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

Xiamen University

Status: Active, not recruiting

Conditions: Idiopathic Sudden Sensorineural Hearing Loss

Treatments: Drug: Vitamin D Supplementation+ standard treatment; Other: standard treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07045883

2024QNB016 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 197 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:1.Sensorineural hearing loss occurring within 72 hours, with a loss of >30 dB at three adjacent frequencies; 2.first-time unilateral occurrence; illness duration ≤14 days, no prior treatment; 3.age ≥18 years.

Exclusion Criteria: 1.middle ear lesions, inner ear malformations, or retrocochlear lesions; 2.age <18 years, pregnant or lactating women;3. history of ear surgery or familial hereditary deafness; 4.With osteoporosis, osteochondrosis, rickets and other systemic serious systemic diseases.

5.Those who refuse to be enrolled.; 6.Lack of complete clinical data.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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197 participants in 2 patient groups

Vitamin D Supplementation

Experimental group

Description:

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

Treatment:

Drug: Vitamin D Supplementation+ standard treatment

Standard Care

Other group

Description:

Standard treatment

Treatment:

Other: standard treatment