Trial record 11 of 115 for:    Open Studies | parenteral nutrition

Essential Fatty Acid Status & Immune Function in Parenteral Nutrition Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by Radboud University
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Geert Wanten, Radboud University
ClinicalTrials.gov Identifier:
NCT01986153
First received: November 11, 2013
Last updated: November 17, 2013
Last verified: November 2013
  Purpose

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
Intestinal Failure

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical examination of clinical signs/symptoms of essential fatty acid deficiency [ Time Frame: On day of blood withdrawal ] [ Designated as safety issue: No ]
  • Immune function: expression of cell surface markers, stimulus-induced reactive oxygen species production, cytokine production by leukocytes [ Time Frame: On day of blood withdrawal ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01986153

Contacts
Contact: Geert Wanten, MD PhD MSc +31 24 3614760 Geert.Wanten@radboudumc.nl

Locations
Netherlands
Department of Gastroenterology and Hepatology Not yet recruiting
Nijmegen, Netherlands, 6525 GA
Contact: Geert Wanten, MD PhD MSc    +31 24 3614760    Geert.Wanten@radboudumc.nl   
Sponsors and Collaborators
Geert Wanten
Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Geert Wanten, MD, PhD, MSc, Radboud University
ClinicalTrials.gov Identifier: NCT01986153     History of Changes
Other Study ID Numbers: 2013/475
Study First Received: November 11, 2013
Last Updated: November 17, 2013
Health Authority: Netherlands: Independent Ethics Committee

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

ClinicalTrials.gov processed this record on August 19, 2014