NCT03869957

Brief Summary

Randomized, double-blind, controlled clinical trial to evaluate the effect of parenteral nutrition (PN) supplemented with lipid emulsions containing 0.1-0.2 g omega 3 polyunsaturated fatty acids (n-3 PUFA)/kg body weight/day for 7 days on malondialdehyde (MDA) levels, a marker of lipoperoxidation of reactive species, compared with a control group (without n-3 PUFA) in patients with intestinal failure (IF).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

2.4 years

First QC Date

February 25, 2019

Last Update Submit

September 22, 2025

Conditions

Intestinal Failure

Keywords

omega 3 polyunsaturated fatty acidsintestinal failureoxidative stress

Outcome Measures

Primary Outcomes (1)

  • Change of malondialdehyde (MDA) in serum from baseline to day 7

    Measurement of malondialdehyde (MDA) that is a marker for oxidative stress, determined in serum in ng/dl.

    Change from baseline (day 0) at day 7

Secondary Outcomes (36)

  • Change of glutathione (GSH) in plasma from baseline to day 7

    Change from baseline (day 0) at day 7

  • Change of oxidized glutathione (GSSG) in plasma from baseline to day 7

    Change from baseline (day 0) at day 7

  • Change of GSH/GSSG ratio from baseline to day 7

    Change from baseline (day 0) at day 7

  • Change of carbonylated protein in serum from baseline to day 7.

    Change from day 0 at day 7.

  • Change of lipopolysaccharide (LPS) in serum from baseline to day 7.

    Change from baseline (day 0) at day 7

  • +31 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Dietary Supplement: Intervention group

Control group

NO INTERVENTION

Will be administering \~1.0 g/kg/d the lipid emulsion Clinoleic® (80% olive oil/20 soybean oil) without n-3 PUFAs.

Interventions

Intervention groupDIETARY_SUPPLEMENT

0.1-0.2 g n-3 PUFA/kg body weight/day for 7 days

Also known as: n-3 PUFAs
Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted in the non-critical areas of the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ) with a nutritional risk between January 2019 and July 2020 will be considered eligible.
  • 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).

You may not qualify if:

  • Patients with contraindications for PN
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Tlalpan, 14080, Mexico

Location

Related Publications (13)

  • 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.

    PMID: 25311444RESULT

  • 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.

    PMID: 25934046RESULT

  • 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.

    PMID: 22698933RESULT

  • 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.

    PMID: 12324199RESULT

  • 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.

    PMID: 25272324RESULT

  • 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.

    PMID: 26791189RESULT

  • 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.

    PMID: 22683685RESULT

  • 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.

    PMID: 27072665RESULT

  • 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.

    PMID: 28086227RESULT

  • 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.

    PMID: 24345866RESULT

  • 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.

    PMID: 28900017RESULT

  • 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.

    PMID: 29907355RESULT

  • 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.

    PMID: 19914380RESULT

MeSH Terms

Conditions

Intestinal Failure

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Aurora E Serralde-Zúñiga, MD, PhD

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
A team researcher will use Stata 12, to perform randomization with a 1:1 allocation using random block sizes of 4. Once the treatment group is determined, the PN will be prescribed accordingly and the preparation will be carried out in the pharmacy and it will have the same appearance in both arms. Patients and researchers who will evaluate the outcomes and perform the statistical analysis will be blinded to the assigned group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, double-blind, controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 25, 2019

First Posted

March 11, 2019

Study Start

December 1, 2019

Primary Completion

May 1, 2022

Study Completion

June 30, 2022

Last Updated

September 25, 2025

Record last verified: 2025-09

Locations

ME(1)