Bone Narrow TransplantationNCT02199821
Inflammatory Response With Different Lipid Emulsions In Parenteral Nutrition In Children After Bone Marrow Transplantation
A study testing Formula with soybean oil, medium-chain triglycerides and Soybean oil formula commonly used in the hospital in people with Bone Narrow Transplantation, run by Maimónides Biomedical Research Institute of Córdoba.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 14 years
- Conditions the study is for
- Bone Narrow Transplantation
- What is being tested?
- Formula with soybean oil, medium-chain triglycerides and Soybean oil formula commonly used in the hospital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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).
- Conditions
- Bone Narrow Transplantation
- Being tested
- Formula with soybean oil, medium-chain triglycerides, Soybean oil formula commonly used in the hospital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formula with soybean oil, medium-chain triglyceridesDietary supplement
Soybean oil formula commonly used in the hospitalDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Soybean oil formula commonly used in the hospita | Active comparator | Not described Receives: Dietary Supplement: Soybean oil formula commonly used in the hospital |
| Formula with soybean oil, medium-chain triglyce | Experimental | Not described Receives: Dietary Supplement: Formula with soybean oil, medium-chain triglycerides |
What is being measured
The primary outcome is the main question the study is designed to answer.
average cytokines plasma levels between groups of children with the two different lipid formulas.
The primary outcome of the trial was average cytokines plasma levels between groups of children with the two different lipid formulas.
Measured: 21 days
Secondary outcomes (2)
Anthropometric measurements such as: weight height
Measured: 21 days
Incidence of adverse effects associated with formula consumption.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startFeb 2011
- Primary completionFeb 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Narrow TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199821
- Sponsor's protocol ID
- PI-00000
- Status last verified
- May 2014
- First submitted
- 30 Apr 2014
- Last updated
- 25 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Response With Different Lipid Emulsions In Parenteral Nutrition In Children After Bone Marrow Transplantation
- ClinicalTrials.gov ID
- NCT02199821
- Acronym / sponsor ID
- PI-00000
- Conditions
- Bone Narrow Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soybean oil formula commonly used in the hospita | Active comparator | Dietary Supplement: Soybean oil formula commonly used in the hospital |
| Formula with soybean oil, medium-chain triglyce | Experimental | Dietary Supplement: Formula with soybean oil, medium-chain triglycerides |
Who may qualify
- Ages
- 1 day to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formula with soybean oil, medium-chain triglycerides | Dietary supplement | Formula with soybean oil, medium-chain triglyce |
| Soybean oil formula commonly used in the hospital | Dietary supplement | Soybean oil formula commonly used in the hospita |
Primary outcome
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.
2 secondary outcomes
Anthropometric measurements such as: weight height
Time frame: 21 days
Incidence of adverse effects associated with formula consumption.
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Formula with soybean oil, medium-chain triglycerides and Soybean oil formula commonly used in the hospital in people with Bone Narrow Transplantation, run by Maimónides Biomedical Research Institute of Córdoba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
average cytokines plasma levels between groups of children with the two different lipid formulas. (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2014.