NCT04844957

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started May 2020

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

April 5, 2022

Status Verified

March 1, 2022

Enrollment Period

2.6 years

First QC Date

March 28, 2021

Last Update Submit

March 24, 2022

Conditions

Vitamin D

Keywords

children ; VVS； vitamin D ; symptom score ; RAAS

Outcome Measures

Primary Outcomes (1)

  • Vitamin D levels

    Vitamin D levels after supplementation

    3 months after taking the drug

Secondary Outcomes (1)

  • RAAS levels

    3 months after taking the drug

Other Outcomes (1)

  • OI symptom scores

    3 months after taking the drug

Study Arms (1)

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 DDevice: Full automatic chemiluminescence measuring instrument

Interventions

Vitamin DDRUG

Clinical Study

Also known as: Vitamin D drops
Clinical Study of Vitamin D in Children With NMS
Full automatic chemiluminescence measuring instrumentDEVICE

Chemiluminescence immunoassay

Clinical Study of Vitamin D in Children With NMS

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kongyujie

Lanzhou, Gansu, 733000, China

RECRUITING

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • xiangyu Dong, Professor

    LanZhou University

    STUDY DIRECTOR

Central Study Contacts

yujie Kong, M.D

CONTACT

1870931696613523396714@163.com

xiangyu Dong, Professor

CONTACT

13609370003dxy0223@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Graduate student

Study Record Dates

First Submitted

March 28, 2021

First Posted

April 14, 2021

Study Start

May 20, 2020

Primary Completion

December 20, 2022

Study Completion

December 20, 2022

Last Updated

April 5, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Experimental outcomes

Locations

CN(1)