- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03221972
Vitamin D of Chinese Children and Adolescents
July 18, 2017 updated by: Lichen Yang
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
15000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100050
- National Institute for Nutrition and Health, China CDC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The participants of this study were aged 6-17y selected from the Chinese national nutrition and health survey
Description
Inclusion Criteria:
Participanted in China national nutrition and health survey (CNNHS) 2010-2012; Aged 6-17 years; Had blood taken;
Exclusion Criteria: No.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
25 hydroxyvitamin D
Time Frame: through study completion, an average of 1 year
|
To describe the vitamin D status,ng/mL.
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic data
Time Frame: through study completion, an average of 1 year
|
age, gender, ethnicity
|
through study completion, an average of 1 year
|
|
Environmental data
Time Frame: up to 25 weeks
|
season,region type, latitude, ambient ultraviolet B radiation level
|
up to 25 weeks
|
|
Outdoor time
Time Frame: through study completion, an average of 1 year
|
outdoor activity time
|
through study completion, an average of 1 year
|
|
Vitamin D supplementation
Time Frame: through study completion, an average of 1 year
|
frequency of vitamin D supplements taking for each participant
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Lichen Yang, National Institute for Nutrition and Health, China CDC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
- Holick 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. Erratum In: J Clin Endocrinol Metab. 2011 Dec;96(12):3908.
- Institute 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/
- Golden 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.
- Turer 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.
- Mansbach 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. Erratum In: Pediatrics. 2009 Dec;124(6):1709.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2010
Primary Completion (Actual)
December 30, 2013
Study Completion (Actual)
October 30, 2016
Study Registration Dates
First Submitted
July 12, 2017
First Submitted That Met QC Criteria
July 18, 2017
First Posted (Actual)
July 19, 2017
Study Record Updates
Last Update Posted (Actual)
July 19, 2017
Last Update Submitted That Met QC Criteria
July 18, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20120212
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
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.
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vitamin D Deficiency
-
The Jerzy Kukuczka Academy of Physical Education...RecruitingVitamin D Deficiency/Insufficiency | Vitamin D 25-Hydroxylase DeficiencyPoland
-
University Hospital, Clermont-FerrandTerminated
-
Rajavithi HospitalQueen Sirikit National Institute of Child HealthCompleted
-
Universidade de Passo FundoUnknownDeficiency, Vitamin DBrazil
-
Federal University of Rio Grande do SulCompletedDeficiency, Vitamin DBrazil
-
Nutrition Institute, SloveniaEuropean Regional Development Fund; Vizera d.o.o.; Frutarom Etol d.o.o.CompletedVitamin B 12 Deficiency | Vitamin d Deficiency | Protein DeficiencySlovenia
-
University of PaviaIstituti Clinici Scientifici Maugeri SpAUnknownVitamin D Deficiency | Vitamin D3 Deficiency | Vitamin DItaly
-
Wageningen UniversityDSM Nutritional Products, Inc.; Top Institute Food and NutritionCompletedElderly, Frail | Deficiency, Vitamin DNetherlands
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNot yet recruitingVitamin d DeficiencyChina
-
Ondokuz Mayıs UniversityCompletedD Vitamin Deficiency | Osteocalcin | Gingival Crevicular FluidTurkey