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

Sponsor
Kongyujie (Other)
Overall Status
Recruiting
CT.gov ID
NCT04844957
Collaborator
LanZhou University (Other)
100
Enrollment
1
Location
1
Arm
31
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Vitamin D
  • Device: Full automatic chemiluminescence measuring instrument
 Early Phase 1

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

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Correlation Between Vitamin D and Symptoms Severity of Autonomic Nervous Mediated Syncope（NMS） Child and it 's RAAS
Actual Study Start Date :
May 20, 2020
Anticipated Primary Completion Date :
Dec 20, 2022
Anticipated Study Completion Date :
Dec 20, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Vitamin D levels [3 months after taking the drug]

      Vitamin D levels after supplementation

    Secondary Outcome Measures

    1. RAAS levels [3 months after taking the drug]

      RAAS levels after vitamin D supplementation

    Other Outcome Measures

    1. OI symptom scores [3 months after taking the drug]

      OI symptom scores after vitamin D supplementation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 14 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kongyujie Lanzhou Gansu China 733000

    Sponsors and Collaborators

    • Kongyujie
    • LanZhou University

    Investigators

    • Study Director: xiangyu Dong, Professor, LanZhou University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kongyujie, Graduate student, LanZhou University
    ClinicalTrials.gov Identifier:
    NCT04844957
    Other Study ID Numbers:
    • 2021A-057
    First Posted:
    Apr 14, 2021
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Kongyujie, Graduate student, LanZhou University
    children ; VVS； vitamin D ; symptom score ; RAAS
    Additional relevant MeSH terms:
    Syncope
    Vitamin D
    Ergocalciferols
    Cholecalciferol
    Vitamins

    Study Results

    No Results Posted as of Apr 5, 2022