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Study of the Relationship Between Glycogen Storage Disease Type Ia and Inflammatory Bowel Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01854242
Recruitment Status : Completed
First Posted : May 15, 2013
Results First Posted : December 18, 2014
Last Update Posted : February 20, 2019
Sponsor:
Collaborator:
Prometheus Laboratories
Information provided by (Responsible Party):
University of Florida

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Inflammatory Bowel Disease
Glycogen Storage Disease Type Ia
Intervention Other: Glycogen Storage Disease type Ia patients
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Glycogen Storage Disease Type Ia Patients
Hide Arm/Group Description The participants will have one blood draw for this study. The test will be performed on the blood.
Period Title: Overall Study
Started 50
Completed 50
Not Completed 0
Arm/Group Title Glycogen Storage Disease Type Ia Patients
Hide Arm/Group Description The participants will have one blood draw for this study. The test will be performed on the blood.
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
<=18 years
32
  64.0%
Between 18 and 65 years
18
  36.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
23
  46.0%
Male
27
  54.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants
50
1.Primary Outcome
Title Serologic, Genetic and Inflammatory Markers Consistent With Inflammatory Bowel Disease
Hide Description Participants who tested positive for Crohn disease, ulcerative colitis, or unspecified inflammatory bowel disease (IBD) on a panel for IBD are reported in the Outcome Measure Data Table.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glycogen Storage Disease Type Ia Patients
Hide Arm/Group Description:
The participants will have one blood draw for this study. The test will be performed on the blood.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants testing positive
11
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Glycogen Storage Disease Type Ia Patients
Hide Arm/Group Description The participants will have one blood draw for this study. The test will be performed on the blood.
All-Cause Mortality
Glycogen Storage Disease Type Ia Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Glycogen Storage Disease Type Ia Patients
Affected / at Risk (%)
Total   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Glycogen Storage Disease Type Ia Patients
Affected / at Risk (%)
Total   0/50 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David A. Weinstein, MD, MMSc
Organization: University of Florida
Phone: 3522650855
EMail: weinsda@peds.ufl.edu
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01854242     History of Changes
Other Study ID Numbers: IRB201300312
COL13IBD01 ( Other Grant/Funding Number: Prometheus Laboratories/COL13IBD01 )
First Submitted: May 10, 2013
First Posted: May 15, 2013
Results First Submitted: December 10, 2014
Results First Posted: December 18, 2014
Last Update Posted: February 20, 2019