Vitamin D for Chronic Sinusitis

Not Applicable

Completed

• Conditions: Chronic Sinusitis
• Interventions: Dietary Supplement: vitamin D placebo; Dietary Supplement: Vitamin D

• Registration Number: NCT01007799
• Lead Sponsor: University of Chicago

Brief Summary

The purpose of this study is to examine if vitamin D improves the symptoms of chronic sinusitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-03
• Study First Submitted QC: 2009-11-03
• Study First Posted: 2009-11-04
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-25
• Last Update Posted: 2016-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	vitamin D placebo	Placebo pills to take for 12 weeks
Vitamin D	Vitamin D	Vitamin D supplement for 12 weeks

Primary Outcome Measures

Name	Time	Method
score on the Sinonasal Outcome Test-22 (SNOT-22)	study onset, mid-point and conclusion

Secondary Outcome Measures

Name	Time	Method
Quality of life as measured by SF-36	At entry and at completion of study

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States