Plasma Citrulline Level in Relation to Absorptive Surface

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT00286039

First received: February 1, 2006

Last updated: September 29, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 1, 2006

Last Updated Date

September 29, 2011

Start Date ^ICMJE

August 2005

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Correlation between determination of citrulline in plasma or dried blood [ Time Frame: Untill end of study ] [ Designated as safety issue: No ]
Reference ranges for healthy children and babies [ Time Frame: Until end of study ] [ Designated as safety issue: No ]
Longitudinal follow-up of citrulline in preterm babies [ Time Frame: Untill end of study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Correlation between determination of citrulin on plasma or dried blood
Develoment of reference ranges for healthy children and babies
Longitudinal follow-up of citrulin of preterm babies
Study to compare the biochrom amino acids analyser and the LC-MSMS regarding the reproducibility and costs

Change History

Complete list of historical versions of study NCT00286039 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Plasma Citrulline Level in Relation to Absorptive Surface

Official Title ^ICMJE

Plasma Citrulline Level in Relation to Absorptive Surface

Brief 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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Intestinal "Failure"

Intervention ^ICMJE

Procedure: Blood sampling

Blood sampling is used.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

200

Completion Date

September 2010

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

0-18 years
preterm babies up to 1.500g
preterm babies over 1.500g

Exclusion Criteria:

gastro-intestinal problems (except for the preterm babies)
congenital metabolic disorders
dysfunction of the liver or kidneys
congenital defects

Gender

Both

Ages

up to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT00286039

Other Study ID Numbers ^ICMJE

2005/163

Has Data Monitoring Committee

Responsible Party

University Hospital, Ghent

Study Sponsor ^ICMJE

University Hospital, Ghent

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Eddy Robberecht, MD, PhD

University Hospital, Ghent

Information Provided By

University Hospital, Ghent

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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