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

ISRCTN ISRCTN85099875
DOI https://doi.org/10.1186/ISRCTN85099875
Secondary identifying numbers N0045113499
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
12/01/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Anita MacDonald
Scientific

Birmingham Children's Hospital
Dietetics Department
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom

Phone +44 (0)121 333 8024
Email anita.macdonald@bhamchildrens.wmids.nhs.uk

Study information

Study designRandomised cross over prospective study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesDose a lower dose of protein substitute achieve the same or better level of blood phenylalanine control when compared to the higher dosage recommended by the MRC Working Group on PKU?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNutritional, Metabolic, Endocrine: Phenylketonuria (PKU)
InterventionProtocol A: 2 g/kg/day of protein equivalent
Protocol B: 1.2 g/kg/day protein equivalent
Intervention typeOther
Primary outcome measureA change in blood phenylalanine levels on a lower dose of protein substitute.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/05/2002
Completion date30/04/2003

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit2 Years
Upper age limit10 Years
SexNot Specified
Target number of participants25
Key inclusion criteria25 subjects with well controlled PKU aged between 2-10 years of age.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/05/2002
Date of final enrolment30/04/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Birmingham Children's Hospital
Birmingham
B4 6NH
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Birmingham Children's Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2006 Yes No