Vitamin A DeficiencyNCT01559766
Dietary Vitamin A Requirement in Chinese Children and the New Technology of Dietary Assessment
An observational study of Vitamin A Deficiency, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Vitamin A Deficiency
- How many people
- 403 participants
- Where
- 1 siteChina
- Study dates
- Jul 2009to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 9 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- well-nourished children with normal serum retinol(>=1.40umol/L)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
Shiyan Centre for Disease Control and Prevention
Shiyan, Hubei, 442500
About this study
Official title: 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.
- 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
- Medical subject headings
- Vitamin A Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 4-6 years old group | Not described | |
| 7-9 years old group | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startJul 2009
- Primary completionJul 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin A DeficiencyStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- ShiYan Centre for Disease Control and Prevention, Tufts Medical Center
- Responsible party
- Principal investigator, Xiufa Sun, Huazhong University of Science and Technology
- Investigators
- Xiufa Sun, BS, Principal investigator, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559766
- Sponsor's protocol ID
- No.2008BAI58B03
- Status last verified
- Mar 2012
- First submitted
- 19 Mar 2012
- Last updated
- 21 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating Dietary Vitamin A Requirement in Chinese Children by Stable-isotope Dilution Technique
- ClinicalTrials.gov ID
- NCT01559766
- Acronym / sponsor ID
- No.2008BAI58B03
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- ShiYan Centre for Disease Control and Prevention, Tufts Medical Center
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 21 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-6 years old group | – | – |
| 7-9 years old group | – | – |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- well-nourished children with normal serum retinol(>=1.40umol/L)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiufa Sun, BS principal investigator
Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin A Deficiency, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2012.