Evaluation of PKU Sphere in Maternal PKU
- Conditions
- Maternal Phenylketonuria
- Registration Number
- NCT04224142
- Lead Sponsor
- Vitaflo International, Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- 11
Inclusion Criteria:<br><br> - Diagnosis of phenylketonuria (PKU) or hyperphenylalaninemia (hyperphe) which<br> requires dietary management during pre-conception and/or pregnancy.<br><br> - Aged 16 years and above.<br><br> - Following dietary management advice pre-conceptually and/or during pregnancy, aiming<br> for phenylalanine levels of 120-250µmol/L.<br><br> - Prior positive PKU sphere taste test completed as part of routine care.<br><br> - Chosen to take part or full requirement of protein substitute as PKU sphere<br> pre-conceptually and/or during pregnancy.<br><br> - Willingly given, written, informed consent from patient.<br><br> - Participant is, in the opinion of the investigator, able to participate and can<br> comply with the study protocol.<br><br>Exclusion Criteria:<br><br> - Conception of pregnancy without commencement of phe-restricted diet and blood<br> phenylalanine not maintained within target range by 10 weeks' gestation.<br><br> - Patients with known soya, milk or fish allergies / intolerance.<br><br> - Intake of pegvaliase or large neutral amino acids within 30 days prior to screening<br> visit.<br><br> - Patients who are currently participating in, plan to participate in, or have<br> participated in an interventional investigational drug, food or medical device trial<br> within 30 days prior to screening visit.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in blood spot phenylalanine levels;Change in blood spot tyrosine levels;Change in adherence to study product intake;Participants' gastrointestinal adverse events;Change in weight;Change in plasma amino acid profile;Change in plasma micronutrient profile;Pregnancy outcome
- Secondary Outcome Measures
Name Time Method