Vitamin D for Chronic Sinusitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01007799
First received: November 3, 2009
Last updated: September 27, 2013
Last verified: September 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: University of Chicago
ClinicalTrials.gov Identifier: NCT01007799     History of Changes
Other Study ID Numbers: 16601A
Study First Received: November 3, 2009
Last Updated: September 27, 2013
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
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 30, 2014