Essential Fatty Acid Status & Immune Function in Parenteral Nutrition Patients

Intestinal Failure Clinical Trial

Official title:

Essential Fatty Acid Status & Immune Function in Parenteral Nutrition Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986153
• Other study ID #: 2013/475
• Status: Completed
• Phase: N/A
• First received: November 11, 2013
• Last updated: November 11, 2014
• Start date: December 2013
• Est. completion date: November 2014

Study information

• Verified date: November 2013
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Intestinal Failure

Locations

Country	Name	City	State
Netherlands	Department of Gastroenterology and Hepatology	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Geert Wanten	Baxter Healthcare Corporation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		On day of blood withdrawal	No
Secondary	Physical examination of clinical signs/symptoms of essential fatty acid deficiency		On day of blood withdrawal	No
Secondary	Immune function: expression of cell surface markers, stimulus-induced reactive oxygen species production, cytokine production by leukocytes		On day of blood withdrawal	No