The COPENHAGEN Puberty Study Providing Normative Data of Healthy Danish Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,957
- 试验地点
- 1
- 主要终点
- Pubertal Onset
研究概览
简要总结
By clinical examinations and withdrawing of blood samples from a large number of healthy Danish children, this study will reveal if age of pubertal onset is declining. Furthermore, the extensive normative data will provide detailed insight into normal ranges and individual changes of anthropometrics and hormone levels in healthy children during childhood and adolescence.
详细描述
The COPENHAGEN Puberty Study is a combined cross sectional and longitudinal study of healthy Danish children.
All children will be thoroughly examined and blood- and urine samples will be collected at every visit. The families fill out questionaires.
Physical examination: Height; sitting-height; weight; circumference of waist, hip, arm; measurement of fatfolds (biceps, triceps, flank, subscapularis); voice-break (yes/no), blood pressure; pubertal staging according to Tanners classification: breast development (B1-B5), genitalia development boys (G1-G5), pubic hair development (PH1-PH5), axillary hair (yes/no), sweat (yes/no), acne (yes/no
Urine sample: For measurement of FSH, LH and endocrine disrupters.
Blood sample: For measurement of hormone levels (FSH, LH, estradiol, SHBG, testosterone, DHEAS, androstenedione, inhibin A, inhibin B, Insl3, kisspeptin, ghrelin, leptin, IGF-1, IGFBP3, TSH, T4, Free T4, T3, HbA1C, calcium-ion, PTH, phosphate, 25-OH-vitamine D, AMH), endocrine disrupters (PCB´s, dioxines, parabens, phthalates), isolation of DNA and RNA to evaluate relevant polymorphisms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all children accepting to participate were included
排除标准
- •no children were excluded from examination or blood sampling. In case of chronic diseases, medical treatment, or ethnicity the children may be excluded from specific final data analysis.
结局指标
主要结局
Pubertal Onset
时间窗: up to 8 year period.
Pubertal onset (according to Tanner stageing - Marshall \& Tanner 1969 and 1970), i.e. Tanner stages B2+ or G2+ \[Tanner stages included genital stages 1-5 as well as pubic hairs tages 1-6\] Data of both arms were pooled for calculation of means.
次要结局
未报告次要终点
研究者
Anders Juul
Professor
Rigshospitalet, Denmark