Safety and Tolerability of Intravenous Fish Oil Lipid Emulsion in Children Undergoing Hematopoietic Cell Transplantation
Public ClinicalTrials.gov record NCT02512718. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Children undergoing hematopoietic cell transplantation (HCT) for cancer or blood disorders frequently develop gastrointestinal, metabolic and infectious complications related to preparative high-dose chemotherapy and/or radiation-related toxicity. Parenteral nutrition (PN) with lipid emulsion is commonly required while gastrointestinal complications preclude adequate oral or enteral intake. PN and lipids may increase the risk of metabolic and infectious complications in HCT patients who are inherently immune compromised. Supplementation with omega-3 fatty acids has been linked to improvements in outcomes in several populations. Provision of fish oil lipid emulsion (FOLE), rich in omega-3 fatty acids, to children undergoing HCT is an innovative nutritional strategy that could mitigate the metabolic and inflammatory side effects of HCT and its treatment. With its potential to safely maintain essential fatty acid status, normalize blood lipids and alleviate the inflammatory response to illness, the use of FOLE may reduce the risk of infections, regimen-related toxicity, and other morbidities after HCT. A randomized, controlled pilot study is proposed to test the safety and tolerability of FOLE, compared to standard lipid emulsion, in 20 children during hospitalization for HCT. Results of this study will provide the preliminary data needed for a larger clinical trial examining the effect of FOLE on important clinical outcomes in this population. This novel approach to nutritional care of this high-risk group will advance clinical knowledge of the impact of FOLE, and will support further investigation into nutritional adjuncts to pediatric cancer treatment.
Study identification
- NCT ID
- NCT02512718
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 20 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2016
- Primary completion
- May 17, 2023
- Completion
- May 17, 2023
- Last update posted
- Sep 21, 2025
2016 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02512718, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 21, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02512718 live on ClinicalTrials.gov.