Chronic Rhinosinusitis With Nasal PolypsPhase 3NCT02668861
Effect of Oral Vitamin D3 on Chronic Rhinosinusitis Treatment in Adults With Lower Vitamin D Levels
A Phase 3 study testing Vitamin D and Budesonide Nasal Spray in people with Chronic Rhinosinusitis With Nasal Polyps, run by The First Affiliated Hospital of Shanxi Medical University at 1 site in China.
Trial summary
The purpose of the study is to test the clinical efficacy of oral Vitamin D3 on Wound Healing in patients with Chronic Rhinosinusitis With Nasal Polyposis and Lower Vitamin D Levels After Endonasal Endoscopic Sinus Surgery Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- Vitamin D and Budesonide Nasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- May 2016to May 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Clinical diagnosis of Chronic Rhinosinusitis with nasal polyps 2. Be 18-60 years old of Chinese people and of either sex，the Han nationality 3. Vitamin D level of less than 30 ng/ml
Who cannot join
- 1. Women must not be pregnant, breast feeding 2. Chronic oral corticosteroid therapy 3. History of physician-diagnosed nephrolithiasis 4. Chronic diseases（ diabetes，Hypertension，renal insufficiency, severe liver disease） 5.prior surgeries of the paranasal sinuses 6. With an upper respiratory tract infection within 4 weeks of entering the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi
Huang F Hui, 13934518228, 13934518228@163.com
About this study
Official title: Influence of Oral Vitamin D3 on Wound Healing After Endonasal Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis and Lower Vitamin D Levels
The purpose of the study is to test the clinical efficacy of oral Vitamin D3 on Wound Healing in patients with Chronic Rhinosinusitis With Nasal Polyposis and Lower Vitamin D Levels After Endonasal Endoscopic Sinus Surgery
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- Vitamin D, Budesonide Nasal Spray, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Vitamin D 4000IU/day for 8 weeks
Budesonide Nasal SprayDrug
Also called Rhinocort Aqua
Budesonide Nasal Spray 128ug/d for 8 week
placeboOther
placebo for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D+Budesonide Nasal Spray | Experimental | Vitamin D 4000IU/day for 8 weeks + Budesonide Nasal Spray 128ug/d for 8 week Receives: Drug: Vitamin D; Drug: Budesonide Nasal Spray |
| placebo+Budesonide Nasal Spray | Placebo comparator | Placebo for 8 weeks + Budesonide Nasal Spray128ug/d for 8 week Receives: Drug: Budesonide Nasal Spray; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS evaluation of usual symptoms in patients with CRSwNP
The evaluated symptoms were nasal obstruction, anterior nasal discharge and post-nasal drip, smelling reduction and facial pain
Measured: at 8 weeks after first drug intake
Questionnaire：SNOT-20 evaluates the quality of Life
Measured: at 8 weeks after first drug intake
Change of Lund-Kennedy scores
Measured: at 8 weeks after first drug intake
Secondary outcomes (2)
Inflammatory mediators in serum
Measured: 8 weeks
Histologic analysis of nasal mucosa
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Tian, The First Affiliated Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668861
- Sponsor's protocol ID
- FirstTianjunMU
- Status last verified
- Dec 2016
- First submitted
- 27 Jan 2016
- Last updated
- 6 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Oral Vitamin D3 on Wound Healing After Endonasal Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis and Lower Vitamin D Levels
- ClinicalTrials.gov ID
- NCT02668861
- Acronym / sponsor ID
- FirstTianjunMU
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Shanxi Medical UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 29 Jan 2016 (estimated)
- 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.
The purpose of the study is to test the clinical efficacy of oral Vitamin D3 on Wound Healing in patients with Chronic Rhinosinusitis With Nasal Polyposis and Lower Vitamin D Levels After Endonasal Endoscopic Sinus Surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D+Budesonide Nasal Spray | Experimental | Drug: Vitamin D, Drug: Budesonide Nasal SprayVitamin D 4000IU/day for 8 weeks + Budesonide Nasal Spray 128ug/d for 8 week |
| placebo+Budesonide Nasal Spray | Placebo comparator | Drug: Budesonide Nasal Spray, Other: placeboPlacebo for 8 weeks + Budesonide Nasal Spray128ug/d for 8 week |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Clinical diagnosis of Chronic Rhinosinusitis with nasal polyps 2. Be 18-60 years old of Chinese people and of either sex，the Han nationality 3. Vitamin D level of less than 30 ng/ml
Key exclusion criteria (1 listed)
- 1. Women must not be pregnant, breast feeding 2. Chronic oral corticosteroid therapy 3. History of physician-diagnosed nephrolithiasis 4. Chronic diseases（ diabetes，Hypertension，renal insufficiency, severe liver disease） 5.prior surgeries of the paranasal sinuses 6. With an upper respiratory tract infection within 4 weeks of entering the study
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 DVitamin D 4000IU/day for 8 weeks | Drug | Vitamin D+Budesonide Nasal Spray |
| Budesonide Nasal SprayAlso: Rhinocort AquaBudesonide Nasal Spray 128ug/d for 8 week | Drug | Vitamin D+Budesonide Nasal Spray, placebo+Budesonide Nasal Spray |
| placeboplacebo for 8 weeks | Other | placebo+Budesonide Nasal Spray |
Primary outcome
VAS evaluation of usual symptoms in patients with CRSwNP
Time frame: at 8 weeks after first drug intake
The evaluated symptoms were nasal obstruction, anterior nasal discharge and post-nasal drip, smelling reduction and facial pain
Questionnaire：SNOT-20 evaluates the quality of Life
Time frame: at 8 weeks after first drug intake
Change of Lund-Kennedy scores
Time frame: at 8 weeks after first drug intake
2 secondary outcomes
Inflammatory mediators in serum
Time frame: 8 weeks
Histologic analysis of nasal mucosa
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D and Budesonide Nasal Spray in people with Chronic Rhinosinusitis With Nasal Polyps, run by The First Affiliated Hospital of Shanxi Medical 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: status not confirmed, as of the sponsor's last update on 6 Dec 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Tian (13603514451, zguotian@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS evaluation of usual symptoms in patients with CRSwNP (time frame: at 8 weeks after first drug intake). The study lists 3 primary outcomes in all. 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 6 Dec 2016.