Vitamin D DeficiencyNCT03349879
Familial Clustering of Vitamin D Deficiency Via Shared Environment: The Korean National Health And Nutrition Examination Survey 2008-2012
An observational study of Vitamin D Deficiency, run by Yonsei University at 1 site in South Korea.
Trial summary
Vitamin D deficiency is a modifiable risk factor for poor bone health. Familial correlation of serum 25-hydroxyvitamin D concentration (25(OH)D) was reported in twin- or family-based studies, mostly from Caucasian parent-offspring pairs. Read more about this study
- Who is it for?
- Ages 10 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- How many people
- 28,551 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2008to 31 Dec 2012
- 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 10 to 95 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study was based on data from the Korean National Health and Nutrition Examination Survey (KNHANES) (IV-2, 3 and V), conducted from 2008 to 2012. The KNHANES is a nationwide cross-sectional survey performed by the Division of Chronic Disease Surveillance, Korea Centers for Disease Control and Prevention (CDC), which assessed the health, nutritional status, and socioeconomic status of the non-institutionalized civilian population of South Korea. Subjects were selected using a stratified multistage clustered probability sampling design. Families, including at least two family members with serum 25(OH)D measurements and whose family relationships could be accurately identified were selected for the study. After the selection process, a total of 28,551 subjects from 10,882 families were included in our study.
Who may be able to join
- KNHANES(Korean National Health and Nutrition Examination Survey) 2008-2012 participants
Who cannot join
- missing value on 25-hydroxyvitamin D levels
- data on another household member was unavailable
- the precise family relationship between the subjects was unclear
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Endocrinology, Department of internal Medicine, Yonsei University College of Medicine, Severance Hospital
Seoul, 03722
About this study
Vitamin D deficiency is a modifiable risk factor for poor bone health. Familial correlation of serum 25-hydroxyvitamin D concentration (25(OH)D) was reported in twin- or family-based studies, mostly from Caucasian parent-offspring pairs. However, data on the familial association of 25(OH)D in extended family structure and the relative contribution of genetic and shared environmental factors on serum 25(OH)D level are limited in Asian populations. In this study, the investigators aimed to assess the relative contribution of additive genetic and environmental components on serum 25(OH)D level by variance components method in a nationwide family-based cohort. Further, the investigators will evaluate the association of vitamin D status of index individual with prevalent vitamin D deficiency of each family member including spouse, offspring, sibling, and grand-offspring. Additive influences of paternal and maternal vitamin D status on offspring will be also investigated.
Read the detailed description
From the Korean National Health and Nutritional Examination Survey (KNHANES) conducted between 2008 and 2012, familial correlations for 25(OH)D will be estimated in different types of family relation pairs in 28551 subjects from 10882 families. The relative contribution of additive genetic and shared or individual environmental factors for variance of 25(OH)D level will be calculated using variance component method. Interactions between paternal and maternal vitamin D status for 25(OH)D level of offspring will be evaluated.
- Conditions
- Vitamin D Deficiency
- Medical subject headings
- Vitamin D Deficiency
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 |
|---|---|---|
| Vitamin D deficiency | serum 25(OH)D < 30 nmol/L | |
| Vitamin D insufficiency | serum 25(OH)D between 30 and 49 nmol/L | |
| Vitamin D sufficiency | serum 25(OH)D ≥ 50 nmol/L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D deficiency
Vitamin D deficiency (serum 25(OH)D < 30 nmol/L)
Measured: 1 minute after the survey (cross-sectional analysis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start1 Jan 2008
- Primary completion31 Dec 2012
- Study completion31 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Observational
- Observational model
- Family based
- Time perspective
- Retrospective
- Enrolment
- 28,551 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349879
- Sponsor's protocol ID
- 2012-01EXP-01-2C
- Status last verified
- Nov 2017
- First submitted
- 16 Nov 2017
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Familial Clustering of Vitamin D Deficiency Via Shared Environment: The Korean National Health And Nutrition Examination Survey 2008-2012
- ClinicalTrials.gov ID
- NCT03349879
- Acronym / sponsor ID
- 2012-01EXP-01-2C
- Conditions
- Vitamin D Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28,551 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2012 (actual)
- Study completion
- 31 Dec 2012 (actual)
- First posted
- 22 Nov 2017 (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.
Vitamin D deficiency is a modifiable risk factor for poor bone health. Familial correlation of serum 25-hydroxyvitamin D concentration (25(OH)D) was reported in twin- or family-based studies, mostly from Caucasian parent-offspring pairs. However, data on the familial association of 25(OH)D in extended family structure and the relative contribution of genetic and shared environmental factors on serum 25(OH)D level are limited in Asian populations. In this study, the investigators aimed to assess the relative contribution of additive genetic and environmental components on serum 25(OH)D level by variance components method in a nationwide family-based cohort. Further, the investigators will evaluate the association of vitamin D status of index individual with prevalent vitamin D deficiency of each family member including spouse, offspring, sibling, and grand-offspring. Additive influences of paternal and maternal vitamin D status on offspring will be also investigated.
Detailed description
From the Korean National Health and Nutritional Examination Survey (KNHANES) conducted between 2008 and 2012, familial correlations for 25(OH)D will be estimated in different types of family relation pairs in 28551 subjects from 10882 families. The relative contribution of additive genetic and shared or individual environmental factors for variance of 25(OH)D level will be calculated using variance component method. Interactions between paternal and maternal vitamin D status for 25(OH)D level of offspring will be evaluated.
Study design
- Observational model
- Family based
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin D deficiency | – | –serum 25(OH)D < 30 nmol/L |
| Vitamin D insufficiency | – | –serum 25(OH)D between 30 and 49 nmol/L |
| Vitamin D sufficiency | – | –serum 25(OH)D ≥ 50 nmol/L |
Who may qualify
- Ages
- 10 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study was based on data from the Korean National Health and Nutrition Examination Survey (KNHANES) (IV-2, 3 and V), conducted from 2008 to 2012. The KNHANES is a nationwide cross-sectional survey performed by the Division of Chronic Disease Surveillance, Korea Centers for Disease Control and Prevention (CDC), which assessed the health, nutritional status, and socioeconomic status of the non-institutionalized civilian population of South Korea. Subjects were selected using a stratified multistage clustered probability sampling design. Families, including at least two family members with serum 25(OH)D measurements and whose family relationships could be accurately identified were selected for the study. After the selection process, a total of 28,551 subjects from 10,882 families were included in our study.
Key inclusion criteria (1 listed)
- KNHANES(Korean National Health and Nutrition Examination Survey) 2008-2012 participants
Key exclusion criteria (3 listed)
- missing value on 25-hydroxyvitamin D levels
- data on another household member was unavailable
- the precise family relationship between the subjects was unclear
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
Vitamin D deficiency
Time frame: 1 minute after the survey (cross-sectional analysis)
Vitamin D deficiency (serum 25(OH)D < 30 nmol/L)
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 24 Nov 2017.
- 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 Vitamin D Deficiency, run by Yonsei University at 1 site in South Korea.
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 3 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 24 Nov 2017. 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 South Korea. 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?
Vitamin D deficiency (time frame: 1 minute after the survey (cross-sectional analysis)). 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 24 Nov 2017.