GMP Maternal
Research type
Research Study
Full title
A study to evaluate the impact of Glycomacropeptide (GMP) when used in the dietary management of pregnant women with Phenylketonuria (PKU) and Hyperphenylalaninemia (hyperphe)
IRAS ID
238568
Contact name
Charlotte Ellerton
Contact email
Sponsor organisation
Vitaflo (International) Ltd
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
This is an exploratory, non-randomised, controlled study evaluating the use of PKU Sphere in the dietary management of PKU during pregnancy. There will be a control group with a maximum of five patients that opt to take their preferred amino acid supplement instead of PKU Sphere. Patients in the intervention group have chosen to take PKU Sphere in place of their usual amino acid supplement.
Patients will be aged 16 years onwards and will be recruited from the start of their pregnancy or up to 24 weeks post-conception, in order to provide an adequate time period for assessment. As this can be a stressful time for patients, the majority of data collected during this study will be from assessments/tests/procedures that are standard of care; there will be some additional questionnaires related to their pregnancy and intake of PKU Sphere (or the amino acid supplement). Much of the data will be collected via diaries completed at home or telephone consultations with the dietitian, which is standard practice, minimising hospital visits.
Phenylalanine and tyrosine monitoring will not be increased compared to standard care. Additional procedures related to the study are diaries and questionnaires related to adherence, gastrointestinal tolerance and acceptability of the product.
There will be very limited outcome data collection on the neonate. Similar assessments will continue during the postpartum phase which will last for 12 months or until the patient stops breastfeeding, whichever is longer.
REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/1281
Date of REC Opinion
13 Aug 2018
REC opinion
Unfavourable Opinion