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Mechanism and Application of Vitamin D in Idiopathic Sudden Sensorineural Hearing Loss

NCT07045883 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-06-01
Last updated
2025-07-04

Condition(s) studied

Idiopathic Sudden Sensorineural Hearing Loss

Investigational drug(s) / intervention(s)

Vitamin D Supplementation+ standard treatmentstandard treatment

Vitamin D Supplementation+ standard treatment: The experimental group was tested for 25(OH)D concentration after enrollment, and the experimental group was divided into vitamin D deficiency group and vitamin D normal group. In the vitamin D-deficient group, participants will receive standard treatment plus oral vitamin D3 supplementation (800 IU daily for 4 weeks), whereas the vitamin D normal group will receive standard treatment alone

standard treatment: The experimental group was tested for 25(OH)D concentration after enrollment, and the experimental group was divided into vitamin D deficiency group and vitamin D normal group. The vitamin D normal group will receive standard treatment alone

Study summary

Clinical Trial Protocol: Investigating the Therapeutic Efficacy of Vitamin D in ISSNHL。Core Research Questions Can vitamin D supplementation improve the prognosis of Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)? What potential medical issues might arise during vitamin D administration? Study Design

A controlled trial comparing:

Intervention group: Vitamin D supplementation + standard care Control group: Standard care alone Participant Procedures

Baseline assessment:

Venous blood draw (2 mL) for 25(OH)D level measurement. intervention phase:Daily vitamin D supplementation for 1 month

Endpoint evaluation (1-month follow-up):

Repeat audiometric testing (pure-tone audiometry). Post-treatment 25(OH)D concentration analysis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: Clinical diagnosis of Idiopathic Sudden Sensorineural Hearing Loss First-time unilateral occurrence Illness duration ≤14 days No prior treatment Exclusion Criteria: Middle ear lesions, inner ear malformations, or retrocochlear lesion Age \<18 years, pregnant or lactating women History of ear surgery or familial hereditary deafness With osteoporosis, osteochondrosis, rickets and other systemic serious systemic diseases Those who refuse to be enrolled

Primary outcome measure(s)

  • Vitamin D deficiency as a prognostic factor in ISSNHL — From enrollment to the end of follow-upt at 14 weeks
    Plasma 25(OH)D concentrations of all enrolled cases in the experimental group and the healthy control group were compared to explore whether 25(OH)D differed in the idiopathic sudden deafness group and with the healthy control group.

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Hospital of Xiamen University, School of Medicine, Xiamen University Xiamen Fujian
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07045883 on ClinicalTrials.gov ↗ ← All trials in China