Comparison of Intralipid With SMOF Lipid Following HSCT

NCT06625372 | Recruiting DMC

• 1 other identifier: 0311.212
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leukemia; HSCT

Keywords

mortality; SMOF; Intralipid; Engrafment; Complications

Outcome Measures

Primary Outcomes (1)

• Engraftment

  blood counts of Neutrophils and platelets

  Within 35 days after transplantation

Secondary Outcomes (14)

• 100-day survival rate

  Within 100 days after transplantation

• Incidence of infection

  Within 30 days after transplant

• Incidence of bleeding

  Within 30 days after transplantation

• Hospitalization

  up to 7 weeks after transplantation

• Mortality

  up to 7 weeks after transplantation

Study Arms (2)

SMOF lipid

EXPERIMENTAL

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

Dietary Supplement: SMOF lipid

Intralipid

ACTIVE COMPARATOR

intralipids

Dietary Supplement: INTRALIPIDS

Interventions

SMOF lipid DIETARY_SUPPLEMENT

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

SMOF lipid

INTRALIPIDS DIETARY_SUPPLEMENT

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

Intralipid

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shahid Beheshti University: lead

Study Sites (1)

Children's Medical Center, Pediatrics Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Zahra Vahdat Shariatpanahi, Professor

  School of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zahra Vahdat Shariatpanahi, Professor

CONTACT

0098-021-22357484; nutritiondata@yahoo.com

Zahra Vahdat Shariatpanahi, Professor

CONTACT

09122138186; nutritiondata@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 28, 2024
• First Posted: October 3, 2024
• Study Start: October 12, 2024
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)