The COPENHAGEN Puberty Study Providing Normative Data of Healthy Danish Children and Adolescents
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The COPENHAGEN Puberty Study|
- Pubertal onset [ 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. ] [ Designated as safety issue: No ]Female age at pubertal onset was 9.86 years. Male age at pubertal onset was 11.66 years
Biospecimen Retention: Samples With DNA
serum, white cells, urine
|Study Start Date:||January 2006|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Cross- sectional cohort
Schools were randomly selected and 6203 children (50.0 % girls) were invited to participate. 1864 (1097 girls and 767 boys) (age 5.6-20.0 years) were included, resulting in an overall participation-rate of 30%. Blood samples were drawn, and a thorough clinical examination was performed in all participating children
209 healthy Danish children (108 girls), were examined and blood samples were drawn every 6 months. In july 2011, the mean (range) number of examinations per child was 7 (2-10).
116 (63 boys and 53 girls) continued from the cross sectional study to the longitudinal study. Thus, the total number of participants in The COPENHAGEN Puberty Study was 2020 children.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411527
|Department of Growth and Reproduction, Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Study Director:||Anders Juul, PhD, DMSc||Rigshospitalet, dept. of Growth and Reproduction|