The COPENHAGEN Puberty Study Providing Normative Data of Healthy Danish Children and Adolescents
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01411527|
Recruitment Status : Unknown
Verified December 2013 by Anders Juul, Rigshospitalet, Denmark.
Recruitment status was: Active, not recruiting
First Posted : August 8, 2011
Last Update Posted : December 9, 2013
|Condition or disease|
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 Type :||Observational|
|Actual Enrollment :||2020 participants|
|Official Title:||The COPENHAGEN Puberty Study|
|Study Start Date :||January 2006|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||January 2017|
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.
- 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. ]Female age at pubertal onset was 9.86 years. Male age at pubertal onset was 11.66 years
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411527
|Department of Growth and Reproduction, Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Study Director:||Anders Juul, PhD, DMSc||Rigshospitalet, dept. of Growth and Reproduction|