Crohn DiseasePhase 4ω3CDNCT03901937
The Effects of Parenteral ω-3 Polyunsaturated Fatty Acid on Postoperative Complications of Patients With Crohn's Disease
A Phase 4 study testing ω-3 polyunsaturated fatty acid and Intestinal surgery for Crohn's Disease in people with Crohn Disease, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- ω-3 polyunsaturated fatty acid and Intestinal surgery for Crohn's Disease
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 1 Mar 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shaw hospital
Hangzhou, Zhejiang, 310016
Xiaolong Ge, PhD, 13867106984, gxlnjumed09@126.com
About this study
Official title: Department of General Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310016, China
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
- Being tested
- ω-3 polyunsaturated fatty acid, Intestinal surgery for Crohn's Disease
- Keywords
- postoperative complications
- Medical subject headings
- Crohn Disease, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ω-3 polyunsaturated fatty acidDrug
Also called Omegaven®10%
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).
Intestinal surgery for Crohn's DiseaseProcedure or surgery
Patients receive bowel resection due to complications of Crohn's Disease
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | parenteral nutrition without ω-3 polyunsaturated fatty acid Receives: 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 Receives: Procedure: Intestinal surgery for Crohn's Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Postoperative complications
postoperative complications after surgery for Crohn's Disease according to clavien-dindo system
Measured: postoperative 1-30 days
Secondary outcomes (7)
Length of postoperative hospital stay
postoperative hospital stay after surgery for Crohn's Disease
Measured: from surgery to discharge
Blood Concentration of IL-6
Blood Concentration of IL-6 after surgery
Measured: postoperative 1, 3, and 6 day
Blood Concentration of TNF-α
Blood Concentration of TNF-α after surgery
Measured: postoperative 1, 3, and 6 day
Blood Concentration of IL-1β
Blood Concentration of IL-1β after surgery
Measured: postoperative 1, 3, and 6 day
Blood Concentration of albumin
Blood Concentration of albumin after surgery
Measured: postoperative 1, 3, and 6 day
Blood Concentration of C-reactive protein
Blood Concentration of C-reactive protein after surgery
Measured: postoperative 1, 3, and 6 day
Blood White blood cell level
Blood White blood cell level after surgery
Measured: postoperative 1, 3, and 6 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start1 Mar 2019
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhou, Sir Run Run Shaw Hospital
- Investigators
- Xiujun Cai, Study chair, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901937
- Sponsor's protocol ID
- SRRSH20180925-8
- Acronym
- ω3CD
- Status last verified
- Apr 2019
- First submitted
- 12 Mar 2019
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data collection from 2019-3 to 2020-9
Publications
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.
PubMed 38569774
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of General Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310016, China
- ClinicalTrials.gov ID
- NCT03901937
- Acronym / sponsor ID
- ω3CD / SRRSH20180925-8
- Conditions
- Crohn Disease
- Keywords
- postoperative complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: ω-3 polyunsaturated fatty acid, Procedure: Intestinal surgery for Crohn's Diseaseparenteral nutrition without ω-3 polyunsaturated fatty acid |
| ω-3 fatty acid | Experimental | Procedure: Intestinal surgery for Crohn's Diseaseparenteral nutrition with ω-3 polyunsaturated fatty acid |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Emergency surgery;
- With severe comorbidity and/or organ (kidney,liver,or heart) dysfunction;
- Incomplete laboratory data;
- With parenteral nutrition before surgery;
- Pregnant;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ω-3 polyunsaturated fatty acidAlso: Omegaven®10%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). | Drug | Placebo |
| Intestinal surgery for Crohn's DiseasePatients receive bowel resection due to complications of Crohn's Disease | Procedure or surgery | Placebo, ω-3 fatty acid |
Primary outcome
Rate of Postoperative complications
Time frame: postoperative 1-30 days
postoperative complications after surgery for Crohn's Disease according to clavien-dindo system
7 secondary outcomes
Length of postoperative hospital stay
Time frame: from surgery to discharge
Blood Concentration of IL-6
Time frame: postoperative 1, 3, and 6 day
Blood Concentration of TNF-α
Time frame: postoperative 1, 3, and 6 day
Blood Concentration of IL-1β
Time frame: postoperative 1, 3, and 6 day
Blood Concentration of albumin
Time frame: postoperative 1, 3, and 6 day
Blood Concentration of C-reactive protein
Time frame: postoperative 1, 3, and 6 day
Blood White blood cell level
Time frame: postoperative 1, 3, and 6 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Derived from this study: PubMed 38569774Ge 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.
- Individual participant dataSharing planned: No. Data collection from 2019-3 to 2020-9
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiujun Cai study chair
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ω-3 polyunsaturated fatty acid and Intestinal surgery for Crohn's Disease in people with Crohn Disease, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhou, MD PHD (13588706479, zhouw@srrsh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Postoperative complications (time frame: postoperative 1-30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03901937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.