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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Ministry of Science, Technology and Innovation, Denmark
European Commission
Information provided by (Responsible Party):
Anders Juul, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01411527
First received: August 3, 2011
Last updated: December 6, 2013
Last verified: December 2013

August 3, 2011
December 6, 2013
January 2006
January 2017   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01411527 on ClinicalTrials.gov Archive Site
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Not Provided
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The COPENHAGEN Puberty Study Providing Normative Data of Healthy Danish Children and Adolescents
The COPENHAGEN Puberty Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

serum, white cells, urine

Non-Probability Sample

In the cross sectional study, all children at randomly selected schools in Copenhagen were invited (6203 children). 1864 accepted to participate.

In the longitudinal study, children at two schools with the highest participating rate were invited to participate in the follow-up study. Ongoing recruitment was continued until at least 100 boys and 100 girls were enrolled in the logitudinal study.

Puberty
Not Provided
  • 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
  • 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. Thus, the total number of participants in The COPENHAGEN Puberty Study was 2020 children.


*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2020
January 2017
January 2017   (final data collection date for primary outcome measure)

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.
Both
5 Years to 20 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01411527
KF01282214
No
Anders Juul, Rigshospitalet, Denmark
Rigshospitalet, Denmark
  • The Ministry of Science, Technology and Innovation, Denmark
  • European Commission
Study Director: Anders Juul, PhD, DMSc Rigshospitalet, dept. of Growth and Reproduction
Rigshospitalet, Denmark
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP