- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03764800
The Prevalence of Micronutrient Deficiency in Early School-age Children
July 24, 2019 updated by: Hsun-Chin Chao, Chang Gung Memorial Hospital
The Prevalence of Micronutrient Deficiency in Early School-age Children and Its Correlation With Eating Behavior, Dietary Habits, Development, Physical Activity, Nutritional Status and Health Status
This study aim to assess the prevalence of deficiency in micronutrients in early school-age children and its correlation with picky eating behavior, physical activity, nutritional status, and health status.
Study Overview
Status
Unknown
Conditions
Detailed Description
A structured questionnaire is used to conduct a cross-sectional descriptive study of 250 early school-age children aged 4-7 years (<7 years old) in Taiwan.
Data collection would include: demographics, food preferences, eating behavior, body weight and height, body mass index (BMI), physical activity, records of medical illness, peripheral cell blood count, serum values of ferritin and micronutrients (iron, zinc, copper).
Data from children define as picky or non-picky eaters base on parental' questionnaire responses, are analyzed and compared using standard statistical tests.
The correlations among eating behavior, dietary habits, development, physical activity, nutritional status, and health status, and micronutrient deficiency are evaluated.
Study Type
Observational
Enrollment (Actual)
250
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
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Taoyuan, Taiwan, 333
- Chang Gung Memorial Hospital
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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
4 years to 7 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
This cross-sectional descriptive study uses a structured questionnaire to elicit information from parents in Taiwan who are early school-age children aged 4-7 years (<7 years old).
Participants are recruited from clinic in Chang Gung Children's medical center, Chang Gung Memorial Hospital.
A total of 250 participants who meet the eligibility criteria are enrolled.
Description
Inclusion Criteria:
- 4-7 years old (<7 years old) school-age children, legal representatives willing to sign the consent form and fill in the questionnaire
Exclusion Criteria:
- At the time of the enrollment, there is an acute infection (respiratory, gastrointestinal or urinary tract), and there are organic diseases (heart, lung, brain, hepatobiliary, kidney, endocrine metabolic disease or heredity).
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 |
|---|---|---|
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Change serum concentrations of Hb (g/dL) may be found in children's serum
Time Frame: On the day of enrollment
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Change serum concentrations of Hb (g/dL) may be found in children with picky eating behavior, low quality of development, inadequacy of physical activity, undernutrition, and poor health status.
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On the day of enrollment
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Change serum concentrations of ferritin (ng/ mL) may be found in children's serum
Time Frame: On the day of enrollment
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Change serum concentrations of ferritin (ng/ mL) may be found in children with picky eating behavior, low quality of development, inadequacy of physical activity, undernutrition, and poor health status.
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On the day of enrollment
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Change serum concentrations of iron (μg/dL), zinc (μg/dL), and copper (μg/dL) may be found in children's serum
Time Frame: On the day of enrollment
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Change serum concentrations of iron (μg/dL), zinc (μg/dL), and copper (μg/dL) may be found in children with picky eating behavior, low quality of development, inadequacy of physical activity, undernutrition, and poor health status.
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On the day of enrollment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Hsun-Chin Chao, A.P., Chang Gung Memorial Hospital
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, 2019
Primary Completion (Anticipated)
January 1, 2020
Study Completion (Anticipated)
December 5, 2020
Study Registration Dates
First Submitted
December 4, 2018
First Submitted That Met QC Criteria
December 4, 2018
First Posted (Actual)
December 5, 2018
Study Record Updates
Last Update Posted (Actual)
July 25, 2019
Last Update Submitted That Met QC Criteria
July 24, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 201801719A3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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