Inflammatory Response With Different Lipid Emulsions In Parenteral Nutrition In Children After Bone Marrow Transplantation

Not Applicable

Completed

• Conditions: Bone Narrow Transplantation
• Interventions: Dietary Supplement: Formula with soybean oil, medium-chain triglycerides; Dietary Supplement: Soybean oil formula commonly used in the hospital

• Registration Number: NCT02199821
• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2013-02
• Study Completion: 2014-02
• Study First Submitted: 2014-04-30
• Status Verified: 2014-05
• Study First Submitted QC: 2014-07-24
• Last Update Submitted: 2014-07-24
• Study First Posted: 2014-07-25
• Last Update Posted: 2014-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Term infants. Children with a stable medical condition. Children in need of parenteral nutrition for at least 10 days, except for the cardiac group would be at least 5 days.

Exclusion Criteria

Premature infants Children over 14 years Children with hypersensitivity to egg ingestion or soy protein Children with severe insufficiency of an organ, Children with inborn error of metabolism, and any condition that does not allow random use of lipid emulsion type.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Formula with soybean oil, medium-chain triglyce	Formula with soybean oil, medium-chain triglycerides	-
Soybean oil formula commonly used in the hospita	Soybean oil formula commonly used in the hospital	-

Primary Outcome Measures

Name	Time	Method
average cytokines plasma levels between groups of children with the two different lipid formulas.	21 days	The primary outcome of the trial was average cytokines plasma levels between groups of children with the two different lipid formulas.

Secondary Outcome Measures

Name	Time	Method
Anthropometric measurements such as: weight height	21 days
Incidence of adverse effects associated with formula consumption.	21 days