Evaluation of PKU sphere liquid
Research type
Research Study
Full title
A study to evaluate the acceptability, tolerance and adherence of children and adults consuming PKU sphere liquid, a Food for Special Medical Purposes (FSMP), for the dietary management of phenylketonuria (PKU).
IRAS ID
271801
Contact name
Anita MacDonald
Contact email
Sponsor organisation
Vitaflo (International) Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 2 days
Research summary
We propose to recruit 20 patients with phenylketonuria (PKU) in order to evaluate PKU sphere liquid, a Food For Special Medical Purposes (FSMP).
Before a nutritional product can be used within the NHS, it must be subject to an application to the UK regulator for FSMPs, the Advisory Committee on Borderline Substances (ACBS). The ACBS require that data on a product's acceptability is generated by a clinical trial in the population for whom the product is intended. Acceptability is defined by the ACBS as including participant adherence to recommended intakes, gastrointestinal symptoms experienced and evaluations of palatability. These requirements have closely informed the design of the trial.
Data collection will be by Case Report Forms completed by the investigator at the Baseline and End of Study visits, in addition to data collected by patients over the course of the study.
Each participant will be on the trial for 31 days. This includes a 3-day baseline period and 28 days taking the study product. If deemed appropriate in each individual circumstance, the sponsor of the trial, Vitaflo International Ltd, will continue to supply the product free of charge at the end of the trial. This would continue until the product is either available via regular NHS prescription or is deemed unsuitable for prescription within the NHS by the ACBS.
Patients that do continue to use the product at the end of the trial period will be followed-up as part of routine management. The data collected during such follow-ups may be transferred to the sponsor after having been anonymised and subject to the participant or their parent/guardian specifically agreeing to this on the informed consent form. This follow-up period would last a maximum of 6 months from each participant’s end of study.
REC name
North West - Haydock Research Ethics Committee
REC reference
20/NW/0273
Date of REC Opinion
3 Jul 2020
REC opinion
Further Information Favourable Opinion