Intestinal FailureNCT01986153
Essential Fatty Acid Status & Immune Function in Parenteral Nutrition Patients
An observational study of Intestinal Failure, run by Geert Wanten at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Failure
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2013to Nov 2014
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- home parenteral nutrition: at least 6 months with a minimum frequency of 5 times a week
- age and sex matched healthy volunteer
Who cannot join
- 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:
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Gastroenterology and Hepatology
Nijmegen, 6525 GA
About this study
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.
Read the 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.
- Conditions
- Intestinal Failure
- Keywords
- Fatty acid, essential, Immune system, Home parenteral nutrition
- Medical subject headings
- Intestinal Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: On day of blood withdrawal
Secondary outcomes (2)
Physical examination of clinical signs/symptoms of essential fatty acid deficiency
Measured: On day of blood withdrawal
Immune function: expression of cell surface markers, stimulus-induced reactive oxygen species production, cytokine production by leukocytes
Measured: On day of blood withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Geert Wanten
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor-investigator, Geert Wanten, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986153
- Sponsor's protocol ID
- 2013/475
- Status last verified
- Nov 2013
- First submitted
- 11 Nov 2013
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Essential Fatty Acid Status & Immune Function in Parenteral Nutrition Patients
- ClinicalTrials.gov ID
- NCT01986153
- Acronym / sponsor ID
- 2013/475
- Conditions
- Intestinal Failure
- Keywords
- Fatty acid, essential, Immune system, Home parenteral nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Geert WantenUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Dec 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 18 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- home parenteral nutrition: at least 6 months with a minimum frequency of 5 times a week
- age and sex matched healthy volunteer
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Physical examination of clinical signs/symptoms of essential fatty acid deficiency
Time frame: On day of blood withdrawal
Immune function: expression of cell surface markers, stimulus-induced reactive oxygen species production, cytokine production by leukocytes
Time frame: On day of blood withdrawal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Failure, run by Geert Wanten at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2014; AzTrials last refreshed its copy on 6 Nov 2026.