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Vitamin D of Chinese Children and Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03221972
Recruitment Status : Completed
First Posted : July 19, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Lichen Yang, Centers for Disease Control and Prevention, China

Brief 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.

Condition or disease
Vitamin D Deficiency

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.

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Study Type : Observational
Actual Enrollment : 15000 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Vitamin D Nutritional Status and Its Related Factors for Chinese Children and Adolescents in 2010-2012
Actual Study Start Date : January 1, 2010
Actual Primary Completion Date : December 30, 2013
Actual Study Completion Date : October 30, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D




Primary Outcome Measures :
  1. 25 hydroxyvitamin D [ Time Frame: through study completion, an average of 1 year ]
    To describe the vitamin D status,ng/mL.


Secondary Outcome Measures :
  1. Demographic data [ Time Frame: through study completion, an average of 1 year ]
    age, gender, ethnicity

  2. Environmental data [ Time Frame: up to 25 weeks ]
    season,region type, latitude, ambient ultraviolet B radiation level

  3. Outdoor time [ Time Frame: through study completion, an average of 1 year ]
    outdoor activity time

  4. Vitamin D supplementation [ Time Frame: through study completion, an average of 1 year ]
    frequency of vitamin D supplements taking for each participant


Biospecimen Retention:   Samples Without DNA
2 mL of fasting venous blood was collected and centrifuged at 1500×g for 15 minutes within 30 minutes after blood taken. The upper serum was aliquoted and stored in brown vessel at -20℃ in the laboratory where the investigation point was located. All the serum specimens from all the 150 investigation points were transported to our laboratory by cold chain. All the samples were preserved at -70℃ refrigerator before determination.


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The participants of this study were aged 6-17y selected from the Chinese national nutrition and health survey
Criteria

Inclusion Criteria:

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

Exclusion Criteria: No.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221972


Locations
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China, Beijing
National Institute for Nutrition and Health, China CDC
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Lichen Yang
Investigators
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Study Director: Lichen Yang National Institute for Nutrition and Health, China CDC
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Publications of Results:
Other Publications:
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Responsible Party: Lichen Yang, National Institute for Nutrition and Health, Centers for Disease Control and Prevention, China
ClinicalTrials.gov Identifier: NCT03221972    
Other Study ID Numbers: 20120212
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lichen Yang, Centers for Disease Control and Prevention, China:
25 hydroxyvitamin D
6-17 years old
vitamin D deficiency
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders