Sponsor study identifier
observational
28
1 country
1
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
September 24, 2010
Actual (reported)September 27, 2010
Actual (reported)October 2012
Actual (reported)October 2012
Actual (reported)Adults with PKU or benign HPA followed at The University of Texas Health Science Center at Houston will be invited to participate in the study. In addition, adults with PKU or benign HPA in the State of Texas will be invited to participate.
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Heather W Saavedra, MS
The University of Texas Health Science Center, Houston
28 participants (actual enrollment reported by the registry).
First Submitted
September 24, 2010
First Posted
September 27, 2010
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Study of Phenoptin to Increase Phenylalanine Tolerance in Phenylketonuric Children on a Phenylalanine-restricted Diet
Contact the study team to confirm eligibility.
Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)Last Updated
June 12, 2015
Record last verified: 2015-06
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Source: ClinicalTrials.gov.
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