Nutritional Supplement ToxicityPhase 1NCT04051840
Safely and Efficacy of ClinOleic-based Lipid Parenteral Nutrition
A Phase 1 study testing ClinOleic (Baxter Healthcare, Deerfield, IL, USA) in people with Nutritional Supplement Toxicity, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Small studies suggest differences in efficacy and safety exist between olive oil-based and soybean oil-based parenteral nutrition regimens in hospitalized adult patients. A study in China suggested that olive oil-based parenteral nutrition provided effective nutrition, was well tolerated, was associated with fewer… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nutritional Supplement Toxicity
- What is being tested?
- ClinOleic (Baxter Healthcare, Deerfield, IL, USA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 30 Jun 2020
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hospitalized ≤14 days before enrolment
- required parenteral nutrition
- had the capability to complete at least five days of study treatment;
- useable peripheral vein for parenteral nutrition;
- written informed consent.
Who cannot join
- A life expectancy of <6 days;
- hypersensitivity to the study treatments;
- use of prohibited medications within 30 days before enrolment;
- serious clinically significant condition such as congestive heart failure or severe renal insufficiency;
- impaired hepatic function；
- history of human immunodeficiency virus infection;
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- congenital abnormalities of amino acid metabolism;
- severe dyslipidemia;
- clinically significant abnormalities of plasma electrolytes;
- currently pregnant or lactating; prior enrolment in this clinical trial;
- participation in a clinical trial of any investigational drug or device concomitantly or within 30 days before enrolment in this clinical trial;
- unsuitable in the opinion of the Investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing
Qiang Li, +86 13505191133, liqiang020202@163.com
About this study
Official title: Safely and Efficacy of ClinOleic-based Lipid Parenteral Nutrition After Pancreatectomy:a Prospective Study of Real World Clinical Research in China
Small studies suggest differences in efficacy and safety exist between olive oil-based and soybean oil-based parenteral nutrition regimens in hospitalized adult patients. A study in China suggested that olive oil-based parenteral nutrition provided effective nutrition, was well tolerated, was associated with fewer infections and conferred greater ease-of-use than soybean oil-based parenteral nutrition. The objectives of this study were to assess safety and efficacy of an ClinOleic-based lipid parenteral nutrition regimen compared with Structolipid-based lipid parenteral nutrition regimen in Chinese adults after pancreatectomy for whom oral or enteral nutrition was not possible, insufficient or contraindicated.
- Conditions
- Nutritional Supplement Toxicity
- Being tested
- ClinOleic (Baxter Healthcare, Deerfield, IL, USA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClinOleic (Baxter Healthcare, Deerfield, IL, USA)Drug
ClinOleic group: Patients using ClinOleic or Structolipid-based lipid parenteral nutrition regimen. From day 0 to day 5, the goal of treatment is to deliver 25kcal/kg/day, 1.05g/kg/day amino acids, and 1.1g/kg/day lipid.
| Study group | Role | What they receive |
|---|---|---|
| ClinOleic group | Experimental | Patients will be grouped to ClinOleic-based lipid parenteral nutrition regimen using ClinOleic or Structolipid-based lipid parenteral nutrition regimen using Structolipid. From day 0 to day 5, patients will not to receive any food or liquid oral or enteral nutrition. The goal of treatment is to deliver 25kcal/kg/day, 1.05g/kg/day amino acids, and 1.1g/kg/day lipid. The weight of patient calculated as ideal body weight. The patients will be allowed water based on the clinical judgment of the Investigator. From day 6 through the remainder of the study treatment period, liquid oral or enteral nutrition could be added to the study treatment. The intent is to supply the total calculated daily nutritional requirement with study treatment plus liquid oral or enteral nutrition. Liquid oral or enteral nutrition will be increased daily, as tolerated by the patient, with a concurrent reduction in study treatment, while still supplying the calculated daily nutritional requirement. Receives: Drug: ClinOleic (Baxter Healthcare, Deerfield, IL, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
biomarkers of liver functions
Concentration of AST, ALT, TBIL, DBIL in the blood
Measured: 48 hours after operation.
Secondary outcomes (3)
markers of infection and inflammation
Concentration of CRP, PCT in the blood
Measured: 48 hours after operation.
Trenal function
Concentration of Crea, Urea in the blood
Measured: 48 hours after operation.
lipids and lipid upper derivatives
Concentration of arachidonic acid, eicosapentaenoic acid, linoleic acid, oleic acid in the blood
Measured: 48 hours after operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start1 Jul 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional Supplement ToxicityStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051840
- Sponsor's protocol ID
- 2019-SR-101
- Status last verified
- Jul 2019
- First submitted
- 31 Jul 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safely and Efficacy of ClinOleic-based Lipid Parenteral Nutrition After Pancreatectomy:a Prospective Study of Real World Clinical Research in China
- ClinicalTrials.gov ID
- NCT04051840
- Acronym / sponsor ID
- 2019-SR-101
- Conditions
- Nutritional Supplement Toxicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 9 Aug 2019 (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.
Small studies suggest differences in efficacy and safety exist between olive oil-based and soybean oil-based parenteral nutrition regimens in hospitalized adult patients. A study in China suggested that olive oil-based parenteral nutrition provided effective nutrition, was well tolerated, was associated with fewer infections and conferred greater ease-of-use than soybean oil-based parenteral nutrition. The objectives of this study were to assess safety and efficacy of an ClinOleic-based lipid parenteral nutrition regimen compared with Structolipid-based lipid parenteral nutrition regimen in Chinese adults after pancreatectomy for whom oral or enteral nutrition was not possible, insufficient or contraindicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ClinOleic group | Experimental | Drug: ClinOleic (Baxter Healthcare, Deerfield, IL, USA)Patients will be grouped to ClinOleic-based lipid parenteral nutrition regimen using ClinOleic or Structolipid-based lipid parenteral nutrition regimen using Structolipid. From day 0 to day 5, patients will not to receive any food or liquid oral or enteral nutrition. The goal of treatment is to deliver 25kcal/kg/day, 1.05g/kg/day amino acids, and 1.1g/kg/day lipid. The weight of patient calculated as ideal body weight. The patients will be allowed water based on the clinical judgment of the Investigator. From day 6 through the remainder of the study treatment period, liquid oral or enteral nutrition could be added to the study treatment. The intent is to supply the total calculated daily nutritional requirement with study treatment plus liquid oral or enteral nutrition. Liquid oral or enteral nutrition will be increased daily, as tolerated by the patient, with a concurrent reduction in study treatment, while still supplying the calculated daily nutritional requirement. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- hospitalized ≤14 days before enrolment
- required parenteral nutrition
- had the capability to complete at least five days of study treatment;
- useable peripheral vein for parenteral nutrition;
- written informed consent.
Key exclusion criteria (12 listed)
- A life expectancy of <6 days;
- hypersensitivity to the study treatments;
- use of prohibited medications within 30 days before enrolment;
- serious clinically significant condition such as congestive heart failure or severe renal insufficiency;
- impaired hepatic function；
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 |
|---|---|---|
| ClinOleic (Baxter Healthcare, Deerfield, IL, USA)ClinOleic group: Patients using ClinOleic or Structolipid-based lipid parenteral nutrition regimen. From day 0 to day 5, the goal of treatment is to deliver 25kcal/kg/day, 1.05g/kg/day amino acids, and 1.1g/kg/day lipid. | Drug | ClinOleic group |
Primary outcome
biomarkers of liver functions
Time frame: 48 hours after operation.
Concentration of AST, ALT, TBIL, DBIL in the blood
3 secondary outcomes
markers of infection and inflammation
Time frame: 48 hours after operation.
Trenal function
Time frame: 48 hours after operation.
lipids and lipid upper derivatives
Time frame: 48 hours after operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ClinOleic (Baxter Healthcare, Deerfield, IL, USA) in people with Nutritional Supplement Toxicity, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 12 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 13 Aug 2019. 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Qiang Li, MD (+86 13505191133, liqiang020202@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biomarkers of liver functions (time frame: 48 hours after operation.). 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 13 Aug 2019.