What is the ideal dose of protein substitute in Phenylketonuria (PKU)?
| ISRCTN | ISRCTN85099875 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85099875 |
| Protocol serial number | N0045113499 |
| Sponsor | Department of Health (UK) |
| Funder | Birmingham Children's Hospital NHS Trust (UK) |
- 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
Scientific
Birmingham Children's Hospital
Dietetics Department
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom
| Phone | +44 (0)121 333 8024 |
|---|---|
| anita.macdonald@bhamchildrens.wmids.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised cross over prospective study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
A change in blood phenylalanine levels on a lower dose of protein substitute. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 10 Years |
| Sex | Not Specified |
| Target sample size at registration | 25 |
| Key inclusion criteria | 25 subjects with well controlled PKU aged between 2-10 years of age. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/05/2002 |
| Date of final enrolment | 30/04/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Birmingham Children's Hospital
Birmingham
B4 6NH
United Kingdom
B4 6NH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
