Ignite Creation Date:
2024-05-05 @ 10:52 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01209819
Status:
COMPLETED
Last Update Posted:
2015-06-12
First Post:
2010-09-24
Brief Title:
Bone Mineral Density in Adults With Hyperphenylalaninemia
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Bone Mineral Density in Adults With Hyperphenylalaninemia
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 productformula 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 andor 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
The foundation of this diet is a phe-free medical productformula 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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None