Testing of Four Home Phenylalanine Monitoring Prototype Devices
1 other identifier
observational
9
1 country
3
Brief Summary
The objective of this study is to test four home phenylalanine monitoring prototype devices, selected out of a pool of candidates by the National PKU Alliance Scientific Committee.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2015
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 13, 2015
CompletedFirst Posted
Study publicly available on registry
May 15, 2015
CompletedDecember 11, 2015
December 1, 2015
Same day
May 13, 2015
December 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Intra-variability of the four devices, assessed by phenylalanine values
Phenylalanine values for each of the three runs on each device for the same individual will be compared. Each PKU subject will be assessed separately to assess the reliability of each device since the subjects will have a range of phenylalanine concentrations.
Day 1
Secondary Outcomes (1)
Inter-variability of the four devices, assessed by average phenylalanine concentrations
Day 1
Study Arms (5)
PKU (low phe-level)
A subject diagnosed with phenylketonuria (PKU) with low phenylalanine levels, defined as 1-5 mg/dL
PKU (mid phe-level)
A subject diagnosed with phenylketonuria (PKU) with middle phenylalanine levels, defined as 6-10 mg/dL
PKU (high mid phe-level)
A subject diagnosed with phenylketonuria (PKU) with high middle phenylalanine levels, defined as 11-15 mg/dL
PKU (high phe-level)
A subject diagnosed with phenylketonuria (PKU) with high phenylalanine levels, defined as 16-20+ mg/dL
Control
A normal subject without phenylketonuria (PKU)
Eligibility Criteria
Control will be recruited by distributing an email to all staff on the Emory Genetics Clinic listserv to solicit a volunteer to provide 4ml of whole blood only. Respondents who are within two years of age and the same gender of at least one of the PKU subjects will be considered eligible. Remaining subjects will be recruited through Emory Genetics Clinic and possibly through the Emory Metabolic Nutrition Program's Annual Metabolic Camp.
You may qualify if:
- diagnosis of PKU or hyperphenylalaninemia (PKU group)
- any age
- in good health (PKU and control group)
You may not qualify if:
- pregnant
- have any medical comorbidities
- considered unfit for participation by the principal investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- National PKU Alliancecollaborator
Study Sites (3)
Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia, 30322, United States
Emory University Hospital - Atlanta Clinical and Translational Science Institute (ACTSI)
Atlanta, Georgia, 30322, United States
Emory University Genetics Clinic
Decatur, Georgia, 30033, United States
Biospecimen
Whole blood and plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rani H Singh, PhD, RD, LD
Emory University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 13, 2015
First Posted
May 15, 2015
Study Start
May 1, 2015
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
December 11, 2015
Record last verified: 2015-12