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

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

Study Overview

• Status: Recruiting
• Conditions: Vitamin D
• Intervention / Treatment: Drug: Vitamin D; Device: Full automatic chemiluminescence measuring instrument

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: yujie Kong, M.D; Phone Number: 18709316966; Email: 13523396714@163.com
• Study Contact Backup: Name: xiangyu Dong, Professor; Phone Number: 13609370003; Email: dxy0223@163.com

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China, 733000
      • Recruiting
      • Kongyujie
      • Contact: yujie Kong, M.D; Phone Number: 18709316966; Email: 13523396714@163.com
      • Contact: xiangyu Dong, Professor; Phone Number: 13609370003; Email: dxy0223@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Clinical Study of Vitamin D in Children With NMS; Correlation between vitamin D and symptoms severity of autonomic nervous mediated syncope child and it 's RAAS	Drug: Vitamin D; Clinical Study; Other Names: Vitamin D drops; Device: Full automatic chemiluminescence measuring instrument; Chemiluminescence immunoassay

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kongyujie
• Collaborators: LanZhou University
• Investigators: Study Director: xiangyu Dong, Professor, LanZhou University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Anticipated): December 20, 2022
• Study Completion (Anticipated): December 20, 2022

Study Registration Dates

• First Submitted: March 28, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: children ; VVS； vitamin D ; symptom score ; RAAS
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Syncope; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: 2021A-057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Experimental outcomes

Drug and device information, study documents

• 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