| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN85099875 |
| Date ISRCTN assigned | 12/09/2003 |
| Local reference number(s) | N0045113499 |
| Public title | What is the ideal dose of protein substitute in PKU? |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Nutritional, Metabolic, Endocrine: Phenylketonuria (PKU) |
| 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? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| 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 |
| Patient information material |
|
| Anticipated start date | 01/05/2002 |
| Anticipated end date | 30/04/2003 |
| Status of trial | Completed |
| 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 |
| Sponsor name | Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK) |
| Sponsor details | The Department of Health
Richmond House
79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 (0)20 7307 2623 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.doh.gov.uk |
| Contact name | Dr Anita MacDonald |
| Contact details | Birmingham Children's Hospital
Dietetics Department
Steelhouse Lane
Birmingham
United Kingdom
B4 6NH |
| Contact telephone | +44 0121 333 8024 |
| Contact fax | +44 0121 333 8021 |
| Contact email | anita.macdonald@bhamchildrens.wmids.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN85099875 |
| Date last extracted from ISRCTN register | 17/04/2008 |
