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Status unknownNCT04844957Updated Apr 5, 2022

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

An Early Phase 1 interventional study of Vitamin D and Full automatic chemiluminescence measuring instrument in Vitamin D, sponsored by Kongyujie. Status unknown at 1 site in China. Open to participants aged 5 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-05.

Sponsored by Kongyujie · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled May 2020, registered Mar 2021).
Phase
Early Phase 1
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
5 Years to 14 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Vitamin D

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Keywords

  • children ; VVS； vitamin D ; symptom score ; RAAS
03

In context

Syncope

226 studies on the registry are indexed under Syncope; 45 are open to participants now.

This study's planned enrollment of 100 is above the median of 79 across 126 interventional studies indexed under Syncope.

Browse Syncope studies →

Lead sponsor

This is the only study on the registry with Kongyujie as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 14 Years
Sexes eligible
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

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;
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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 · Device: Full automatic chemiluminescence measuring instrument

Interventions

  • DrugVitamin D

    Clinical Study

    Also known as: Vitamin D drops

  • DeviceFull automatic chemiluminescence measuring instrument

    Chemiluminescence immunoassay

06

What researchers measure

Primary outcomes

  1. Vitamin D levels

    Vitamin D levels after supplementation

    Time frame: 3 months after taking the drug

Secondary outcomes

  1. RAAS levels

    RAAS levels after vitamin D supplementation

    Time frame: 3 months after taking the drug

Other outcomes

  1. OI symptom scores

    OI symptom scores after vitamin D supplementation

    Time frame: 3 months after taking the drug

07

Study locations

1 of 1 sites recruiting
  • Kongyujie
    Lanzhou, Gansu 733000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Experimental outcomes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04844957
Lead sponsor
Kongyujie
Collaborators
LanZhou University
Responsible party
Kongyujie (Graduate student, LanZhou University) — Sponsor-investigator
First posted
Apr 14, 2021
Start date
May 20, 2020
Primary completion
Dec 20, 2022 (estimated)
Completion
Dec 20, 2022 (estimated)
Last update
Apr 5, 2022

Study contacts

yujie Kong, M.D
Contact
13523396714@163.com
18709316966
xiangyu Dong, Professor
Contact
dxy0223@163.com
13609370003
xiangyu Dong, Professor
study director · LanZhou University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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