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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02199821

Enrollment

Registered

2014-07-25

Start date

2011-02-28

Completion date

2014-02-28

Last updated

2014-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Narrow Transplantation

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).

Interventions

DIETARY_SUPPLEMENTFormula with soybean oil, medium-chain triglycerides

DIETARY_SUPPLEMENTSoybean oil formula commonly used in the hospital

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Days to 14 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026