The Role of Vitamin D3 in Pediatric Bronchiectasis Severity

Cystic Fibrosis and Non CF Bronchiectasis Clinical Trial

Official title:

The Role of Vitamin D3 in Pediatric Bronchiectasis Severity( CF Versus Non CF Bronchioectasis)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04411901
• Other study ID #: Original study
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 1, 2018
• Est. completion date: March 20, 2019

Study information

• Verified date: May 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 20, 2019
• Est. primary completion date: September 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiectasis
• Cystic Fibrosis
• Cystic Fibrosis and Non CF Bronchiectasis

Intervention

Drug:
• Cholecalciferol (vitaminD3)
Theraputic vitamin D3 for CF and non CF bronchiectasis children

Locations

Country	Name	City	State
Egypt	Children hospital	Cairo	Abbasia

Sponsors (1)

Lead Sponsor	Collaborator
Heba Omara

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reach sufficient vitamin D level	vitamin D more than 30 ng/dl	6 months
Primary	decrease disease severity	decrease excerbations and increase lung function	6 months