NCT04272736撤回不适用
Evaluating the Compliance, Acceptability, Safety and Tolerance of a Lower Calorie Protein Substitute for the Dietary Management of Phenylketonuria in Children and Adults - a Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 30
- 主要终点
- Compliance
研究概览
简要总结
This study will evaluate the compliance, acceptability, gastrointestinal (GI) tolerance and safety of a lower calorie amino acid based liquid protein substitute for patients with Phenylketonuria (PKU) or hyperphenylalaninemia (HPA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •3 years of age or above
- •Diagnosed with classical or variant type phenylketonuria (PKU), or hyperphenylalaninemia (HPA)
- •Have been compliant in taking at least one amino acid-based, Phe-free protein substitute, providing at least 20g protein equivalent daily, for at least 1 month prior to study commencement
- •Have a prescribed daily Phe allowance
- •Written informed consent from patient, or from parent / carer if applicable
排除标准
- •Pregnant or lactating
- •Requiring enteral tube or parenteral nutrition
- •Major hepatic or renal dysfunction
- •Participation in other studies within 1 month prior to entry to this study
- •Allergy to any of the study product ingredients
- •Investigator concern around the patient being underweight (e.g.: BMI lower than 18.5kg/m2 for adults) and/or having an eating disorder
- •Investigator concern around willingness/ability of patient or parent/carer to comply with protocol requirements
结局指标
主要结局
Compliance
时间窗: Daily for 31 days
Questionnaire on amounts offered and amounts actually consumed, compared to recommended amount. Amounts (values) are recorded
次要结局
- Blood phenylalanine and other amino acid levels(Recorded at baselien and end of intervention (day 31))
- Gastro-intestinal tolerance(recorded at baseline, beginning of intervention and end of intervention(12 out of 31 days in total))
- Anthropometry(Recorded at baseline and end of intervention (day 31))
- Acceptability: Tick-box questionnaire(Recorded at baseline and end of intervetnion (day 31))
- Nutrient intake(Recorded at basleine and end of intervention (day 31))
研究者
相似试验
已完成
不适用
GMP Drink for PKU StudyPhenylketonuriaNCT02915510Nutricia UK Ltd40
暂停
不适用
IDDSI Nutritional Drink for Dysphagia StudyDysphagiaMalnutritionNCT03679078Nutricia UK Ltd40
已完成
不适用
Acceptability and Tolerance Study of a Low Calorie Peptide Based Paediatric Tube Feed Formula.Cerebral PalsyNCT03718208Société des Produits Nestlé (SPN)15
已完成
不适用
Acceptability, Gastro Intestinal Tolerance Compliance of a Paediatric Tube-feed Formula Derived From Food for ChildrenChild Nutrition DisordersNCT03718195Société des Produits Nestlé (SPN)19
已完成
不适用
Acceptability and Tolerance Study of a ThickenerDysphagiaNCT05026476Société des Produits Nestlé (SPN)21