Nutrition Status of Adults With Phenylketonuria Treated With Pegvaliase
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Mean concentrations of serum marker(s) of protein status
研究概览
简要总结
Conduct a cross-sectional analysis of the nutritional status of individuals with PKU treated with pegvaliase for one or more years or who have followed an unrestricted diet for 6 or more months while on pegvaliase treatment. We will evaluate laboratory markers of nutritional status, including markers of protein and micronutrient nutriture. In addition, a three-day food record and food frequency questionnaire will be obtained to assess protein intake and overall diet quality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of phenylketonuria
- •Aged 18-65 years
- •Currently treated with pegvaliase
- •Have either 1) received treatment with pegvaliase for one or more years or 2) followed an unrestricted diet for 6 or more months while on pegvaliase
- •Currently following an unrestricted diet that meets or exceeds the RDA for protein (0.8 g/kg/day)
排除标准
- •Unable to consent to study
- •Under age 18 years or over age 65
- •Routine food intake provides less than the RDA for protein (0.8 g/kg/d)
- •Consuming any PKU medical foods
结局指标
主要结局
Mean concentrations of serum marker(s) of protein status
时间窗: through study completion, an average of 1 year
Mean concentrations of serum marker(s) of micronutrient status
时间窗: through study completion, an average of 1 year
Mean concentrations of serum marker(s) of essential fatty acid status
时间窗: through study completion, an average of 1 year
Mean concentrations of serum marker(s) of cardiovascular status
时间窗: through study completion, an average of 1 year
Mean protein intake (g/day) as reported on a three-day food record
时间窗: through study completion, an average of 1 year
Mean micronutrient intake (%DRI) as reported on a three-day food record
时间窗: through study completion, an average of 1 year
次要结局
- Mean Healthy Eating Index-2015 scores calculated from the Diet History Questionnaire III(through study completion, an average of 1 year)
- Correlation between serum micronutrient concentrations and average micronutrient intake(through study completion, an average of 1 year)
研究者
Krista Viau
Clinical Nutrition Specialist II
Boston Children's Hospital