Chronic Sinusitis | Vitamin D for Chronic Sinusitis
Chronic Sinusitis research study
What is the primary objective of this study?
The purpose of this study is to examine if vitamin D improves the symptoms of chronic sinusitis.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Dietary Supplement:vitamin D placebo12 weeks of placebo
Dietary Supplement:Vitamin D12 weeks supplementation based on serum vitamin D levels
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
PlaceboPlacebo pills to take for 12 weeks
Vitamin DVitamin D supplement for 12 weeks
Start Date: November 2009
Completed Date: September 2011
Primary Outcome: score on the Sinonasal Outcome Test-22 (SNOT-22)
Secondary Outcome: Quality of life as measured by SF-36
Study sponsors, principal investigator, and references
Principal Investigator: Jayant Pinto, MD
Lead Sponsor: University of Chicago