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
  Purpose

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.


Condition
Puberty

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The COPENHAGEN Puberty Study

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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


Enrollment: 2020
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)
Groups/Cohorts
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.


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.

  Eligibility

Ages Eligible for Study:   5 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01411527

Locations
Denmark
Department of Growth and Reproduction, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
The Ministry of Science, Technology and Innovation, Denmark
European Commission
Investigators
Study Director: Anders Juul, PhD, DMSc Rigshospitalet, dept. of Growth and Reproduction
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anders Juul, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01411527     History of Changes
Other Study ID Numbers: KF01282214
Study First Received: August 3, 2011
Last Updated: December 6, 2013
Health Authority: Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:
Hormones
Endocrine Disrupters
Polymorphism, Genetic

ClinicalTrials.gov processed this record on October 23, 2014