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NCT00688844 · ClinicalTrials.gov registry record
Nutritional and Neurotransmitter Changes in PKU Subjects on BH4
A clinical trial, sponsored by Emory University.
- Completed
- Registry status
- 58
- Enrollment target
NCT00688844: Completed study, sponsored by Emory University.
NCT00688844 is a clinical trial that has completed, run by Emory University. The registered enrollment target is 58 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00688844 has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- 58 participants
- Enrollment target
Study Summary
HYPOTHESIS: The investigators hypothesize that KuvanTM therapy could influence nutritional and body composition parameters and neurotransmitter concentrations in pediatric and adult PKU subjects. SUMMARY: Though the investigators know that KuvanTM lowers blood Phe levels and improves tolerance for natural protein in at least half of the PKU (Phenylketonuria) patient population, investigators do not know the full effects this medicine will have on the patient's diet, or what impact the medicine or diet changes will have on the body composition or nutrient status of PKU patients. Since KuvanTM may also help the body produce neurotransmitters, investigators also want to find out if taking KuvanTM changes neurotransmitter levels in PKU patients, and if PKU patients who are benefitting from KuvanTM feel less stigmatized and have a better outlook on life as a result of the treatment. Therefore, the research study has several objectives. These are to investigate the impact KuvanTM therapy has on (1) body composition parameters of PKU patients: such as lean body mass, percent body fat, bone density, weight gain, and growth (2) dietary changes, and the effect of those changes, on intake of calories and essential nutrients (3) changes in blood biomarkers of certain nutrients (4) blood and urine neurotransmitter levels, since these changes could indicate improved neurological functioning, (5) and quality of life of PKU patients, who may feel less burdened due to the dietary freedom KuvanTM provides.
Primary Outcome
Change in Body mass index (BMI) from baseline of Kuvan study to 12 months post-baseline
Interventions
- DRUG KuvanTM Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2008-10 |
| Est. Completion | 2010-10 |
What the finished NCT00688844 record still lists
NCT00688844 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 58 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which KuvanTM Therapy is the first listed.
NCT00688844 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00688844 about?
NCT00688844 is a clinical study titled "Nutritional and Neurotransmitter Changes in PKU Subjects on BH4". HYPOTHESIS: The investigators hypothesize that KuvanTM therapy could influence nutritional and body composition parameters and neurotransmitter concentrations in pediatric and adult PKU subjects. SUMMARY: Though the investigators know that KuvanTM lowers blood Phe levels and improves tolerance for ...
What is the current status of trial NCT00688844?
This trial is currently completed. The enrollment target is 58 participants. The study started on 2008-10. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00688844?
The interventions under investigation include: KuvanTM Therapy (DRUG).
Who is sponsoring clinical trial NCT00688844?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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