- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02758834
Half-life of Plasma Phytosterols in Preterm Infants on Parenteral Nutrition
April 28, 2016 updated by: Virgilio Paolo Carnielli, Università Politecnica delle Marche
Half-life of Plasma Phytosterols in Very Low-birth-weight Preterm Infants on Routine Parenteral Nutrition With Soy-bean Oil Based Lipid Emulsions
The purpose of this study is to determine plasma phytosterols half-lives in preterm infants who received intravenous soy oil-based lipid emulsions.
Study Overview
Status
Completed
Conditions
Detailed Description
Several studies reported the relationship between plasma phytosterol concentrations and parenteral nutrition-associated cholestasis (PNAC).
Information on plasma phytosterols half-lives in very-low-birth-weight (VLBW) preterm infants on lipid parenteral nutrition (PN) are lacking.
In a prospective cohort study, plasma phytosterols (campesterol, stigmasterol and sitosterol) of VLBW preterm infants on routine PN will be measured by gas chromatography-mass spectrometry (GC-MS) during PN administration and after only lipid stopping.
Plasma phytosterols half-lives will be calculated from the monoexponential decay curves.
Blood samples will be weekly collected from 1st to 7th week of life during routine metabolic tolerance analysis or gas-analysis in order to avoid burden of additional phlebotomy.
Samples will be collected in ethylenediaminetetraacetic acid-tubes and immediately centrifugated.
Plasma will be stored in pyrogallol added-tubes at -20°C until analysis.
Saponification reaction will be done using 5-alpha-cholestane as internal standard.
Study Type
Observational
Enrollment (Actual)
45
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 months to 7 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Preterm infants (24 weeks < gestational age < 32 weeks; 500 g ≤ birth weight < 1250 g) who received intravenous soy oil-based lipid emulsions from the first hours of life.
Description
Inclusion Criteria:
- 24 weeks < gestational age < 32 weeks;
- 500 g ≤ birth weight < 1250 g;
- parenteral nutrition with soy oil-based lipid emulsions from the first hours of life;
- parental consent.
Exclusion Criteria:
- length of parenteral nutrition > 24 days;
- severe malformations;
- inborn errors of metabolism;
- severe congenital sepsis;
- liver dysfunctions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of plasma phytosterol concentrations in preterm infants during parenteral nutrition and after only lipid stopping.
Time Frame: 7, 14, 21, 28, 35, 42 and 49 days
|
Plasma campesterol, stigmasterol and sitosterol concentrations will be measured at 7, 14, 21, 28, 35, 42 and 49 days from PN started.
Plasma phytosterol concentrations will be measured by gas chromatography-mass spectrometry.
Calibration curves will be used to calculate the phytosterol plasma concentrations (mg/L).
|
7, 14, 21, 28, 35, 42 and 49 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Normal liver function of preterm infants will be define by conjugated bilirubin values from blood samples under 1 mg/dl.
Time Frame: 7 days and 42 days of life
|
Eligibility of preterm infants will be related to a normal liver function.
Conjugated bilirubin value from blood sample is a good sign of hepatic function.
The threshold value was defined to 1 mg/dl.
Preterm infants who will have conjugated bilirubin values more of 1 mg/dl will be excluded from the study.
The measure of conjugated bilirubin from blood samples will be routinely done at 7 and 42 days of life.
|
7 days and 42 days of life
|
Plasma phytosterols half-lives
Time Frame: After the collection of 3 or more blood samples collected when the lipid infusion is stopped.
|
Plasma phytosterol half-lives (days) will be measured using 3 or more plasma phytosterol concentrations calculated after only lipid stopping.
Half-life of plasma phytosterols will be calculated from monoexponential decay curves.
|
After the collection of 3 or more blood samples collected when the lipid infusion is stopped.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nghiem-Rao TH, Tunc I, Mavis AM, Cao Y, Polzin EM, Firary MF, Wang X, Simpson PM, Patel SB. Kinetics of phytosterol metabolism in neonates receiving parenteral nutrition. Pediatr Res. 2015 Aug;78(2):181-9. doi: 10.1038/pr.2015.78. Epub 2015 Apr 21.
- Bhattacharyya AK, Connor WE, Lin DS, McMurry MM, Shulman RS. Sluggish sitosterol turnover and hepatic failure to excrete sitosterol into bile cause expansion of body pool of sitosterol in patients with sitosterolemia and xanthomatosis. Arterioscler Thromb. 1991 Sep-Oct;11(5):1287-94. doi: 10.1161/01.atv.11.5.1287.
- Lin HJ, Wang C, Salen G, Lam KC, Chan TK. Sitosterol and cholesterol metabolism in a patient with coexisting phytosterolemia and cholestanolemia. Metabolism. 1983 Feb;32(2):126-33. doi: 10.1016/0026-0495(83)90216-0.
- Salen G, Tint GS, Shefer S, Shore V, Nguyen L. Increased sitosterol absorption is offset by rapid elimination to prevent accumulation in heterozygotes with sitosterolemia. Arterioscler Thromb. 1992 May;12(5):563-8. doi: 10.1161/01.atv.12.5.563.
- Ostlund RE Jr, McGill JB, Zeng CM, Covey DF, Stearns J, Stenson WF, Spilburg CA. Gastrointestinal absorption and plasma kinetics of soy Delta(5)-phytosterols and phytostanols in humans. Am J Physiol Endocrinol Metab. 2002 Apr;282(4):E911-6. doi: 10.1152/ajpendo.00328.2001.
- Pupillo D, Correani A, Biagetti C, D'Ascenzo R, Simonato M, Verlato G, Cogo P, Rocchi MBL, Carnielli VP. Half-life of plasma phytosterols in very low birth weight preterm infants on routine parenteral nutrition with vegetable oil-based lipid emulsions. Clin Nutr. 2018 Feb;37(1):262-269. doi: 10.1016/j.clnu.2016.12.022. Epub 2016 Dec 30.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
April 26, 2016
First Submitted That Met QC Criteria
April 28, 2016
First Posted (Estimate)
May 3, 2016
Study Record Updates
Last Update Posted (Estimate)
May 3, 2016
Last Update Submitted That Met QC Criteria
April 28, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DG-469
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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