LeukemiaNCT06625372
Comparison of Intralipid With SMOF Lipid Following HSCT
A study testing SMOF lipid and INTRALIPIDS in people with Leukemia and HSCT, run by Shahid Beheshti University at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- What is being tested?
- SMOF lipid and INTRALIPIDS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- 12 Oct 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Children's Medical Center, Pediatrics Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran
Tehran
Amirali hamidieh
About this study
Official 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)
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.
Read the 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.
- Being tested
- SMOF lipid, INTRALIPIDS
- Keywords
- mortality, SMOF, Intralipid, Engrafment, Complications
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMOF lipidDietary supplement
The SMOF lipid is given to the patient as a fat component of total parenteral nutrition.
INTRALIPIDSDietary supplement
The Intralipid will be given to the patient as fat component of total parenteral nutrition.
| Study group | Role | What they receive |
|---|---|---|
| SMOF lipid | Experimental | The SMOF lipid is given to the patient as a fat component of total parenteral nutrition. Receives: Dietary Supplement: SMOF lipid |
| Intralipid | Active comparator | intralipids Receives: Dietary Supplement: INTRALIPIDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engraftment
blood counts of Neutrophils and platelets
Measured: Within 35 days after transplantation
Secondary outcomes (14)
100-day survival rate
Determination and comparison of 100-day survival rate after transplantation in both groups
Measured: Within 100 days after transplantation
Incidence of infection
Determining and comparing the incidence of infection
Measured: Within 30 days after transplant
Incidence of bleeding
Determining and comparing the incidence of bleeding
Measured: Within 30 days after transplantation
Hospitalization
Determining and comparing the duration of hospitalization in both groups
Measured: up to 7 weeks after transplantation
Mortality
incidence of mortality in hospital
Measured: up to 7 weeks after transplantation
MAC (mid arm circumference)
Determination and comparison of MAC in both groups
Measured: On days 15 and 30 after transplantation
Albumin
Determination and comparison of serum albumin
Measured: 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.
Measured: Up to 100 days after transplantation
Duration of parenteral nutrition
Determining and comparing the duration of using parenteral nutrition
Measured: during hospitalization, up to 7 weeks after transplantation
Weight
Determination and comparison of weight in both groups
Measured: On days 15 and 30 after transplantation
Blood sugar
Determination and comparison of blood sugar,
Measured: On days 15 and 30 after transplantation
Serum electrolytes
Determination and comparison of serum electrolytes
Measured: On days 15 and 30 after transplantation
Serum lipids
Determination and comparison of serum lipids
Measured: On days 15 and 30 after transplantation
Serum Interleukin 6 (IL-6)
Determination of serum interleukin 6 (IL-6)
Measured: On days 15 and 30 after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start12 Oct 2024
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Vahdat Shariatpanahi, Shahid Beheshti University
- Investigators
- Zahra Vahdat Shariatpanahi, Professor, Principal investigator, School of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625372
- Sponsor's protocol ID
- 0311.212
- Status last verified
- Oct 2024
- First submitted
- 28 Sep 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06625372
- Acronym / sponsor ID
- 0311.212
- Keywords
- mortality, SMOF, Intralipid, Engrafment, Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Study start
- 12 Oct 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 \>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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMOF lipid | Experimental | Dietary Supplement: SMOF lipidThe SMOF lipid is given to the patient as a fat component of total parenteral nutrition. |
| Intralipid | Active comparator | Dietary Supplement: INTRALIPIDSintralipids |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMOF lipidThe SMOF lipid is given to the patient as a fat component of total parenteral nutrition. | Dietary supplement | SMOF lipid |
| INTRALIPIDSThe Intralipid will be given to the patient as fat component of total parenteral nutrition. | Dietary supplement | Intralipid |
Primary outcome
Engraftment
Time frame: Within 35 days after transplantation
blood counts of Neutrophils and platelets
14 secondary outcomes
100-day survival rate
Time frame: Within 100 days after transplantation
Incidence of infection
Time frame: Within 30 days after transplant
Incidence of bleeding
Time frame: Within 30 days after transplantation
Hospitalization
Time frame: up to 7 weeks after transplantation
Mortality
Time frame: up to 7 weeks after transplantation
MAC (mid arm circumference)
Time frame: On days 15 and 30 after transplantation
Albumin
Time frame: On days 15 and 30 after transplantation
Acute gastrointestinal complications
Time frame: Up to 100 days after transplantation
Duration of parenteral nutrition
Time frame: during hospitalization, up to 7 weeks after transplantation
Weight
Time frame: On days 15 and 30 after transplantation
Blood sugar
Time frame: On days 15 and 30 after transplantation
Serum electrolytes
Time frame: On days 15 and 30 after transplantation
Serum lipids
Time frame: On days 15 and 30 after transplantation
Serum Interleukin 6 (IL-6)
Time frame: On days 15 and 30 after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zahra Vahdat Shariatpanahi, Professor principal investigator
School of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMOF lipid and INTRALIPIDS in people with Leukemia and HSCT, run by Shahid Beheshti University at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zahra Vahdat Shariatpanahi, Professor (0098-021-22357484, nutritiondata@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engraftment (time frame: Within 35 days after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.