Feeding Patterns and Practices in Young Children With PKU During the First Two Years of Life

PKU Clinical Trial

— PKU-weaning  

Official title:

Feeding Patterns and Practices in Young Children With PKU During the First Two Years of Life: Acceptability and Efficacy of a New Protein Substitute

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03913156
• Other study ID #: B2970
• Status: Completed
• Phase: N/A
• Start date: March 15, 2010
• Est. completion date: December 2016

Study information

• Verified date: June 2020
• Source: Nutricia Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study the feeding patterns and practices at the introduction of a second stage phe-free protein substitute will be assessed in young children with PKU. This will be compared with the normal weaning process in healthy non-PKU age-matched children. In addition, tolerability and acceptability of the study product will be evaluated in a smaller group of subjects who have already been transferred onto a second stage protein substitute. The study is performed in 3 centers in the United Kingdom.

Description:

Part 1:

For subjects with PKU, the study product will be incorporated in the diet as the second stage protein substitute until the subjects are 2 years of age.

The healthy non-PKU age-matched subjects will not have the study product incorporated in their diet in order to be able to compare the weaning experience and nutritional intake of PKU subjects with non-PKU subjects. The healthy subjects will also be part of the study until the subjects are 2 years of age.

Part 2:

All PKU subjects will take the study product for 7 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2016
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

Inclusion Criteria:

• Diagnosis of PKU identified on screening during the newborn period and requiring a phenylalanine free protein substitute

• Subjects who are about to commence weaning and require a concentrated phe-free protein substitute to meet their total protein requirements and are aged between 4 and 10 months (Part 1)

• Subjects aged under 5 years who have already been fully transferred onto a concentrated phe-free protein substitute and are willing to try the study product for 7 days (Part 2)

• Written informed consent obtained from subject or parents / caregiver

• May or may not have commenced weaning solids (i.e. using normal foods)

Exclusion Criteria:

• Presence of serious concurrent illness

• Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements

• Any child who has not commenced a second stage protein substitute and is over the age of 10 months

• Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study

• Any children having taken antibiotics over the previous 2 weeks leading up to the study

Related Conditions & MeSH terms

• PKU

Intervention

Other:
• B2970 Metabolic Texture Modified Protein Substitute
The study product is a powdered phe-free protein substitute supplemented with long chain polyunsaturated fatty acids (LCP's), containing essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals and trace elements and has been designed for use in the management of proven PKU in children aged 6 months to 5 years.

Locations

Country	Name	City	State
United Kingdom	Birmingham Children's Hospital	Birmingham
United Kingdom	Bradford Teaching Hospitals NHS Foundation Trust, St Luke's Hospital	Bradford
United Kingdom	JB Russell House, Gartnavel Royal Hospital	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feeding patterns- product intake	Actual intake of product and prescribed amount of product [# sachets] will be recorded as documented in diaries.	up to 2 years
Primary	Feeding patterns - intake other than study product	Intakes of standard formulas / breast-milk and normal foods [mL] or [g/day] and [frequency] of breastfeeding, as documented in diaries.	up to 2 years
Primary	Feeding practices and difficulties by questionnaire; position	Feeding practices entered by parents in diaries: the way the child has been fed will be assessed : categories [sitting position e.g on lap, in chair etc]	up to 2 years
Primary	Feeding practices and difficulties by questionnaire; self feeding	Feeding practices entered by parents in diaries; the way the child has been fed will be assessed : [self-feeding; parent feeding]; [type of self feeding: bottle, finger; spoon, fork]	up to 2 years
Primary	Occurence of Adverse Events [ Safety and tolerability]	Occurence of Adverse Events	up to 2 years
Primary	Gastro-Intestinal symptoms	Occurence of GI symptoms [yes/no] for: Mouth Ulcers; Tummy upset; Harder poos; Constipation; Softer poos; Vomiting; Colic; Other (free entry)	up to 2 years
Primary	Product Acceptability yes/no	Acceptability questions [yes/no] for: Refuses more than takes; Refuses as much as takes; Takes more than refuses; Spits out product; Puts spoon away; Holds in mouth but won't swallow; Closes mouth on feeding; Cries at beginning of feed; Cries at end of feed; Deliberately spills feed; Turns head away; Other (free entry)	up to 2 years
Primary	Blood Phenylalanine control: Phe levels	Phe levels [umol/L]	up to 2 years
Primary	Blood Tyrosine levels	Tyrosine levels [umol/L]	up to 2 years
Primary	Intake of energy and nutritients: Study product	Intakes of energy and nutrients from the study product [diet diary; #g product/day]	up to 2 years
Primary	Intake of energy and nutritients: Weaning	Intakes of energy and nutrients from the weaning diet: descriptive information, intakes [g/day]	up to 2 years
Primary	Intake of energy and nutritients: Weaning	Intakes of energy and nutrients from the weaning diet: descriptive information, intakes [# meals or snacks/day]	up to 2 years
Primary	Anthropometry: weight	Weight [g]	up to 2 years
Primary	Anthropometry: length	Length [cm]	up to 2 years
Secondary	Weaning per group (with our without protein substitute) - descriptive	Compare the weaning , nutritional intakes [g/day] and metabolic control of infants taking the study product, with historical controls of the same age and weaning stage whose diet did not incorporate a semi-solid second stage protein substitute during the same time period [parent questionnaires]	up to 2 years
Secondary	Anxiety levels of parents - Beck's Anxiety inventory	The Beck's Anxiety Inventory, scores on domains [0 not at all - 3 severely]	up to 2 years
Secondary	Coping mechanisms of parents by questionnaire	Coping Health Inventory for Parents (scores on domains coping behaviour [3 extremely helpful -0 not helpful]	up to 2 years
Secondary	Parent experience of Feeding via questionnaire	Feeding time Parent Questionnaire, experience of parents of their child's feeding time, scores on various domains [0-7]	up to 2 years

External Links

•   Growth, protein, and energy intake in children with PKU taking a weaning protein substitute in the first 2 years of life: a case-control study; Nutrients 2019, 11(3), 552;
•   How Does Feeding Development and Progression onto Solid Foods in PKU Compare with Non-PKU Children During Weaning?; Nutrients 2019, 11(3), 529
•   Mealtime Anxiety and Coping Behaviour in Parents and Children During Weaning in PKU: A Case-Control Study; Nutrients. 2019 Dec; 11(12): 2857