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

S

Shanxi Medical University

Status and phase

Unknown
Phase 3

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Treatments

Drug: Vitamin D
Drug: Budesonide Nasal Spray
Other: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02668861
FirstTianjunMU

Details and patient eligibility

About

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

Enrollment

40 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

40 participants in 2 patient groups, including a placebo group

Vitamin D+Budesonide Nasal Spray
Experimental group
Description:
Vitamin D 4000IU/day for 8 weeks + Budesonide Nasal Spray 128ug/d for 8 week
Treatment:
Drug: Budesonide Nasal Spray
Drug: Vitamin D
placebo+Budesonide Nasal Spray
Placebo Comparator group
Description:
Placebo for 8 weeks + Budesonide Nasal Spray128ug/d for 8 week
Treatment:
Other: placebo
Drug: Budesonide Nasal Spray

Trial contacts and locations

1

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Central trial contact

Ying Y Fang; Jun Tian

Data sourced from clinicaltrials.gov

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