The COPENHAGEN Puberty Study Providing Normative Data of Healthy Danish Children and Adolescents
This trial is active, not recruiting.
|Collaborator||The Ministry of Science, Technology and Innovation, Denmark|
|Start date||January 2006|
|End date||January 2017|
|Trial size||2020 participants|
|Trial identifier||NCT01411527, KF01282214|
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.
time frame: The pubertal stage and age were recorded in each participating individual in the cross sectional study from January 2006 to January 2009. Probit analysis was used to determine the age of pubertal onset in boys and girls.
Male or female participants from 5 years up to 20 years old.
Inclusion Criteria: - all children accepting to participate were included Exclusion Criteria: - 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.
|Official title||The COPENHAGEN Puberty Study|
|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.|
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