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

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).

Study Overview

• Status: Completed
• Conditions: Bone Narrow Transplantation
• Intervention / Treatment: Dietary supplement: Soybean oil formula commonly used in the hospital; Dietary supplement: Formula with soybean oil, medium-chain triglycerides

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
average cytokines plasma levels between groups of children with the two different lipid formulas.	The primary outcome of the trial was average cytokines plasma levels between groups of children with the two different lipid formulas.	21 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Anthropometric measurements such as: weight height	21 days
Incidence of adverse effects associated with formula consumption.	21 days

Collaborators and Investigators

• Sponsor: Maimónides Biomedical Research Institute of Córdoba

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: April 30, 2014
• First Submitted That Met QC Criteria: July 24, 2014
• First Posted (Estimate): July 25, 2014

Study Record Updates

• Last Update Posted (Estimate): July 25, 2014
• Last Update Submitted That Met QC Criteria: July 24, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: PI-00000