Puberty
Conditions
Keywords
Hormones, Endocrine Disrupters, Polymorphism, Genetic
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.
Interventions
None listed
Sponsors
The Ministry of Science, Technology and Innovation, Denmark
European Commission
Rigshospitalet, Denmark
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 20 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Denmark
Participant flow
Recruitment details
Cross-sectional study: All pupils at 10 different schools in the Copenhagen area were invited to participate. Longitudinal study: All pupils from 2 of the 10 schools were invited to participate in the follow up study. This includes pupils that have been recruited to the cross-sectional part. (see footnote)
Pre-assignment details
No participants were excluded
Participants by arm
| Arm | Count |
|---|---|
| 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 | 1,748 |
| Longitudinal Cohort 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. | 209 |
| Total | 1,957 |
Baseline characteristics
| Characteristic | Cross- Sectional Cohort | Longitudinal Cohort | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1748 Participants | 209 Participants | 1957 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 11.8 years | 11.8 years | 11.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1748 Participants | 209 Participants | 1957 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Denmark | 1748 participants | 209 participants | 0 participants |
| Sex: Female, Male Female | 1044 Participants | 108 Participants | 1152 Participants |
| Sex: Female, Male Male | 704 Participants | 101 Participants | 805 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1,957 |
| other Total, other adverse events | 0 / 1,957 |
| serious Total, serious adverse events | 0 / 1,957 |
Outcome results
Primary
Pubertal Onset
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.
Time frame: up to 8 year period.
Population: Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cross- Sectional Cohort | Pubertal Onset | Girls | 9.86 years |
| Cross- Sectional Cohort | Pubertal Onset | Boys | 11.66 years |
| Longitudinal Cohort | Pubertal Onset | Girls | 9.86 years |
| Longitudinal Cohort | Pubertal Onset | Boys | 11.66 years |