The Role of Vitamin D3 in Pediatric Bronchiectasis Severity

Phase 2

Completed

• Conditions: Cystic Fibrosis and Non CF Bronchiectasis
• Interventions: Drug: Cholecalciferol (vitaminD3)

• Registration Number: NCT04411901
• Lead Sponsor: Heba Omara

Brief Summary

Vitamin D3 therapy was effective in decreasing the frequency of pulmonary exacerbations and preserving lung functions , thereby improving the disease severity even more in non CF than CF bronchiectasis patients

Detailed Description

Objectives: To compare the effect of vitamin D3 on modifying the disease severity in CF and non CF bronchiectasis pediatric patients.

Patients and Methods: This was a randomized clinical trial evaluating the role of oral vitamin D3 supplementation for 6 months in forty patients with CF and non CF bronchiectasis under the age of 18 years with vitamin D deficiency or insufficiency . The primary outcome was to reach the sufficient Vitamin D level. The secondary outcome was to follow up the frequency of pulmonary exacerbations and lung function after vitamin D3 supplementation.

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2018-09-06
• Study Completion: 2019-03-20
• Status Verified: 2020-05
• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-28
• Last Update Submitted: 2020-05-28
• Study First Posted: 2020-06-02
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• ages less than 18 years .
• Patients with documented diagnosis of CF (by the presence of a twice positive sweat chloride test and or paired CFTR DNA genetic mutations).
• Patients with non CF bronchiectasis diagnosed clinically and radiologically ( sweat chloride test negative) with a high resolution CT-confirmed diagnosis and clinical history consistent with bronchiectasis .
• Vitamin D deficient or insufficient CF and non CF bronchiectasis patients

Exclusion Criteria

if they had

• sufficient Vitamin D level .
• chronic lung diseases other than CF and non CF bronchiectasis , liver or renal diseases.
• reported taking vitamin-D supplements or steroid therapy in the last 6 weeks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vitamin D 3	Cholecalciferol (vitaminD3)	oral vitamin D3 drops and tablets

Primary Outcome Measures

Name	Time	Method
reach sufficient vitamin D level	6 months	vitamin D more than 30 ng/dl
decrease disease severity	6 months	decrease excerbations and increase lung function

Trial Locations

Locations (1)

Children hospital; 🇪🇬 Cairo, Abbasia, Egypt