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Immune Modulation by Parenteral Fish Oil in Patients With Crohn's Disease

NCT02349594 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2015-11-10

No results posted yet for this study

Summary

To evaluate the effects of infusion of a Fish oil-based lipid emulsion on TNF-α production and other relevant immune functions. A soybean oil emulsion, rich in the omega-6 polyunsaturated fatty acid linoleic acid, will serve as control.

Conditions

  • Crohn Disease

Interventions

DRUG

Omegaven 10%

intravenous administration 10% (w/v) fish oil emulsion (Omegaven) for 1 hour on three consecutive days at a dose of 0.2 g/kg bodyweight/hr.

DRUG

Intralipid 20%

intravenous administration of 20% (w/v) lipid-control (Intralipid®), for 1 hour on three consecutive days at a dose of 0.2 g/kg bodyweight/hr.

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • G. Wanten, MD, PhD · Radboud University Nijmegen Medical Center

  • F. Hoentjen, MD, PhD · Radboud University Nijmegen Medical Center

  • D de Jong, MD, PhD · Radboud University Nijmegen Medical Center

  • P. Calder, MD, PhD · University Hospital Southampton NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-05-31
Completion
2015-09-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02349594 on ClinicalTrials.gov