Completed
NCT Number: NCT02199821
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).
Completed
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Notify MeKey information
Conditions
Age range
1 day–14 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Soybean oil formula commonly used in the hospital
Dietary SupplementPrimary outcomes
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average cytokines plasma levels between groups of children with the two different lipid formulas.
Time frame: 21 days
The primary outcome of the trial was average cytokines plasma levels between groups of children with the two different lipid formulas.
Secondary outcomes
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Anthropometric measurements such as: weight height
Time frame: 21 days
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Incidence of adverse effects associated with formula consumption.
Time frame: 21 days
Sponsors and collaborators
Lead sponsor
Maimónides Biomedical Research Institute of Córdoba
Other
Registry information
Important dates
- Study start
- 2011
- Primary completion
- 2013
- Study completion
- 2014
- First posted
- Jul 25, 2014
- Registry last updated
- Jul 25, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.