NCT03764800

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2020

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

December 4, 2018

Last Update Submit

July 24, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • years old (\<7 years old) school-age children, legal representatives willing to sign the consent form and fill in the questionnaire

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Study Officials

  • Hsun-Chin Chao, A.P.

    Chang Gung Memorial Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

December 4, 2018

First Posted

December 5, 2018

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

December 5, 2020

Last Updated

July 25, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations