Clinical trial NCT01559766: Dietary Vitamin A Requirement in Chinese Children and the New Technology of Dietary Assessment
Official title: Estimating Dietary Vitamin A Requirement in Chinese Children by Stable-isotope Dilution Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin A Deficiency
Keywords: Vitamin A
Dietary requirement
Dietary records
Deuterated retinol dilution technique
Chinese children
Dietary intake of vitamin A
Vitamin A liver reserves
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: ShiYan Centre for Disease Control and Prevention
name: Tufts Medical Center
First posted: 2012-03-21
Enrollment: 403
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shiyan
country: China
facility: Shiyan Centre for Disease Control and Prevention
state: Hubei
Study officials:
affiliation: Tongji Medical College, Huazhong University of Science and Technology
name: Xiufa Sun, BS
role: PRINCIPAL_INVESTIGATOR
References: