Comparison of Intralipid With SMOF Lipid Following HSCT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-12

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to have a successful engraftment in after bone transplantation. Acute leukemia patient of both sexes aged 2 to 18 years, who are transplant candidates, participate in this study. Primary hypothesis is Patients receiving SMOF LIPID will have better grafts than patients receiving intralipid. Also, complications after surgery and malnutrition will be less in this group.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety, Tolerability, and Efficacy of Enteral Nutrition Versus Standard of Care Nutrition in Hematopoietic Stem Cell Transplant Patients: A Pilot Study

NCT06004063

Stem Cell

ACTIVE_NOT_RECRUITING NA

Nutritional Support With TGF-β2 Food for Special Medical Purposes (TGF-β2 FSMP) in Adult Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) for the Prevention of Malnutrition: a Prospective, Randomized, Multicenter Study

NCT07010068

Malnutrition (Calorie) Stem Cell Transplant Complications

NOT_YET_RECRUITING NA

Impact of Oral Nutritional Supplements on Patients Undergoing Haematopoietic Stem Cell Transplantation

NCT05460013

Haematological Malignancy

UNKNOWN NA

Nutritional Status of Patients After Hematopoietic Stem Cell Transplantation

NCT04146870

Nutrition Hematopoietic Stem Cell Transplantation

RECRUITING

The Optimization of Haploidentical Hematopoietic Stem Cell Transplantation

NCT05629260

Hematological Malignancy

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients will be randomly divided into two groups: the intervention group (TPN based on SMOFLipid) and the control group (TPN based on IntraLipid). At baseline (before HSCT) and after obtaining informed consent and assent, blood samples will be collected to test for biochemical markers, including total cholesterol, TG, LDL, HDL, FBS, Alb, Na, K, Ph, Ca, Mg, CRP, IL-6, BUN, Cr, and CBC. Furthermore, data on nutritional intake (total energy and protein) and appetite status will be gathered. The primary outcomes are neutrophil and platelet engraftment, defined as \&gt;500 for neutrophils and \&gt;20,000 for platelets, respectively. The possibility of oral intake, as well as the achievement of oral + ONS and total oral nutrition alongside TPN duration, will be recorded. On days +15 and +30, biochemical and anthropometric markers will be collected again. Furthermore, clinical outcomes such as acute GVHD, cholestasis, bleeding, infections, hospitalization, and mortality will be reported.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leukemia HSCT

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SMOF lipid

The SMOF lipid is given to the patient as a fat component of total parenteral nutrition.

Group Type EXPERIMENTAL

SMOF lipid

Intervention Type DIETARY_SUPPLEMENT

The SMOF lipid is given to the patient as a fat component of total parenteral nutrition.

Intralipid

intralipids

Group Type ACTIVE_COMPARATOR

INTRALIPIDS

Intervention Type DIETARY_SUPPLEMENT

The Intralipid will be given to the patient as fat component of total parenteral nutrition.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SMOF lipid

The SMOF lipid is given to the patient as a fat component of total parenteral nutrition.

Intervention Type DIETARY_SUPPLEMENT

INTRALIPIDS

The Intralipid will be given to the patient as fat component of total parenteral nutrition.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 \&gt; 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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No