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The NIH UNI Study: Urea Cycle Disorders, Nutrition and Immunity

NCT01421888 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 4

Last updated 2019-12-09

No results posted yet for this study

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 hepatitis A vaccines.
* To compare differences in nutrition and immune systems of people with urea cycle disorders with that of healthy volunteers.

Eligibility:

* Healthy males and females at least 2 years of age who are able to travel to the National Institutes of Health hospital in Bethesda, MD
* Males and females at least 2 years of age who have a urea cycle disorder and are able to travel to the National Institutes of Health hospital in Bethesda, MD.

Design:

For Patients with urea cycle disorder:

* Participants will spend 2 to 3 days in the National Institutes of Health hospital for the following tests:
* A physical exam and review of medical history
* Food log for 3 days before the start of the study
* Blood tests
* 24-hour urine collection
* Resting metabolism test
* DEXA scan imaging study of bones and body fat
* Participants who are old enough to do certain tasks by themselves (like dressing and eating) can choose to have the following extra tests:
* 24-hour metabolic room measurements
* BodPod(Registered Trademark) study to measure bones and body fat
* Participants may choose to have a flu shot and/ or Hepatitis A shot at the end of the study and will be monitored to check for possible side effects.
* Participants will return within 1 to 3 months for follow-up tests/immunizations.

For Healthy Volunteers:

* Participants will be seen at the outpatient clinics at the National Institutes of Health hospital for up to 2 visits for the following:
* Review food log completed 3 days before the start of the study
* Blood tests
* Participants may choose to have a flu shot and/ or Hepatitis A shot at the end of the study and will be monitored to check for possible side effects.
* Participants will return within 1 to 3 months for follow-up tests/immunizations.
* Review of second food log completed 3 days before second outpatient visit

Conditions

  • Argininosuccinic Aciduria
  • Carbamoyl-Phosphate Synthase I Deficiency
  • Citrullinemia
  • Ornithine Carbamoyltransferase Deficiency
  • Hyperargininemia
  • N-Acetylglutamate Synthase Deficiency

Sponsors & Collaborators

  • National Human Genome Research Institute (NHGRI)

    lead NIH

Principal Investigators

  • Peter J McGuire, M.D. · National Human Genome Research Institute (NHGRI)

Eligibility

Min Age
2 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-08
Completion
2013-04-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01421888 on ClinicalTrials.gov