Correlation Between Vitamin D and Symptoms Severity of Au... | NCT04844957

Studies
Correlation Between Vitamin D and Symptoms Severity of Autonomic Nervous Mediated Syncope Child and it 's RAAS

NCT04844957

Sponsor

Kongyujie

Status

Unknown status

Last Update Posted

Apr 5, 2022Actual

Enrollment

100Estimated

Phase

Early Phase 1

Conditions

Vitamin D

Interventions

Vitamin D
Full automatic chemiluminescence measuring instrument

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

May 20, 2020Actual

Primary Completion Date

Dec 20, 2022Estimated

Completion Date

Dec 20, 2022Estimated

First Submitted Date

Mar 28, 2021

First Submission Date that Met QC Criteria

Apr 12, 2021

First Posted Date

Apr 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2022

Last Update Posted Date

Apr 5, 2022Actual

Name	Class
LanZhou University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Drug: Vitamin D Device: Full automatic chemiluminescence measuring instrument

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D	Drug	Clinical Study	Clinical Study of Vitamin D in Children With NMS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vitamin D levels	Vitamin D levels after supplementation	3 months after taking the drug

Secondary Outcomes

Measure	Description	Time Frame
RAAS levels	RAAS levels after vitamin D supplementation	3 months after taking the drug

Other Outcomes

Measure	Description	Time Frame
OI symptom scores	OI symptom scores after vitamin D supplementation	3 months after taking the drug

Eligibility Module

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;

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
yujie Kong, M.D	Contact	18709316966		13523396714@163.com
xiangyu Dong, Professor	Contact	13609370003		dxy0223@163.com

Overall Officials

Name	Affiliation	Role
xiangyu Dong, Professor	LanZhou University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kongyujie	Recruiting	Lanzhou	Gansu	733000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Experimental outcomes

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014807	Vitamin D

Ancestor Terms

ID	Term
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided