The COPENHAGEN Puberty Study

Completed

• Conditions: Puberty

• Registration Number: NCT01411527
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2011-08-03
• Study First Submitted QC: 2011-08-05
• Study First Posted: 2011-08-08
• Primary Completion: 2016-12
• Study Completion: 2016-12-31
• Results First Submitted: 2017-04-25
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-19
• Last Update Submitted: 2019-09-19
• Results First Posted: 2019-10-10
• Last Update Posted: 2019-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1957

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pubertal Onset	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.

Trial Locations

Locations (1)

Department of Growth and Reproduction, Rigshospitalet; 🇩🇰 Copenhagen, Denmark