Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
12/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes