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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01986153
Other study ID # 2013/475
Secondary ID
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


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
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