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Clinical Trials/NCT01007799
NCT01007799CompletedNot Applicable

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

University of Chicago2 sites in 1 country30 target enrollmentStarted: November 2009Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
score on the Sinonasal Outcome Test-22 (SNOT-22)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Time Frame: study onset, mid-point and conclusion

Secondary Outcomes

  • Quality of life as measured by SF-36(At entry and at completion of study)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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