- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01559766
Dietary Vitamin A Requirement in Chinese Children and the New Technology of Dietary Assessment
March 20, 2012 updated by: Xiufa Sun, Huazhong University of Science and Technology
Estimating Dietary Vitamin A Requirement in Chinese Children by Stable-isotope Dilution Technique
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
403
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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Hubei
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Shiyan, Hubei, China, 442500
- Shiyan Centre for Disease Control and Prevention
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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 9 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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)
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
Cohorts and Interventions
Group / Cohort |
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4-6 years old group
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7-9 years old group
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xiufa Sun, BS, Tongji Medical College, Huazhong University of Science and Technology
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
July 1, 2009
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
March 19, 2012
First Submitted That Met QC Criteria
March 20, 2012
First Posted (Estimate)
March 21, 2012
Study Record Updates
Last Update Posted (Estimate)
March 21, 2012
Last Update Submitted That Met QC Criteria
March 20, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- No.2008BAI58B03
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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