Status unknownNCT03901937ω3CDUpdated Apr 3, 2019

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

A Phase 4 interventional study of ω-3 polyunsaturated fatty acid and Intestinal surgery for Crohn's Disease in Crohn Disease, sponsored by Sir Run Run Shaw Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-04-03.

Sponsored by Sir Run Run Shaw Hospital · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 4
Study type: Interventional
Enrollment: 158
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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 studied

Crohn Disease

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Keywords

postoperative complications

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's planned enrollment of 158 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Sir Run Run Shaw Hospital is the lead sponsor of 123 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 158 participants (estimated)

Study arms

Placebo comparator
Placebo
parenteral nutrition without ω-3 polyunsaturated fatty acid
Drug: ω-3 polyunsaturated fatty acid · Procedure: Intestinal surgery for Crohn's Disease
Experimental
ω-3 fatty acid
parenteral nutrition with ω-3 polyunsaturated fatty acid
Procedure: Intestinal surgery for Crohn's Disease

Interventions

Drugω-3 polyunsaturated fatty acid
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%
ProcedureIntestinal surgery for Crohn's Disease
Patients receive bowel resection due to complications of Crohn's Disease

What researchers measure

Primary outcomes

Rate of Postoperative complications
postoperative complications after surgery for Crohn's Disease according to clavien-dindo system
Time frame: postoperative 1-30 days

Secondary outcomes

Length of postoperative hospital stay
postoperative hospital stay after surgery for Crohn's Disease
Time frame: from surgery to discharge
Blood Concentration of IL-6
Blood Concentration of IL-6 after surgery
Time frame: postoperative 1, 3, and 6 day
Blood Concentration of TNF-α
Blood Concentration of TNF-α after surgery
Time frame: postoperative 1, 3, and 6 day
Blood Concentration of IL-1β
Blood Concentration of IL-1β after surgery
Time frame: postoperative 1, 3, and 6 day
Blood Concentration of albumin
Blood Concentration of albumin after surgery
Time frame: postoperative 1, 3, and 6 day
Blood Concentration of C-reactive protein
Blood Concentration of C-reactive protein after surgery
Time frame: postoperative 1, 3, and 6 day
Blood White blood cell level
Blood White blood cell level after surgery
Time frame: postoperative 1, 3, and 6 day

Study locations

1 of 1 sites recruiting

Sir Run Run Shaw hospital
Hangzhou, Zhejiang 310016, China
- Xiaolong Ge, PhD · Contact · gxlnjumed09@126.com · 13867106984
Recruiting

References and documents

Individual participant data

Plan to share: No — Data collection from 2019-3 to 2020-9

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03901937
Lead sponsor: Sir Run Run Shaw Hospital
Responsible party: Wei Zhou (Clinical Professor, Sir Run Run Shaw Hospital) — Principal investigator
First posted: Apr 3, 2019
Start date: Mar 1, 2019
Primary completion: Sep 1, 2020 (estimated)
Completion: Mar 1, 2021 (estimated)
Last update: Apr 3, 2019

Study contacts

Wei Zhou, MD PHD

Contact

zhouw@srrsh.com

13588706479

Xiujun Cai

study chair · Sir Run Run Shaw Hospital

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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