NCT01007799

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

August 26, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

November 3, 2009

Last Update Submit

August 25, 2016

Conditions

Chronic Sinusitis

Outcome Measures

Primary Outcomes (1)

  • score on the Sinonasal Outcome Test-22 (SNOT-22)

    study onset, mid-point and conclusion

Secondary Outcomes (1)

  • Quality of life as measured by SF-36

    At entry and at completion of study

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo pills to take for 12 weeks

Dietary Supplement: vitamin D placebo

Vitamin D

ACTIVE COMPARATOR

Vitamin D supplement for 12 weeks

Dietary Supplement: Vitamin D

Interventions

vitamin D placeboDIETARY_SUPPLEMENT

12 weeks of placebo

Placebo
Vitamin DDIETARY_SUPPLEMENT

12 weeks supplementation based on serum vitamin D levels

Vitamin D

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African American (4 grandparents with AA ancestry)
  • Age\>18 years
  • Diagnosis of chronic sinusitis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Jayant Pinto, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2009

First Posted

November 4, 2009

Study Start

November 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

August 26, 2016

Record last verified: 2016-08

Locations

US(1)