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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 is a clinical trial that was terminated before completion, run by National Human Genome Research Institute (NHGRI). The registered enrollment target is 4 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01421888
The ClinicalTrials.gov registry entry for NCT01421888 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Human Genome Research Institute (NHGRI), which has 185 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01421888 reports 0 study locations.
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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