Testing of Four Home Phenylalanine Monitoring Prototype Devices

Phenylketonurias Clinical Trial

Official title:

Testing of Four Home Phenylalanine Monitoring Prototype Devices Using Whole Blood From Normal and PKU Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02445521
• Other study ID #: IRB00079788
• Status: Completed
• Phase: N/A
• First received: May 13, 2015
• Last updated: December 9, 2015
• Start date: May 2015
• Est. completion date: May 2015

Study information

• Verified date: December 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

A real time, point-of-care and home phenylalanine monitoring system would provide patients with quick results and feedback. Home monitoring devices' phenylalanine measurements will be compared to the current gold-standard measurement of phenylalanine (plasma concentration) in four subjects with PKU and one control subject. The study will enroll subjects with different baseline phenylalanine concentrations (i.e., patients with poor to good metabolic control, assessed by comparing current phenylalanine concentrations to established treatment ranges).

For each prototype device, three separate measurements of phenylalanine per subject will be performed. Three prototype devices require whole blood, thus 1 teaspoon (approximately 4mL) of whole blood will be collected through venipuncture and blood spots will be used to conduct tests. One prototype requires capillary blood to be collected through a fingerstick, and will require three blood spots from the stick. A single plasma amino acid analysis for each participant will also be performed using leftover whole blood from the 4mL blood draw through quantitative ion exchange chromatography, reported as micromoles/L.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• diagnosis of PKU or hyperphenylalaninemia (PKU group)

• any age

• in good health (PKU and control group)

Exclusion Criteria:

• pregnant

• have any medical comorbidities

• considered unfit for participation by the principal investigator

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Phenylketonurias

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta (CHOA)	Atlanta	Georgia
United States	Emory University Hospital - Atlanta Clinical and Translational Science Institute (ACTSI)	Atlanta	Georgia
United States	Emory University Genetics Clinic	Decatur	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National PKU Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Inter-variability of the four devices, assessed by average phenylalanine concentrations	Average phenylalanine values measured by the four tests of each device in each subject will be calculated. Mean concentrations for each device will be compared to the control (gold standard measure of plasma phenylalanine).	Day 1	No