Nutritional Supplement Toxicity Clinical Trial
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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; - 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. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Nanjing Medical University | Nanjing |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital with Nanjing Medical University | Baxter Healthcare Corporation |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | biomarkers of liver functions | Concentration of AST, ALT, TBIL, DBIL in the blood | 48 hours after operation. | |
Secondary | markers of infection and inflammation | Concentration of CRP, PCT in the blood | 48 hours after operation. | |
Secondary | Trenal function | Concentration of Crea, Urea in the blood | 48 hours after operation. | |
Secondary | lipids and lipid upper derivatives | Concentration of arachidonic acid, eicosapentaenoic acid, linoleic acid, oleic acid in the blood | 48 hours after operation. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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