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

N/AActive Not RecruitingNCT07045883

Zhongshan Hospital Xiamen University197 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

197

Conditions

Idiopathic Sudden Sensorineural Hearing Loss

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Vitamin D deficiency as a prognostic factor in ISSNHL

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.

Time frame: From enrollment to the end of follow-upt at 14 weeks