|
ISRCTN
|
ISRCTN85099875
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
What is the ideal dose of protein substitute in PKU?
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0045113499
|
|
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 controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Nutritional, Metabolic, Endocrine: Phenylketonuria (PKU)
|
|
Participants - inclusion criteria
|
25 subjects with well controlled PKU aged between 2-10 years of age.
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/05/2002
|
|
Anticipated end date
|
30/04/2003
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
25
|
|
Interventions
|
A randomised cross over prospective study.
|
|
Primary outcome measure(s)
|
A change in blood phenylalanine levels on a lower dose of protein substitute.
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Birmingham Children's Hospital NHS Trust
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Anita
MacDonald
|
|
Address
|
Birmingham Children's Hospital
Dietetics Department
Steelhouse Lane
|
|
City/town
|
Birmingham
|
|
Zip/Postcode
|
B4 6NH
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 0121 333 8024
|
|
Fax
|
+44 0121 333 8021
|
|
Email
|
anita.macdonald@bhamchildrens.wmids.nhs.uk
|
|
Sponsor
|
Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
|
|
Address
|
The Department of Health
Richmond House
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Fax
|
+44 (0)20 7307 2623
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.doh.gov.uk
|
|
Date applied
|
12/09/2003
|
|
Last edited
|
10/01/2006
|
|
Date ISRCTN assigned
|
12/09/2003
|
