An interventional study of PKU Start in Phenylketonuria and Inborn Errors of Metabolism, sponsored by Vitaflo International, Ltd. Completed at 3 sites in United Kingdom. Open to participants aged 4 Weeks to 2 Years. Per ClinicalTrials.gov, last updated 2024-02-16.
Sponsored by Vitaflo International, Ltd (part of Nestlé S.A.) · Not applicable, Interventional, and Treatment
To evaluate the acceptability, tolerance and effect on metabolic control of PKU Start, a new Phe free protein substitute for the dietary management of PKU in infants from birth.
This is an assessment of ten (10) infants who require a protein restricted diet that is low in Phe. Infants who routinely use a Phe free infant formula as part of their dietary therapy will be recruited for a 28-day assessment of PKU Start, to evaluate tolerance and acceptability.
The outcome of this assessment will be used in a submission to the regulatory authorities, Advisory Committee on Borderline Substances (ACBS), for PKU Start to become reimbursable on prescription in the UK.
The participant's dietitian will advise on an appropriate amount of PKU Start based on individual requirements. Parents/carers will be asked to substitute their usual Phe-free infant formula with PKU Start for one (1) month. The sponsor will supply PKU Start free of charge.
Prior to starting PKU Start, parents/carers will be asked to record information about the infant's usual GI tolerance and feeding pattern for a period of three (3) days, to allow for comparison between their existing formula and PKU Start.
They will be asked to record information about the following:
Stools Vomiting and Spit-up Feed / Fluid Intake and Compliance Phenylalanine Levels Final Evaluation about the presentation of the product, ease of preparation and how PKU Start flowed through the teat of a bottle.
191 studies on the registry are indexed under Phenylketonurias; 40 are open to participants now.
This study's enrollment of 10 is below the median of 27 across 122 interventional 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.
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:
Daily feed, substituting the participant's normal phe-free formula for PKU Start.
Dietary Supplement: PKU Start
PKU Start is a powdered, phenylalanine-free, infant formula, containing essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals, trace elements and long chain polyunsaturated fatty acids (LCPs); Arachidonic acid (AA) and Docosahexaenoic acid (DHA). It is suitable for use from birth. The recommended amount of the product for each participant will be determined and prescribed by a dietitian.
Product compliance daily diary
Quantitative assessments from subject questionnaires that allow evaluation of compliance with the study product, i.e. actual versus prescribed intake.
Time frame: Days 1-28
GI tolerance daily diary
Qualitative assessments from subject questionnaires that allow evaluation of the gastro-intestinal tolerance of the study product.
Time frame: Days 1-28
Ease of use questionnaire
Qualitative assessment from subject questionnaire that allows evaluation of the ease of use of the study product.
Time frame: Day 29
Daily phenylalanine control
Collection of quantitative data regarding phenylalanine control using routine biochemical testing
Time frame: Days 1-28
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Mar 2017 to primary completion in Sep 2017, 6 months.
Of 33 interventional studies with no phase under Phenylketonurias, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 28. This study's 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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