paid for it
- Funding
- Funding not disclosed
Publication
- Published
- 2010-06-05 · J Pediatr Gastroenterol Nutr · vol. 51 · issue 4 · pp. 514–521
- Publisher
- Lippincott Williams & Wilkins
- Cited
- 221 citations · more than 98% of similar papers · 8.6× the field average
- Impact
- Top 10% most cited in its field
- References
- 46 works
- Access
- Paywalled
- Research areas
- Infant Nutrition and Health · Clinical Nutrition and Gastroenterology · Neonatal skin health care
- Keywords
- Medicine, Fish oil, Soybean oil, Olive oil, Emulsion, Lipid emulsion, Double blind, Parenteral nutrition, Clinical trial, Fat emulsion, Food science, Medium-chain triglyceride, Fish <Actinopterygii>, Triglyceride, Surgery, Biochemistry, Internal medicine, Cholesterol, Fishery
- MeSH
- humans, body weight, weight gain, thinness, soybean oil, fat emulsions, intravenous, triglycerides, fish oils, plant oils, treatment outcome, parenteral nutrition, double-blind method, infant, newborn, infant, premature, infant nutritional physiological phenomena, olive oil
6 authors
From HU
- Erika Tomsits · correspondingSemmelweis University
- Margit Pataki · correspondingSemmelweis University
- Andrea Tölgyesi · correspondingSemmelweis University
- György Fekete · correspondingSemmelweis University
- Katalin RischákSemmelweis University
- Lajos G. SzollárSemmelweis University
Abstract
Objectives
Safety, tolerability, and efficacy of a novel lipid emulsion containing a mixture of soybean oil, medium-chain triglycerides, olive oil, and fish oil (SMOFlipid 20%) with reduced n-6 fatty acids (FA), increased monounsaturated and n-3 FA, and enriched in vitamin E were evaluated in premature infants compared with a soybean oil-based emulsion.
Patients and methods
Sixty (30/30) premature neonates (age 3-7 days, gestational age ≤ 34 weeks, birth weights 1000-2500 g) received parenteral nutrition (PN) with either SMOFlipid 20% (study group) or a conventional lipid emulsion (Intralipid 20%, control group) for a minimum of 7 up to 14 days. Lipid supply started at 0.5 g · kg body weight(-1) · day(-1) on day 1 and increased stepwise (by 0.5 g) up to 2 g · kg body weight(-1) · day(-1) on days 4 to 14. Safety and efficacy parameters were assessed on days 0, 8, and 15 if PN was continued.
Results
Adverse events, serum triglycerides, vital signs, local tolerance, and clinical laboratory did not show noticeable group differences, confirming the safety of study treatment. At study end, γ-glutamyl transferase was lower in the study versus the control group (107.8 ± 81.7 vs 188.8 ± 176.7 IU/L, P < 0.05). The relative increase in body weight (day 8 vs baseline) was 5.0% ± 6.5% versus 5.1% ± 6.6% (study vs control, not significant). In the study group, an increase in n-3 FA in red blood cell phospholipids and n-3:n-6 FA ratio was observed. Plasma α-tocopherol (study vs control) was increased versus baseline on day 8 (26.35 ± 10.03 vs 3.67 ± 8.06 μmol/L, P < 0.05) and at study termination (26.97 ± 18.32 vs 8.73 ± 11.41 μmol/L, P < 0.05).
Conclusions
Parenteral infusion of SMOFlipid was safe and well tolerated and showed a potential beneficial influence on cholestasis, n-3 FA, and vitamin E status in premature infants requiring PN.
Abstract via Europe PMC. Copyright remains with the authors or publisher.
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