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Neurocognitive Outcomes in Mild Hyperphenylalaninemia (MHP)MHP Study

NCT01924026 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2016-02-17

No results posted yet for this study

Summary

Phenylketonuria (PKU) is a genetic disorder known to cause severe reduction in intelligence and deficits in cognitive function; it is associated with an elevated level of Phenylalanine (Phe) in blood.

Newborn screening and early treatment with restricted protein diet supplemented by a formula of amino-acids will preserve intelligence. In those with the severe form treated from birth, some deficits that affect higher functions of the brain are seen.

Given this, there is disagreement about how milder forms of this disease should be managed and what level of Phe is safe to be left untreated.

We seek to assess whether higher Phe levels, between 360 and 600µmol/L, are safe with respect to preservation of intelligence and higher cognitive functions.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Annette Feigenbaum, MD · The Hospital for Sick Children

  • Komudi Siriwardena, MD · Stollery Children's Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01924026 on ClinicalTrials.gov