The Effects of CGMP in Children and Adults With PKU

NACompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

April 26, 2019

Primary Completion Date

January 31, 2023

Study Completion Date

January 31, 2023

Conditions
Phenylketonurias
Interventions
DIETARY_SUPPLEMENT

CGMP protein substitute

PKU sphere is a powdered, low phenylalanine protein substitute, containing a balanced mix of casein glycomacropeptide (CGMP) isolate, essential and non-essential amino acids, carbohydrate, vitamins, minerals, trace elements and the omega-3 long chain polyunsaturated fatty acid (LCP); docosahexaenoic acid.

DIETARY_SUPPLEMENT

L-amino acid protein substitute

Patient may choose from a list of products, specified in the protocol, that are nutritionally comparable to PKU Sphere.

Trial Locations (3)

2100

Rigshospitalet, Copenhagen

BS2 8BJ

Bristol Royal Hospital for Children, Bristol

B4 6NH

Birmingham Children's Hospital, Birmingham

All Listed Sponsors
collaborator

Arla Foods

INDUSTRY

lead

Vitaflo International, Ltd

INDUSTRY

NCT04076176 - The Effects of CGMP in Children and Adults With PKU | Biotech Hunter | Biotech Hunter