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NCT01421888 · ClinicalTrials.gov registry record
The NIH UNI Study: Urea Cycle Disorders, Nutrition and Immunity
A clinical trial, sponsored by National Human Genome Research Institute (NHGRI).
- Terminated
- Registry status
- 4
- Enrollment target
NCT01421888: Clinical Trial study, sponsored by National Human Genome Research Institute (NHGRI).
NCT01421888 is a clinical trial that was terminated before completion, run by National Human Genome Research Institute (NHGRI). The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01421888 was terminated before completion, sponsored by National Human Genome Research Institute (NHGRI).
- TERMINATED
- Registry status
- 4 participants
- Enrollment target
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. * Revi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2011-08-08 |
| Est. Completion | 2013-04-17 |
Why NCT01421888 stopped before completion
NCT01421888 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 4 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01421888 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01421888 about?
NCT01421888 is a clinical study titled "The NIH UNI Study: Urea Cycle Disorders, Nutrition and Immunity". 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 c...
What is the current status of trial NCT01421888?
This trial is currently terminated. The enrollment target is 4 participants. The study started on 2011-08-08. Estimated completion is 2013-04-17.
Who is sponsoring clinical trial NCT01421888?
This trial is sponsored by National Human Genome Research Institute (NHGRI), which has 185 total clinical trials registered on ClinicalTrials.gov.
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