An interventional study of Vitamin D Supplementation+ standard treatment and standard treatment in Idiopathic Sudden Sensorineural Hearing Loss, sponsored by Zhongshan Hospital Xiamen University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-04.
Sponsored by Zhongshan Hospital Xiamen University · Not applicable, Interventional, and Treatment
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.
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
Participants receive Vitamin D3 (dose: 800 IU/day, orally, for 4 weeks)
Drug: Vitamin D Supplementation+ standard treatment
Standard treatment
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. 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
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Zhongshan Hospital Xiamen University