Essential Fatty Acid Status & Immune Function in Parenteral Nutrition Patients
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2013
CompletedFirst Posted
Study publicly available on registry
November 18, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedNovember 13, 2014
November 1, 2013
11 months
November 11, 2013
November 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
On day of blood withdrawal
Secondary Outcomes (2)
Physical examination of clinical signs/symptoms of essential fatty acid deficiency
On day of blood withdrawal
Immune function: expression of cell surface markers, stimulus-induced reactive oxygen species production, cytokine production by leukocytes
On day of blood withdrawal
Study Arms (2)
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.
Eligibility Criteria
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.
You may qualify if:
- home parenteral nutrition: at least 6 months with a minimum frequency of 5 times a week
You may not qualify if:
- 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:
- age and sex matched healthy volunteer
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Geert Wantenlead
- Baxter Healthcare Corporationcollaborator
Study Sites (1)
Department of Gastroenterology and Hepatology
Nijmegen, 6525 GA, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD, MSc
Study Record Dates
First Submitted
November 11, 2013
First Posted
November 18, 2013
Study Start
December 1, 2013
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
November 13, 2014
Record last verified: 2013-11