NCT01411527

The COPENHAGEN Puberty Study

The COPENHAGEN Puberty Study Providing Normative Data of Healthy Danish Children and Adolescents

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,957 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 5 Years – 20 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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. Questionaire: regarding information of previous growth and health.

Conditions

• Puberty

Timeline

• Start date: 2006-07-01
• Primary completion: 2016-12-01
• Completion: 2016-12-31
• First posted: 2011-08-08
• Last updated: 2019-10-10
• Results posted: 2019-10-10

Locations

1 site across 1 country: Denmark