Zhongshan Hospital of Xiamen University, School of Medicine, Xiamen University
Xiamen, Fujian, 361004, China
Active, Not Recruiting
NCT Number: NCT07045883
Mechanism and Application of Vitamin D in Idiopathic Sudden Sensorineural Hearing Loss
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.
Active, Not Recruiting
This study is active but is not currently recruiting participants.
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Vitamin D Supplementation+ standard treatment
DrugThe 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
standard treatment
OtherThe 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
Primary outcomes
-
Vitamin D deficiency as a prognostic factor in ISSNHL
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Zhongshan Hospital Xiamen University
Other
Registry information
Official study title
Mechanism and Clinical Application of Vitamin D in Influencing the Prognosis of Idiopathic Sudden Sensorineural Hearing Loss
Acronym: N
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jul 1, 2025
- Registry last updated
- Jul 4, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.