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Essential Fatty Acid Status & Immune Function in Parenteral Nutrition Patients

NCT ID: NCT01986153

Last Updated: 2014-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-11-30

Brief Summary

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The purpose of this study is to determine if patients on long-term olive oil-based parenteral nutrition have an adequate essential fatty acid status and immune status, compared to age- and sex-matched healthy controls.

Detailed Description

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Patients, who suffer from severe chronic intestinal failure and whose nutritional intake cannot be met by oral food intake, have as their final option total parenteral nutrition, which contains all necessary macro- and micronutrients. Lipid emulsions are essential for these patients as they are a source of non glucose fuel calories, and they contain (essential) fatty acids which are important as structural component for many cells in the human body. Home parenteral nutrition patients are at risk for essential fatty acid deficiency. Data are lacking that indicate the optimal amount of essential fatty acids required for these patients. The latter seems especially relevant for patients receiving lipid prescriptions which are low in essential fatty acids, like ClinOleic®. Long-term parenteral nutrition dependent patients successfully use ClinOleic®. It is however unknown whether these patient remain to have an adequate essential fatty acid status in the long run.

Conditions

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Intestinal Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Home parenteral nutrition patients

Patients who receive home parenteral nutrition.

No interventions assigned to this group

Healthy controls

Those who don't receive home parenteral nutrition and consume a normal diet.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* home parenteral nutrition: at least 6 months with a minimum frequency of 5 times a week


* age and sex matched healthy volunteer

Exclusion Criteria

* active immune modulating (underlying) disease
* use of immune suppressives
* use of oral fish oil substrates
* smoking more than 5 cigarettes/day
* do not eat more than 5 portions of fatty fish per week

Healthy controls:


* active immune modulating (underlying) disease
* use of immune suppressives
* use of oral fish oil substrates
* smoking more than 5 cigarettes/day
* do not eat more than 5 portions of fatty fish per week
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Geert Wanten

OTHER

Sponsor Role lead

Responsible Party

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Geert Wanten

MD, PhD, MSc

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Gastroenterology and Hepatology

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2013/475

Identifier Type: -

Identifier Source: org_study_id