Effect of Parenteral Nutrition With n-3 PUFAs on Patients With Intestinal Failure
NCT ID: NCT03869957
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2019-12-01
2022-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of n-3 Polyunsaturated Fatty Acid Supplements in Patients With Non-alcoholic Fatty Liver Disease
NCT00819338
The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention
NCT02096757
Fish Oil for Patients With Liver Disease Due to Parenteral Nutrition
NCT01565278
Effects of N-3 Polyunsaturated Fatty Acids On Chylomicron Secretion And Expression Of Genes That Regulate Intestinal Lipid Metabolism In Men With Type 2 Diabetes
NCT01449773
Effects of a PUFA-rich Diet on Acute Metabolic and Inflammatory High-Fat Meal Responses
NCT02246933
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Although some studies have reported beneficial effects of n-3 PUFA to prevent and reverse the liver disease associated with IF (6-7), due to its antioxidant (8-10) and anti-inflammatory activity (11-12) and in the modulation of the intestinal microbiota (13), the literature on the use of n-3 PUFA in non-critical patients with IF and PN is limited and the results have not been conclusive.
Therefore, a randomized, double-blind, controlled clinical trial to evaluate the effect of PN supplemented with lipid emulsions containing n-3 PUFA/kg body weight/day for 7 days on oxidative stress (concentrations of MDA), compared with a control group (without n-3 PUFA) will be performed.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention group
We will use \~0.8-0.9 g/kg/day of Clinoleic® (80% olive oil/20 soybean oil) + 0.2-0.1 g/kg/day \[Omegaven® \](100% fish oil), to cover the proposed amount of n-3 PUFAs for 7 days. The infusion rate should not exceed 0.5 ml Omegaven® / kg body weight / hour = 0.05 g fish oil / kg body weight / hour. The intervention group will return to PN without n-3 PUFA after 7 days.
Intervention group
0.1-0.2 g n-3 PUFA/kg body weight/day for 7 days
Control group
Will be administering \~1.0 g/kg/d the lipid emulsion Clinoleic® (80% olive oil/20 soybean oil) without n-3 PUFAs.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intervention group
0.1-0.2 g n-3 PUFA/kg body weight/day for 7 days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with recent diagnosis of IF type II (an evolution \>28 days) originate from various gastrointestinal or systemic diseases (short bowel, intestinal fistula, intestinal dysmotility, mechanical obstruction, and extensive small bowel mucosal disease).
Exclusion Criteria
* Patients with known allergies to the components of the PN formula
* Severe liver or renal insufficiency
* Uncontrolled diabetes mellitus
* Certain acute and life-threatening conditions
* Immunological diseases (such as autoimmune diseases, human immunodeficiency virus infection, cancer, etc.)
* Those that take immunosuppressant medications
* Severe hemorrhagic disorders
* Pregnant or lactating
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Aurora Elizabeth Serralde Zúñiga
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Aurora E Serralde-Zúñiga, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Tlalpan, Mexico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Pironi L, Arends J, Baxter J, Bozzetti F, Pelaez RB, Cuerda C, Forbes A, Gabe S, Gillanders L, Holst M, Jeppesen PB, Joly F, Kelly D, Klek S, Irtun O, Olde Damink SW, Panisic M, Rasmussen HH, Staun M, Szczepanek K, Van Gossum A, Wanten G, Schneider SM, Shaffer J; Home Artificial Nutrition & Chronic Intestinal Failure; Acute Intestinal Failure Special Interest Groups of ESPEN. ESPEN endorsed recommendations. Definition and classification of intestinal failure in adults. Clin Nutr. 2015 Apr;34(2):171-80. doi: 10.1016/j.clnu.2014.08.017. Epub 2014 Sep 21.
Korpela K, Mutanen A, Salonen A, Savilahti E, de Vos WM, Pakarinen MP. Intestinal Microbiota Signatures Associated With Histological Liver Steatosis in Pediatric-Onset Intestinal Failure. JPEN J Parenter Enteral Nutr. 2017 Feb;41(2):238-248. doi: 10.1177/0148607115584388. Epub 2016 Sep 30.
Omata J, Pierre JF, Heneghan AF, Tsao FH, Sano Y, Jonker MA, Kudsk KA. Parenteral nutrition suppresses the bactericidal response of the small intestine. Surgery. 2013 Jan;153(1):17-24. doi: 10.1016/j.surg.2012.04.001. Epub 2012 Jun 13.
Cadenas S, Cadenas AM. Fighting the stranger-antioxidant protection against endotoxin toxicity. Toxicology. 2002 Oct 30;180(1):45-63. doi: 10.1016/s0300-483x(02)00381-5.
Lacaille F, Gupte G, Colomb V, D'Antiga L, Hartman C, Hojsak I, Kolacek S, Puntis J, Shamir R; ESPGHAN Working Group of Intestinal Failure and Intestinal Transplantation. Intestinal failure-associated liver disease: a position paper of the ESPGHAN Working Group of Intestinal Failure and Intestinal Transplantation. J Pediatr Gastroenterol Nutr. 2015 Feb;60(2):272-83. doi: 10.1097/MPG.0000000000000586.
Nandivada P, Fell GL, Gura KM, Puder M. Lipid emulsions in the treatment and prevention of parenteral nutrition-associated liver disease in infants and children. Am J Clin Nutr. 2016 Feb;103(2):629S-34S. doi: 10.3945/ajcn.114.103986. Epub 2016 Jan 20.
Burns DL, Gill BM. Reversal of parenteral nutrition-associated liver disease with a fish oil-based lipid emulsion (Omegaven) in an adult dependent on home parenteral nutrition. JPEN J Parenter Enteral Nutr. 2013 Mar;37(2):274-80. doi: 10.1177/0148607112450301. Epub 2012 Jun 8.
Ventro G, Chen M, Yang Y, Harmon CM. Molecular impact of omega 3 fatty acids on lipopolysaccharide-mediated liver damage. J Pediatr Surg. 2016 Jun;51(6):1039-43. doi: 10.1016/j.jpedsurg.2016.02.078. Epub 2016 Mar 2.
Wu G, Zhou W, Zhao J, Pan X, Sun Y, Xu H, Shi P, Geng C, Gao L, Tian X. Matrine alleviates lipopolysaccharide-induced intestinal inflammation and oxidative stress via CCR7 signal. Oncotarget. 2017 Feb 14;8(7):11621-11628. doi: 10.18632/oncotarget.14598.
Giordano E, Visioli F. Long-chain omega 3 fatty acids: molecular bases of potential antioxidant actions. Prostaglandins Leukot Essent Fatty Acids. 2014 Jan;90(1):1-4. doi: 10.1016/j.plefa.2013.11.002. Epub 2013 Dec 3.
Calder PC. Omega-3 fatty acids and inflammatory processes: from molecules to man. Biochem Soc Trans. 2017 Oct 15;45(5):1105-1115. doi: 10.1042/BST20160474. Epub 2017 Sep 12.
Osowska S, Kunecki M, Sobocki J, Tokarczyk J, Majewska K, Omidi M, Radkowski M, Fisk HL, Calder PC. Effect of changing the lipid component of home parenteral nutrition in adults. Clin Nutr. 2019 Jun;38(3):1355-1361. doi: 10.1016/j.clnu.2018.05.028. Epub 2018 Jun 6.
Laparra JM, Sanz Y. Interactions of gut microbiota with functional food components and nutraceuticals. Pharmacol Res. 2010 Mar;61(3):219-25. doi: 10.1016/j.phrs.2009.11.001. Epub 2009 Nov 13.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2846
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.