NCT01559766

Brief Summary

Vitamin A deficiency remains a major public health problem in developing country worldwide. Young Children are considered to be at greatest risk of deficiency. However, there is little information on the vitamin A requirement of Chinese children. In the present study, about 400 children aged between 4 and 9 years old in a kindergarten and an elementary school of Shiyan City were screened before admission by questionnaire and anthropometric measurement. The vitamin A status of children was assessed by serum vitamin A level, relative dosage reaction and stable-isotope dilution technique. At the same time, their dietary vitamin A intakes were estimated by weighted-food dietary survey. The dietary vitamin A requirement in young children was determined on the basis of dietary vitamin A intakes in Children with adequate vitamin A level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
403

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2012

Completed
Last Updated

March 21, 2012

Status Verified

March 1, 2012

Enrollment Period

1 year

First QC Date

March 19, 2012

Last Update Submit

March 20, 2012

Conditions

Keywords

Vitamin ADietary requirementDietary recordsDeuterated retinol dilution techniqueChinese childrenDietary intake of vitamin AVitamin A liver reserves

Study Arms (2)

4-6 years old group

7-9 years old group

Eligibility Criteria

Age4 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study was carried out in a kindergarten and an elementary school in Shiyan city, Hubei province of China. Initially, 201 kindergarten children (4-6 years old) and 202 grade children (7-9 years old) were subjected to a questionnaire survey on personal information, medical history and dietary habits including dietary supplements.ongoing or previous illnesses, having taken nutritional supplements within 3 months, positive results in the fat absorption test or parasite test, increased level of CRP (\> 8 mg/L), or lower serum level of retinol (\<1.40 umol/L), and higher ratio in relative dosage reaction test(\>20%) .After the screening, 123 children were selected and completed the study, but 60 subjects were randomly selected for the DRD test to evaluate liver vitamin A storage.

You may qualify if:

  • well-nourished children with normal serum retinol(\>=1.40umol/L)

You may not qualify if:

  • ongoing or previous illnesses,
  • having taken nutritional supplements within 3 months,
  • positive results in the fat absorption test or parasite test,
  • increased level of CRP (\> 8 mg/L), or
  • lower serum level of retinol (\< 1.40 umol/L)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiyan Centre for Disease Control and Prevention

Shiyan, Hubei, 442500, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Vitamin A Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Xiufa Sun, BS

    Tongji Medical College, Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 19, 2012

First Posted

March 21, 2012

Study Start

July 1, 2009

Primary Completion

July 1, 2010

Study Completion

September 1, 2010

Last Updated

March 21, 2012

Record last verified: 2012-03

Locations