Comparison of Intralipid With SMOF Lipid Following HSCT | NCT06625372

Studies
Comparison of Intralipid With SMOF Lipid Following HSCT

NCT06625372

Sponsor

Shahid Beheshti University

Status

Recruiting

Last Update Posted

Oct 16, 2024Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Leukemia
HSCT

Interventions

SMOF lipid
INTRALIPIDS

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 12, 2024Actual

Primary Completion Date

Aug 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Sep 28, 2024

First Submission Date that Met QC Criteria

Oct 1, 2024

First Posted Date

Oct 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2024

Last Update Posted Date

Oct 16, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zahra Vahdat Shariatpanahi, Associate professor, Shahid Beheshti UniversityPrincipal Investigator

Lead Sponsor

Shahid Beheshti UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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 &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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
SMOF lipid	Dietary Supplement	The SMOF lipid is given to the patient as a fat component of total parenteral nutrition.	SMOF lipid

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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 &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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zahra Vahdat Shariatpanahi, Professor	Contact	0098-021-22357484		nutritiondata@yahoo.com
Zahra Vahdat Shariatpanahi, Professor	Contact	09122138186		nutritiondata@yahoo.com

Overall Officials

Name	Affiliation	Role
Zahra Vahdat Shariatpanahi, Professor	School of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Medical Center, Pediatrics Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran	Recruiting	Tehran			Iran

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007938	Leukemia

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

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Browse Branches

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