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

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

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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: Vitamin D

Drug: Budesonide Nasal Spray

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