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Effect of Oral Vitamin D3 on Chronic Rhinosinusitis Treatment in Adults With Lower Vitamin D Levels

NCT ID: NCT02668861

Last Updated: 2016-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-05-31

Brief Summary

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The purpose of the study is to test the clinical efficacy of oral Vitamin D3 on Wound Healing in patients with Chronic Rhinosinusitis With Nasal Polyposis and Lower Vitamin D Levels After Endonasal Endoscopic Sinus Surgery

Detailed Description

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Conditions

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Chronic Rhinosinusitis With Nasal Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Vitamin D+Budesonide Nasal Spray

Vitamin D 4000IU/day for 8 weeks + Budesonide Nasal Spray 128ug/d for 8 week

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

Vitamin D 4000IU/day for 8 weeks

Budesonide Nasal Spray

Intervention Type DRUG

Budesonide Nasal Spray 128ug/d for 8 week

placebo+Budesonide Nasal Spray

Placebo for 8 weeks + Budesonide Nasal Spray128ug/d for 8 week

Group Type PLACEBO_COMPARATOR

Budesonide Nasal Spray

Intervention Type DRUG

Budesonide Nasal Spray 128ug/d for 8 week

placebo

Intervention Type OTHER

placebo for 8 weeks

Interventions

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Vitamin D

Vitamin D 4000IU/day for 8 weeks

Intervention Type DRUG

Budesonide Nasal Spray

Budesonide Nasal Spray 128ug/d for 8 week

Intervention Type DRUG

placebo

placebo for 8 weeks

Intervention Type OTHER

Other Intervention Names

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Rhinocort Aqua

Eligibility Criteria

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Inclusion Criteria

* 1\. Clinical diagnosis of Chronic Rhinosinusitis with nasal polyps 2. Be 18-60 years old of Chinese people and of either sex，the Han nationality 3. Vitamin D level of less than 30 ng/ml

Exclusion Criteria

* 1\. Women must not be pregnant, breast feeding 2. Chronic oral corticosteroid therapy 3. History of physician-diagnosed nephrolithiasis 4. Chronic diseases（ diabetes，Hypertension，renal insufficiency, severe liver disease） 5.prior surgeries of the paranasal sinuses 6. With an upper respiratory tract infection within 4 weeks of entering the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Shanxi Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jun Tian

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun Tian

Role: CONTACT

Phone: 13603514451

Email: [email protected]

Ying Y Fang

Role: CONTACT

Phone: 15703410761

Email: [email protected]

Facility Contacts

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Huang F Hui

Role: primary

Other Identifiers

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FirstTianjunMU

Identifier Type: -

Identifier Source: org_study_id