Comparison of Intralipid With SMOF Lipid Following HSCT

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Leukemia; HSCT
• Intervention / Treatment: Dietary supplement: SMOF lipid; Dietary supplement: INTRALIPIDS

Detailed Description

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 >500 for neutrophils and >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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zahra Vahdat Shariatpanahi, Professor; Phone Number: 0098-021-22357484; Email: nutritiondata@yahoo.com
• Study Contact Backup: Name: Zahra Vahdat Shariatpanahi, Professor; Phone Number: 09122138186; Email: nutritiondata@yahoo.com

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Recruiting
    • Children's Medical Center, Pediatrics Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran
    • Contact: Amirali hamidieh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SMOF lipid; The SMOF lipid is given to the patient as a fat component of total parenteral nutrition.	Dietary supplement: SMOF lipid; The SMOF lipid is given to the patient as a fat component of total parenteral nutrition.
Active Comparator: Intralipid; intralipids	Dietary supplement: INTRALIPIDS; The Intralipid will be given to the patient as fat component of total parenteral nutrition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engraftment	blood counts of Neutrophils and platelets	Within 35 days after transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
100-day survival rate	Determination and comparison of 100-day survival rate after transplantation in both groups	Within 100 days after transplantation
Incidence of infection	Determining and comparing the incidence of infection	Within 30 days after transplant
Incidence of bleeding	Determining and comparing the incidence of bleeding	Within 30 days after transplantation
Hospitalization	Determining and comparing the duration of hospitalization in both groups	up to 7 weeks after transplantation
Mortality	incidence of mortality in hospital	up to 7 weeks after transplantation
MAC (mid arm circumference)	Determination and comparison of MAC in both groups	On days 15 and 30 after transplantation
Albumin	Determination and comparison of serum albumin	On days 15 and 30 after transplantation
Acute gastrointestinal complications	Determining and comparing the incidence of acute gastrointestinal complications (including acute GVHD, cholestasis) in both groups.	Up to 100 days after transplantation
Duration of parenteral nutrition	Determining and comparing the duration of using parenteral nutrition	during hospitalization, up to 7 weeks after transplantation
Weight	Determination and comparison of weight in both groups	On days 15 and 30 after transplantation
Blood sugar	Determination and comparison of blood sugar,	On days 15 and 30 after transplantation
Serum electrolytes	Determination and comparison of serum electrolytes	On days 15 and 30 after transplantation
Serum lipids	Determination and comparison of serum lipids	On days 15 and 30 after transplantation
Serum Interleukin 6 (IL-6)	Determination of serum interleukin 6 (IL-6)	On days 15 and 30 after transplantation

Collaborators and Investigators

• Sponsor: Shahid Beheshti University
• Investigators: Principal Investigator: Zahra Vahdat Shariatpanahi, Professor, School of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 28, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 12, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Complications; mortality; Intralipid; SMOF; Engrafment
• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Parenteral Nutrition Solutions; Fat Emulsions, Intravenous; Soybean oil, phospholipid emulsion
• Other Study ID Numbers: 0311.212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No