Inflammatory Response With Different Lipid Emulsions In Parenteral Nutrition In Children After Bone Marrow Transplantation
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|ClinicalTrials.gov Identifier: NCT02199821|
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : July 25, 2014
Background and Aims: Nutritional support is considered an integral part of the supportive care of bone marrow transplantation patients. Parenteral nutrition emulsions enriched with omega-3 fatty acids can modify the inflammatory response. The aim of this study is to compare plasma cytokines levels in children after bone marrow transplantation using a lipid formula enriched in n-3 FA and other classic soybean oil formula in parenteral nutrition.
Methods: A randomized double blinded controlled study including 14 children with BMT and requiring PN for at least 10 days was conducted using a lipid emulsion with fish oil, or soybean oil. Blood samples at baseline, at 10 days and at the end of the PN were taken to analyze plasma interleukins 1 beta, 2, 6, 8, 10 (IL-10) and tumor necrosis factor alpha (TNF-α).
|Condition or disease||Intervention/treatment||Phase|
|Bone Narrow Transplantation||Dietary Supplement: Formula with soybean oil, medium-chain triglycerides Dietary Supplement: Soybean oil formula commonly used in the hospital||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2014|
|Active Comparator: Soybean oil formula commonly used in the hospita||
Dietary Supplement: Soybean oil formula commonly used in the hospital
|Experimental: Formula with soybean oil, medium-chain triglyce||
Dietary Supplement: Formula with soybean oil, medium-chain triglycerides
- average cytokines plasma levels between groups of children with the two different lipid formulas. [ Time Frame: 21 days ]The primary outcome of the trial was average cytokines plasma levels between groups of children with the two different lipid formulas.
- Anthropometric measurements such as: weight height [ Time Frame: 21 days ]
- Incidence of adverse effects associated with formula consumption. [ Time Frame: 21 days ]