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

NCT ID: NCT07045883

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-06-01

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.

Conditions

Idiopathic Sudden Sensorineural Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vitamin D Supplementation

Participants receive Vitamin D3 (dose: 800 IU/day, orally, for 4 weeks)

Group Type: EXPERIMENTAL

Vitamin D Supplementation+ standard treatment

Intervention Type: DRUG

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 Care

Standard treatment

Group Type: OTHER

standard treatment

Intervention Type: OTHER

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhongshan Hospital Xiamen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Hospital of Xiamen University, School of Medicine, Xiamen University

Xiamen, Fujian, China

Countries

China

Other Identifiers

2024QNB016

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024QNB016

Identifier Type: -

Identifier Source: org_study_id