Mechanism and Application of Vitamin D in Idiopathic Sudden Sensorineural Hearing Loss
NCT07045883 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 197
Last updated 2025-07-04
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
Interventions
- DRUG
-
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
- OTHER
-
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
Sponsors & Collaborators
-
Zhongshan Hospital Xiamen University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-06-01
- Primary Completion
- 2026-06-01
- Completion
- 2026-06-01
Countries
- China
Study Locations
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