The Effects of Parenteral ω-3 Polyunsaturated Fatty Acid on Postoperative Complications of Patients With Crohn's Disease

NCT03901937 | Unknown Phase 4 DMC

• 1 other identifier: SRRSH20180925-8
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intended to investigate the safety and efficacy of ω-3 polyunsaturated fatty acid-based parenteral nutrition (PN) for patients with Crohn's disease.

Conditions

Crohn Disease

Keywords

postoperative complications

Outcome Measures

Primary Outcomes (1)

• Rate of Postoperative complications

  postoperative complications after surgery for Crohn's Disease according to clavien-dindo system

  postoperative 1-30 days

Secondary Outcomes (7)

• Length of postoperative hospital stay

  from surgery to discharge

• Blood Concentration of IL-6

  postoperative 1, 3, and 6 day

• Blood Concentration of TNF-α

  postoperative 1, 3, and 6 day

• Blood Concentration of IL-1β

  postoperative 1, 3, and 6 day

• Blood Concentration of albumin

  postoperative 1, 3, and 6 day

Study Arms (2)

Placebo

PLACEBO COMPARATOR

parenteral nutrition without ω-3 polyunsaturated fatty acid

Drug: ω-3 polyunsaturated fatty acid; Procedure: Intestinal surgery for Crohn's Disease

ω-3 fatty acid

EXPERIMENTAL

parenteral nutrition with ω-3 polyunsaturated fatty acid

Procedure: Intestinal surgery for Crohn's Disease

Interventions

ω-3 polyunsaturated fatty acid DRUG

CD patients are divided into two groups, which include with and without ω-3 polyunsaturated fatty acid-based PN (0.1-0.2g/kg/d).

Also known as: Omegaven®10%

Placebo

Intestinal surgery for Crohn's Disease PROCEDURE

Patients receive bowel resection due to complications of Crohn's Disease

Placebo; ω-3 fatty acid

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis as Crohn's disease according to definition;
• Bowel resection;
• With parenteral nutrition at least 5 days
• years old\<age\<75 years old;
• Sign the informed consent.

You may not qualify if:

• Emergency surgery;
• With severe comorbidity and/or organ (kidney,liver,or heart) dysfunction;
• Incomplete laboratory data;
• With parenteral nutrition before surgery;
• Pregnant;
• Allergy of ω-3 polyunsaturated fatty acid.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw hospital

Hangzhou, Zhejiang, 310016, China

RECRUITING

Related Publications (1)

• Ge X, Liu H, Wu Y, Liu W, Qi W, Ye L, Cao Q, Lian H, Bai R, Zhou W. Parenteral n-3 polyunsaturated fatty acids supplementation improves postoperative recovery for patients with Crohn's disease after bowel resection: a randomized, unblinded controlled clinical trial. Am J Clin Nutr. 2024 Apr;119(4):1027-1035. doi: 10.1016/j.ajcnut.2023.12.022. Epub 2024 Feb 19.

  PMID: 38569774 DERIVED

MeSH Terms

Conditions

Crohn Disease; Postoperative Complications

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiujun Cai

  Sir Run Run Shaw Hospital

  STUDY CHAIR

Central Study Contacts

Wei Zhou, MD PHD

CONTACT

13588706479; zhouw@srrsh.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: April 3, 2019
• Study Start: March 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: March 1, 2021
• Last Updated: April 3, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)