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NCT03221972 Clinical Trial

Vitamin D of Chinese Children and Adolescents

Vitamin D Deficiency Clinical Trial

Official title:
Vitamin D Nutritional Status and Its Related Factors for Chinese Children and Adolescents in 2010-2012

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03221972
Other study ID # 20120212
Secondary ID
Status Completed
Phase N/A
First received July 12, 2017
Last updated July 18, 2017
Start date January 1, 2010
Est. completion date October 30, 2016

Study information
Verified date July 2017
Source Centers for Disease Control and Prevention, China
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 15000
Est. completion date October 30, 2016
Est. primary completion date December 30, 2013
Accepts healthy volunteers No
Gender All
Age group 6 Years to 17 Years
Eligibility Inclusion Criteria:

Participanted in China national nutrition and health survey (CNNHS) 2010-2012; Aged 6-17 years; Had blood taken;

Exclusion Criteria: No.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China National Institute for Nutrition and Health, China CDC Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Lichen Yang

Country where clinical trial is conducted

China, 

References & Publications (6)

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. Review. — View Citation

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. — View Citation

Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 25 hydroxyvitamin D To describe the vitamin D status,ng/mL. through study completion, an average of 1 year
Secondary Demographic data age, gender, ethnicity through study completion, an average of 1 year
Secondary Environmental data season,region type, latitude, ambient ultraviolet B radiation level up to 25 weeks
Secondary Outdoor time outdoor activity time through study completion, an average of 1 year
Secondary Vitamin D supplementation frequency of vitamin D supplements taking for each participant through study completion, an average of 1 year
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