NCT04224142

Evaluation of PKU Sphere in Maternal PKU

An Observational Study to Evaluate Metabolic Control and Dietary Management in Women With PKU Taking PKU Sphere During Pre-conception and/or Pregnancy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12 (actual)
• Sponsor: Vitaflo International, Ltd · Industry
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: * Blood spot phenylalanine and tyrosine levels to measure metabolic control * Changes to dietary management and any adaptations arising from incorporating PKU Sphere * Compliance/adherence of patients to their recommended amount of protein substitute prescription. * Tolerance of PKU sphere with respect to gastrointestinal (GI) symptoms and pregnancy associated nausea and vomiting. * Acceptability of concurrent protein substitute(s) (if applicable). * Nutritional status and weight management. * Routine standard of care data on the final pregnancy outcome and postpartum.

Conditions

• Maternal Phenylketonuria

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-07-29
• Primary completion: 2025-10-07
• Completion: 2025-10-07
• First posted: 2020-01-13
• Last updated: 2025-11-28

Locations

3 sites across 1 country: United Kingdom