Development, ChildRVDRGPCPIDNCT03742310
The Relationship Between VDR Gene Polymorphism and Children's Physical and Intellectual Development
A study testing Vitamin D in people with Development, Child, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
This study was used to determine the relationship between vitamin D receptor gene polymorphism and children's physical and intellectual development, further adjust the doses of vitamin D supplementation after birth, and provide individualized vitamin D and calcium supplements. Read more about this study
- Who is it for?
- Ages 1 day to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Development, Child
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Mar 2021
- Phase
- Interventional
- 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 1 day to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- infant age from 0 to 3 years old
- enjoy good health, there is no history of specific diseases
Who cannot join
- this time or always exists serious lung infection, or with nervous system disease, kidney disease, malignant tumor, etc
- has bone metabolic diseases or other genetic metabolic disease
- taking affect bone metabolism of drugs for a long time
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Hui A Li, PhD, MD, +8618991232133, huili@mail.xjtu.edu.cn
About this study
Official title: Multi-Center Clinical Study on the Relationship Between Vitamin D Receptor Gene Polymorphism and Children's Physical and Intellectual Development
This study was used to determine the relationship between vitamin D receptor gene polymorphism and children's physical and intellectual development, further adjust the doses of vitamin D supplementation after birth, and provide individualized vitamin D and calcium supplements.
Read the detailed description
High risk children aged 0-3 years old who visited the pediatrics clinic and ward of the first affiliated hospital of Xi'an Jiaotong university and other cooperative hospitals from 2018 to 2020 were randomly selected. Personal information of the children and parents who were enrollment was collected by questionnaire survey and a follow-up file was established. 500 to 1,000 people are planned to participate in the study, were randomly divided into research group and the control group. Then collect the sample(saliva) of children to examine Vitamin D Receptor(VDR) genotype, according to results, divide the research group into high, medium and low risk, given individual vitamin D and calcium supplement. Monitor the children's weight, body length, head circumference, the Neonatal Behavioral Assessment Scale(NBAS), bailey rating scale respectively, up to 3 years old. All sample analyses were performed by the Gene Medical Laboratory. Laboratory personnel were blinded to mother and infant outcomes.
- Conditions
- Development, Child
- Being tested
- Vitamin D
- Keywords
- Vitamin D Receptor gene, physical development, intelligent development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called calcitriol
Vitamin D is essential for healthy bones, and to control the amount of calcium in our blood.It is important at every stage of life, but especially for rapidly growing infants and teenagers and for pregnant and breastfeeding women.
| Study group | Role | What they receive |
|---|---|---|
| identical supplement group | Experimental | Take vitamin D supplements according to genotype. If the genotype result is "high risk", we will give vitamin d 800 international unit(IU)/d, when the result is "middle risk", we will give 600 international unit(IU)/d, when the result is "low risk", we will give 400 international unit(IU)/d. Receives: Drug: Vitamin D |
| control group | No intervention | General dose. Whatever the result is, we all give 400 international unit(IU)/d. |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
We will use the baby scale to measure infant body weight
Measured: From date of randomization until the date of three year-old
body height
We will use the baby scale to measure infant body height
Measured: From date of randomization until the date of three year-old
head circumference
We will use the tape to measure infant head circumference
Measured: From date of randomization until the date of three year-old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development, ChildStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xian Children's Hospital, The First Affiliated Hospital of Zhengzhou University
- Responsible party
- Sponsor
- Investigators
- Hui Li, PHD,MD, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742310
- Sponsor's protocol ID
- HX201856
- Acronym
- RVDRGPCPID
- Status last verified
- Jul 2018
- First submitted
- 12 Nov 2018
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Clinical Study on the Relationship Between Vitamin D Receptor Gene Polymorphism and Children's Physical and Intellectual Development
- ClinicalTrials.gov ID
- NCT03742310
- Acronym / sponsor ID
- RVDRGPCPID / HX201856
- Conditions
- Development, Child
- Keywords
- Vitamin D Receptor gene, physical development, intelligent development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Xian Children's Hospital, The First Affiliated Hospital of Zhengzhou University
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 15 Nov 2018 (actual)
- 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.
This study was used to determine the relationship between vitamin D receptor gene polymorphism and children's physical and intellectual development, further adjust the doses of vitamin D supplementation after birth, and provide individualized vitamin D and calcium supplements.
Detailed description
High risk children aged 0-3 years old who visited the pediatrics clinic and ward of the first affiliated hospital of Xi'an Jiaotong university and other cooperative hospitals from 2018 to 2020 were randomly selected. Personal information of the children and parents who were enrollment was collected by questionnaire survey and a follow-up file was established. 500 to 1,000 people are planned to participate in the study, were randomly divided into research group and the control group. Then collect the sample(saliva) of children to examine Vitamin D Receptor(VDR) genotype, according to results, divide the research group into high, medium and low risk, given individual vitamin D and calcium supplement. Monitor the children's weight, body length, head circumference, the Neonatal Behavioral Assessment Scale(NBAS), bailey rating scale respectively, up to 3 years old. All sample analyses were performed by the Gene Medical Laboratory. Laboratory personnel were blinded to mother and infant outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| identical supplement group | Experimental | Drug: Vitamin DTake vitamin D supplements according to genotype. If the genotype result is "high risk", we will give vitamin d 800 international unit(IU)/d, when the result is "middle risk", we will give 600 international unit(IU)/d, when the result is "low risk", we will give 400 international unit(IU)/d. |
| control group | No intervention | –General dose. Whatever the result is, we all give 400 international unit(IU)/d. |
Who may qualify
- Ages
- 1 day to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- infant age from 0 to 3 years old
- enjoy good health, there is no history of specific diseases
Key exclusion criteria (3 listed)
- this time or always exists serious lung infection, or with nervous system disease, kidney disease, malignant tumor, etc
- has bone metabolic diseases or other genetic metabolic disease
- taking affect bone metabolism of drugs for a long time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: calcitriolVitamin D is essential for healthy bones, and to control the amount of calcium in our blood.It is important at every stage of life, but especially for rapidly growing infants and teenagers and for pregnant and breastfeeding women. | Drug | identical supplement group |
Primary outcome
body weight
Time frame: From date of randomization until the date of three year-old
We will use the baby scale to measure infant body weight
body height
Time frame: From date of randomization until the date of three year-old
We will use the baby scale to measure infant body height
head circumference
Time frame: From date of randomization until the date of three year-old
We will use the tape to measure infant head circumference
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
Hui Li, PHD,MD study chair
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Development, Child, run by First Affiliated Hospital Xi'an Jiaotong University 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Nov 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Li, PHD,MD (+8618991232133, huili@mail.xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body weight (time frame: From date of randomization until the date of three year-old). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 15 Nov 2018.