Intestinal FailureNCT00286039
Plasma Citrulline Level in Relation to Absorptive Surface
A study testing Blood sampling in people with Intestinal Failure, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Correlation between determination of citrulline in plasma or dried blood Reference ranges for healthy children and babies Longitudinal follow-up of citrulline in preterm babies Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Intestinal Failure
- What is being tested?
- Blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2005to Sep 2010
- Phase
- Interventional
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 0-18 years
- preterm babies up to 1.500g
- preterm babies over 1.500g
Who cannot join
- gastro-intestinal problems (except for the preterm babies)
- congenital metabolic disorders
- dysfunction of the liver or kidneys
- congenital defects
Trial locations and contacts
1 site in 1 country.
About this study
Correlation between determination of citrulline in plasma or dried blood
Reference ranges for healthy children and babies
Longitudinal follow-up of citrulline in preterm babies
- Conditions
- Intestinal Failure
- Being tested
- Blood sampling
- Medical subject headings
- Intestinal Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
Blood sampling is used.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between determination of citrulline in plasma or dried blood
Measured: Untill end of study
Reference ranges for healthy children and babies
Measured: Until end of study
Longitudinal follow-up of citrulline in preterm babies
Measured: Untill end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startAug 2005
- Primary completionSep 2010
- Study completionSep 2010
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eddy Robberecht, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286039
- Sponsor's protocol ID
- 2005/163
- Status last verified
- Jul 2021
- First submitted
- 1 Feb 2006
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Citrulline Level in Relation to Absorptive Surface
- ClinicalTrials.gov ID
- NCT00286039
- Acronym / sponsor ID
- 2005/163
- Conditions
- Intestinal Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 2 Feb 2006 (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.
Correlation between determination of citrulline in plasma or dried blood
Reference ranges for healthy children and babies
Longitudinal follow-up of citrulline in preterm babies
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 0-18 years
- preterm babies up to 1.500g
- preterm babies over 1.500g
Key exclusion criteria (4 listed)
- gastro-intestinal problems (except for the preterm babies)
- congenital metabolic disorders
- dysfunction of the liver or kidneys
- congenital defects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood sampling is used. | Procedure or surgery | – |
Primary outcome
Correlation between determination of citrulline in plasma or dried blood
Time frame: Untill end of study
Reference ranges for healthy children and babies
Time frame: Until end of study
Longitudinal follow-up of citrulline in preterm babies
Time frame: Untill end of study
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 Jul 2021.
- Website University Hospital GhentLink provided by the sponsor.
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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.
Eddy Robberecht, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Intestinal Failure, run by University Hospital, Ghent at 1 site in Belgium.
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 3 inclusion and 4 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 Jul 2021. 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 Belgium. 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?
Correlation between determination of citrulline in plasma or dried blood (time frame: Untill end of study). The study lists 3 primary outcomes in all. 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 Jul 2021.