Vitamin DEarly Phase 1NCT04844957
Correlation Between Vitamin D and Symptoms Severity of Autonomic Nervous Mediated Syncope Child and it 's RAAS
A Early Phase 1 study testing Vitamin D and Full automatic chemiluminescence measuring instrument in people with Vitamin D, run by Kongyujie at 1 site in China.
Trial summary
children ; autonomic nervous mediated syncope； vitamin D ; symptom score ; renin-angiotensin-aldosterone-system Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D
- What is being tested?
- Vitamin D and Full automatic chemiluminescence measuring instrument
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2020to 20 Dec 2022
- Phase
- Early Phase 1
- 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 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children diagnosed with OI;
- Compliance with the diagnostic guidelines for Syncope in children (2016 edition) and 2018 syncope in children and adolescents in the cardiovascular group of the Society of Pediatrics, Chinese Medical Association The diagnostic criteria of Oi in the Diagnostic and therapeutic guidelines.
Who cannot join
- Taken 3 months prior to admission Vitamin D or hormone drugs;
- Heart, brain, nerves, metabolism, blood and other apparatus Syncope or aura of syncope caused by a qualitative disease;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Kongyujie
Lanzhou, Gansu, 733000
yujie Kong, M.D, 18709316966, 13523396714@163.com
xiangyu Dong, Professor, 13609370003, dxy0223@163.com
About this study
Official title: Correlation Between Vitamin D and Symptoms Severity of Autonomic Nervous Mediated Syncope（NMS） Child and it 's RAAS
children ; autonomic nervous mediated syncope； vitamin D ; symptom score ; renin-angiotensin-aldosterone-system
Read the detailed description
children with autonomic nervous mediated syncope have seriously affects children's physical and mental health and quality of life, and the incidence rate is also increasing year by year. But the current treatment measures are not ideal, Therefore, we need to look for new biological indicators, according to different biological indicators to develop different treatment options, so as to improve the current situation of poor treatment of children with NMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called Vitamin D drops
Clinical Study
Full automatic chemiluminescence measuring instrumentDevice
Chemiluminescence immunoassay
| Study group | Role | What they receive |
|---|---|---|
| Clinical Study of Vitamin D in Children With NMS | Other | Correlation between vitamin D and symptoms severity of autonomic nervous mediated syncope child and it 's RAAS Receives: Drug: Vitamin D; Device: Full automatic chemiluminescence measuring instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D levels
Vitamin D levels after supplementation
Measured: 3 months after taking the drug
Secondary outcomes (1)
RAAS levels
RAAS levels after vitamin D supplementation
Measured: 3 months after taking the drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start20 May 2020
- Primary completion20 Dec 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin DStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kongyujie
- Sponsor type
- University, hospital or other
- Collaborators
- LanZhou University
- Responsible party
- Sponsor-investigator, Kongyujie, LanZhou University
- Investigators
- xiangyu Dong, Professor, Study director, LanZhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844957
- Sponsor's protocol ID
- 2021A-057
- Status last verified
- Mar 2022
- First submitted
- 28 Mar 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: Experimental outcomes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Vitamin D and Symptoms Severity of Autonomic Nervous Mediated Syncope（NMS） Child and it 's RAAS
- ClinicalTrials.gov ID
- NCT04844957
- Acronym / sponsor ID
- 2021A-057
- Conditions
- Vitamin D
- Keywords
- children ; VVS； vitamin D ; symptom score ; RAAS
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- KongyujieUniversity, hospital or other
- Collaborators
- LanZhou University
- Study start
- 20 May 2020 (actual)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 14 Apr 2021 (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.
children ; autonomic nervous mediated syncope； vitamin D ; symptom score ; renin-angiotensin-aldosterone-system
Detailed description
children with autonomic nervous mediated syncope have seriously affects children's physical and mental health and quality of life, and the incidence rate is also increasing year by year. But the current treatment measures are not ideal, Therefore, we need to look for new biological indicators, according to different biological indicators to develop different treatment options, so as to improve the current situation of poor treatment of children with NMS
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical Study of Vitamin D in Children With NMS | Other | Drug: Vitamin D, Device: Full automatic chemiluminescence measuring instrumentCorrelation between vitamin D and symptoms severity of autonomic nervous mediated syncope child and it 's RAAS |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children diagnosed with OI;
- Compliance with the diagnostic guidelines for Syncope in children (2016 edition) and 2018 syncope in children and adolescents in the cardiovascular group of the Society of Pediatrics, Chinese Medical Association The diagnostic criteria of Oi in the Diagnostic and therapeutic guidelines.
Key exclusion criteria (2 listed)
- Taken 3 months prior to admission Vitamin D or hormone drugs;
- Heart, brain, nerves, metabolism, blood and other apparatus Syncope or aura of syncope caused by a qualitative disease;
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: Vitamin D dropsClinical Study | Drug | Clinical Study of Vitamin D in Children With NMS |
| Full automatic chemiluminescence measuring instrumentChemiluminescence immunoassay | Device | Clinical Study of Vitamin D in Children With NMS |
Primary outcome
Vitamin D levels
Time frame: 3 months after taking the drug
Vitamin D levels after supplementation
1 secondary outcome
RAAS levels
Time frame: 3 months after taking the drug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Individual participant dataSharing planned: No. Experimental outcomes
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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.
xiangyu Dong, Professor study director
LanZhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vitamin D and Full automatic chemiluminescence measuring instrument in people with Vitamin D, run by Kongyujie 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 2 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 5 Apr 2022. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 yujie Kong, M.D (18709316966, 13523396714@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D levels (time frame: 3 months after taking the drug). 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 5 Apr 2022.