NCT01185808

Brief Summary

The purpose of this study is to determine if Vitamin D supplementation improves clinical and immunologic parameters in chronic rhinosinusitis with nasal polyps.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

July 30, 2010

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 20, 2010

Completed
3.1 years until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

Same day

First QC Date

July 30, 2010

Last Update Submit

April 27, 2018

Conditions

Chronic Sinusitis

Keywords

sinusitischronic sinusitis with polyps

Outcome Measures

Primary Outcomes (1)

  • Clinical symptom score

    Symptoms will be graded using Sinonasal Outcomes Test-22.

    6 weeks

Secondary Outcomes (2)

  • Nasal peak inspiratory flow

    6 weeks

  • Systemic and local immunologic parameters

    6 weeks

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

Vitamin D 5,000IU/day for 6 weeks

Biological: Vitamin D

Placebo

PLACEBO COMPARATOR

Placebo for 6 weeks.

Biological: Vitamin D

Interventions

Vitamin DBIOLOGICAL

Vitamin D 5000IU/day for 6 weeks

Also known as: Vitamin D3
PlaceboVitamin D

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic sinusitis with polyps

You may not qualify if:

  • Use of systemic steroids, or other immunmodulatory agents in preceding monthS, other immunologic, renal, gastrointestinal, endocrine or skeletal disorder (rheumatoid arthritis, immunodeficiency, cystic fibrosis, ciliary dyskinesia, malabsorption, etc.)
  • Pregnancy or age less than 14 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Sinusitis

Interventions

Vitamin DCholecalciferol

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipids

Study Officials

  • Rodney Schlosser, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

July 30, 2010

First Posted

August 20, 2010

Study Start

October 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

May 1, 2018

Record last verified: 2018-04

Locations

US(1)