NCT04210206终止不适用
Kurzfristiger Einfluss Einer Guten Stoffwechseleinstellung Auf Kognitive Funktion, Wohlbefinden Und Stoffwechselparameter Bei Erwachsenen Patienten Mit Phenylketonurie (Short-term Effects of Good Metabolic Control on Cognitive Function, Wellbeing, and Metabolic Parameters in Adult Patients With Phenylketonuria)
Klaus Parhofer1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2019年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Spatial working memory strategy index
研究概览
简要总结
The goal of this study is to evaluate if in adult patients with phenylketonuria (PKU) without strict metabolic control during the last 12 months, strict metabolic control for 8 weeks results in an improvement of cognitive function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with classical PKU
- •Age ≥ 18 years
- •Good metabolic control during childhood (at least until 12 years of age)
- •Plasma Phe levels ≥ 15 mg/dl for ≥ 1 year
- •Written informed consent prior to study participation
排除标准
- •Reduced cognitive function (unability to perform test battery)
- •Drug and or alcohol abuse
- •Treatment with BH4
- •Treatment with drugs known to affect cognitive function
研究组 & 干预措施
Diet
Experimental
干预措施: PHE-diet (Other)
Control
No Intervention
结局指标
主要结局
Spatial working memory strategy index
时间窗: 8 weeks
cognitive function; scores range from 4 to 28, with lower scores representing better outcome
次要结局
- Reaction time(8 weeks)
- Paired Associates Learning(8 weeks)
- Multitasking Test(8 weeks)
研究者
Klaus Parhofer
Professor of Endocrinology and Metabolism
Ludwig-Maximilians - University of Munich
研究点 (1)
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