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OpenTrials
Completed

NCT Number: NCT01007799

Vitamin D for Chronic Sinusitis

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

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Key information

Conditions

Chronic Sinusitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D placebo

Dietary Supplement

12 weeks of placebo

Vitamin D

Dietary Supplement

12 weeks supplementation based on serum vitamin D levels

Primary outcomes

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

    Time frame: study onset, mid-point and conclusion

Secondary outcomes

  1. Quality of life as measured by SF-36

    Time frame: At entry and at completion of study

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 4, 2009
Registry last updated
Aug 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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