Dietary Vitamin A Requirement in Chinese Children and the New Technology of Dietary Assessment

• ClinicalTrials.gov Identifier: NCT01559766
• Recruitment Status: Completed
• First Posted: March 21, 2012
• Last Update Posted: March 21, 2012
• Sponsor: Huazhong University of Science and Technology
• Collaborators: ShiYan Centre for Disease Control and Prevention; Tufts Medical Center
• Information provided by (Responsible Party): Xiufa Sun, Huazhong University of Science and Technology

Tracking Information

• First Submitted Date: March 19, 2012
• First Posted Date: March 21, 2012
• Last Update Posted Date: March 21, 2012
• Study Start Date: July 2009
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

serum

• 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.
• Condition: Vitamin A Deficiency
• Intervention: Not Provided

Study Groups/Cohorts

• 4-6 years old group
• 7-9 years old group

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 20, 2012): 403
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: September 2010
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 4 Years to 9 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01559766
• Other Study ID Numbers: No.2008BAI58B03
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Xiufa Sun, Huazhong University of Science and Technology
• Study Sponsor: Huazhong University of Science and Technology

Collaborators

• ShiYan Centre for Disease Control and Prevention
• Tufts Medical Center

Investigators

• Principal Investigator: Xiufa Sun, BS; Tongji Medical College, Huazhong University of Science and Technology

• PRS Account: Huazhong University of Science and Technology
• Verification Date: March 2012