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

NCT ID: NCT02199821

Last Updated: 2014-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bone Narrow Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Soybean oil formula commonly used in the hospita

Group Type ACTIVE_COMPARATOR

Soybean oil formula commonly used in the hospital

Intervention Type DIETARY_SUPPLEMENT

Formula with soybean oil, medium-chain triglyce

Group Type EXPERIMENTAL

Formula with soybean oil, medium-chain triglycerides

Intervention Type DIETARY_SUPPLEMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Formula with soybean oil, medium-chain triglycerides

Intervention Type DIETARY_SUPPLEMENT

Soybean oil formula commonly used in the hospital

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PI-00000

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.