Vitamin D DeficiencyNCT03304795
Vitamin D Deficiency Still Growing
An observational study of Vitamin D Deficiency, run by DongGuk University.
Trial summary
Vitamin D deficiency has become one of the most prevalent health problems in modern society. However, there has been no study that has reported the trend of vitamin D status in Asia. This study investigated the trend of vitamin D status in Korea between 2008 and 2014. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- How many people
- 39,759 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 31 Dec 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The KNHANES is an ongoing surveillance system to evaluate the health and nutritional status of the civilian non-institutionalized population of South Korea. The present study population is from the KNHANES 2008-2014. Among the participants in KNHANES 2008-2014, those aged 10 years and older with serum 25(OH)D levels were finally included (n=39,759).
Who may be able to join
- Participants in the KNHANES from 2008 to 2014
- Participants who were examined for serum 25-hydroxyvitamin D level
Who cannot join
- Participants without serum 25-hydroxyvitamin D level data
About this study
Official title: Is Vitamin D Deficiency Still Growing? Seven-Year Trend in KNHANES 2008-2014
Vitamin D deficiency has become one of the most prevalent health problems in modern society. However, there has been no study that has reported the trend of vitamin D status in Asia. This study investigated the trend of vitamin D status in Korea between 2008 and 2014.
This study is based on a representative national database acquired from the Korea National Health and Nutrition Examination Surveys (KNHANES) conducted from 2008 to 2014. Serum 25-hydroxyvitamin D [25(OH)D] levels were measured by radioimmunoassay among those aged 10 yrs or older. The temporal change of vitamin D status will be statistically analyzed.
Read the detailed description
Most epidemiologic studies that assessed vitamin D status in various populations have been performed in a cross-sectional design. Some studies from western countries have assessed the trends of vitamin D status over the past decades. However, there was no study that investigated the trend of vitamin D status in Asian population.
In the present study, an assessment of the seven-year trend of vitamin D status and the prevalence of vitamin D deficiency in the Korean population, based on the KNHANES conducted from 2008 to 2014 was performed.
The KNHANES is an ongoing surveillance system that has been conducted by the Division of Health and Nutrition Survey within the Korea Centers for Disease Control and Prevention to evaluate the health and nutritional status of the civilian non-institutionalized population of South Korea. Since the KNHANES was initiated in 1998, surveys for the KNHANES I (1998), KNHANES II (2001), KNHANES III (2005), KNHANES IV (2007-2009), KNHANES V (2010-2012), and KNHANES VI (2013-2015) have been executed, and the survey for KNHANES VII (2016-2018) is still in progress. The present study is based on the data acquired from the KNHANES IV-VI, conducted between 2008 and 2014. Among those participants, serum 25(OH)D levels were measured from 39,759 individuals (6,925 in 2008; 8,303 in 2009; 6,815 in 2010; 6,704 in 2011; 6,308 in 2012; 2,355 in 2013; and 2,349 in 2014) aged 10 years and older. Serum 25(OH)D concentration was categorized into 4 levels (<25, 25 to <50, 50 to <75, and ≥75 nmol/L) and the vitamin D deficiency was defined as the Serum 25 (OH) D concentration < 50 nmol/L.
Statistical analyses were conducted to evaluate the effects of participant characteristics (age, season, and residential region) on serum 25(OH)D concentrations, and the temporal change in the mean concentration of serum 25(OH)D over years 2008-2014.
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D, Asia, Trend, KNHANES, Temporal change
- 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-hydroxyvitamin D level is less than 50 nmol/L. | |
| Normal | Serum 25-hydroxyvitamin D level is 50 nmol/L or greater. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D deficiency
Serum 25-hydroxyvitamin D level less than 50 nmol/L
Measured: 2008-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start1 Jan 2008
- Primary completion31 Dec 2014
- Study completion31 Dec 2014
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.
- 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
- 39,759 participants (actual)
Sponsor and investigators
- Lead sponsor
- DongGuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Seok Choi, DongGuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304795
- Sponsor's protocol ID
- NRF-2015R1C1A1A01054333
- Status last verified
- Oct 2017
- First submitted
- 4 Oct 2017
- Last updated
- 9 Oct 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 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Vitamin D Deficiency Still Growing? Seven-Year Trend in KNHANES 2008-2014
- ClinicalTrials.gov ID
- NCT03304795
- Acronym / sponsor ID
- NRF-2015R1C1A1A01054333
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D, Asia, Trend, KNHANES, Temporal change
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39,759 participants (actual)
- Lead sponsor
- DongGuk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 9 Oct 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 has become one of the most prevalent health problems in modern society. However, there has been no study that has reported the trend of vitamin D status in Asia. This study investigated the trend of vitamin D status in Korea between 2008 and 2014.
This study is based on a representative national database acquired from the Korea National Health and Nutrition Examination Surveys (KNHANES) conducted from 2008 to 2014. Serum 25-hydroxyvitamin D [25(OH)D] levels were measured by radioimmunoassay among those aged 10 yrs or older. The temporal change of vitamin D status will be statistically analyzed.
Detailed description
Most epidemiologic studies that assessed vitamin D status in various populations have been performed in a cross-sectional design. Some studies from western countries have assessed the trends of vitamin D status over the past decades. However, there was no study that investigated the trend of vitamin D status in Asian population.
In the present study, an assessment of the seven-year trend of vitamin D status and the prevalence of vitamin D deficiency in the Korean population, based on the KNHANES conducted from 2008 to 2014 was performed.
The KNHANES is an ongoing surveillance system that has been conducted by the Division of Health and Nutrition Survey within the Korea Centers for Disease Control and Prevention to evaluate the health and nutritional status of the civilian non-institutionalized population of South Korea. Since the KNHANES was initiated in 1998, surveys for the KNHANES I (1998), KNHANES II (2001), KNHANES III (2005), KNHANES IV (2007-2009), KNHANES V (2010-2012), and KNHANES VI (2013-2015) have been executed, and the survey for KNHANES VII (2016-2018) is still in progress. The present study is based on the data acquired from the KNHANES IV-VI, conducted between 2008 and 2014. Among those participants, serum 25(OH)D levels were measured from 39,759 individuals (6,925 in 2008; 8,303 in 2009; 6,815 in 2010; 6,704 in 2011; 6,308 in 2012; 2,355 in 2013; and 2,349 in 2014) aged 10 years and older. Serum 25(OH)D concentration was categorized into 4 levels (<25, 25 to <50, 50 to <75, and ≥75 nmol/L) and the vitamin D deficiency was defined as the Serum 25 (OH) D concentration < 50 nmol/L.
Statistical analyses were conducted to evaluate the effects of participant characteristics (age, season, and residential region) on serum 25(OH)D concentrations, and the temporal change in the mean concentration of serum 25(OH)D over years 2008-2014.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D deficiency | – | –Serum 25-hydroxyvitamin D level is less than 50 nmol/L. |
| Normal | – | –Serum 25-hydroxyvitamin D level is 50 nmol/L or greater. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The KNHANES is an ongoing surveillance system to evaluate the health and nutritional status of the civilian non-institutionalized population of South Korea. The present study population is from the KNHANES 2008-2014. Among the participants in KNHANES 2008-2014, those aged 10 years and older with serum 25(OH)D levels were finally included (n=39,759).
Key inclusion criteria (2 listed)
- Participants in the KNHANES from 2008 to 2014
- Participants who were examined for serum 25-hydroxyvitamin D level
Key exclusion criteria (1 listed)
- Participants without serum 25-hydroxyvitamin D level data
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: 2008-2014
Serum 25-hydroxyvitamin D level less than 50 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 9 Oct 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency, run by DongGuk University.
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: finished, as of the sponsor's last update on 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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: 2008-2014). 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 9 Oct 2017.