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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HYPERPHENYLALANINEMIA are added.
By submitting, you agree to our Terms of use
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.