An Observational Study to Evaluate Metabolic Control and Dietary Management in Women With PKU Taking PKU Sphere During Pre-conception and/or Pregnancy
This observational study aims to recruit females, aged 16 years and over, with phenylketonuria (PKU) or hyperphenylalaninemia (hyperphe) following dietary management advice pre-conception and/or during pregnancy, who are willing to take PKU sphere as part of their dietarty management.
• Diagnosis of phenylketonuria (PKU) or hyperphenylalaninemia (hyperphe) which requires dietary management during pre-conception and/or pregnancy.
• Aged 16 years and above.
• Following dietary management advice pre-conceptually and/or during pregnancy, aiming for phenylalanine levels of 120-250µmol/L.
• Prior positive PKU sphere taste test completed as part of routine care.
• Chosen to take part or full requirement of protein substitute as PKU sphere pre-conceptually and/or during pregnancy.
• Willingly given, written, informed consent from patient.
• Participant is, in the opinion of the investigator, able to participate and can comply with the study protocol.