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Vitamin D for Chronic Sinusitis

Primary Purpose

Chronic Sinusitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
vitamin D placebo
Vitamin D
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinusitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Vitamin D

Arm Description

Placebo pills to take for 12 weeks

Vitamin D supplement for 12 weeks

Outcomes

Primary Outcome Measures

score on the Sinonasal Outcome Test-22 (SNOT-22)

Secondary Outcome Measures

Quality of life as measured by SF-36

Full Information

First Posted
November 3, 2009
Last Updated
August 25, 2016
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01007799
Brief Title
Vitamin D for Chronic Sinusitis
Official Title
A Randomized, Clinical Trial of a Novel Immunotherapy for Chronic Sinusitis: Vitamin D
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo pills to take for 12 weeks
Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Description
Vitamin D supplement for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D placebo
Intervention Description
12 weeks of placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
12 weeks supplementation based on serum vitamin D levels
Primary Outcome Measure Information:
Title
score on the Sinonasal Outcome Test-22 (SNOT-22)
Time Frame
study onset, mid-point and conclusion
Secondary Outcome Measure Information:
Title
Quality of life as measured by SF-36
Time Frame
At entry and at completion of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayant Pinto, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

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Vitamin D for Chronic Sinusitis

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