Tiny study tests special diet drink for Moms-to-Be with PKU
NCT ID NCT04224142
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed study followed 12 women with PKU who chose to use PKU Sphere, a special low-protein medical food, before and during pregnancy. Researchers tracked their blood amino acid levels, diet adherence, and pregnancy outcomes. The goal was to see if the product helps maintain safe metabolic control during this critical time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PKU sphere (a low-phenylalanine medical food powder)
- What this could lead to
- If successful, this could show that PKU Sphere helps women with PKU maintain safe amino acid levels before and during pregnancy, supporting better outcomes for mother and baby.
- What could go wrong
- This is a very small observational study (12 participants) with no comparison group, so results may not apply broadly. It only looks at dietary management, not whether the product prevents pregnancy complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
12 people
The number who actually took part.
- Started
-
Jul 2019
- Finished
-
Oct 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Maternal and preconception females, aged 16 years onwards with phenylketonuria (PKU) requiring dietary management with protein substitutes.
- Ages
-
16 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * Conception of pregnancy without commencement of phe-restricted diet and blood phenylalanine not maintained within target range by 10 weeks' gestation. * Patients with known soya, milk or fish allergies / intolerance. * Intake of pegvaliase or large neutral amino acids within 30 days prior to screening visit. * Patients who are currently participating in, plan to participate in, or have participated in an interventional investigational drug, food or medical device trial within 30 days prior to screening visit.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hyperphenylalaninemia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Royal Victoria Hospital
Belfast, United Kingdom
-
University College London Hospitals NHS Foundation Trust
London, United Kingdom
-
University Hospital of Wales
Cardiff, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.