Chronic Sinusitis
Conditions
Brief summary
The purpose of this study is to examine if vitamin D improves the symptoms of chronic sinusitis.
Interventions
DIETARY_SUPPLEMENTvitamin D placebo
12 weeks of placebo
DIETARY_SUPPLEMENTVitamin D
12 weeks supplementation based on serum vitamin D levels
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| score on the Sinonasal Outcome Test-22 (SNOT-22) | study onset, mid-point and conclusion |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life as measured by SF-36 | At entry and at completion of study |
Countries
United States
Outcome results
None listed