Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-02-26 @ 10:30 PM
Study NCT ID:
NCT02758834
Status:
COMPLETED
Last Update Posted:
2016-05-03
First Post:
2016-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Half-life of Plasma Phytosterols in Preterm Infants on Parenteral Nutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-28', 'studyFirstSubmitDate': '2016-04-26', 'studyFirstSubmitQcDate': '2016-04-28', 'lastUpdatePostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of plasma phytosterol concentrations in preterm infants during parenteral nutrition and after only lipid stopping.', 'timeFrame': '7, 14, 21, 28, 35, 42 and 49 days', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Normal liver function of preterm infants will be define by conjugated bilirubin values from blood samples under 1 mg/dl.', 'timeFrame': '7 days and 42 days of life', 'description': '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.'}, {'measure': 'Plasma phytosterols half-lives', 'timeFrame': 'After the collection of 3 or more blood samples collected when the lipid infusion is stopped.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Preterm Infants', 'Phytosterols', 'Parenteral Nutrition'], 'conditions': ['Liver Diseases']}, 'referencesModule': {'references': [{'pmid': '25897540', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '1911714', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '6827984', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11882512', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '1576118', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28063717', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine plasma phytosterols half-lives in preterm infants who received intravenous soy oil-based lipid emulsions.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '32 Weeks', 'minimumAge': '24 Weeks', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 24 weeks \\< gestational age \\< 32 weeks;\n* 500 g ≤ birth weight \\< 1250 g;\n* parenteral nutrition with soy oil-based lipid emulsions from the first hours of life;\n* parental consent.\n\nExclusion Criteria:\n\n* length of parenteral nutrition \\> 24 days;\n* severe malformations;\n* inborn errors of metabolism;\n* severe congenital sepsis;\n* liver dysfunctions.'}, 'identificationModule': {'nctId': 'NCT02758834', 'briefTitle': 'Half-life of Plasma Phytosterols in Preterm Infants on Parenteral Nutrition', 'organization': {'class': 'OTHER', 'fullName': 'Università Politecnica delle Marche'}, 'officialTitle': 'Half-life of Plasma Phytosterols in Very Low-birth-weight Preterm Infants on Routine Parenteral Nutrition With Soy-bean Oil Based Lipid Emulsions', 'orgStudyIdInfo': {'id': 'DG-469'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Virgilio P. Carnielli, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università Politecnica delle Marche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università Politecnica delle Marche', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Phd', 'investigatorFullName': 'Virgilio Paolo Carnielli', 'investigatorAffiliation': 'Università Politecnica delle Marche'}}}}