NCT01676090终止不适用
An Epidemiologic, Descriptive and Cross-sectional Study of the IGF-1, IGFBP-3 and ALS Normative Ranges in a Healthy Paediatric Spanish Population, Divided Into Chronological Age, Sex and Pubertal Stage
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Ipsen
- 入组人数
- 304
- 试验地点
- 9
- 主要终点
- IGF-1 levels according to age, sex and pubertal stage in healthy paediatric volunteers
研究概览
简要总结
To determine the normative ranges of the Insulin-like Growth Factor 1 (IGF-1), Insulin-like growth factor-binding protein 3 (IGFBP-3), Acid-Labile Subunit (ALS) according to age, sex and pubertal stage of a healthy paediatric Spanish population.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children of either sex of Caucasian parents
- •Age: newborns up to and including 18 years of age
- •Length/height, weight and body mass index (BMI) within the mean +/- 2SD (Standard Deviation) and in accordance with the growth charts of the 2010 Spanish cross-sectional growth study (Carrascosa Lezcano et al 2010)
- •Signed consent by at least one parent or legal guardian (if subject is ≤18 years) and by subject if ≥12 years
排除标准
- •Early or advanced puberty (pubertal signs: between 8 and 9 years old in girls, and between 9 and 10 years old in boys), or delayed puberty (no puberty onset in ≥ 13 year-old girls, and in ≥ 14 year-old boys)
- •Chronic diseases including, but not limited to, endocrinologic diseases, chromosomal diseases, chronic diseases of renal, hepatic and/or cardiac aetiology, and tumour processes
- •An acute disease during the last two weeks prior to recruitment
- •Any clinically significant out-of-range lab value
- •Healthy paediatric volunteers who are under medical treatment (contraception permitted)
- •A family history of short stature (either parent < P3)
- •Children born small for gestational age (birth weight, length, or head circumference < P10)
- •Adopted children or conceived through in vitro fertilization ( IVF )
- •Subjects who are unwilling or unable in the opinion of the investigator or sponsor to undergo all the study procedures
结局指标
主要结局
IGF-1 levels according to age, sex and pubertal stage in healthy paediatric volunteers
时间窗: At the time of participant's single study visit (day 1)
次要结局
- IGFBP-3 levels according to age, sex and pubertal stage in healthy paediatric volunteers(At the time of participant's single study visit (day 1))
- ALS levels according to age, sex and pubertal stage in healthy paediatric volunteers(At the time of participant's single study visit (day 1))
研究者
研究点 (9)
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