Child DevelopmentNCT02550236
LIFE Child (LIFE Leipzig Research Centre for Civilization Diseases)
An observational study of Child Development, run by University of Leipzig at 1 site in Germany.
Trial summary
The Leipzig Research Centre for Civilization Diseases (LIFE) Child Study is a prospective longitudinal population-based study with a life course approach to health and disease. The LIFE Child Study focuses on two main research objectives: What are premises of normal growth, development and health in children? Which… Read more about this study
- Who is it for?
- Ages 0 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- Type of treatment
- Vaccines, Pill or oral medicine
- How many people
- 7,000 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The LIFE Child study is a prospective longitudinal population-based cohort study. All children with their families and pregnant women of the area of Leipzig are eligible to participate in the LIFE Child study. This sample is supposed to represent the population of the city.
Who may be able to join
- children with their families and pregnant women of the area of Leipzig
Who cannot join
- severe diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Antje Körner, Prof., MD contact
LIFE Child contact
Germany1 site, 1 recruiting
- Recruiting
LIFE Leipzig Research Centre for Civilization Diseases, University of Leipzig
Leipzig, Saxony, 04103
Antje Körner, Prof. MD, antje.koerner@medizin.uni-leipzig.de
LIFE Child, lifechild@medizin.uni-leipzig.de
About this study
Official title: Prospective Population-based Childhood Cohort Study in the Leipzig Area Investigating Genetic, Environmental, and Metabolic Factors and Their Association With the Development of Civilization Diseases
The Leipzig Research Centre for Civilization Diseases (LIFE) Child Study is a prospective longitudinal population-based study with a life course approach to health and disease.
The LIFE Child Study focuses on two main research objectives:
- What are premises of normal growth, development and health in children?
- Which factors contribute to the development of non-communicable diseases such as childhood obesity and its co-morbidities, atopy and mental health problems?
Detailed assessments will be conducted alongside long-term storage of biological samples in 1,000 pregnant women and more than 5,000 children and their families.
Read the detailed description
- The LIFE Child study is part of LIFE, a life sciences research program of the University of Leipzig (Leipzig Research Centre for Civilization Diseases - LIFE). The measurements are performed in a well-equipped research centre located on the premises of the University Hospital of Leipzig.
- The study collects detailed information from clinical examinations, questionnaires and interviews and includes a collection of several types of biological materials at various time points (urine, stool, hair, blood for direct analyses, genomic DNA, dried blood spots, paxgenes (for RNA isolation and expression/eQTL studies). Children and adolescents from 0 to 20 years at baseline and their families are included. Participants are followed annually over a period of several years irrespective of the age at the first participation in the study until they reach the age of 20.
- Prenatal examinations are conducted in the 24th and 36th week of gestation and postnatal examinations in the 3rd, 6th and 12th month in the offspring. The birth cohort study collects detailed information from clinical examinations, questionnaires and interviews and biological materials (blood, cord blood, placental tissue, breast milk, hair, urine and stool)
- In addition, the LIFE Child study focuses in the disease cohort LIFE Child OBESITY and disease free controls in more detail. The aim of these subgroups is to examine aetiological associations and comorbidities with more in-depth methods.
- Conditions
- Child Development
- Keywords
- Children, Pregnancy, Growth, Lifestyle, Metabolic and cardiovascular health, Birth, Development, Reference Values
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LIFE Child Health | The LIFE Child HEALTH cohort is a sample of over 5.000 children and adolescents. A basic program that will be carried out annually at each study centre visit. This program includes clinical history (perinatal and past medical history, medications, allergies, immunizations, developmental history and family history) clinical examination, collection of blood, hair, stool and urine samples, anthropometry and different age-dependent questionnaires. Questionnaires are completed by the parents and starting at the age of ten years also by the child itself. | |
| LIFE Child Obesity | The LIFE Child OBESITY cohort is a sample of 500 obese children and adolescents that will be assessed and compared to a lean control group (N=500) with equally detailed phenotyping including metabolic and cardiovascular evaluation. The LIFE Child OBESITY cohort (including the control group) performs the basic program of the LIFE Child HEALTH cohort plus additional parameters such as electrical bioimpedance, assessment of basal metabolic rate, oral glucose tolerance test, liver elastography and spirometry. | |
| LIFE Child Health: Pregnancy/Birth | The LIFE child Pregnancy/Birth cohort is a sample of over 1,200 pregnant women and their offspring. Prenatal examinations are conducted during the 24th to 26th and 34th to 36th week of gestation. During the first year of life, data is collected from children at 3, 6 and 12 month of age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Civilization diseases and their risk factors
Assess lifestyle, metabolic and genetic risk factors of civilization diseases (e.g. diabetes mellitus, obesity, allergy, cardiovascular diseases) from fetal life to adulthood.
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startOct 2010
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- European Social Fund, European Regional Development Fund, Free State of Saxony, Helmholtz Center for Environmental Research Leipzig, Leipzig Research Center for Early Child Development, Robert Koch Institute Berlin
- Responsible party
- Principal investigator, Antje Koerner, Prof. Dr. med., University of Leipzig
- Investigators
- Antje Körner, Prof., MD, Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550236
- Sponsor's protocol ID
- LIFE Child Leipzig
- Status last verified
- Feb 2024
- First submitted
- 15 Dec 2014
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Neininger MP, Bremer SUJ, Dathan-Stumpf A, Stepan H, Kiess W, Bertsche A, Vogel M, Bertsche T. High prevalence of magnesium supplementation during pregnancy: results from the LIFE Child study. Arch Gynecol Obstet. 2026 Aug 31;313(1):261. doi: 10.1007/s00404-026-08522-z.
PubMed 42675291Allner IE, Kiess W, Kratzsch J, Vogel M. Growth parameters and IGF-1 axis biomarkers differ among omnivorous, vegetarian, and vegan children. Eur J Nutr. 2026 Aug 29;65(6):245. doi: 10.1007/s00394-026-04085-6.
PubMed 42667434Trenkmann L, Ziegelasch N, Dittrich K, Willenberg A, Kiess W, Vogel M. Examining commonly used equations for estimating the glomerular filtration rate (GFR) in a healthy cohort of children and adolescents. BMC Nephrol. 2026 Jul 25;27(1):446. doi: 10.1186/s12882-026-05219-y.
PubMed 42509536Stasche HIU, Georgi GM, Korner A, Kiess W, Biemann R, Turp JC, Hirsch C. Oral Contraceptive Use Is Associated With Increased Tenderness to Palpation in the Masticatory System in Female Adolescents-Results of the Epidemiological LIFE Child Study. J Oral Rehabil. 2026 Jul 21. doi: 10.1111/joor.70270. Online ahead of print.
PubMed 42481438Poulain T, Schmidt R, Kiess W, Krause S, Golz S, Meigen C. Performance on an attention test is positively related to reading but negatively related to watching TV and playing video games in children. BMC Pediatr. 2025 Oct 28;25(1):872. doi: 10.1186/s12887-025-06260-w.
PubMed 41146137Durgen P, Wolfle PJ, Ceglarek U, Kratzsch J, Kiess W, Vogel M. New sex hormone-binding globulin and estimated free testosterone reference intervals for children and adolescents: The effects of age, sex, BMI and oral contraceptives. Clin Chim Acta. 2026 Jan 15;579:120621. doi: 10.1016/j.cca.2025.120621. Epub 2025 Sep 25.
PubMed 41015329von Heimburg P, Baber R, Willenberg A, Wolfle P, Kratzsch J, Kiess W, Vogel M. Effect of sex, pubertal stage, body mass index, oral contraceptive use, and C-reactive protein on vitamin D binding protein reference values. Front Endocrinol (Lausanne). 2025 Feb 18;16:1470513. doi: 10.3389/fendo.2025.1470513. eCollection 2025.
PubMed 40041287Gruning Parache L, Vogel M, Meigen C, Kiess W, Poulain T. Family structure, socioeconomic status, and mental health in childhood. Eur Child Adolesc Psychiatry. 2024 Jul;33(7):2377-2386. doi: 10.1007/s00787-023-02329-y. Epub 2023 Dec 26.
PubMed 38147107Wex I, Geserick M, Leibert T, Igel U, Sobek C, Meigen C, Kiess W, Vogel M. Active school transport in an urban environment:prevalence and perceived barriers. BMC Public Health. 2023 Mar 23;23(1):557. doi: 10.1186/s12889-023-15464-7.
PubMed 36959624Schild CE, Meigen C, Kappelt J, Kiess W, Poulain T. Associations between sociodemographic and behavioural parameters and child development depending on age and sex: a cross-sectional analysis. BMJ Open. 2022 Nov 2;12(11):e065936. doi: 10.1136/bmjopen-2022-065936.
PubMed 36323480Kiess A, Green J, Willenberg A, Ceglarek U, Dahnert I, Jurkutat A, Korner A, Hiemisch A, Kiess W, Vogel M. Age-Dependent Reference Values for hs-Troponin T and NT-proBNP and Determining Factors in a Cohort of Healthy Children (The LIFE Child Study). Pediatr Cardiol. 2022 Jun;43(5):1071-1083. doi: 10.1007/s00246-022-02827-x. Epub 2022 Mar 12.
PubMed 35277733Hovestadt I, Kiess W, Lewien C, Willenberg A, Poulain T, Meigen C, Korner A, Vogel M. HbA1c percentiles and the association between BMI, age, gender, puberty, and HbA1c levels in healthy German children and adolescents. Pediatr Diabetes. 2022 Mar;23(2):194-202. doi: 10.1111/pedi.13297. Epub 2021 Dec 20.
PubMed 34877761Menzel P, Vogel M, Austin S, Sprenger N, Grafe N, Hilbert C, Jurkutat A, Kiess W, Binia A. Concentrations of oligosaccharides in human milk and child growth. BMC Pediatr. 2021 Oct 30;21(1):481. doi: 10.1186/s12887-021-02953-0.
PubMed 34717578Ziegelasch N, Vogel M, Korner A, Koch E, Jurkutat A, Ceglarek U, Dittrich K, Kiess W. Cystatin C relates to metabolism in healthy, pubertal adolescents. Pediatr Nephrol. 2022 Feb;37(2):423-432. doi: 10.1007/s00467-021-05209-2. Epub 2021 Aug 25.
PubMed 34432142Surup H, Vogel M, Koerner A, Hiemisch A, Oelkers L, Willenberg A, Kiess W, Kratzsch J. Pediatric Reference Intervals for Thyrotropin, Free Triiodothyronine, and Free Thyroxine and the Relevance of Body Mass Index and Puberty in Measurement Interpretation. Thyroid. 2021 Aug;31(8):1192-1202. doi: 10.1089/thy.2020.0780. Epub 2021 Jun 21.
PubMed 33906420
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Population-based Childhood Cohort Study in the Leipzig Area Investigating Genetic, Environmental, and Metabolic Factors and Their Association With the Development of Civilization Diseases
- ClinicalTrials.gov ID
- NCT02550236
- Acronym / sponsor ID
- LIFE Child Leipzig
- Conditions
- Child Development
- Keywords
- Children, Pregnancy, Growth, Lifestyle, Metabolic and cardiovascular health, Birth, Development, Reference Values
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- European Social Fund, European Regional Development Fund, Free State of Saxony, Helmholtz Center for Environmental Research Leipzig, Leipzig Research Center for Early Child Development, Robert Koch Institute Berlin
- Study start
- Oct 2010
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Leipzig Research Centre for Civilization Diseases (LIFE) Child Study is a prospective longitudinal population-based study with a life course approach to health and disease.
The LIFE Child Study focuses on two main research objectives:
- What are premises of normal growth, development and health in children?
- Which factors contribute to the development of non-communicable diseases such as childhood obesity and its co-morbidities, atopy and mental health problems?
Detailed assessments will be conducted alongside long-term storage of biological samples in 1,000 pregnant women and more than 5,000 children and their families.
Detailed description
- The LIFE Child study is part of LIFE, a life sciences research program of the University of Leipzig (Leipzig Research Centre for Civilization Diseases - LIFE). The measurements are performed in a well-equipped research centre located on the premises of the University Hospital of Leipzig.
- The study collects detailed information from clinical examinations, questionnaires and interviews and includes a collection of several types of biological materials at various time points (urine, stool, hair, blood for direct analyses, genomic DNA, dried blood spots, paxgenes (for RNA isolation and expression/eQTL studies). Children and adolescents from 0 to 20 years at baseline and their families are included. Participants are followed annually over a period of several years irrespective of the age at the first participation in the study until they reach the age of 20.
- Prenatal examinations are conducted in the 24th and 36th week of gestation and postnatal examinations in the 3rd, 6th and 12th month in the offspring. The birth cohort study collects detailed information from clinical examinations, questionnaires and interviews and biological materials (blood, cord blood, placental tissue, breast milk, hair, urine and stool)
- In addition, the LIFE Child study focuses in the disease cohort LIFE Child OBESITY and disease free controls in more detail. The aim of these subgroups is to examine aetiological associations and comorbidities with more in-depth methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LIFE Child Health | – | –The LIFE Child HEALTH cohort is a sample of over 5.000 children and adolescents. A basic program that will be carried out annually at each study centre visit. This program includes clinical history (perinatal and past medical history, medications, allergies, immunizations, developmental history and family history) clinical examination, collection of blood, hair, stool and urine samples, anthropometry and different age-dependent questionnaires. Questionnaires are completed by the parents and starting at the age of ten years also by the child itself. |
| LIFE Child Obesity | – | –The LIFE Child OBESITY cohort is a sample of 500 obese children and adolescents that will be assessed and compared to a lean control group (N=500) with equally detailed phenotyping including metabolic and cardiovascular evaluation. The LIFE Child OBESITY cohort (including the control group) performs the basic program of the LIFE Child HEALTH cohort plus additional parameters such as electrical bioimpedance, assessment of basal metabolic rate, oral glucose tolerance test, liver elastography and spirometry. |
| LIFE Child Health: Pregnancy/Birth | – | –The LIFE child Pregnancy/Birth cohort is a sample of over 1,200 pregnant women and their offspring. Prenatal examinations are conducted during the 24th to 26th and 34th to 36th week of gestation. During the first year of life, data is collected from children at 3, 6 and 12 month of age. |
Who may qualify
- Ages
- 0 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The LIFE Child study is a prospective longitudinal population-based cohort study. All children with their families and pregnant women of the area of Leipzig are eligible to participate in the LIFE Child study. This sample is supposed to represent the population of the city.
Key inclusion criteria (1 listed)
- children with their families and pregnant women of the area of Leipzig
Key exclusion criteria (1 listed)
- severe diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Civilization diseases and their risk factors
Time frame: 20 years
Assess lifestyle, metabolic and genetic risk factors of civilization diseases (e.g. diabetes mellitus, obesity, allergy, cardiovascular diseases) from fetal life to adulthood.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Derived from this study: PubMed 42675291Neininger MP, Bremer SUJ, Dathan-Stumpf A, Stepan H, Kiess W, Bertsche A, Vogel M, Bertsche T. High prevalence of magnesium supplementation during pregnancy: results from the LIFE Child study. Arch Gynecol Obstet. 2026 Aug 31;313(1):261. doi: 10.1007/s00404-026-08522-z.
- Derived from this study: PubMed 42667434Allner IE, Kiess W, Kratzsch J, Vogel M. Growth parameters and IGF-1 axis biomarkers differ among omnivorous, vegetarian, and vegan children. Eur J Nutr. 2026 Aug 29;65(6):245. doi: 10.1007/s00394-026-04085-6.
- Derived from this study: PubMed 42509536Trenkmann L, Ziegelasch N, Dittrich K, Willenberg A, Kiess W, Vogel M. Examining commonly used equations for estimating the glomerular filtration rate (GFR) in a healthy cohort of children and adolescents. BMC Nephrol. 2026 Jul 25;27(1):446. doi: 10.1186/s12882-026-05219-y.
- Derived from this study: PubMed 42481438Stasche HIU, Georgi GM, Korner A, Kiess W, Biemann R, Turp JC, Hirsch C. Oral Contraceptive Use Is Associated With Increased Tenderness to Palpation in the Masticatory System in Female Adolescents-Results of the Epidemiological LIFE Child Study. J Oral Rehabil. 2026 Jul 21. doi: 10.1111/joor.70270. Online ahead of print.
- Derived from this study: PubMed 41146137Poulain T, Schmidt R, Kiess W, Krause S, Golz S, Meigen C. Performance on an attention test is positively related to reading but negatively related to watching TV and playing video games in children. BMC Pediatr. 2025 Oct 28;25(1):872. doi: 10.1186/s12887-025-06260-w.
- Derived from this study: PubMed 41015329Durgen P, Wolfle PJ, Ceglarek U, Kratzsch J, Kiess W, Vogel M. New sex hormone-binding globulin and estimated free testosterone reference intervals for children and adolescents: The effects of age, sex, BMI and oral contraceptives. Clin Chim Acta. 2026 Jan 15;579:120621. doi: 10.1016/j.cca.2025.120621. Epub 2025 Sep 25.
- Derived from this study: PubMed 40041287von Heimburg P, Baber R, Willenberg A, Wolfle P, Kratzsch J, Kiess W, Vogel M. Effect of sex, pubertal stage, body mass index, oral contraceptive use, and C-reactive protein on vitamin D binding protein reference values. Front Endocrinol (Lausanne). 2025 Feb 18;16:1470513. doi: 10.3389/fendo.2025.1470513. eCollection 2025.
- Derived from this study: PubMed 38147107Gruning Parache L, Vogel M, Meigen C, Kiess W, Poulain T. Family structure, socioeconomic status, and mental health in childhood. Eur Child Adolesc Psychiatry. 2024 Jul;33(7):2377-2386. doi: 10.1007/s00787-023-02329-y. Epub 2023 Dec 26.
- Derived from this study: PubMed 36959624Wex I, Geserick M, Leibert T, Igel U, Sobek C, Meigen C, Kiess W, Vogel M. Active school transport in an urban environment:prevalence and perceived barriers. BMC Public Health. 2023 Mar 23;23(1):557. doi: 10.1186/s12889-023-15464-7.
- Derived from this study: PubMed 36323480Schild CE, Meigen C, Kappelt J, Kiess W, Poulain T. Associations between sociodemographic and behavioural parameters and child development depending on age and sex: a cross-sectional analysis. BMJ Open. 2022 Nov 2;12(11):e065936. doi: 10.1136/bmjopen-2022-065936.
- Derived from this study: PubMed 35277733Kiess A, Green J, Willenberg A, Ceglarek U, Dahnert I, Jurkutat A, Korner A, Hiemisch A, Kiess W, Vogel M. Age-Dependent Reference Values for hs-Troponin T and NT-proBNP and Determining Factors in a Cohort of Healthy Children (The LIFE Child Study). Pediatr Cardiol. 2022 Jun;43(5):1071-1083. doi: 10.1007/s00246-022-02827-x. Epub 2022 Mar 12.
- Derived from this study: PubMed 34877761Hovestadt I, Kiess W, Lewien C, Willenberg A, Poulain T, Meigen C, Korner A, Vogel M. HbA1c percentiles and the association between BMI, age, gender, puberty, and HbA1c levels in healthy German children and adolescents. Pediatr Diabetes. 2022 Mar;23(2):194-202. doi: 10.1111/pedi.13297. Epub 2021 Dec 20.
- List of all publications, sorted by topicLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antje Körner, Prof., MD contact
LIFE Child contact
Antje Körner, Prof., MD principal investigator
University of Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antje Körner, Prof., MD (antje.koerner@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Civilization diseases and their risk factors (time frame: 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02550236, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.