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

Vitamin D Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04844957
• Other study ID #: 2021A-057
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 20, 2020
• Est. completion date: December 20, 2022

Study information

• Verified date: March 2022
• Source: LanZhou University
• Contact: yujie Kong, M.D
• Phone: 18709316966
• Email: 13523396714[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

children ; autonomic nervous mediated syncope； vitamin D ; symptom score ; renin-angiotensin-aldosterone-system

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 14 Years

Eligibility

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;

Related Conditions & MeSH terms

• Syncope
• Vitamin D

Intervention

Drug:
• Vitamin D
Clinical Study

Device:
• Full automatic chemiluminescence measuring instrument
Chemiluminescence immunoassay

Locations

Country	Name	City	State
China	Kongyujie	Lanzhou	Gansu

Sponsors (2)

Lead Sponsor	Collaborator
Kongyujie	LanZhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	OI symptom scores	OI symptom scores after vitamin D supplementation	3 months after taking the drug
Primary	Vitamin D levels	Vitamin D levels after supplementation	3 months after taking the drug
Secondary	RAAS levels	RAAS levels after vitamin D supplementation	3 months after taking the drug