PKU Start Follow-up
Research type
Research Study
Full title
A follow-up study to evaluate a phenylalanine free formula for use in the dietary management of Phenylketonuria in infants in order to assess longer term growth and tolerance.
IRAS ID
265417
Contact name
Anita MacDonald
Contact email
Sponsor organisation
Vitaflo (International) Ltd
Duration of Study in the UK
0 years, 2 months, 30 days
Research summary
This is a retrospecdtive, follow-up study of patients that participated in the original PKU Start study (IRAS ID: 209920, REC ref: 17/NW/0035) in 2017.
As PKU Start is a new product, used from infancy, the sponsor considered it prudent to obtain some long-term follow-up data on the participants' growth, phenylalanine control, gastrointestinal tolerance and overall dietary management including adherence to this and other infant formulas and protein substitutes.
This information will be obtained solely from each patient's medical records and there will be no direct involvement of patients in this follow-up study, aside from obtaining consent from their parent/guardian.
REC name
London - Brent Research Ethics Committee
REC reference
19/LO/1027
Date of REC Opinion
2 Jul 2019
REC opinion
Further Information Favourable Opinion