ObesityNCT00928473
The Danish Childhood Obesity Biobank
A study testing A family-centered, multidisciplinary obesity treatment program in people with Obesity and Metabolic Disease, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The Danish Childhood Obesity Biobank aims to produce a scientific platform for research in obesity: Bio-clinical data are collected from two cohorts - an obesity clinic cohort and a population-based cohort. Read more about this study
- Who is it for?
- Ages 2 to 100 years
- Conditions the study is for
- Obesity, Metabolic Disease, NAFLD, Non-alcoholic Fatty Liver Disease
- What is being tested?
- A family-centered, multidisciplinary obesity treatment program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2009to Dec 2025
- Phase
- Interventional
- 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 2 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 2- 100 Years old
- Adipose, BMI > 90 % percentile
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Jens-Christian Holm, Ph.d., MD contact
Denmark1 site, 1 recruiting
- Recruiting
The Children's Obesity Clinic, Paediatric department, University Hospital Holbæk, Region Zealand
Holbæk, 4300
Jens-Christian Holm, Ph.d, MD, jhom@regionsjaelland.dk
About this study
The Danish Childhood Obesity Biobank aims to produce a scientific platform for research in obesity: Bio-clinical data are collected from two cohorts - an obesity clinic cohort and a population-based cohort. The biobank thus facilitates translation between research and clinical practice of obesity treatment and related complications.
Read the detailed description
The Danish Childhood Obesity Biobank collects data from two cohorts - an obesity clinic cohort and a population-based cohort, of which the latter functions as a reference group.
The biobank continuously and longitudinally includes clinical data and biological samples from children and adolescents in obesity treatment. The population-based cohort has been recruited in a cross-sectional manner from Danish schools, high schools, and dentistries.
Data included in the biobank include venous blood samples, stool, urine, saliva, anthropometrics, body composition by dual-energy X-ray absorptiometry, magnetic resonance imaging and spectroscopy, and genetic markers among others. The data are stored in a central secured electronic database and biological materials are stored in -80-degree Celsius freezers until analyses.
To date, the Danish Childhood Obesity Biobank have included data from more than 5250 children, adolescents and adults from the obesity clinic cohort and more than 4200 from the population-based cohort.
- Conditions
- Obesity, Metabolic Disease, NAFLD, Non-alcoholic Fatty Liver Disease, Cardiovascular Diseases
- Being tested
- A family-centered, multidisciplinary obesity treatment program
- Medical subject headings
- Obesity, Metabolic Diseases, Non-alcoholic Fatty Liver Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A family-centered, multidisciplinary obesity treatment programBehavioural
Also called (Holm, J. C. et al. Chronic care treatment of obese children and adolescents. Int. J. Pediatr. Obes. 6, 188-196, 2011).
The obese children will start a treatment for obesity in the Children's Obesity Clinic. This treatment includes lifestyle counseling, objective examination, weight-controls, visiting a psychologist, visiting a dietician and blood samples, DXA-scan, eventually MRI.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | The obese children will start a treatment for obesity in the Children's Obesity Clinic. This treatment includes lifestyle counseling, objective examination, weight-controls, visiting a psychologist, visiting a dietician and blood samples, DXA-scan, eventually MRI. Receives: Behavioral: A family-centered, multidisciplinary obesity treatment program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weightloss, changes in blood parameters and in fatty liver developement.
Measured: continuously
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Steno Diabetes Center Copenhagen, Holbaek Sygehus
- Responsible party
- Principal investigator, Jens Christian Holm, University of Copenhagen
- Investigators
- Jens-Christian Holm, Ph.d., MD, Study chair, The Children's Obesity Clinic and The Danish Childhood Obesity Biobank
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928473
- Sponsor's protocol ID
- 250609
- Status last verified
- Nov 2020
- First submitted
- 25 Jun 2009
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stinson SE, Jonsson AE, Andersen MK, Lund MAV, Holm LA, Fonvig CE, Huang Y, Stankevic E, Juel HB, Angquist L, Sorensen TIA, Ongstad EL, Gaddipati R, Grimsby J, Rhodes CJ, Pedersen O, Christiansen M, Holm JC, Hansen T. High Plasma Levels of Soluble Lectin-like Oxidized Low-Density Lipoprotein Receptor-1 Are Associated With Inflammation and Cardiometabolic Risk Profiles in Pediatric Overweight and Obesity. J Am Heart Assoc. 2023 Feb 7;12(3):e8145. doi: 10.1161/JAHA.122.027042. Epub 2023 Jan 25.
PubMed 36695299Johansen MJ, Vonsild Lund MA, Angquist L, Fonvig CE, Holm LA, Chabanova E, Thomsen HS, Hansen T, Holm JC. Possible prediction of obesity-related liver disease in children and adolescents using indices of body composition. Pediatr Obes. 2022 Oct;17(10):e12947. doi: 10.1111/ijpo.12947. Epub 2022 Jun 21.
PubMed 35726748Frithioff-Bojsoe C, Lund MAV, Lausten-Thomsen U, Fonvig CE, Lankjaer IOJ, Hansen T, Hansen T, Baker JL, Holm JC. Early detection of childhood overweight and related complications in a Danish population-based cohort aged 2-8 years. Obes Res Clin Pract. 2022 May-Jun;16(3):228-234. doi: 10.1016/j.orcp.2022.04.001. Epub 2022 May 3.
PubMed 35514021Stinson SE, Jonsson AE, de Retana Alzola IF, Lund MAV, Frithioff-Bojsoe C, Aas Holm L, Fonvig CE, Pedersen O, Angquist L, Sorensen TIA, Holst JJ, Christiansen M, Holm JC, Hartmann B, Hansen T. Hyperglucagonemia in Pediatric Adiposity Associates With Cardiometabolic Risk Factors but Not Hyperglycemia. J Clin Endocrinol Metab. 2022 May 17;107(6):1569-1576. doi: 10.1210/clinem/dgac108.
PubMed 35213713Stinson SE, Jonsson AE, Lund MAV, Frithioff-Bojsoe C, Aas Holm L, Pedersen O, Angquist L, Sorensen TIA, Holst JJ, Christiansen M, Holm JC, Hartmann B, Hansen T. Fasting Plasma GLP-1 Is Associated With Overweight/Obesity and Cardiometabolic Risk Factors in Children and Adolescents. J Clin Endocrinol Metab. 2021 May 13;106(6):1718-1727. doi: 10.1210/clinem/dgab098.
PubMed 33596309Lund MAV, Thostrup AH, Frithioff-Bojsoe C, Lausten-Thomsen U, Hedley PL, Pedersen O, Christiansen M, Hansen T, Holm JC. Low-grade inflammation independently associates with cardiometabolic risk in children with overweight/obesity. Nutr Metab Cardiovasc Dis. 2020 Aug 28;30(9):1544-1553. doi: 10.1016/j.numecd.2020.04.024. Epub 2020 May 5.
PubMed 32571613Jors A, Lund MAV, Jespersen T, Hansen T, Poulsen HE, Holm JC. Urinary markers of nucleic acid oxidation increase with age, obesity and insulin resistance in Danish children and adolescents. Free Radic Biol Med. 2020 Aug 1;155:81-86. doi: 10.1016/j.freeradbiomed.2020.05.009. Epub 2020 May 25.
PubMed 32464183Frithioff-Bojsoe C, Lund MAV, Lausten-Thomsen U, Hedley PL, Pedersen O, Christiansen M, Baker JL, Hansen T, Holm JC. Leptin, adiponectin, and their ratio as markers of insulin resistance and cardiometabolic risk in childhood obesity. Pediatr Diabetes. 2020 Mar;21(2):194-202. doi: 10.1111/pedi.12964. Epub 2019 Dec 26.
PubMed 31845423Johansen MJ, Gade J, Stender S, Frithioff-Bojsoe C, Lund MAV, Chabanova E, Thomsen HS, Pedersen O, Fonvig CE, Hansen T, Holm JC. The Effect of Overweight and Obesity on Liver Biochemical Markers in Children and Adolescents. J Clin Endocrinol Metab. 2020 Feb 1;105(2):dgz010. doi: 10.1210/clinem/dgz010.
PubMed 31617910Viitasalo A, Schnurr TM, Pitkanen N, Hollensted M, Nielsen TRH, Pahkala K, Atalay M, Lind MV, Heikkinen S, Frithioff-Bojsoe C, Fonvig CE, Grarup N, Kahonen M, Carrasquilla GD, Larnkjaer A, Pedersen O, Michaelsen KF, Lakka TA, Holm JC, Lehtimaki T, Raitakari O, Hansen T, Kilpelainen TO. Abdominal adiposity and cardiometabolic risk factors in children and adolescents: a Mendelian randomization analysis. Am J Clin Nutr. 2019 Nov 1;110(5):1079-1087. doi: 10.1093/ajcn/nqz187.
PubMed 31504107Hollensted M, Fogh M, Schnurr TM, Kloppenborg JT, Have CT, Ruest Haarmark Nielsen T, Rask J, Asp Vonsild Lund M, Frithioff-Bojsoe C, Ostergaard Johansen M, Vincent Rosenbaum Appel E, Mahendran Y, Grarup N, Kadarmideen HN, Pedersen O, Holm JC, Hansen T. Genetic Susceptibility for Childhood BMI has no Impact on Weight Loss Following Lifestyle Intervention in Danish Children. Obesity (Silver Spring). 2018 Dec;26(12):1915-1922. doi: 10.1002/oby.22308.
PubMed 30460774Fonvig CE, Hamann SA, Nielsen TRH, Johansen MO, Gronbaek HN, Mollerup PM, Holm JC. Subjective evaluation of psychosocial well-being in children and youths with overweight or obesity: the impact of multidisciplinary obesity treatment. Qual Life Res. 2017 Dec;26(12):3279-3288. doi: 10.1007/s11136-017-1667-5. Epub 2017 Jul 31.
PubMed 28762099Nielsen TRH, Lausten-Thomsen U, Fonvig CE, Bojsoe C, Pedersen L, Bratholm PS, Hansen T, Pedersen O, Holm JC. Dyslipidemia and reference values for fasting plasma lipid concentrations in Danish/North-European White children and adolescents. BMC Pediatr. 2017 Apr 28;17(1):116. doi: 10.1186/s12887-017-0868-y.
PubMed 28454530Rischel HE, Nielsen LA, Gamborg M, Moller P, Holm JC. Comparison of sensory-specific satiety between normal weight and overweight children. Appetite. 2016 Dec 1;107:486-493. doi: 10.1016/j.appet.2016.08.123. Epub 2016 Sep 1.
PubMed 27593452Trier C, Dahl M, Stjernholm T, Nielsen TR, Bojsoe C, Fonvig CE, Pedersen O, Hansen T, Holm JC. Effects of a Family-Based Childhood Obesity Treatment Program on Parental Weight Status. PLoS One. 2016 Aug 25;11(8):e0161921. doi: 10.1371/journal.pone.0161921. eCollection 2016.
PubMed 27560141
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Danish Childhood Obesity Biobank
- ClinicalTrials.gov ID
- NCT00928473
- Acronym / sponsor ID
- 250609
- Conditions
- Obesity, Metabolic Disease, NAFLD, Non-alcoholic Fatty Liver Disease, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen, Steno Diabetes Center Copenhagen, Holbaek Sygehus
- Study start
- Jan 2009
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Jun 2009 (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 Danish Childhood Obesity Biobank aims to produce a scientific platform for research in obesity: Bio-clinical data are collected from two cohorts - an obesity clinic cohort and a population-based cohort. The biobank thus facilitates translation between research and clinical practice of obesity treatment and related complications.
Detailed description
The Danish Childhood Obesity Biobank collects data from two cohorts - an obesity clinic cohort and a population-based cohort, of which the latter functions as a reference group.
The biobank continuously and longitudinally includes clinical data and biological samples from children and adolescents in obesity treatment. The population-based cohort has been recruited in a cross-sectional manner from Danish schools, high schools, and dentistries.
Data included in the biobank include venous blood samples, stool, urine, saliva, anthropometrics, body composition by dual-energy X-ray absorptiometry, magnetic resonance imaging and spectroscopy, and genetic markers among others. The data are stored in a central secured electronic database and biological materials are stored in -80-degree Celsius freezers until analyses.
To date, the Danish Childhood Obesity Biobank have included data from more than 5250 children, adolescents and adults from the obesity clinic cohort and more than 4200 from the population-based cohort.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: A family-centered, multidisciplinary obesity treatment programThe obese children will start a treatment for obesity in the Children's Obesity Clinic. This treatment includes lifestyle counseling, objective examination, weight-controls, visiting a psychologist, visiting a dietician and blood samples, DXA-scan, eventually MRI. |
Who may qualify
- Ages
- 2 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 2- 100 Years old
- Adipose, BMI > 90 % percentile
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| A family-centered, multidisciplinary obesity treatment programAlso: (Holm, J. C. et al. Chronic care treatment of obese children and adolescents. Int. J. Pediatr. Obes. 6, 188-196, 2011).The obese children will start a treatment for obesity in the Children's Obesity Clinic. This treatment includes lifestyle counseling, objective examination, weight-controls, visiting a psychologist, visiting a dietician and blood samples, DXA-scan, eventually MRI. | Behavioural | Lifestyle counseling |
Primary outcome
Weightloss, changes in blood parameters and in fatty liver developement.
Time frame: continuously
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Derived from this study: PubMed 36695299Stinson SE, Jonsson AE, Andersen MK, Lund MAV, Holm LA, Fonvig CE, Huang Y, Stankevic E, Juel HB, Angquist L, Sorensen TIA, Ongstad EL, Gaddipati R, Grimsby J, Rhodes CJ, Pedersen O, Christiansen M, Holm JC, Hansen T. High Plasma Levels of Soluble Lectin-like Oxidized Low-Density Lipoprotein Receptor-1 Are Associated With Inflammation and Cardiometabolic Risk Profiles in Pediatric Overweight and Obesity. J Am Heart Assoc. 2023 Feb 7;12(3):e8145. doi: 10.1161/JAHA.122.027042. Epub 2023 Jan 25.
- Derived from this study: PubMed 35726748Johansen MJ, Vonsild Lund MA, Angquist L, Fonvig CE, Holm LA, Chabanova E, Thomsen HS, Hansen T, Holm JC. Possible prediction of obesity-related liver disease in children and adolescents using indices of body composition. Pediatr Obes. 2022 Oct;17(10):e12947. doi: 10.1111/ijpo.12947. Epub 2022 Jun 21.
- Derived from this study: PubMed 35514021Frithioff-Bojsoe C, Lund MAV, Lausten-Thomsen U, Fonvig CE, Lankjaer IOJ, Hansen T, Hansen T, Baker JL, Holm JC. Early detection of childhood overweight and related complications in a Danish population-based cohort aged 2-8 years. Obes Res Clin Pract. 2022 May-Jun;16(3):228-234. doi: 10.1016/j.orcp.2022.04.001. Epub 2022 May 3.
- Derived from this study: PubMed 35213713Stinson SE, Jonsson AE, de Retana Alzola IF, Lund MAV, Frithioff-Bojsoe C, Aas Holm L, Fonvig CE, Pedersen O, Angquist L, Sorensen TIA, Holst JJ, Christiansen M, Holm JC, Hartmann B, Hansen T. Hyperglucagonemia in Pediatric Adiposity Associates With Cardiometabolic Risk Factors but Not Hyperglycemia. J Clin Endocrinol Metab. 2022 May 17;107(6):1569-1576. doi: 10.1210/clinem/dgac108.
- Derived from this study: PubMed 33596309Stinson SE, Jonsson AE, Lund MAV, Frithioff-Bojsoe C, Aas Holm L, Pedersen O, Angquist L, Sorensen TIA, Holst JJ, Christiansen M, Holm JC, Hartmann B, Hansen T. Fasting Plasma GLP-1 Is Associated With Overweight/Obesity and Cardiometabolic Risk Factors in Children and Adolescents. J Clin Endocrinol Metab. 2021 May 13;106(6):1718-1727. doi: 10.1210/clinem/dgab098.
- Derived from this study: PubMed 32571613Lund MAV, Thostrup AH, Frithioff-Bojsoe C, Lausten-Thomsen U, Hedley PL, Pedersen O, Christiansen M, Hansen T, Holm JC. Low-grade inflammation independently associates with cardiometabolic risk in children with overweight/obesity. Nutr Metab Cardiovasc Dis. 2020 Aug 28;30(9):1544-1553. doi: 10.1016/j.numecd.2020.04.024. Epub 2020 May 5.
- Derived from this study: PubMed 32464183Jors A, Lund MAV, Jespersen T, Hansen T, Poulsen HE, Holm JC. Urinary markers of nucleic acid oxidation increase with age, obesity and insulin resistance in Danish children and adolescents. Free Radic Biol Med. 2020 Aug 1;155:81-86. doi: 10.1016/j.freeradbiomed.2020.05.009. Epub 2020 May 25.
- Derived from this study: PubMed 31845423Frithioff-Bojsoe C, Lund MAV, Lausten-Thomsen U, Hedley PL, Pedersen O, Christiansen M, Baker JL, Hansen T, Holm JC. Leptin, adiponectin, and their ratio as markers of insulin resistance and cardiometabolic risk in childhood obesity. Pediatr Diabetes. 2020 Mar;21(2):194-202. doi: 10.1111/pedi.12964. Epub 2019 Dec 26.
- Derived from this study: PubMed 31617910Johansen MJ, Gade J, Stender S, Frithioff-Bojsoe C, Lund MAV, Chabanova E, Thomsen HS, Pedersen O, Fonvig CE, Hansen T, Holm JC. The Effect of Overweight and Obesity on Liver Biochemical Markers in Children and Adolescents. J Clin Endocrinol Metab. 2020 Feb 1;105(2):dgz010. doi: 10.1210/clinem/dgz010.
- Derived from this study: PubMed 31504107Viitasalo A, Schnurr TM, Pitkanen N, Hollensted M, Nielsen TRH, Pahkala K, Atalay M, Lind MV, Heikkinen S, Frithioff-Bojsoe C, Fonvig CE, Grarup N, Kahonen M, Carrasquilla GD, Larnkjaer A, Pedersen O, Michaelsen KF, Lakka TA, Holm JC, Lehtimaki T, Raitakari O, Hansen T, Kilpelainen TO. Abdominal adiposity and cardiometabolic risk factors in children and adolescents: a Mendelian randomization analysis. Am J Clin Nutr. 2019 Nov 1;110(5):1079-1087. doi: 10.1093/ajcn/nqz187.
- Derived from this study: PubMed 30460774Hollensted M, Fogh M, Schnurr TM, Kloppenborg JT, Have CT, Ruest Haarmark Nielsen T, Rask J, Asp Vonsild Lund M, Frithioff-Bojsoe C, Ostergaard Johansen M, Vincent Rosenbaum Appel E, Mahendran Y, Grarup N, Kadarmideen HN, Pedersen O, Holm JC, Hansen T. Genetic Susceptibility for Childhood BMI has no Impact on Weight Loss Following Lifestyle Intervention in Danish Children. Obesity (Silver Spring). 2018 Dec;26(12):1915-1922. doi: 10.1002/oby.22308.
- Derived from this study: PubMed 28762099Fonvig CE, Hamann SA, Nielsen TRH, Johansen MO, Gronbaek HN, Mollerup PM, Holm JC. Subjective evaluation of psychosocial well-being in children and youths with overweight or obesity: the impact of multidisciplinary obesity treatment. Qual Life Res. 2017 Dec;26(12):3279-3288. doi: 10.1007/s11136-017-1667-5. Epub 2017 Jul 31.
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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.
Jens-Christian Holm, Ph.d., MD contact
Jens-Christian Holm, Ph.d., MD study chair
The Children's Obesity Clinic and The Danish Childhood Obesity Biobank
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A family-centered, multidisciplinary obesity treatment program in people with Obesity and Metabolic Disease, run by Zealand University Hospital at 1 site in Denmark.
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 0 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 12 Nov 2020. 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 Denmark. 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?
Contact Jens-Christian Holm, Ph.d., MD (jhom@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weightloss, changes in blood parameters and in fatty liver developement. (time frame: continuously). 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 NCT00928473, which also lists 22 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 12 Nov 2020; AzTrials last refreshed its copy on 6 Nov 2026.