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Essential Fatty Acid Status & Immune Function in Parenteral Nutrition Patients

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ClinicalTrials.gov Identifier: NCT01986153
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : November 13, 2014
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Geert Wanten, Radboud University

Brief Summary:
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.

Condition or disease
Intestinal Failure

Detailed Description:
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.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Essential Fatty Acid Status & Immune Function in Parenteral Nutrition Patients
Study Start Date : December 2013
Primary Completion Date : November 2014
Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Home parenteral nutrition patients
Patients who receive home parenteral nutrition.
Healthy controls
Those who don't receive home parenteral nutrition and consume a normal diet.



Primary Outcome Measures :
  1. Essential fatty acid status of plasma phospholipids and peripheral blood mononuclear cells, including the biochemical determination of the Holman index (ratio of mead acid/ arachidonic acid) [ Time Frame: On day of blood withdrawal ]

Secondary Outcome Measures :
  1. Physical examination of clinical signs/symptoms of essential fatty acid deficiency [ Time Frame: On day of blood withdrawal ]
  2. Immune function: expression of cell surface markers, stimulus-induced reactive oxygen species production, cytokine production by leukocytes [ Time Frame: On day of blood withdrawal ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Long-term parenteral nutrition dependent patients:Patients who visit the outpatient clinic of the Department of Gastroenterology and Hepatology at the Radboud University Medical Nijmegen Center.

Healthy controls: volunteers who are residents in the Netherlands.

Criteria

Home parenteral nutrition patients:

Inclusion Criteria:

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

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:

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986153


Locations
Netherlands
Department of Gastroenterology and Hepatology
Nijmegen, Netherlands, 6525 GA
Sponsors and Collaborators
Geert Wanten
Baxter Healthcare Corporation

Responsible Party: Geert Wanten, MD, PhD, MSc, Radboud University
ClinicalTrials.gov Identifier: NCT01986153     History of Changes
Other Study ID Numbers: 2013/475
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: November 13, 2014
Last Verified: November 2013

Keywords provided by Geert Wanten, Radboud University:
Fatty acid, essential
Immune system
Home parenteral nutrition