Chronic SinusitisNCT01007799
Vitamin D for Chronic Sinusitis
A study testing Vitamin D in people with Chronic Sinusitis, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to examine if vitamin D improves the symptoms of chronic sinusitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Sep 2011
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American (4 grandparents with AA ancestry)
- Age>18 years
- Diagnosis of chronic sinusitis
Who cannot join
- Women of childbearing potential not utilizing contraception
- Subjects with contraindications to vitamin D therapy
- History of nephrolithiasis, hypercalcemia, sarcoidosis, recent (3 month) hospitalization
- Use of immunosuppressants/medications that interfere with vitamin D metabolism (e.g., phenytoin and carbamazepine)
- Malignancy
- Kidney, gastrointestinal, or liver disorders
Show all 9Show fewer
- Immunodeficiency
- Morbid obesity (BMI>35 kg/m2)
- Changes to medications for 6 months prior to study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Clinical Trial of a Novel Immunotherapy for Chronic Sinusitis: Vitamin D
The purpose of this study is to examine if vitamin D improves the symptoms of chronic sinusitis.
- Conditions
- Chronic Sinusitis
- Being tested
- vitamin D placebo, Vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D placeboDietary supplement
12 weeks of placebo
Vitamin DDietary supplement
12 weeks supplementation based on serum vitamin D levels
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo pills to take for 12 weeks Receives: Dietary Supplement: vitamin D placebo |
| Vitamin D | Active comparator | Vitamin D supplement for 12 weeks Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
score on the Sinonasal Outcome Test-22 (SNOT-22)
Measured: study onset, mid-point and conclusion
Secondary outcomes (1)
Quality of life as measured by SF-36
Measured: At entry and at completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jayant Pinto, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007799
- Sponsor's protocol ID
- 16601A
- Status last verified
- Aug 2016
- First submitted
- 3 Nov 2009
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Clinical Trial of a Novel Immunotherapy for Chronic Sinusitis: Vitamin D
- ClinicalTrials.gov ID
- NCT01007799
- Acronym / sponsor ID
- 16601A
- Conditions
- Chronic Sinusitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 4 Nov 2009 (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 this study is to examine if vitamin D improves the symptoms of chronic sinusitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: vitamin D placeboPlacebo pills to take for 12 weeks |
| Vitamin D | Active comparator | Dietary Supplement: Vitamin DVitamin D supplement for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- African American (4 grandparents with AA ancestry)
- Age>18 years
- Diagnosis of chronic sinusitis
Key exclusion criteria (9 listed)
- Women of childbearing potential not utilizing contraception
- Subjects with contraindications to vitamin D therapy
- History of nephrolithiasis, hypercalcemia, sarcoidosis, recent (3 month) hospitalization
- Use of immunosuppressants/medications that interfere with vitamin D metabolism (e.g., phenytoin and carbamazepine)
- Malignancy
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 placebo12 weeks of placebo | Dietary supplement | Placebo |
| Vitamin D12 weeks supplementation based on serum vitamin D levels | Dietary supplement | Vitamin D |
Primary outcome
score on the Sinonasal Outcome Test-22 (SNOT-22)
Time frame: study onset, mid-point and conclusion
1 secondary outcome
Quality of life as measured by SF-36
Time frame: At entry and at completion of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 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.
Jayant Pinto, MD principal investigator
University of Chicago
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 in people with Chronic Sinusitis, run by University of Chicago at 1 site in United States.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 26 Aug 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
score on the Sinonasal Outcome Test-22 (SNOT-22) (time frame: study onset, mid-point and conclusion). 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 26 Aug 2016.