Malnutrition, ChildPhase 4NCT03563222
Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age
A Phase 4 study testing Smoflipid and Intralipid, 20% in people with Malnutrition, Child, run by Fresenius Kabi at 1 site in United States.
Trial summary
Evaluate the safety and efficacy of Smoflipid compared to standard of care lipid emulsion Intralipid 20% administered via a central vein in pediatric patients 3 months to 16 years of age who require parenteral nutrition for at least 90 days and up to 1 year. Read more about this study
- Who is it for?
- Ages 3 months to 16 years
- Conditions the study is for
- Malnutrition, Child
- What is being tested?
- Smoflipid and Intralipid, 20%
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2019to 8 Jul 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female patients 3 months to 16 years of age.
- Patients who require PN for at least 5 days/week.
- Patients who receive 60% or more of their total energy requirements as PN at enrollment and who are expected to receive 60% or more of their total energy requirements as PN for at least 90 days.
- Written informed consent from parent(s) or legal representative(s). If possible, patient assent must also be obtained (according to local law).
Who cannot join
- Known hypersensitivity to fish, egg, soybean, or peanut proteins, or to any of the active ingredients or excipients of Smoflipid or Intralipid 20%.
- Hyperlipidemia or disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentration > 250 mg/dL).
- Inborn errors of amino acid metabolism.
- Cardiopulmonary instability (including pulmonary edema, cardiac insufficiency, myocardial infarction, acidosis and hemodynamic instability requiring significant vasopressor support).
- Hemophagocytic syndrome.
- Liver enzymes (either AST, or ALT, or GGT) exceeding 5 x upper limit of normal range
Show all 16Show fewer
- Direct bilirubin ≥ 2.0 mg/dl
- INR > 2.
- Any known hepatic condition outside of Intestinal Failure-Associated Liver Disease (IFALD) that will increase direct bilirubin ≥ 2.0 mg/dl.
- Clinically significant abnormal levels of any serum electrolyte (sodium, potassium, magnesium, calcium, chloride, phosphate).
- Active bloodstream infection demonstrated by positive blood culture at screening.
- Severe renal failure including patients on renal replacement therapy.
- Abnormal blood pH, oxygen saturation, or carbon dioxide.
- Pregnancy or lactation.
- Participation in another clinical study.
- Unlikely to survive longer than 90 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
About this study
Official title: Prospective, Randomized (1:1), Double-Blind, Parallel-Group, Active-Controlled, Multicenter Study to Compare Safety and Efficacy of Smoflipid to Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age Requiring Parenteral Nutrition for at Least 90 Days and up to 1 Year
Evaluate the safety and efficacy of Smoflipid compared to standard of care lipid emulsion Intralipid 20% administered via a central vein in pediatric patients 3 months to 16 years of age who require parenteral nutrition for at least 90 days and up to 1 year.
- Conditions
- Malnutrition, Child
- Being tested
- Smoflipid, Intralipid, 20%
- Keywords
- Parenteral nutrition, Pediatrics, Malnutrition, Nutritional needs
- Medical subject headings
- Child Nutrition Disorders, Hyperphagia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmoflipidDrug
Also called Smoflipid® Lipid Injectible Emulsion, USP 20%
The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter.
The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour.
The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid.
Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy.
Intralipid, 20%Drug
Also called Intralipid® 20% (20% i.v. fat emulsion)
The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter.
The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour.
The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid.
Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy.
| Study group | Role | What they receive |
|---|---|---|
| Smoflipid | Experimental | Smoflipid is a sterile, nonpyrogenic, white, homogenous lipid emulsion for intravenous infusion. The lipid content of Smoflipid is 0.20 g/mL, and comprises a mixture of soybean oil, medium chain triglycerides, olive oil, and fish oil. Smoflipid is indicated as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
The mean essential fatty acid content of Smoflipid is 35 mg/mL linoleic acid (omega-6) and 4.5 mg/mL α-linolenic acid (omega-3). Receives: Drug: Smoflipid |
| Intralipid, 20% | Active comparator | Intralipid 20% is a sterile, non-pyrogenic fat emulsion intended as a source of calories and essential fatty acids. Intralipid 20% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time and as a source of essential fatty acids for prevention of essential fatty acid deficiency. The major component fatty acids are linoleic acid, oleic acid, palmitic acid, α-linolenic acid and stearic acid. Receives: Drug: Intralipid, 20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Body weight of patients (patients < 36 months of age)
Measured: from day 1 monthly to day 365
Body Height
Height oder length of body (patients <36 months of age)
Measured: from day 1 monthly to day 365
Head Circumference
Circumference of head in patients > 36 months old
Measured: from day 1 monthly to day 365
Fatty Acid Profile in Total Plasma
Fatty acid profile including linoleic acid, α-linolenic acid, arachidonic acid, docosahexaenoic acid, eicosapentaenoic acid and Mead acid, analyzed in total plasma
Measured: from day 1 monthly to day 365
Fatty Acid Profile in Red Blood Cell Membranes
Fatty acid profile including linoleic acid, α-linolenic acid, arachidonic acid, docosahexaenoic acid, eicosapentaenoic acid and Mead acid, analyzed in red blood cell membranes
Measured: from day 1 monthly to day 365
Triene/Tetraene Ratio
Triene/tetraene ratio (Holman Index) in total plasma to assess essential fatty acid deficiency (EFAD)
Measured: from day 1 weekly to day 365
Number of Patients in Each Treatment Group With Direct Bilirubin Levels > 2 mg/dL
Measured: from day 1 monthly to day 365
Time Until Reaching Direct Bilirubin Levels > 2 mg/dL
Measured: from day 1 monthly to day 365
Sterols in Plasma Including Phytosterols
Measured: from day 1 monthly to day 365
Change From Baseline Triglycerides
Measured: from day 1 weekly to day 365
Change From Baseline Urea Nitrogen
Measured: from day 1 weekly to day 365
Change From Baseline Alanine Aminotransferase (ALT)
Measured: from day 1 weekly to day 365
Change From Baseline Aspartate Aminotransferase (AST)
Measured: from day 1 weekly to day 365
Change From Baseline Direct Bilirubin
Measured: from day 1 weekly to day 365
Change From Baseline Total Bilirubin
Measured: from day 1 weekly to day 365
Change From Baseline Gamma-glutamyl Transferase (GGT)
Measured: from day 1 weekly to day 365
Change Form Baseline Alkaline Phosphatase (ALP)
Measured: from day 1 weekly to day 365
Change From Baseline Creatinine
Measured: from day 1 weekly to day 365
Change From Baseline Electrolytes (Na, K, Mg, Cl,Ca, Phosphate)
Measured: from day 1 weekly to day 365
Change From Baseline Trace Elements (Ferritin, Zn, Se, Cu, Mn, Cr)
Measured: from day 1 weekly to day 365
Change From Baseline Glucose
Measured: from day 1 weekly to day 365
Change From Baseline Total Protein
Measured: from day 1 weekly to day 365
Change From Baseline C-reactive Protein (CRP)
Measured: from day 1 weekly to day 365
Change From Baseline White Blood Cell (WBC) Count
Measured: from day 1 weekly to day 365
Change From Baseline Red Blood Cell (RBC) Count
Measured: from day 1 weekly to day 365
Change From Baseline Platelet Count
Measured: from day 1 weekly to day 365
Change From Baseline Hemoglobin
Measured: from day 1 weekly to day 365
Change From Baseline Hematocrit
Measured: from day 1 weekly to day 365
Change From Baseline International Normalized Ratio (INR)
Measured: from day 1 weekly to day 365
Change From Baseline Sterols (Beta-sitosterol, Campesterol, Stigmasterol, Brassicasterol, Ergosterol, Cholesterol, Desmosterol, Lanosterol, Beta-sitostanol, Lathosterol, Squalene)
Measured: from day 1 monthly to day 365
Vital Signs: Blood Pressure
Systolic and diastolic blood pressure
Measured: from day 1 monthly to day 365
Vital Signs: Heart Rate
Measured: from day 1 monthly to day 365
Vital Signs: Body Temperature
Measured: from day 1 monthly to day 365
Adverse Events
Measured: from day 1 weekly to day 365
Genetic Polymorphisms of Fatty Acid Desaturase Genes FADS1 and FADS2
The relation between genetic polymorphisms in the fatty acid desaturase genes Fatty acid desaturase 1 (FADS1) and Fatty acid desaturase 2 (FADS2) and plasma concentrations of linoleic acid, α-linolenic acid, arachidonic acid, docosahexaenoic acid, eicosapentaenoic acid, and Mead acid, as well as relation to and EFAD (triene/tetraene ratio)
Measured: once during treatment phase (day 1 to day 365)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start18 Dec 2019
- Primary completion12 Nov 2020
- Study completion8 Jul 2022
Why it stopped: Prematurely stopped in agreement with authorities (FDA)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malnutrition, ChildStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Rudolph, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563222
- Sponsor's protocol ID
- SMOF-028-CP4
- Status last verified
- Nov 2022
- First submitted
- 5 Jun 2018
- Last updated
- 12 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized (1:1), Double-Blind, Parallel-Group, Active-Controlled, Multicenter Study to Compare Safety and Efficacy of Smoflipid to Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age Requiring Parenteral Nutrition for at Least 90 Days and up to 1 Year
- ClinicalTrials.gov ID
- NCT03563222
- Acronym / sponsor ID
- SMOF-028-CP4
- Conditions
- Malnutrition, Child
- Keywords
- Parenteral nutrition, Pediatrics, Malnutrition, Nutritional needs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Prematurely stopped in agreement with authorities (FDA)
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 12 Nov 2020 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 20 Jun 2018 (actual)
- Results
- Posted 12 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety and efficacy of Smoflipid compared to standard of care lipid emulsion Intralipid 20% administered via a central vein in pediatric patients 3 months to 16 years of age who require parenteral nutrition for at least 90 days and up to 1 year.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoflipid | Experimental | Drug: SmoflipidSmoflipid is a sterile, nonpyrogenic, white, homogenous lipid emulsion for intravenous infusion. The lipid content of Smoflipid is 0.20 g/mL, and comprises a mixture of soybean oil, medium chain triglycerides, olive oil, and fish oil. Smoflipid is indicated as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. The mean essential fatty acid content of Smoflipid is 35 mg/mL linoleic acid (omega-6) and 4.5 mg/mL α-linolenic acid (omega-3). |
| Intralipid, 20% | Active comparator | Drug: Intralipid, 20%Intralipid 20% is a sterile, non-pyrogenic fat emulsion intended as a source of calories and essential fatty acids. Intralipid 20% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time and as a source of essential fatty acids for prevention of essential fatty acid deficiency. The major component fatty acids are linoleic acid, oleic acid, palmitic acid, α-linolenic acid and stearic acid. |
Who may qualify
- Ages
- 3 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male and female patients 3 months to 16 years of age.
- Patients who require PN for at least 5 days/week.
- Patients who receive 60% or more of their total energy requirements as PN at enrollment and who are expected to receive 60% or more of their total energy requirements as PN for at least 90 days.
- Written informed consent from parent(s) or legal representative(s). If possible, patient assent must also be obtained (according to local law).
Key exclusion criteria (16 listed)
- Known hypersensitivity to fish, egg, soybean, or peanut proteins, or to any of the active ingredients or excipients of Smoflipid or Intralipid 20%.
- Hyperlipidemia or disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentration > 250 mg/dL).
- Inborn errors of amino acid metabolism.
- Cardiopulmonary instability (including pulmonary edema, cardiac insufficiency, myocardial infarction, acidosis and hemodynamic instability requiring significant vasopressor support).
- Hemophagocytic syndrome.
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 |
|---|---|---|
| SmoflipidAlso: Smoflipid® Lipid Injectible Emulsion, USP 20%The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter. The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour. The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid. Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy. | Drug | Smoflipid |
| Intralipid, 20%Also: Intralipid® 20% (20% i.v. fat emulsion)The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter. The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour. The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid. Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy. | Drug | Intralipid, 20% |
Primary outcome
Body Weight
Time frame: from day 1 monthly to day 365
Body weight of patients (patients < 36 months of age)
Body Height
Time frame: from day 1 monthly to day 365
Height oder length of body (patients <36 months of age)
Head Circumference
Time frame: from day 1 monthly to day 365
Circumference of head in patients > 36 months old
Fatty Acid Profile in Total Plasma
Time frame: from day 1 monthly to day 365
Fatty acid profile including linoleic acid, α-linolenic acid, arachidonic acid, docosahexaenoic acid, eicosapentaenoic acid and Mead acid, analyzed in total plasma
Fatty Acid Profile in Red Blood Cell Membranes
Time frame: from day 1 monthly to day 365
Fatty acid profile including linoleic acid, α-linolenic acid, arachidonic acid, docosahexaenoic acid, eicosapentaenoic acid and Mead acid, analyzed in red blood cell membranes
Triene/Tetraene Ratio
Time frame: from day 1 weekly to day 365
Triene/tetraene ratio (Holman Index) in total plasma to assess essential fatty acid deficiency (EFAD)
Number of Patients in Each Treatment Group With Direct Bilirubin Levels > 2 mg/dL
Time frame: from day 1 monthly to day 365
Time Until Reaching Direct Bilirubin Levels > 2 mg/dL
Time frame: from day 1 monthly to day 365
Sterols in Plasma Including Phytosterols
Time frame: from day 1 monthly to day 365
Change From Baseline Triglycerides
Time frame: from day 1 weekly to day 365
Change From Baseline Urea Nitrogen
Time frame: from day 1 weekly to day 365
Change From Baseline Alanine Aminotransferase (ALT)
Time frame: from day 1 weekly to day 365
Change From Baseline Aspartate Aminotransferase (AST)
Time frame: from day 1 weekly to day 365
Change From Baseline Direct Bilirubin
Time frame: from day 1 weekly to day 365
Change From Baseline Total Bilirubin
Time frame: from day 1 weekly to day 365
Change From Baseline Gamma-glutamyl Transferase (GGT)
Time frame: from day 1 weekly to day 365
Change Form Baseline Alkaline Phosphatase (ALP)
Time frame: from day 1 weekly to day 365
Change From Baseline Creatinine
Time frame: from day 1 weekly to day 365
Change From Baseline Electrolytes (Na, K, Mg, Cl,Ca, Phosphate)
Time frame: from day 1 weekly to day 365
Change From Baseline Trace Elements (Ferritin, Zn, Se, Cu, Mn, Cr)
Time frame: from day 1 weekly to day 365
Change From Baseline Glucose
Time frame: from day 1 weekly to day 365
Change From Baseline Total Protein
Time frame: from day 1 weekly to day 365
Change From Baseline C-reactive Protein (CRP)
Time frame: from day 1 weekly to day 365
Change From Baseline White Blood Cell (WBC) Count
Time frame: from day 1 weekly to day 365
Change From Baseline Red Blood Cell (RBC) Count
Time frame: from day 1 weekly to day 365
Change From Baseline Platelet Count
Time frame: from day 1 weekly to day 365
Change From Baseline Hemoglobin
Time frame: from day 1 weekly to day 365
Change From Baseline Hematocrit
Time frame: from day 1 weekly to day 365
Change From Baseline International Normalized Ratio (INR)
Time frame: from day 1 weekly to day 365
Change From Baseline Sterols (Beta-sitosterol, Campesterol, Stigmasterol, Brassicasterol, Ergosterol, Cholesterol, Desmosterol, Lanosterol, Beta-sitostanol, Lathosterol, Squalene)
Time frame: from day 1 monthly to day 365
Vital Signs: Blood Pressure
Time frame: from day 1 monthly to day 365
Systolic and diastolic blood pressure
Vital Signs: Heart Rate
Time frame: from day 1 monthly to day 365
Vital Signs: Body Temperature
Time frame: from day 1 monthly to day 365
Adverse Events
Time frame: from day 1 weekly to day 365
Genetic Polymorphisms of Fatty Acid Desaturase Genes FADS1 and FADS2
Time frame: once during treatment phase (day 1 to day 365)
The relation between genetic polymorphisms in the fatty acid desaturase genes Fatty acid desaturase 1 (FADS1) and Fatty acid desaturase 2 (FADS2) and plasma concentrations of linoleic acid, α-linolenic acid, arachidonic acid, docosahexaenoic acid, eicosapentaenoic acid, and Mead acid, as well as relation to and EFAD (triene/tetraene ratio)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Malnutrition, Child
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
Active, not recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
Active, not recruitingPhase 2
Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children
Small Intestine Bacterial Overgrowth
Recruiting
Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition
Acute Malnutrition With no Complications
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.
Jeffrey Rudolph, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Smoflipid and Intralipid, 20% in people with Malnutrition, Child, run by Fresenius Kabi at 1 site in United States.
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 4 inclusion and 16 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: stopped early, as of the sponsor's last update on 12 Dec 2022. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: from day 1 monthly to day 365). The study lists 35 primary outcomes in all. 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 12 Dec 2022.