Contact information
Type
Scientific
Primary contact
Dr Anita MacDonald
ORCID ID
Contact details
Birmingham Children's Hospital
Dietetics Department
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom
+44 (0)121 333 8024
anita.macdonald@bhamchildrens.wmids.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0045113499
Study information
Scientific title
Acronym
Study hypothesis
Dose 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
Not provided at time of registration
Study design
Randomised cross over prospective study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Nutritional, Metabolic, Endocrine: Phenylketonuria (PKU)
Intervention
Protocol A: 2 g/kg/day of protein equivalent
Protocol B: 1.2 g/kg/day protein equivalent
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
A change in blood phenylalanine levels on a lower dose of protein substitute.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/05/2002
Overall trial end date
30/04/2003
Reason abandoned
Eligibility
Participant inclusion criteria
25 subjects with well controlled PKU aged between 2-10 years of age.
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
25
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/05/2002
Recruitment end date
30/04/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Birmingham Children's Hospital
Birmingham
B4 6NH
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Birmingham Children's Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16547085
Publication citations
-
Results
MacDonald A, Chakrapani A, Hendriksz C, Daly A, Davies P, Asplin D, Hall K, Booth IW, Protein substitute dosage in PKU: how much do young patients need?, Arch. Dis. Child., 2006, 91, 7, 588-593, doi: 10.1136/adc.2005.084285.