Idiopathic Sudden Sensorineural Hearing Loss
Conditions
Keywords
Idiopathic sudden sensorineural hearing loss, vitamin D, 25（OH）D
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.
Interventions
DRUGVitamin 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
OTHERstandard 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
Sponsors
Zhongshan Hospital Xiamen University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed