An observational study in Maternal Phenylketonuria, sponsored by Vitaflo International, Ltd. Completed at 3 sites in United Kingdom. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by Vitaflo International, Ltd (part of Nestlé S.A.) · Observational
This observational study aims to recruit females, aged 16 years and over, with phenylketonuria (PKU) or hyperphenylalaninemia (hyperphe) following dietary management advice pre-conception and/or during pregnancy, who are willing to take PKU sphere as part of their dietarty management.
The aim of this study is to observe dietary management and metabolic control in women taking PKU sphere pre-conceptually and/or during pregnancy. To do this the following data points will be captured:
191 studies on the registry are indexed under Phenylketonurias; 40 are open to participants now.
This study's enrollment of 12 is below the median of 37 across 61 observational studies indexed under Phenylketonurias.
Browse Phenylketonurias studies →Vitaflo International, Ltd is the lead sponsor of 23 studies on the registry; none are open to participants now.
First submitted after Vitaflo International, Ltd became part of Nestlé S.A..
Counted across the registry records on this site, refreshed daily.
Maternal and preconception females, aged 16 years onwards with phenylketonuria (PKU) requiring dietary management with protein substitutes.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PKU sphere (an FSMP) as per individual requirements determined by a dietitian.
Dietary Supplement: PKU sphere
PKU sphere is a Food for Special Medical Purposes (FSMP). This product is for use in the dietary management of phenylketonuria (PKU). It is a powdered, low phenylalanine medical food containing a balanced mix of GMP, essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals, and DHA. It is available in 27g sachets providing 15g PE and contains 28mg Phe and 35g sachets providing 20g PE and contains 36mg Phe.
Change in blood spot phenylalanine levels
Measurement of fasting phenylalanine concentrations completed once (1) to twice (2) weekly preconception (which may last for an indeterminate amount of time), twice (2) to three (3) times weekly during pregnancy and one month postpartum. Collected as dried bloodspots on Guthrie cards in the patient's own home and posted to the hospital laboratory for analysis.
Time frame: Baseline, 1-2 times weekly during preconception (max. 2 years), 2-3 times weekly during pregnancy, one month postpartum.
Change in blood spot tyrosine levels
Measurement of fasting tyrosine concentrations completed once (1) to twice (2) weekly preconception (which may last for an indeterminate amount of time), twice (2) to three (3) times weekly during pregnancy and one month postpartum. Collected as dried bloodspots on Guthrie cards in the patient's own home and posted to the hospital laboratory for analysis.
Time frame: Baseline, 1-2 times weekly during preconception (max. 2 years), 2-3 times weekly during pregnancy, one month postpartum.
Change in adherence to study product intake
3-day diary recording compliance/adherence of patients to their prescribed amount of protein substitute.
Time frame: Every 12 weeks from baseline during preconception (max. 2 years) and pregnancy until the end of the pregnancy
Participants' gastrointestinal adverse events
Participant to report any gastrointestinal (GI) symptoms and pregnancy-associated nausea and vomiting while consuming PKU Sphere.
Time frame: Throughout the study until one month postpartum
Change in weight
Weight (kg)
Time frame: Baseline, every 24 weeks during preconception (max. 2 years) and pregnancy, one month postpartum
Change in plasma amino acid profile
Plasma amino acid profile
Time frame: Baseline, all routine results during preconception (max. 2 years) and pregnancy, one month postpartum
Change in plasma micronutrient profile
Plasma micronutrient profile
Time frame: Baseline, all routine results during preconception (max. 2 years) and pregnancy, one month postpartum
Pregnancy outcome
Standard of care data on the outcome of the pregnancy
Time frame: End of pregnancy
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.