Vitamin D for Chronic Sinusitis

Chronic Sinusitis Clinical Trial

Official title:

A Randomized, Clinical Trial of a Novel Immunotherapy for Chronic Sinusitis: Vitamin D

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007799
• Other study ID #: 16601A
• Status: Completed
• Phase: N/A
• First received: November 3, 2009
• Last updated: August 25, 2016
• Start date: November 2009
• Est. completion date: September 2011

Study information

• 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

Clinical Trial Summary

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

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Sinusitis
• Sinusitis

Intervention

Dietary Supplement:
• vitamin D placebo
12 weeks of placebo
• Vitamin D
12 weeks supplementation based on serum vitamin D levels

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

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