Comparing two types of lipid solutions for children after bone marrow transplants
Comparison of the Effect of Intralipid Parenteral Nutritional With SMOF Lipid Parenteral Nutritional on Biochemical Markers, Hematologic Markers, and Clinical Outcomes Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
This study is testing whether a new type of fat solution called SMOF lipid helps children with acute leukemia who are getting a bone marrow transplant recover better than the standard Intralipid solution.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | Shahid Beheshti University Academic / other |
| Locations | 1 site (Tehran) |
| Trial ID | NCT06625372 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of SMOF lipid compared to Intralipid in promoting successful engraftment in children aged 2 to 18 years undergoing hematopoietic stem cell transplantation (HSCT) for acute leukemia. Participants will be randomly assigned to receive either SMOF lipid or Intralipid as part of their total parenteral nutrition (TPN). Blood samples will be collected to assess various biochemical markers and nutritional intake before and after the intervention. The primary outcomes include the rates of neutrophil and platelet engraftment, as well as the incidence of complications such as acute graft-versus-host disease (GVHD) and infections.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2 to 18 years with a definitive diagnosis of acute leukemia who are eligible for hematopoietic stem cell transplantation.
Not a fit: Patients with severe organ failure, liver dysfunction, or those who are allergic to egg or soy protein may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved engraftment rates and reduced complications for pediatric leukemia patients undergoing HSCT.
How similar studies have performed: While there have been studies on lipid emulsions in parenteral nutrition, this specific comparison of SMOF lipid and Intralipid in the context of HSCT is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Willingness to cooperate and complete the informed consent form by the legal guardian of the child; * Age ≤ 18 years; * Definitive diagnosis of acute leukemia and candidate for hematopoietic stem ● cell transplantation; * Eligible for parenteral nutrition support; * No contraindications for parenteral nutrition; * No history of allergy to egg or soy protein; * Absence of severe organ failure or impaired liver function test (bilirubin \> 2.5 mg/dL). Exclusion Criteria: * Death of the child earlier than 5 days from the start of the intervention; * Unwillingness to continue cooperation during study; * Occurrence of side effects during the study; * In case of sepsis, hypotension, shock, thrombosis, myocardial infarction, liver dysfunction, the patient will be excluded from the study.
Where this trial is running
Tehran
- Children's Medical Center, Pediatrics Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran — Tehran, Iran (Recruiting)
Study contacts
- Principal investigator: Zahra Vahdat Shariatpanahi, Professor — School of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences
- Study coordinator: Zahra Vahdat Shariatpanahi, Professor
- Email: nutritiondata@yahoo.com
- Phone: 0098-021-22357484
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.