Chronic Sinusitis Clinical Trial
Official title:
A Randomized, Clinical Trial of a Novel Immunotherapy for Chronic Sinusitis: Vitamin D
Verified date | August 2016 |
Source | University of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to examine if vitamin D improves the symptoms of chronic sinusitis.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - African American (4 grandparents with AA ancestry) - Age>18 years - Diagnosis of chronic sinusitis Exclusion Criteria: - 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 - Immunodeficiency - Morbid obesity (BMI>35 kg/m2) - Changes to medications for 6 months prior to study entry |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | score on the Sinonasal Outcome Test-22 (SNOT-22) | study onset, mid-point and conclusion | No | |
Secondary | Quality of life as measured by SF-36 | At entry and at completion of study | No |
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