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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03764800
Other study ID # 201801719A3
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 5, 2020

Study information

Verified date July 2019
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 250
Est. completion date December 5, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 7 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Chang Gung Memorial Hospital Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change serum concentrations of Hb (g/dL) may be found in children's serum 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. On the day of enrollment
Primary Change serum concentrations of ferritin (ng/ mL) may be found in children's serum 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. On the day of enrollment
Primary Change serum concentrations of iron (µg/dL), zinc (µg/dL), and copper (µg/dL) may be found in children's serum 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. On the day of enrollment
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