Mechanism and Clinical Application of Vitamin D in Influencing the Prognosis of Idiopathic Sudden Sensorineural Hearing Loss
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- Vitamin D deficiency as a prognostic factor in ISSNHL
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of Idiopathic Sudden Sensorineural Hearing Loss First-time unilateral occurrence Illness duration ≤14 days No prior treatment
排除标准
- •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
研究组 & 干预措施
Vitamin D Supplementation
Participants receive Vitamin D3 (dose: 800 IU/day, orally, for 4 weeks)
干预措施: Vitamin D Supplementation+ standard treatment (Drug)
Standard Care
Standard treatment
干预措施: standard treatment (Other)
结局指标
主要结局
Vitamin D deficiency as a prognostic factor in ISSNHL
时间窗: 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.
次要结局
未报告次要终点