Nutritional Physiological PhenomenaNRC250NCT02522390
The Nutrition Researcher Cohort 2014 Study
An observational study of Nutritional Physiological Phenomena and Health, run by TNO at 12 sites in 12 countries.
Trial summary
The primary objective of the planned Nutrition Research Cohort (NRC) n250 study is to develop and evaluate the open access Nutrition Researcher Cohort for gathering personal health data from nutrition researchers, including analytical methods, standards and operation procedures, data infrastructure, ethical and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutritional Physiological Phenomena, Health, Biological Markers
- What is being tested?
- Research activities
- How many people
- 192 participants
- Where
- 12 sitesin 12 countries
- Study dates
- Jan 2015to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The NRC cohort will be composed of employees and students in the area of life sciences. This allows optimal involvement of participants in shaping all aspects of the cohort and the ownership of data. We aim to recruit about 250 male and female scientists for the entire cohort. For each participating country it is aimed to recruit about 25 participants, taking drop-out and varying submission and/or starting dates between the 15 participating countries into account. Besides, a higher number of participants will increase the chance of being able to compare the data with other countries.
Who may be able to join
- Employees or students that are active in the field of nutrition and/or biology and/or health (e.g. epidemiologists, dieticians, nutrition students and researchers) that have a basic knowledge of nutrition and/or human biology and are thus able to form a scientific judgement on his/her own health data;
- good understanding of the English written language, since all communication is handled in English.
Who cannot join
- None
Trial locations and contacts
12 sites in 12 countries.
12 sites in 12 countries
Italy1 site
CRA-NUT - Centro di Ricerca per gli Alimenti e la Nutrizione
Rome, 00178
About this study
Official title: The Nutrition Researcher Cohort 2014 Study; New Standardized Self-quantification Methodologies Serving Both Research and Personal Health Maintenance
The primary objective of the planned Nutrition Research Cohort (NRC) n250 study is to develop and evaluate the open access Nutrition Researcher Cohort for gathering personal health data from nutrition researchers, including analytical methods, standards and operation procedures, data infrastructure, ethical and privacy aspects, and governance.
Besides, the study aims to exploit and analyse data on food, nutrient and bioactive compound intake and exposure, biomarkers for food, health and/or disease and health and/or disease related measurements to study the relation between nutrition, health and development of disease (on individual level).
Read more
In addition, data will be used to develop applications that visualise personal health risks based for example on (validated) recommendations and applications that predict individual health risks.
The study is designed as an open, one-group, exploratory cohort study. The total NRC cohort will be composed of about 250 life sciences employees and students from different, predominantly European, countries. This allows optimal involvement of participants in shaping all aspects of the cohort and the ownership of data. We aim to recruit about in total 20 male and female scientists per participating country.
Read the detailed description
The NRC n250 study is an open, one-group, open-ended cohort study, which will include participants from 10 different countries. The study will be coordinated by national contact points from each of the participating countries.
The NRC cohort study will start early 2015 and continue developing from that moment on. Recruitment will start immediately after approval of the study protocol in the country where it has been submitted. The Participant Information Form, which contains the complete research protocol as developed by the consortium partners, is available online via the NRC website. This way, potential participants can make an informed decision on whether or not they want to participate.
The NRC n250 study will provide a dataset from 250 individuals, including food intake, microbiome composition, oral glucose tolerance tests, a series of plasma (bio)chemistry outcomes, plasma and urine metabolome and DNA damage, together with anthropometrics and life style questionnaires.
Since the aim is to build up a powerful open access cohort, there is no end-date defined for this study. The collected data will be used for various analyses on food intake, biomarkers for food intake and/or health and/or disease, and health/disease related measurements.
The research questions that will be answered with this cohort are largely not known yet, since it is not known which data will become available. A NRC Scientific committee is established to judge whether or not the data in the cohort may be used for answering the proposed research questions. This Scientific committee consists of the principal investigators of the individual participating countries.
The Scientific committee is the entity that views all proposals (new studies, research questions) and decides whether or not it is in line with aim of NRC as well as ethics as well as scientifically robust. Approval for proposals can be obtained by positive response from a majority of the members (quality and ethics of proposals).
Institutions/companies that obtain data for a specific proposal, are only allowed to use the data for that specific purpose.
The NRC cohort also aims to serve as a platform to validate specific questionnaires (including food intake) or additional measurements (that are within scope of the NRC objectives). For offering an additional measurement or questionnaire to participants for health parameters that are already included in the protocols, also a request for approval should be filed to the scientific committee. The scientific committee will then decide (based on a positive response of the majority of the committee) if this measurement or questionnaire may be added. A request for data analysis with these new measures or questionnaires, other than validation purposes, has to be filed separately. If a request for approval is granted, participants still have the opportunity to opt out their data for use for this purpose.
For research questions that require additional measurements for health parameters that are not yet included in the protocol, amendments will be submitted to the Dutch Medical Research and Ethics Committee (MREC).
- Being tested
- Research activities
- Keywords
- data collection, personal health services, personal health records, do-it-yourself, nutrition researchers, cohort studies, databases, factual, self-quantification methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research activitiesOther
Also called Do-it-yourself devices, filling out online-questionnaires, sample collection with supplied kits
Measurements are primarily based on "do-it-yourself" non-invasive or minimally invasive methods. Participants upload collected data to the Personal Health Portal.
The measurements are divided into required and optional measurements. The required measurements mainly include routine methodology (e.g. weight, blood pressure, blood glucose); the latter also include methods under development that will be fine-tuned along the project. Which additional measures will be offered to participants is dependent on if funding or in-kind sponsoring is available. Participants will receive measurement kits for these analyses at-home and will be responsible for collection, labeling and shipment of samples themselves. After analysis the resulting data are uploaded to the user accounts.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Researcher Cohort | This cohort study is an observational, one-group study. The intervention consists of research activities that participants are asked to perform throughout the cohort, including the use of do-it-yourself devices, filling out online-questionnaires and sample collection with supplied kits for the analysis of various health parameters. The frequency with which participants are asked to measure these health parameters varies, ranging from once to weekly. Receives: Other: Research activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body height
measured with do-it-yourself device in at-home setting
Measured: Baseline (week 1)
Body weight
measured with do-it-yourself device in at-home setting
Measured: Each week during entire cohort (five years in total)
Single Nucleotide Polymorphism (SNP) profile
No specific time of measurement has to be specified as genetic profile is not subject to change
Measured: Once during the cohort at baseline (a timepoint chosen by the participant in the first three months of the cohort)
Waist-to-hip ratio
measured with waist circumference and hip circumference; measured with centimeter in at-home setting
Measured: Monthly during entire cohort (Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 for each year of the five year cohort)
Blood pressure
Diastolic and systolic blood pressure; measured with do-it-yourself device in at-home setting
Measured: Monthly during entire cohort (Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 for each year of the five year cohort)
Resting heart rate
measured after sitting still for at least 5 minutes; measured with do-it-yourself device in at-home setting
Measured: Monthly during entire cohort (Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 for each year of the five year cohort)
fasting blood glucose
measured after 8h fasting (only drinking water is allowed); measured with do-it-yourself device in at-home setting
Measured: Monthly during entire cohort (Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 for each year of the five year cohort)
Blood cholesterol
HDL, LDL, total cholesterol, triglycerides; measured with do-it-yourself device in at-home setting
Measured: quarterly during entire cohort (Month 3, M6, M9, M12 for each year of the five year cohort)
Food intake
registration of food intake during two weekdays and one weekend day via an online application (e.g. FatSecret)
Measured: quarterly during entire cohort (Month 3, M6, M9, M12 for each year of the five year cohort)
Physical activity tracker
Registration of physical activity with a physical activity tracker (e.g. FitBit) for at least one week continuously
Measured: quarterly during entire cohort (Month 3, M6, M9, M12 for each year of the five year cohort)
Secondary outcomes (13)
biomarker profile
biomarkers for food intake (vitamins, fatty acids) and other blood biomarkers (cortisol, C Reactive protein (CRP), thyroid stimulating hormone (TSH), etc.)
Measured: once, at baseline (at a timepoint chosen by the participant in the first three months of the cohort); this measure will be repeated only if funding for analysis becomes available
do-it-yourself oral glucose tolerance test
insulin, glucose, c-peptide, HbA1c; including response profile after oral glucose tolerance test
Measured: once, at baseline (at a timepoint chosen by the participant in the first three months of the cohort); this measure will be repeated only if funding for analysis becomes available
metabolomics
Measured: once, at baseline (at a timepoint chosen by the participant in the first three months of the cohort); this measure will be repeated only if funding for analysis becomes available
metagenome
Measured: once, at baseline (at a timepoint chosen by the participant in the first three months of the cohort); this measure will be repeated only if funding for analysis becomes available
general health status
via a questionnaire
Measured: once per year during entire cohort (Month 12, M24, M36, M48, M60)
lifestyle (smoking, alcohol consumption, etc.)
via a questionnaire
Measured: once per year during entire cohort (Month 12, M24, M36, M48, M60)
general food intake
via a food frequency questionnaire
Measured: once per year during entire cohort (Month 12, M24, M36, M48, M60)
quality of sleep
via a questionnaire
Measured: once per year during entire cohort (Month 12, M24, M36, M48, M60)
stress questionnaire
Measured: once per year during entire cohort (Month 12, M24, M36, M48, M60)
physical activity
via a questionnaire
Measured: once per year during entire cohort (Month 12, M24, M36, M48, M60)
wellness
via a questionnaire
Measured: once per year during entire cohort (Month 12, M24, M36, M48, M60)
cognition
via a questionnaire
Measured: once per year during entire cohort (Month 12, M24, M36, M48, M60)
quality of life
via a questionnaire
Measured: once per year during entire cohort (Month 12, M24, M36, M48, M60)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional Physiological PhenomenaStudies 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
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- TNO
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland, Lund University, NIHS, University of Barcelona, University College Dublin, Newcastle University, Technical University Munchen, Universitaire Ziekenhuizen KU Leuven, University of Oslo, University of Copenhagen, University of Graz, Tufts University, Charles University, Czech Republic, NuGo, VITAS Analytical Services, Humboldt-Universität zu Berlin, CSIRO Animal, Food and Health Sciences, SwissAnalysis AG, Agroscope Liebefeld-Posieux Research Station ALP, CRA NUT - Centro di Ricerca per gli Alimenti e la Nutrizione
- Responsible party
- Principal investigator, Ivana Bobeldijk-Pastorova, TNO
- Investigators
- André Boorsma, PhD, Principal investigator, TNOBaukje de Roos, Principal investigator, Newcastle UniversityGiuditta Perozzi, Principal investigator, CRA-NUTLorraine Brennan, Principal investigator, University College DublinChristophe Matthys, Principal investigator, University LeuvenIrina Dobre, Principal investigator, University of CopenhagenMiroslav Petr, Principal investigator, Charles University PragueAndre Mazur, Principal investigator, INRA - French National Institute for Agricultural Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522390
- Sponsor's protocol ID
- P9616
- Acronym
- NRC250
- Status last verified
- Apr 2017
- First submitted
- 23 Mar 2015
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An internal review board, consisting of Principal Investigators from all participating countries, will review all data requests. A data request format is available that should be used for filing such a request. The format requires stating the research questions that should be answered with the requested data, type of data, populations requirements (exclusion criteria), data analysis and public disclosure. All study participants have the ability to withdraw their data from use for answering specific research questions at any time.
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nutrition Researcher Cohort 2014 Study; New Standardized Self-quantification Methodologies Serving Both Research and Personal Health Maintenance
- ClinicalTrials.gov ID
- NCT02522390
- Acronym / sponsor ID
- NRC250 / P9616
- Keywords
- data collection, personal health services, personal health records, do-it-yourself, nutrition researchers, cohort studies, databases, factual, self-quantification methods
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (actual)
- Lead sponsor
- TNOUniversity, hospital or other
- Collaborators
- University of Eastern Finland, Lund University, NIHS, University of Barcelona, University College Dublin, Newcastle University, Technical University Munchen, Universitaire Ziekenhuizen KU Leuven, University of Oslo, University of Copenhagen, University of Graz, Tufts University, Charles University, Czech Republic, NuGo, VITAS Analytical Services, Humboldt-Universität zu Berlin, CSIRO Animal, Food and Health Sciences, SwissAnalysis AG, Agroscope Liebefeld-Posieux Research Station ALP, CRA NUT - Centro di Ricerca per gli Alimenti e la Nutrizione
- Study start
- Jan 2015
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 13 Aug 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 primary objective of the planned Nutrition Research Cohort (NRC) n250 study is to develop and evaluate the open access Nutrition Researcher Cohort for gathering personal health data from nutrition researchers, including analytical methods, standards and operation procedures, data infrastructure, ethical and privacy aspects, and governance.
Besides, the study aims to exploit and analyse data on food, nutrient and bioactive compound intake and exposure, biomarkers for food, health and/or disease and health and/or disease related measurements to study the relation between nutrition, health and development of disease (on individual level).
In addition, data will be used to develop applications that visualise personal health risks based for example on (validated) recommendations and applications that predict individual health risks.
The study is designed as an open, one-group, exploratory cohort study. The total NRC cohort will be composed of about 250 life sciences employees and students from different, predominantly European, countries. This allows optimal involvement of participants in shaping all aspects of the cohort and the ownership of data. We aim to recruit about in total 20 male and female scientists per participating country.
Detailed description
The NRC n250 study is an open, one-group, open-ended cohort study, which will include participants from 10 different countries. The study will be coordinated by national contact points from each of the participating countries.
The NRC cohort study will start early 2015 and continue developing from that moment on. Recruitment will start immediately after approval of the study protocol in the country where it has been submitted. The Participant Information Form, which contains the complete research protocol as developed by the consortium partners, is available online via the NRC website. This way, potential participants can make an informed decision on whether or not they want to participate.
The NRC n250 study will provide a dataset from 250 individuals, including food intake, microbiome composition, oral glucose tolerance tests, a series of plasma (bio)chemistry outcomes, plasma and urine metabolome and DNA damage, together with anthropometrics and life style questionnaires.
Since the aim is to build up a powerful open access cohort, there is no end-date defined for this study. The collected data will be used for various analyses on food intake, biomarkers for food intake and/or health and/or disease, and health/disease related measurements.
The research questions that will be answered with this cohort are largely not known yet, since it is not known which data will become available. A NRC Scientific committee is established to judge whether or not the data in the cohort may be used for answering the proposed research questions. This Scientific committee consists of the principal investigators of the individual participating countries.
The Scientific committee is the entity that views all proposals (new studies, research questions) and decides whether or not it is in line with aim of NRC as well as ethics as well as scientifically robust. Approval for proposals can be obtained by positive response from a majority of the members (quality and ethics of proposals).
Institutions/companies that obtain data for a specific proposal, are only allowed to use the data for that specific purpose.
The NRC cohort also aims to serve as a platform to validate specific questionnaires (including food intake) or additional measurements (that are within scope of the NRC objectives). For offering an additional measurement or questionnaire to participants for health parameters that are already included in the protocols, also a request for approval should be filed to the scientific committee. The scientific committee will then decide (based on a positive response of the majority of the committee) if this measurement or questionnaire may be added. A request for data analysis with these new measures or questionnaires, other than validation purposes, has to be filed separately. If a request for approval is granted, participants still have the opportunity to opt out their data for use for this purpose.
For research questions that require additional measurements for health parameters that are not yet included in the protocol, amendments will be submitted to the Dutch Medical Research and Ethics Committee (MREC).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutrition Researcher Cohort | – | Other: Research activitiesThis cohort study is an observational, one-group study. The intervention consists of research activities that participants are asked to perform throughout the cohort, including the use of do-it-yourself devices, filling out online-questionnaires and sample collection with supplied kits for the analysis of various health parameters. The frequency with which participants are asked to measure these health parameters varies, ranging from once to weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The NRC cohort will be composed of employees and students in the area of life sciences. This allows optimal involvement of participants in shaping all aspects of the cohort and the ownership of data. We aim to recruit about 250 male and female scientists for the entire cohort. For each participating country it is aimed to recruit about 25 participants, taking drop-out and varying submission and/or starting dates between the 15 participating countries into account. Besides, a higher number of participants will increase the chance of being able to compare the data with other countries.
Key inclusion criteria (2 listed)
- Employees or students that are active in the field of nutrition and/or biology and/or health (e.g. epidemiologists, dieticians, nutrition students and researchers) that have a basic knowledge of nutrition and/or human biology and are thus able to form a scientific judgement on his/her own health data;
- good understanding of the English written language, since all communication is handled in English.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Research activitiesAlso: Do-it-yourself devices, filling out online-questionnaires, sample collection with supplied kitsMeasurements are primarily based on "do-it-yourself" non-invasive or minimally invasive methods. Participants upload collected data to the Personal Health Portal. The measurements are divided into required and optional measurements. The required measurements mainly include routine methodology (e.g. weight, blood pressure, blood glucose); the latter also include methods under development that will be fine-tuned along the project. Which additional measures will be offered to participants is dependent on if funding or in-kind sponsoring is available. Participants will receive measurement kits for these analyses at-home and will be responsible for collection, labeling and shipment of samples themselves. After analysis the resulting data are uploaded to the user accounts. | Other | Nutrition Researcher Cohort |
Primary outcome
Body height
Time frame: Baseline (week 1)
measured with do-it-yourself device in at-home setting
Body weight
Time frame: Each week during entire cohort (five years in total)
measured with do-it-yourself device in at-home setting
Single Nucleotide Polymorphism (SNP) profile
Time frame: Once during the cohort at baseline (a timepoint chosen by the participant in the first three months of the cohort)
No specific time of measurement has to be specified as genetic profile is not subject to change
Waist-to-hip ratio
Time frame: Monthly during entire cohort (Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 for each year of the five year cohort)
measured with waist circumference and hip circumference; measured with centimeter in at-home setting
Blood pressure
Time frame: Monthly during entire cohort (Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 for each year of the five year cohort)
Diastolic and systolic blood pressure; measured with do-it-yourself device in at-home setting
Resting heart rate
Time frame: Monthly during entire cohort (Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 for each year of the five year cohort)
measured after sitting still for at least 5 minutes; measured with do-it-yourself device in at-home setting
fasting blood glucose
Time frame: Monthly during entire cohort (Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 for each year of the five year cohort)
measured after 8h fasting (only drinking water is allowed); measured with do-it-yourself device in at-home setting
Blood cholesterol
Time frame: quarterly during entire cohort (Month 3, M6, M9, M12 for each year of the five year cohort)
HDL, LDL, total cholesterol, triglycerides; measured with do-it-yourself device in at-home setting
Food intake
Time frame: quarterly during entire cohort (Month 3, M6, M9, M12 for each year of the five year cohort)
registration of food intake during two weekdays and one weekend day via an online application (e.g. FatSecret)
Physical activity tracker
Time frame: quarterly during entire cohort (Month 3, M6, M9, M12 for each year of the five year cohort)
Registration of physical activity with a physical activity tracker (e.g. FitBit) for at least one week continuously
13 secondary outcomes
biomarker profile
Time frame: once, at baseline (at a timepoint chosen by the participant in the first three months of the cohort); this measure will be repeated only if funding for analysis becomes available
do-it-yourself oral glucose tolerance test
Time frame: once, at baseline (at a timepoint chosen by the participant in the first three months of the cohort); this measure will be repeated only if funding for analysis becomes available
metabolomics
Time frame: once, at baseline (at a timepoint chosen by the participant in the first three months of the cohort); this measure will be repeated only if funding for analysis becomes available
metagenome
Time frame: once, at baseline (at a timepoint chosen by the participant in the first three months of the cohort); this measure will be repeated only if funding for analysis becomes available
general health status
Time frame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
lifestyle (smoking, alcohol consumption, etc.)
Time frame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
general food intake
Time frame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
quality of sleep
Time frame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
stress questionnaire
Time frame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
physical activity
Time frame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
wellness
Time frame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
cognition
Time frame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
quality of life
Time frame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Individual participant dataSharing planned: Yes. An internal review board, consisting of Principal Investigators from all participating countries, will review all data requests. A data request format is available that should be used for filing such a request. The format requires stating the research questions that should be answered with the requested data, type of data, populations requirements (exclusion criteria), data analysis and public disclosure. All study participants have the ability to withdraw their data from use for answering specific research questions at any time.
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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. This study is not recruiting at the moment.
André Boorsma, PhD principal investigator
TNO
Baukje de Roos principal investigator
Newcastle University
Giuditta Perozzi principal investigator
CRA-NUT
12 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Physiological Phenomena and Health, run by TNO at 12 sites in 12 countries.
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 2 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: status not confirmed, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Austria, Belgium, Czechia, Denmark, Finland and 7 more countries. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body height (time frame: Baseline (week 1)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2017.