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

Not Applicable

Active, not recruiting

• Conditions: Idiopathic Sudden Sensorineural Hearing Loss
• Interventions: Drug: Vitamin D Supplementation+ standard treatment; Other: standard treatment

• Registration Number: NCT07045883
• Lead Sponsor: Zhongshan Hospital Xiamen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-01
• Study First Submitted: 2025-06-23
• Study First Submitted QC: 2025-06-23
• Status Verified: 2025-07
• Study First Posted: 2025-07-01
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-04
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 197

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vitamin D Supplementation	Vitamin D Supplementation+ standard treatment	Participants receive Vitamin D3 (dose: 800 IU/day, orally, for 4 weeks)
Standard Care	standard treatment	Standard treatment

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Zhongshan Hospital of Xiamen University, School of Medicine, Xiamen University; 🇨🇳 Xiamen, Fujian, China