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

M

Maimónides Biomedical Research Institute of Córdoba

Status

Completed

Conditions

Bone Narrow Transplantation

Treatments

Dietary Supplement: Soybean oil formula commonly used in the hospital
Dietary Supplement: Formula with soybean oil, medium-chain triglycerides

Study type

Interventional

Funder types

Other

Identifiers

NCT02199821
PI-00000

Details and patient eligibility

About

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).

Enrollment

14 patients

Sex

All

Ages

1 day to 14 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

14 participants in 2 patient groups

Soybean oil formula commonly used in the hospita
Active Comparator group
Treatment:
Dietary Supplement: Soybean oil formula commonly used in the hospital
Formula with soybean oil, medium-chain triglyce
Experimental group
Treatment:
Dietary Supplement: Formula with soybean oil, medium-chain triglycerides

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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