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New PKU drink tried in kids: will they drink it?

NCT ID NCT05995717

Disease control Sponsor: Vitaflo International, Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a special drink called PKU UP in 16 children with phenylketonuria (PKU) aged 1 to 10 years. The drink is designed to replace some of the protein they need while keeping their phenylalanine levels safe. Researchers checked how well the children tolerated the drink, whether they liked it, and if it helped control their condition over 26 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PKU UP (a special medical food drink for managing PKU)
What this could lead to
If this product is well-tolerated, it could offer a more convenient and palatable dietary option for children with PKU, helping them stick to their diet and maintain better metabolic control.
What could go wrong
This was a small, single-arm study with only 16 children, so results may not apply to everyone. It tested acceptability, not long-term health outcomes, and the product may still cause gastrointestinal issues or be refused by some children.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

16 people

The number who actually took part.

Started

Jan 2024

Finished

Mar 2026

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.

Ages

1 year to 10 years

Sex

Anyone

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

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 PKU requiring a low-protein diet and protein substitute. * Participants who are adherent with their blood phenylalanine (Phe) testing, in the opinion of the investigator. * Participants aged 1-10 years. * Participants who in the opinion of the investigator are anticipated to be able to take at least half of their daily protein equivalent requirement from PKU UP (in order to assess this, a taste test (or similar) may be conducted at investigator's discretion as part of the screening process). * Willingly given, written, informed consent from the parent(s)/guardian(s). * Willingly given, written assent by the participant (if appropriate). Exclusion Criteria: * Inability to comply with the study protocol, in the opinion of the investigator. * Any co-morbidity, which, in the opinion of the investigator, would preclude participation in the study. * Diagnosis of persistent hyperphenylalaninemia, or mild PKU not requiring a low protein diet and protein substitute. * Allergy or intolerance to milk. * Participants who are currently participating in, plan to participate in or have participated in an interventional investigational drug, food or medical device study within 30 days prior to the screening visit. * Use of additional micronutrient supplements during the evaluation period, unless clinically indicated and prescribed by the Investigator (must be recorded in both the medical records and case report form).

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Conditions

The condition(s) this trial relates to.

phenylketonuria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PKU

Contacts and locations

Locations

  • Birmingham Children's Hospital

    Birmingham, B4 6NH, United Kingdom

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    London, WC1N 3JH, United Kingdom

  • Nottingham Children's Hospital

    Nottingham, NG7 2UH, United Kingdom

  • Royal Belfast Hospital for Sick Children

    Belfast, BT12 6BE, United Kingdom

  • Sheffield Children's Hospital

    Sheffield, S10 2TH, United Kingdom

  • St. Luke's Hospital

    Bradford, BD5 0NA, United Kingdom

  • University Hospitals Bristol and Weston NHS Foundation Trust

    Bristol, BS2 8BJ, United Kingdom

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