Vitamin D DeficiencyNCT03221972
Vitamin D of Chinese Children and Adolescents
An observational study of Vitamin D Deficiency, run by Lichen Yang at 1 site in China.
Trial summary
The aim of this study was to assess the vitamin D status and analyze risk factors for vitamin D inadequacy of Chinese children and adolescents aged 6-17y. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Vitamin D Deficiency
- How many people
- 15,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2010to 30 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: The participants of this study were aged 6-17y selected from the Chinese national nutrition and health survey
Who may be able to join
- Participanted in China national nutrition and health survey (CNNHS) 2010-2012; Aged 6-17 years; Had blood taken;
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
National Institute for Nutrition and Health, China CDC
Beijing, Beijing Municipality, 100050
About this study
Official title: Vitamin D Nutritional Status and Its Related Factors for Chinese Children and Adolescents in 2010-2012
The aim of this study was to assess the vitamin D status and analyze risk factors for vitamin D inadequacy of Chinese children and adolescents aged 6-17y.
Read the detailed description
In this study, we analyzed the vitamin D status of Chinese children and adolescents aged 6-17y, and related risk factors (such as gender, region strata, ambient UVB level at area of residence, season, and outdoor time, etc.). Serum 25 hydroxyvitamin D [25(OH)D] was measured with a radioimmunoassay kit in 15 000 children and adolescent participants in Chinese national nutrition and health survey (CNNHS) 2010-2012. Age, gender, region type, ethnicity, outdoor time, vitamin D supplementation were recorded in unified design questionnaires. Season was recorded by the date of blood taken; location was divided into north and south by China's Qinling mountains and Huaihe river; and ambient ultraviolet B (UVB) radiation level was classified according to the corresponding dose of each participant living area from National Aeronautics and Space Administration data.
- Conditions
- Vitamin D Deficiency
- Keywords
- 25 hydroxyvitamin D, 6-17 years old, vitamin D deficiency
- Medical subject headings
- Vitamin D Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
25 hydroxyvitamin D
To describe the vitamin D status,ng/mL.
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Demographic data
age, gender, ethnicity
Measured: through study completion, an average of 1 year
Environmental data
season,region type, latitude, ambient ultraviolet B radiation level
Measured: up to 25 weeks
Outdoor time
outdoor activity time
Measured: through study completion, an average of 1 year
Vitamin D supplementation
frequency of vitamin D supplements taking for each participant
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start1 Jan 2010
- Primary completion30 Dec 2013
- Study completion30 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 15,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lichen Yang
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Lichen Yang, Centers for Disease Control and Prevention, China
- Investigators
- Lichen Yang, Study director, National Institute for Nutrition and Health, China CDC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221972
- Sponsor's protocol ID
- 20120212
- Status last verified
- Jul 2017
- First submitted
- 12 Jul 2017
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The total database of CNHHS 2010-2012 including the database used in our study cannot be made public before the publication of nutrition survey monographs.
Publications
Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
PubMed 17634462Institute of Medicine (US) Committee to Review Dietary Reference Intakes for Vitamin D and Calcium; Ross AC, Taylor CL, Yaktine AL, Del Valle HB, editors. Dietary Reference Intakes for Calcium and Vitamin D. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK56070/
PubMed 21796828Golden NH, Abrams SA; Committee on Nutrition. Optimizing bone health in children and adolescents. Pediatrics. 2014 Oct;134(4):e1229-43. doi: 10.1542/peds.2014-2173.
PubMed 25266429Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6.
PubMed 21646368Turer CB, Lin H, Flores G. Prevalence of vitamin D deficiency among overweight and obese US children. Pediatrics. 2013 Jan;131(1):e152-61. doi: 10.1542/peds.2012-1711. Epub 2012 Dec 24.
PubMed 23266927Mansbach JM, Ginde AA, Camargo CA Jr. Serum 25-hydroxyvitamin D levels among US children aged 1 to 11 years: do children need more vitamin D? Pediatrics. 2009 Nov;124(5):1404-10. doi: 10.1542/peds.2008-2041.
PubMed 19951983
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Nutritional Status and Its Related Factors for Chinese Children and Adolescents in 2010-2012
- ClinicalTrials.gov ID
- NCT03221972
- Acronym / sponsor ID
- 20120212
- Conditions
- Vitamin D Deficiency
- Keywords
- 25 hydroxyvitamin D, 6-17 years old, vitamin D deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,000 participants (actual)
- Lead sponsor
- Lichen YangOther government
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Dec 2013 (actual)
- Study completion
- 30 Oct 2016 (actual)
- First posted
- 19 Jul 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.
The aim of this study was to assess the vitamin D status and analyze risk factors for vitamin D inadequacy of Chinese children and adolescents aged 6-17y.
Detailed description
In this study, we analyzed the vitamin D status of Chinese children and adolescents aged 6-17y, and related risk factors (such as gender, region strata, ambient UVB level at area of residence, season, and outdoor time, etc.). Serum 25 hydroxyvitamin D [25(OH)D] was measured with a radioimmunoassay kit in 15 000 children and adolescent participants in Chinese national nutrition and health survey (CNNHS) 2010-2012. Age, gender, region type, ethnicity, outdoor time, vitamin D supplementation were recorded in unified design questionnaires. Season was recorded by the date of blood taken; location was divided into north and south by China's Qinling mountains and Huaihe river; and ambient ultraviolet B (UVB) radiation level was classified according to the corresponding dose of each participant living area from National Aeronautics and Space Administration data.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The participants of this study were aged 6-17y selected from the Chinese national nutrition and health survey
Key inclusion criteria (1 listed)
- Participanted in China national nutrition and health survey (CNNHS) 2010-2012; Aged 6-17 years; Had blood taken;
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.
Primary outcome
25 hydroxyvitamin D
Time frame: through study completion, an average of 1 year
To describe the vitamin D status,ng/mL.
4 secondary outcomes
Demographic data
Time frame: through study completion, an average of 1 year
Environmental data
Time frame: up to 25 weeks
Outdoor time
Time frame: through study completion, an average of 1 year
Vitamin D supplementation
Time frame: through study completion, an average of 1 year
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 19 Jul 2017.
- Background: PubMed 17634462Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
- Background: PubMed 21796828Institute of Medicine (US) Committee to Review Dietary Reference Intakes for Vitamin D and Calcium; Ross AC, Taylor CL, Yaktine AL, Del Valle HB, editors. Dietary Reference Intakes for Calcium and Vitamin D. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK56070/
- Background: PubMed 25266429Golden NH, Abrams SA; Committee on Nutrition. Optimizing bone health in children and adolescents. Pediatrics. 2014 Oct;134(4):e1229-43. doi: 10.1542/peds.2014-2173.
- Results publication: PubMed 21646368Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6.
- Results publication: PubMed 23266927Turer CB, Lin H, Flores G. Prevalence of vitamin D deficiency among overweight and obese US children. Pediatrics. 2013 Jan;131(1):e152-61. doi: 10.1542/peds.2012-1711. Epub 2012 Dec 24.
- Results publication: PubMed 19951983Mansbach JM, Ginde AA, Camargo CA Jr. Serum 25-hydroxyvitamin D levels among US children aged 1 to 11 years: do children need more vitamin D? Pediatrics. 2009 Nov;124(5):1404-10. doi: 10.1542/peds.2008-2041.
- Individual participant dataSharing planned: Undecided. The total database of CNHHS 2010-2012 including the database used in our study cannot be made public before the publication of nutrition survey monographs.
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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.
Lichen Yang study director
National Institute for Nutrition and Health, China CDC
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 Lichen Yang 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 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: finished, as of the sponsor's last update on 19 Jul 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 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?
25 hydroxyvitamin D (time frame: through study completion, an average of 1 year). 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 NCT03221972, which also lists 6 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 19 Jul 2017.