NCT02349594

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2014

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

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 16, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

1.3 years

First QC Date

January 16, 2015

Last Update Submit

November 9, 2015

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

  • Change of TNF-α production in pg/ml

    whole blood cultures are stimulated with 1 ng/ml lipopolysaccharide for 4 hours. TNF-alpha levels are measured in the supernatant with an enzyme-linked immunosorbent assay. Differences are compared by paired t-test or wilcoxon signed rank test.

    day 0 and day 4

Secondary Outcomes (10)

  • short term change in leukocyte functions

    day 0 and day 4

  • long term change in leukocyte functions

    day 0 and day 11

  • change in Oxygen radical production by neutrophils

    day 0 and day 4

  • change in Oxygen radical production by neutrophils

    day 0 and day 11

  • short term effects on in cytokine production

    day 0 and day 4

  • +5 more secondary outcomes

Study Arms (2)

treatment order A

ACTIVE COMPARATOR

Participants in this arm first receive 'Omegaven 10%' and after crossing over the 'Intralipid 20%'

Drug: Omegaven 10%Drug: Intralipid 20%

treament order B

ACTIVE COMPARATOR

Participants in this arm first receive 'Intralipid 20%' and after crossing over the 'Omegaven 10%'

Drug: Omegaven 10%Drug: Intralipid 20%

Interventions

Omegaven 10%DRUG

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.

Also known as: fish oil, N-3 polyunsaturated fatty acids atty acids
treament order Btreatment order A
Intralipid 20%DRUG

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.

Also known as: soybean oil, N-6 polyunsaturated fatty acids atty acids
treament order Btreatment order A

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with Crohn's disease with previous bowel surgery, currently in remission (without the need for immunosuppressive drugs) and with a high inherent TNF-α production.

You may not qualify if:

  • Patients with other active inflammatory / immune mediated underlying diseases
  • Smoking \> 5 cigarettes a day
  • Diet with \>2 portions of fatty fish (tuna, salmon, mackerel, herring, and trout) a week
  • History of metabolic disorder (especially diabetes or lipid disorders)
  • Crohn's disease activity, including the presence of active fistulas
  • On need for medical (other than 5-aminosalicylic acid preparations) or surgical treatment for Crohn's disease activity
  • Use of non-steroidal anti-inflammatory drugs or aspirin
  • C-reactive protein levels of \>10 mg/l
  • History of venous or arterial thrombosis
  • Active malignancy
  • Presence of severe pulmonary, cardiovascular, renal, liver, coagulation or hematological disease
  • Pregnancy or lactation
  • Age \<18 yrs
  • Allergy for one of the following components: fish, chicken, eggs or soy beans

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Center

Nijmegen, 6525 GA, Netherlands

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Fish OilsSoybean Oil

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

OilsLipidsDietary Fats, UnsaturatedDietary FatsFatsFats, UnsaturatedPlant OilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • G. Wanten, MD, PhD

    Radboud University Nijmegen Medical Center

    STUDY DIRECTOR

  • F. Hoentjen, MD, PhD

    Radboud University Nijmegen Medical Center

    PRINCIPAL INVESTIGATOR

  • D de Jong, MD, PhD

    Radboud University Nijmegen Medical Center

    PRINCIPAL INVESTIGATOR

  • P. Calder, MD, PhD

    University Hospital Southampton NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2015

First Posted

January 29, 2015

Study Start

January 1, 2014

Primary Completion

May 1, 2015

Study Completion

September 1, 2015

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations

NL(1)