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Vitamin D for Chronic Sinusitis

This study is currently recruiting participants.
Verified December 2012 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
Jayant Pinto, University of Chicago
ClinicalTrials.gov Identifier:
NCT01007799
First received: November 3, 2009
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Chronic Sinusitis
 Dietary Supplement: vitamin D placebo
Dietary Supplement: Vitamin D

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Clinical Trial of a Novel Immunotherapy for Chronic Sinusitis: Vitamin D

Resource links provided by NLM:

MedlinePlus related topics: Sinusitis Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • score on the Sinonasal Outcome Test-22 (SNOT-22) [ Time Frame: study onset, mid-point and conclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life as measured by SF-36 [ Time Frame: At entry and at completion of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: November 2009
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo pills to take for 12 weeks
 Dietary Supplement: vitamin D placebo
12 weeks of placebo
Active Comparator: Vitamin D
Vitamin D supplement for 12 weeks
 Dietary Supplement: Vitamin D
12 weeks supplementation based on serum vitamin D levels

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01007799

Contacts
Contact: Marcy deTineo, BSN 773-702-5889 mdetineo@surgery.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: Jayant Pinto, MD            
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Jayant Pinto, MD University of Chicago
  More Information

No publications provided

Responsible Party: Jayant Pinto, Professor, University of Chicago
ClinicalTrials.gov Identifier: NCT01007799     History of Changes
Other Study ID Numbers: 16601A
Study First Received: November 3, 2009
Last Updated: December 14, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
 Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013