Status:
TERMINATED
The NIH UNI Study: Urea Cycle Disorders, Nutrition and Immunity
Lead Sponsor:
National Human Genome Research Institute (NHGRI)
Conditions:
Argininosuccinic Aciduria
Carbamoyl-Phosphate Synthase I Deficiency
Eligibility:
All Genders
2-99 years
Brief Summary
Objectives: * To study nutrition and immune system problems in people with urea cycle disorders. * To study how people with urea cycle disorders and healthy volunteers respond to standard flu and/or ...
Detailed Description
Urea cycle disorders (UCD) are amongst the most frequent of the inborn errors of metabolism (IEM) and result from a block in the hepatic disposal of waste nitrogen from protein catabolism. Viral infec...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients:
- Any gender and ethnicity age 2 years and older with a diagnosis of a urea cycle disorder are eligible to enroll in this protocol.
- Patients need to be medically and nutritionally managed by a local metabolic provider. If necessary, we will obtain written consent from the patient to review medical records from their home physician to confirm eligibility.
- Healthy Volunteers:
- Any gender and ethnicity age 2 years and older are eligible to enroll in this protocol.
- Have access to own personal medical provider \<TAB\>
- EXCLUSION CRITERIA:
- Less than 2 years of age
- Inability to travel to NIH because of their medical condition
- Recent (6 month) history of vaccination or immune modulating drug
- Severe reactions to eggs and or latex
- History of severe reactions to previous immunizations (e.g. hives, rash, difficulty breathing)
- Persons without a personal medical provider
- Persons with current infections or under care of medical provider for an ongoing medical issue
Exclusion
Key Trial Info
Start Date :
August 8 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 17 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01421888
Start Date
August 8 2011
End Date
April 17 2013
Last Update
December 9 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892