Idiopathic Sudden Sensorineural Hearing LossNNCT07045883
Mechanism and Application of Vitamin D in Idiopathic Sudden Sensorineural Hearing Loss
A study testing Vitamin D Supplementation+ standard treatment and standard treatment in people with Idiopathic Sudden Sensorineural Hearing Loss, run by Zhongshan Hospital Xiamen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Sudden Sensorineural Hearing Loss
- What is being tested?
- Vitamin D Supplementation+ standard treatment and standard treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Idiopathic Sudden Sensorineural Hearing Loss First-time unilateral occurrence Illness duration ≤14 days No prior treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital of Xiamen University, School of Medicine, Xiamen University
Xiamen, Fujian, 361004
About this study
Official title: Mechanism and Clinical Application of Vitamin D in Influencing the Prognosis of 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:
Read more
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.
- Being tested
- Vitamin D Supplementation+ standard treatment, standard treatment
- Keywords
- Idiopathic sudden sensorineural hearing loss, vitamin D, 25（OH）D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D Supplementation+ standard treatmentDrug
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
standard treatmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D Supplementation | Experimental | Participants receive Vitamin D3 (dose: 800 IU/day, orally, for 4 weeks) Receives: Drug: Vitamin D Supplementation+ standard treatment |
| Standard Care | Other | Standard treatment Receives: Other: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of follow-upt at 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Sudden Sensorineural Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 197 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Hospital Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045883
- Sponsor's protocol ID
- 2024QNB016
- Other IDs
- 2024QNB016
- Acronym
- N
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism and Clinical Application of Vitamin D in Influencing the Prognosis of Idiopathic Sudden Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT07045883
- Acronym / sponsor ID
- N / 2024QNB016
- Keywords
- Idiopathic sudden sensorineural hearing loss, vitamin D, 25（OH）D
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 197 participants (estimated)
- Lead sponsor
- Zhongshan Hospital Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D Supplementation | Experimental | Drug: Vitamin D Supplementation+ standard treatmentParticipants receive Vitamin D3 (dose: 800 IU/day, orally, for 4 weeks) |
| Standard Care | Other | Other: standard treatmentStandard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Idiopathic Sudden Sensorineural Hearing Loss First-time unilateral occurrence Illness duration ≤14 days No prior treatment
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D Supplementation+ standard treatmentThe 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 | Drug | Vitamin D Supplementation |
| standard treatmentThe 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 | Other | Standard Care |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D Supplementation+ standard treatment and standard treatment in people with Idiopathic Sudden Sensorineural Hearing Loss, run by Zhongshan Hospital Xiamen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D deficiency as a prognostic factor in ISSNHL (time frame: From enrollment to the end of follow-upt at 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.