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Vitamin D for Chronic Sinusitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01007799
First Posted: November 4, 2009
Last Update Posted: August 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Chicago
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Quality of life as measured by SF-36 [ Time Frame: At entry and at completion of study ]

Enrollment: 30
Study Start Date: November 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01007799


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

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01007799     History of Changes
Other Study ID Numbers: 16601A
First Submitted: November 3, 2009
First Posted: November 4, 2009
Last Update Posted: August 26, 2016
Last Verified: August 2016

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
Bone Density Conservation Agents