Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06625372

Comparison of Intralipid With SMOF Lipid Following 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Tehran, Iran

Location status: Recruiting

Location contact

Amirali hamidieh

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SMOF lipid

Dietary Supplement

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

INTRALIPIDS

Dietary Supplement

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

Primary outcomes

  1. Engraftment

    Time frame: Within 35 days after transplantation

    blood counts of Neutrophils and platelets

Secondary outcomes

  1. 100-day survival rate

    Time frame: Within 100 days after transplantation

    Determination and comparison of 100-day survival rate after transplantation in both groups

  2. Incidence of infection

    Time frame: Within 30 days after transplant

    Determining and comparing the incidence of infection

  3. Incidence of bleeding

    Time frame: Within 30 days after transplantation

    Determining and comparing the incidence of bleeding

  4. Hospitalization

    Time frame: up to 7 weeks after transplantation

    Determining and comparing the duration of hospitalization in both groups

  5. Mortality

    Time frame: up to 7 weeks after transplantation

    incidence of mortality in hospital

  6. MAC (mid arm circumference)

    Time frame: On days 15 and 30 after transplantation

    Determination and comparison of MAC in both groups

  7. Albumin

    Time frame: On days 15 and 30 after transplantation

    Determination and comparison of serum albumin

  8. Acute gastrointestinal complications

    Time frame: Up to 100 days after transplantation

    Determining and comparing the incidence of acute gastrointestinal complications (including acute GVHD, cholestasis) in both groups.

  9. Duration of parenteral nutrition

    Time frame: during hospitalization, up to 7 weeks after transplantation

    Determining and comparing the duration of using parenteral nutrition

  10. Weight

    Time frame: On days 15 and 30 after transplantation

    Determination and comparison of weight in both groups

  11. Blood sugar

    Time frame: On days 15 and 30 after transplantation

    Determination and comparison of blood sugar,

  12. Serum electrolytes

    Time frame: On days 15 and 30 after transplantation

    Determination and comparison of serum electrolytes

  13. Serum lipids

    Time frame: On days 15 and 30 after transplantation

    Determination and comparison of serum lipids

  14. Serum Interleukin 6 (IL-6)

    Time frame: On days 15 and 30 after transplantation

    Determination of serum interleukin 6 (IL-6)

Study contacts

Contact information is provided by the study sponsor or research team.

Zahra Vahdat Shariatpanahi, Professor

CONTACT

[email protected]

0098-021-22357484

Zahra Vahdat Shariatpanahi, Professor

CONTACT

[email protected]

09122138186

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University

Other

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.