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.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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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
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Locations
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Royal Victoria Hospital
Belfast, United Kingdom
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University College London Hospitals NHS Foundation Trust
London, United Kingdom
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University Hospital of Wales
Cardiff, United Kingdom