What is the ideal dose of protein substitute in Phenylketonuria (PKU)?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN85099875

Enrollment

Registered

2003-09-12

Start date

2002-05-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional, Metabolic, Endocrine: Phenylketonuria (PKU) Nutritional, Metabolic, Endocrine Phenylketonuria (PKU)

Interventions

Protocol A: 2 g/kg/day of protein equivalent Protocol B: 1.2 g/kg/day protein equivalent

Eligibility

Inclusion criteria

Inclusion criteria: 25 subjects with well controlled PKU aged between 2-10 years of age.

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
A change in blood phenylalanine levels on a lower dose of protein substitute.	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026