Metabolic DiseaseNCT03406234
Observational Study on a Chinese Population
An observational study of Metabolic Disease and Nutrition Disorders, run by Shenzhen Center for Chronic Disease Control at 1 site in China.
Trial summary
An observational study was conducted in a health examination center to distinguish risk factors for health in a randomly recruited volunteers of Chinese population. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease, Nutrition Disorders, Genetic Predisposition to Disease
- How many people
- 2,650 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2013to 31 Dec 2013
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Both males and females were included.
Who may be able to join
- Han population, living in Shenzhen City for > 2 y, not in pregnancy, without hepatic diseases and renal diseases
Who cannot join
- caught by organic diseases
Trial locations and contacts
1 site in 1 country.
China1 site
Shenzhen Center for Chronic Disease Control
Shenzhen, Guangdong, 518020
About this study
Official title: Observational Study on the Risk Factors for Health in a Chinese Population
An observational study was conducted in a health examination center to distinguish risk factors for health in a randomly recruited volunteers of Chinese population.
- Being tested
- No intervention.
- Medical subject headings
- Metabolic Diseases, Nutrition Disorders, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention.Other
Cross-sectional observation without interventions.
| Study group | Role | What they receive |
|---|---|---|
| A group of participants | Not described Receives: Other: No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating 25OHD concentration.
Measured: Jan., 2014 - May., 2015
Secondary outcomes (5)
Body mass index
Measured: Jan.-Dec., 2013
Plasma glucose
Measured: Jan.-Dec., 2013
DNA polymorphisms
Measured: Jan., 2014 - Dec., 2017
Plasma lipids
Measured: Jan.-Dec., 2013
Blood pressure
Measured: Jan.-Dec., 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Jan 2013
- Primary completion31 Dec 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metabolic DiseaseStudies 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
- Cross-sectional
- Enrolment
- 2,650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Center for Chronic Disease Control
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Ji-Chang, Shenzhen Center for Chronic Disease Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406234
- Sponsor's protocol ID
- QLS2013
- Status last verified
- Jan 2018
- First submitted
- 8 Jan 2018
- Last updated
- 23 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen J, Yun C, He Y, Piao J, Yang L, Yang X. Vitamin D status among the elderly Chinese population: a cross-sectional analysis of the 2010-2013 China national nutrition and health survey (CNNHS). Nutr J. 2017 Jan 14;16(1):3. doi: 10.1186/s12937-016-0224-3.
PubMed 28088200Santos BR, Mascarenhas LP, Boguszewski MC, Spritzer PM. Variations in the vitamin D-binding protein (DBP) gene are related to lower 25-hydroxyvitamin D levels in healthy girls: a cross-sectional study. Horm Res Paediatr. 2013;79:162-8. doi: 10.1159/000348847. Epub 2013 Mar 20.
PubMed 23548751Gozdzik A, Zhu J, Wong BY, Fu L, Cole DE, Parra EJ. Association of vitamin D binding protein (VDBP) polymorphisms and serum 25(OH)D concentrations in a sample of young Canadian adults of different ancestry. J Steroid Biochem Mol Biol. 2011 Nov;127(3-5):405-12. doi: 10.1016/j.jsbmb.2011.05.009. Epub 2011 Jun 12.
PubMed 21684333Zhou JC, Zhu Y, Gong C, Liang X, Zhou X, Xu Y, Lyu D, Mo J, Xu J, Song J, Che X, Sun S, Huang C, Liu XL. The GC2 haplotype of the vitamin D binding protein is a risk factor for a low plasma 25-hydroxyvitamin D concentration in a Han Chinese population. Nutr Metab (Lond). 2019 Jan 14;16:5. doi: 10.1186/s12986-019-0332-0. eCollection 2019.
PubMed 30651747
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Risk Factors for Health in a Chinese Population
- ClinicalTrials.gov ID
- NCT03406234
- Acronym / sponsor ID
- QLS2013
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,650 participants (actual)
- Lead sponsor
- Shenzhen Center for Chronic Disease ControlUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 23 Jan 2018 (actual)
- 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.
An observational study was conducted in a health examination center to distinguish risk factors for health in a randomly recruited volunteers of Chinese population.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A group of participants | – | Other: No intervention. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Both males and females were included.
Key inclusion criteria (1 listed)
- Han population, living in Shenzhen City for > 2 y, not in pregnancy, without hepatic diseases and renal diseases
Key exclusion criteria (1 listed)
- caught by organic diseases
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 |
|---|---|---|
| No intervention.Cross-sectional observation without interventions. | Other | A group of participants |
Primary outcome
Circulating 25OHD concentration.
Time frame: Jan., 2014 - May., 2015
5 secondary outcomes
Body mass index
Time frame: Jan.-Dec., 2013
Plasma glucose
Time frame: Jan.-Dec., 2013
DNA polymorphisms
Time frame: Jan., 2014 - Dec., 2017
Plasma lipids
Time frame: Jan.-Dec., 2013
Blood pressure
Time frame: Jan.-Dec., 2013
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Results publication: PubMed 28088200Chen J, Yun C, He Y, Piao J, Yang L, Yang X. Vitamin D status among the elderly Chinese population: a cross-sectional analysis of the 2010-2013 China national nutrition and health survey (CNNHS). Nutr J. 2017 Jan 14;16(1):3. doi: 10.1186/s12937-016-0224-3.
- Results publication: PubMed 23548751Santos BR, Mascarenhas LP, Boguszewski MC, Spritzer PM. Variations in the vitamin D-binding protein (DBP) gene are related to lower 25-hydroxyvitamin D levels in healthy girls: a cross-sectional study. Horm Res Paediatr. 2013;79:162-8. doi: 10.1159/000348847. Epub 2013 Mar 20.
- Results publication: PubMed 21684333Gozdzik A, Zhu J, Wong BY, Fu L, Cole DE, Parra EJ. Association of vitamin D binding protein (VDBP) polymorphisms and serum 25(OH)D concentrations in a sample of young Canadian adults of different ancestry. J Steroid Biochem Mol Biol. 2011 Nov;127(3-5):405-12. doi: 10.1016/j.jsbmb.2011.05.009. Epub 2011 Jun 12.
- Derived from this study: PubMed 30651747Zhou JC, Zhu Y, Gong C, Liang X, Zhou X, Xu Y, Lyu D, Mo J, Xu J, Song J, Che X, Sun S, Huang C, Liu XL. The GC2 haplotype of the vitamin D binding protein is a risk factor for a low plasma 25-hydroxyvitamin D concentration in a Han Chinese population. Nutr Metab (Lond). 2019 Jan 14;16:5. doi: 10.1186/s12986-019-0332-0. eCollection 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Metabolic Disease and Nutrition Disorders, run by Shenzhen Center for Chronic Disease Control at 1 site in China.
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: finished, as of the sponsor's last update on 23 Jan 2018. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Circulating 25OHD concentration. (time frame: Jan., 2014 - May., 2015). 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 NCT03406234, which also lists 4 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 23 Jan 2018.