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NCT01209819 · ClinicalTrials.gov registry record
Bone Mineral Density in Adults With Hyperphenylalaninemia
A clinical trial of Phenylketonurias, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- 28
- Enrollment target
- 1
- Study location
NCT01209819 is a study of Phenylketonurias that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 28 participants, below the 40-participant average among 5 other Phenylketonurias trials with a reported enrollment target (30% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01209819, a study of Phenylketonurias, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
Hyperphenylalaninemia (HPA) is a rare metabolic disorder caused by a deficiency of the enzyme phenylalanine hydroxylase (PAH). Elevated plasma levels of phenylalanine (phe) cause mental retardation, microcephaly, delayed speech, seizures, eczema, and behavior problems. Adequate control of the plasma levels of phe by a phe-restricted diet can prevent the developmental and behavioral problems. The foundation of this diet is a phe-free medical product/formula made from free amino acids. Based on longitudinal studies, it has been reported that the most benefit is attained by individuals who maintain a phe-restricted diet throughout life. Despite the obvious benefits of the diet, it has been suggested that the dietary restrictions may be associated with poor bone health in these patients. However, data supporting this has been reported in studies with small sample sizes and/or inadequate sample populations that include children. There is a paucity of data on bone health in adults with HPA. The investigators propose an observational study to describe the bone health status among adults with a diagnosis of HPA and to compare them to established normative age and gender-specific values among healthy individuals. The investigators hypothesize that adults with HPA will have lower bone density as measured by a dual x-ray absorptiometry (DXA) scan compared to the established normative values.
Conditions Studied
Study Locations (1)
Texas
- University of Texas Health Science Center at Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-10 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01209819
The ClinicalTrials.gov registry entry for NCT01209819 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 40-participant average among 5 other Phenylketonurias trials with a reported enrollment target (30% lower). The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Phenylketonurias appearing as the primary indexed condition, and to 0 interventions.
NCT01209819 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT01209819 about?
NCT01209819 is a clinical study titled "Bone Mineral Density in Adults With Hyperphenylalaninemia". Hyperphenylalaninemia (HPA) is a rare metabolic disorder caused by a deficiency of the enzyme phenylalanine hydroxylase (PAH). Elevated plasma levels of phenylalanine (phe) cause mental retardation, microcephaly, delayed speech, seizures, eczema, and behavior problems. Adequate control of the plasma...
What is the current status of trial NCT01209819?
This trial is currently completed. The enrollment target is 28 participants. The study started on 2010-09. Estimated completion is 2012-10.
What conditions does trial NCT01209819 study?
This clinical trial studies the following conditions: Phenylketonurias.
Who is sponsoring clinical trial NCT01209819?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01209819 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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