Vitamin D for Chronic Sinusitis | NCT01007799

Studies
Vitamin D for Chronic Sinusitis

NCT01007799

Sponsor

University of Chicago

Status

Completed

Last Update Posted

Aug 26, 2016Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Chronic Sinusitis

Interventions

vitamin D placebo
Vitamin D

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Nov 3, 2009

First Submission Date that Met QC Criteria

Nov 3, 2009

First Posted Date

Nov 4, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2016

Last Update Posted Date

Aug 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
vitamin D placebo	Dietary Supplement	12 weeks of placebo	Placebo
Vitamin D

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
score on the Sinonasal Outcome Test-22 (SNOT-22)		study onset, mid-point and conclusion

Secondary Outcomes

Measure	Description	Time Frame
Quality of life as measured by SF-36		At entry and at completion of study

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jayant Pinto, MD	University of Chicago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Chicago		Chicago	Illinois	60637	United States

Intervention Browse Module

MeSH Terms

ID	Term
D014807	Vitamin D

Ancestor Terms

ID	Term
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided