Vitamin D for Chronic Sinusitis

NCT ID: NCT01007799

Last Updated: 2016-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-09-30

Brief Summary

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

Detailed Description

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Conditions

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Chronic Sinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo pills to take for 12 weeks

Group Type PLACEBO_COMPARATOR

vitamin D placebo

Intervention Type DIETARY_SUPPLEMENT

12 weeks of placebo

Vitamin D

Vitamin D supplement for 12 weeks

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

12 weeks supplementation based on serum vitamin D levels

Interventions

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vitamin D placebo

12 weeks of placebo

Intervention Type DIETARY_SUPPLEMENT

Vitamin D

12 weeks supplementation based on serum vitamin D levels

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jayant Pinto, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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16601A

Identifier Type: -

Identifier Source: org_study_id

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