NCT02272101

Brief Summary

A study of the role of vitamin D in elderly subjects with perennial and/or nonallergic rhinitis. The hypothesis is that vitamin D supplementation will improve rhinitis symptoms and rhinitis related quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 12, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
Last Updated

October 22, 2014

Status Verified

October 1, 2014

Enrollment Period

4 months

First QC Date

December 12, 2013

Last Update Submit

October 21, 2014

Conditions

Rhinitis

Outcome Measures

Primary Outcomes (1)

  • Effect of vitamin D on rhinitis symptoms and rhinitis related quality of life measured by standardized questionnaire.

    6 weeks

Secondary Outcomes (1)

  • Associations between baseline serum vitamin D and subjects' demographics and treatment

    6 weeks

Other Outcomes (1)

  • Safety of vitamin D supplementation in the elderly

    6 weeks

Study Arms (2)

Vitamin D

EXPERIMENTAL

Vitamin D 4,000 I.U. orally

Dietary Supplement: Vitamin D versus placebo

Placebo

PLACEBO COMPARATOR

Placebo orally

Dietary Supplement: Vitamin D versus placebo

Interventions

Vitamin D versus placeboDIETARY_SUPPLEMENT

Cross-over design

PlaceboVitamin D

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Subjects 65 years old and older with perennial and/or nonallergic rhinitis

You may not qualify if:

  • Current smokers, digoxin, liver disease, anticoagulants (except for aspirin), planning a surgical procedure during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.

Bryn Mawr, Pennsylvania, 19010, United States

Location

Rohr and Columbo Asthma, Allergy and Immunology Specialists

Bryn Mawr, Pennsylvania, 19010, United States

Location

MeSH Terms

Conditions

Rhinitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Michele Columbo, M.D.

    Rohr and Columbo Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 12, 2013

First Posted

October 22, 2014

Study Start

November 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

October 22, 2014

Record last verified: 2014-10

Locations

US(2)