Compliance, Tolerance and Acceptability of a Tablet Protein Substitute for the Dietary Management of Phenylketonuria

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03333720
• Date of registration: 18/09/2017
• Prospective Registration: Yes
• Primary sponsor: Nutricia UK Ltd
• Public title: Compliance, Tolerance and Acceptability of a Tablet Protein Substitute for the Dietary Management of Phenylketonuria
• Scientific title: Compliance, Tolerance and Acceptability of a Tablet Protein Substitute for the Dietary Management of Phenylketonuria
• Date of first enrolment: July 15, 2019
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT03333720
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: N/A

Contacts

• Name: Rebecca Stratton, PhD
• Affiliation: Nutricia, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female

- 8 years of age and older

- Diagnosed with proven PKU

- Consume a minimum of 20g protein equivalent in tablet format while enrolled on to the
trial

- If routine care and dietary management is not different from normal PKU care and
dietary management, preconception patients may be considered

- Have written informed consent from patient or parent/carer carer

Exclusion Criteria:

- Requiring nutritional support (including enteral and parenteral nutrition)

- Major hepatic or renal dysfunction

- Maternal PKU patients (if a patient becomes pregnant during the study they will be
withdrawn on immediate notice to the Metabolic Dietitian responsible for the patient's
care)

- Participation in other studies within 1 month prior to entry of this study

- Investigator concern around willingness/ability of patient to comply with protocol
requirements



Age minimum: 8 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Phenylketonurias

Intervention(s)

Dietary Supplement: Phenylalanine-free protein substitute tablets

Primary Outcome(s)

Daily Compliance [Time Frame: 35 days]

Secondary Outcome(s)

Incidence of study product emergent adverse events [safety]. [Time Frame: Baseline]

Patient Acceptability [Time Frame: 2 days]

Height [Time Frame: 2 days]

Treatment-Emergent tolerability [Time Frame: 12 days]

Metabolic control [Time Frame: 2 days]

Nutritional Intake [Time Frame: 2 days]

Weight [Time Frame: 2 days]

Secondary ID(s)

PKU.LP2017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors