Home Parenteral NutritionPhase 4NCT03054948
SMOFLipid in Patients Who Are Intralipid Intolerant
A Phase 4 study testing SMOFLipid and Standard therapy in people with Home Parenteral Nutrition and Short Bowel Syndrome, run by Mayo Clinic at 1 site in United States.
Trial summary
Soybean oil based IV fat emulsion (IVFE) has been one of the sole sources of IVFE in the US. Soybean oil based IVFE has higher ratio of omega-6 to omega-3 fatty acids and can be associated with a number of complications including inflammation, abnormal liver function tests (reflecting steatosis, cholestasis, etc.)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Home Parenteral Nutrition, Short Bowel Syndrome
- What is being tested?
- SMOFLipid and Standard therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 20 Mar 2018
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- current Mayo Clinic HPN patient, able to provide informed consent, anticipated duration of HPN greater than 3 months
- infusion company is able to provide SMOFlipid
- no history of alcohol addiction
- noted to be intolerant to SO based IVFE as defined below.
Who cannot join
- Pregnant women
- failure to provide consent
- patients who are deemed to be on HPN for less than three months
- patients who have previous proven addiction and dependence to alcohol/ heavy alcohol consumption reported (during history or reported in the EMR), known hypersensitivity to fish, egg, or soy, patients who will not be managed by the Mayo Clinic HPN team and patients who have active infection (as determined by the clinician) at the time of enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Safety and Efficacy of SMOFlipid in Patients Intolerant to Intralipid.
Soybean oil based IV fat emulsion (IVFE) has been one of the sole sources of IVFE in the US. Soybean oil based IVFE has higher ratio of omega-6 to omega-3 fatty acids and can be associated with a number of complications including inflammation, abnormal liver function tests (reflecting steatosis, cholestasis, etc.), and metabolic abnormalities. Recently the FDA has approved SMOFlipid which contains a mixture of soybean oil, medium chain triglycerides, olive oil, and fish oil. It provides a more positive ratio of omega-3 to omega-6 fatty acids and has been shown in short term trials to be beneficial in cases of intolerance to soybean oil IVFE. This study is designed to investigate the impact of SMOFlipid in prolonged use.
- Conditions
- Home Parenteral Nutrition, Short Bowel Syndrome
- Being tested
- SMOFLipid, Standard therapy
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMOFLipidDrug
SMOFlipid is a lipid emulsion formed using soybean oil, medium chain triglycerides, olive oil, and fish oil.
Standard therapyDrug
In most cases standard therapy will be IntraLipid.
| Study group | Role | What they receive |
|---|---|---|
| SMOFLipid | Experimental | Patients in this arm with be randomized to SMOFlipid as their lipid emulsion Receives: Drug: SMOFLipid |
| Standard therapy | Active comparator | Patients in this arm will be continue with their current lipid emulsion Receives: Drug: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
AST
Primary aim is to assess impact on AST (liver enzyme)
Measured: 3-12 months
Glucose
blood glucose
Measured: 3-12 months
Triglycerides
blood triglycerides
Measured: 3-12 months
ALT
liver enzyme
Measured: 3-12 months
Total bilirubin
Liver study
Measured: 3-12 months
CRP
inflammatory marker
Measured: 3-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start1 Feb 2017
- Primary completion20 Mar 2018 (estimated)
- Study completion20 Mar 2018 (estimated)
Why it stopped: Redesign of study protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Home Parenteral NutritionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manpreet S. Mundi, Mayo Clinic
- Investigators
- Manpreet S Mundi, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054948
- Sponsor's protocol ID
- 16-009516
- Status last verified
- Mar 2018
- First submitted
- 8 Feb 2017
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of SMOFlipid in Patients Intolerant to Intralipid.
- ClinicalTrials.gov ID
- NCT03054948
- Acronym / sponsor ID
- 16-009516
- Conditions
- Home Parenteral Nutrition, Short Bowel Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Redesign of study protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 20 Mar 2018 (estimated)
- Study completion
- 20 Mar 2018 (estimated)
- First posted
- 16 Feb 2017 (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.
Soybean oil based IV fat emulsion (IVFE) has been one of the sole sources of IVFE in the US. Soybean oil based IVFE has higher ratio of omega-6 to omega-3 fatty acids and can be associated with a number of complications including inflammation, abnormal liver function tests (reflecting steatosis, cholestasis, etc.), and metabolic abnormalities. Recently the FDA has approved SMOFlipid which contains a mixture of soybean oil, medium chain triglycerides, olive oil, and fish oil. It provides a more positive ratio of omega-3 to omega-6 fatty acids and has been shown in short term trials to be beneficial in cases of intolerance to soybean oil IVFE. This study is designed to investigate the impact of SMOFlipid in prolonged use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMOFLipid | Experimental | Drug: SMOFLipidPatients in this arm with be randomized to SMOFlipid as their lipid emulsion |
| Standard therapy | Active comparator | Drug: Standard therapyPatients in this arm will be continue with their current lipid emulsion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age greater than 18 years
- current Mayo Clinic HPN patient, able to provide informed consent, anticipated duration of HPN greater than 3 months
- infusion company is able to provide SMOFlipid
- no history of alcohol addiction
- noted to be intolerant to SO based IVFE as defined below.
Key exclusion criteria (4 listed)
- Pregnant women
- failure to provide consent
- patients who are deemed to be on HPN for less than three months
- patients who have previous proven addiction and dependence to alcohol/ heavy alcohol consumption reported (during history or reported in the EMR), known hypersensitivity to fish, egg, or soy, patients who will not be managed by the Mayo Clinic HPN team and patients who have active infection (as determined by the clinician) at the time of enrollment.
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 |
|---|---|---|
| SMOFLipidSMOFlipid is a lipid emulsion formed using soybean oil, medium chain triglycerides, olive oil, and fish oil. | Drug | SMOFLipid |
| Standard therapyIn most cases standard therapy will be IntraLipid. | Drug | Standard therapy |
Primary outcome
AST
Time frame: 3-12 months
Primary aim is to assess impact on AST (liver enzyme)
Glucose
Time frame: 3-12 months
blood glucose
Triglycerides
Time frame: 3-12 months
blood triglycerides
ALT
Time frame: 3-12 months
liver enzyme
Total bilirubin
Time frame: 3-12 months
Liver study
CRP
Time frame: 3-12 months
inflammatory marker
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
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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.
Manpreet S Mundi principal investigator
Mayo Clinic
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 Standard therapy in people with Home Parenteral Nutrition and Short Bowel Syndrome, run by Mayo Clinic 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 5 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: withdrawn, as of the sponsor's last update on 22 Mar 2018. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
AST (time frame: 3-12 months). The study lists 6 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 22 Mar 2018.