DyslipidemiasNCT04707612
VDR SNPs & 25OHD Correlated With Dyslipidemia
An observational study of Dyslipidemias and Single Nucleotide Polymorphism, run by Shenzhen Center for Chronic Disease Control at 1 site in China.
Trial summary
The project was aimed to explore the associations of single nucleotide polymorphisms (SNPs) of vitamin D receptor gene with specific circulating lipids in adult Chinese. The circulating 25-hydroxyvitamin D concentration was also tested to explore its interactions with SNPs in the associations. Read more about this study
- Who is it for?
- Ages 20 to 81 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias, Single Nucleotide Polymorphism
- How many people
- 1,987 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2013to 31 Oct 2016
- 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 20 to 81 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult volunteers visiting a health examination center in Shenzhen city of Guangdong province, China were recruited. A total of 1,987 adults were included in the analysis, aged from 20 to 81 years old. Among them, there were 1,124 females aged 39 (31 - 49) years old and 863 males aged 36 (30 - 44) years old.
Who may be able to join
- 1) ≥ 20 years old Han Chinese;
- 2) living in Shenzhen for > 2 years;
- 3) free of liver diseases, renal diseases, and any cancers in the past 6 months; and
- 4) not in pregnancy for women.
Who cannot join
- 1) had severe organic diseases,
- 2) had acute infection symptoms, allergic diseases, and malignant tumors,
- 3) had a family history of genetic diseases,
- 4) took VD supplements in the past 6 months,
- 5) took medicines to control lipid levels within 12 hours, or
- 6) took diuretics, did strenuous exercise, or overate within 24 hours before the test.
Trial locations and contacts
1 site in 1 country.
China1 site
Shenzhen Center for Chronic Disease Control
Shenzhen, Guangdong, 518020
About this study
The project was aimed to explore the associations of single nucleotide polymorphisms (SNPs) of vitamin D receptor gene with specific circulating lipids in adult Chinese. The circulating 25-hydroxyvitamin D concentration was also tested to explore its interactions with SNPs in the associations.
- Conditions
- Dyslipidemias, Single Nucleotide Polymorphism
- Being tested
- No intervention.
- Keywords
- gene polymorphism, vitamin D receptor, vitamin D, lipid, dyslipidemia
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention.Other
No intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
SNPs of VDR
Polymorphisms of vitamin D receptor gene: Cdx2, Fok1, Apa1, and Taq1
Measured: 6 months
lipid profiles
Serum concentrations of TG, TC, LDLC, and HDLC
Measured: 6 months
25OHD
Plasma 25-hydroxyvitamin D concentration
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Jul 2013
- Primary completion31 Jan 2014
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,987 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Center for Chronic Disease Control
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University
- Responsible party
- Principal investigator, Zhou Ji-Chang, Shenzhen Center for Chronic Disease Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707612
- Sponsor's protocol ID
- QLS2015
- Status last verified
- Jan 2021
- First submitted
- 10 Jan 2021
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VDR SNPs & 25OHD Correlated With Dyslipidemia
- ClinicalTrials.gov ID
- NCT04707612
- Acronym / sponsor ID
- QLS2015
- Conditions
- Dyslipidemias, Single Nucleotide Polymorphism
- Keywords
- gene polymorphism, vitamin D receptor, vitamin D, lipid, dyslipidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,987 participants (actual)
- Lead sponsor
- Shenzhen Center for Chronic Disease ControlUniversity, hospital or other
- Collaborators
- Sun Yat-sen University
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 31 Jan 2014 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 13 Jan 2021 (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.
The project was aimed to explore the associations of single nucleotide polymorphisms (SNPs) of vitamin D receptor gene with specific circulating lipids in adult Chinese. The circulating 25-hydroxyvitamin D concentration was also tested to explore its interactions with SNPs in the associations.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 81 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult volunteers visiting a health examination center in Shenzhen city of Guangdong province, China were recruited. A total of 1,987 adults were included in the analysis, aged from 20 to 81 years old. Among them, there were 1,124 females aged 39 (31 - 49) years old and 863 males aged 36 (30 - 44) years old.
Key inclusion criteria (4 listed)
- 1) ≥ 20 years old Han Chinese;
- 2) living in Shenzhen for > 2 years;
- 3) free of liver diseases, renal diseases, and any cancers in the past 6 months; and
- 4) not in pregnancy for women.
Key exclusion criteria (6 listed)
- 1) had severe organic diseases,
- 2) had acute infection symptoms, allergic diseases, and malignant tumors,
- 3) had a family history of genetic diseases,
- 4) took VD supplements in the past 6 months,
- 5) took medicines to control lipid levels within 12 hours, or
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.No intervention. | Other | – |
Primary outcome
SNPs of VDR
Time frame: 6 months
Polymorphisms of vitamin D receptor gene: Cdx2, Fok1, Apa1, and Taq1
lipid profiles
Time frame: 6 months
Serum concentrations of TG, TC, LDLC, and HDLC
25OHD
Time frame: 6 months
Plasma 25-hydroxyvitamin D concentration
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 13 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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 Dyslipidemias and Single Nucleotide Polymorphism, 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 4 inclusion and 6 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 13 Jan 2021. 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?
SNPs of VDR (time frame: 6 months). The study lists 3 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 13 Jan 2021.