Vitamin D for Chronic Sinusitis

The University of Chicago

Status: Completed

Conditions: Chronic Sinusitis

Treatments: Dietary Supplement: vitamin D placebo; Dietary Supplement: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT01007799

16601A

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo pills to take for 12 weeks

Treatment:

Dietary Supplement: vitamin D placebo

Vitamin D

Active Comparator group

Description:

Vitamin D supplement for 12 weeks

Treatment:

Dietary Supplement: Vitamin D