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

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ClinicalTrials.gov Identifier: NCT02199821
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : July 25, 2014
Sponsor:
Information provided by (Responsible Party):
Maimónides Biomedical Research Institute of Córdoba

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).


Condition or disease Intervention/treatment Phase
Bone Narrow Transplantation Dietary Supplement: Formula with soybean oil, medium-chain triglycerides Dietary Supplement: Soybean oil formula commonly used in the hospital Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : February 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Anthropometric measurements such as: weight height [ Time Frame: 21 days ]
  2. Incidence of adverse effects associated with formula consumption. [ Time Frame: 21 days ]


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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Responsible Party: Maimónides Biomedical Research Institute of Córdoba
ClinicalTrials.gov Identifier: NCT02199821     History of Changes
Other Study ID Numbers: PI-00000
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: July 25, 2014
Last Verified: May 2014