Mechanism and Application of Vitamin D in Idiopathic Sudden Sensorineural Hearing Loss

NCT07045883 | Active Not Recruiting

• 1 other identifier: 2024QNB016
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Sudden Sensorineural Hearing Loss

Keywords

Idiopathic sudden sensorineural hearing loss; vitamin D; 25（OH）D

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of follow-upt at 14 weeks

Study Arms (2)

Vitamin D Supplementation

EXPERIMENTAL

Participants receive Vitamin D3 (dose: 800 IU/day, orally, for 4 weeks)

Drug: Vitamin D Supplementation+ standard treatment

Standard Care

OTHER

Standard treatment

Other: standard treatment

Interventions

Vitamin D Supplementation+ standard treatment DRUG

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

Vitamin D Supplementation

standard treatment OTHER

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

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Idiopathic Sudden Sensorineural Hearing Loss First-time unilateral occurrence Illness duration ≤14 days No prior treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhongshan Hospital Xiamen University: lead

Study Sites (1)

Zhongshan Hospital of Xiamen University, School of Medicine, Xiamen University

Xiamen, Fujian, 361004, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)