Half-life of Plasma Phytosterols in Preterm Infants on Parenteral Nutrition

NCT02758834 | Completed

• 1 other identifier: DG-469
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine plasma phytosterols half-lives in preterm infants who received intravenous soy oil-based lipid emulsions.

Conditions

Liver Diseases

Keywords

Preterm Infants; Phytosterols; Parenteral Nutrition

Outcome Measures

Primary Outcomes (1)

• Change of plasma phytosterol concentrations in preterm infants during parenteral nutrition and after only lipid stopping.

  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 Outcomes (2)

• Normal liver function of preterm infants will be define by conjugated bilirubin values from blood samples under 1 mg/dl.

  7 days and 42 days of life

• Plasma phytosterols half-lives

  After the collection of 3 or more blood samples collected when the lipid infusion is stopped.

Eligibility Criteria

• Age: 24 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• weeks \< gestational age \< 32 weeks;
• g ≤ birth weight \< 1250 g;
• parenteral nutrition with soy oil-based lipid emulsions from the first hours of life;
• parental consent.

You may not qualify if:

• length of parenteral nutrition \> 24 days;
• severe malformations;
• inborn errors of metabolism;
• severe congenital sepsis;
• liver dysfunctions.

Sponsors & Collaborators

• Università Politecnica delle Marche: lead

Related Publications (6)

• 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: 25897540 BACKGROUND

• 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: 1911714 BACKGROUND

• 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: 6827984 BACKGROUND

• 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: 11882512 BACKGROUND

• 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: 1576118 BACKGROUND

• 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.

  PMID: 28063717 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma.

MeSH Terms

Conditions

Liver Diseases; Hyperphagia

Condition Hierarchy (Ancestors)

Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Virgilio P. Carnielli, MD, PhD

  Università Politecnica delle Marche

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Phd

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: May 3, 2016
• Study Start: January 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 3, 2016

Record last verified: 2016-04