Back to resultsCorrelation Between Vitamin D and Symptoms Severity of Autonomic Nervous Mediated Syncope Child and it 's RAAS
Primary Purpose
Vitamin D
Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Vitamin D
Full automatic chemiluminescence measuring instrument
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D focused on measuring children ; VVS； vitamin D ; symptom score ; RAAS
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
Sites / Locations
- KongyujieRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Clinical Study of Vitamin D in Children With NMS
Arm Description
Correlation between vitamin D and symptoms severity of autonomic nervous mediated syncope child and it 's RAAS
Outcomes
Primary Outcome Measures
Vitamin D levels
Vitamin D levels after supplementation
Secondary Outcome Measures
RAAS levels
RAAS levels after vitamin D supplementation
Full Information
NCT ID
NCT04844957
First Posted
March 28, 2021
Last Updated
March 24, 2022
Sponsor
Kongyujie
Collaborators
LanZhou University
1. Study Identification
Unique Protocol Identification Number
NCT04844957
Brief Title
Correlation Between Vitamin D and Symptoms Severity of Autonomic Nervous Mediated Syncope Child and it 's RAAS
Official Title
Correlation Between Vitamin D and Symptoms Severity of Autonomic Nervous Mediated Syncope（NMS） Child and it 's RAAS
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
December 20, 2022 (Anticipated)
Study Completion Date
December 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kongyujie
Collaborators
LanZhou University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D
Keywords
children ; VVS； vitamin D ; symptom score ; RAAS
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clinical Study of Vitamin D in Children With NMS
Arm Type
Other
Arm Description
Correlation between vitamin D and symptoms severity of autonomic nervous mediated syncope child and it 's RAAS
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
Vitamin D drops
Intervention Description
Clinical Study
Intervention Type
Device
Intervention Name(s)
Full automatic chemiluminescence measuring instrument
Intervention Description
Chemiluminescence immunoassay
Primary Outcome Measure Information:
Title
Vitamin D levels
Description
Vitamin D levels after supplementation
Time Frame
3 months after taking the drug
Secondary Outcome Measure Information:
Title
RAAS levels
Description
RAAS levels after vitamin D supplementation
Time Frame
3 months after taking the drug
Other Pre-specified Outcome Measures:
Title
OI symptom scores
Description
OI symptom scores after vitamin D supplementation
Time Frame
3 months after taking the drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yujie Kong, M.D
Phone
18709316966
Email
13523396714@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
xiangyu Dong, Professor
Phone
13609370003
Email
dxy0223@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiangyu Dong, Professor
Organizational Affiliation
LanZhou University
Official's Role
Study Director
Facility Information:
Facility Name
Kongyujie
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
733000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yujie Kong, M.D
Phone
18709316966
Email
13523396714@163.com
First Name & Middle Initial & Last Name & Degree
xiangyu Dong, Professor
Phone
13609370003
Email
dxy0223@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Experimental outcomes
Learn more about this trial
Correlation Between Vitamin D and Symptoms Severity of Autonomic Nervous Mediated Syncope Child and it 's RAAS
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