Back to resultsThe Role of Vitamin D3 in Pediatric Bronchiectasis Severity
Primary Purpose
Cystic Fibrosis and Non CF Bronchiectasis
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Cholecalciferol (vitaminD3)
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis and Non CF Bronchiectasis
Eligibility Criteria
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.
Sites / Locations
- Children hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
vitamin D 3
Arm Description
oral vitamin D3 drops and tablets
Outcomes
Primary Outcome Measures
reach sufficient vitamin D level
vitamin D more than 30 ng/dl
decrease disease severity
decrease excerbations and increase lung function
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04411901
Brief Title
The Role of Vitamin D3 in Pediatric Bronchiectasis Severity
Official Title
The Role of Vitamin D3 in Pediatric Bronchiectasis Severity( CF Versus Non CF Bronchioectasis)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
September 6, 2018 (Actual)
Study Completion Date
March 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Heba Omara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis and Non CF Bronchiectasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vitamin D 3
Arm Type
Experimental
Arm Description
oral vitamin D3 drops and tablets
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol (vitaminD3)
Intervention Description
Theraputic vitamin D3 for CF and non CF bronchiectasis children
Primary Outcome Measure Information:
Title
reach sufficient vitamin D level
Description
vitamin D more than 30 ng/dl
Time Frame
6 months
Title
decrease disease severity
Description
decrease excerbations and increase lung function
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Children hospital
City
Cairo
State/Province
Abbasia
ZIP/Postal Code
02
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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The Role of Vitamin D3 in Pediatric Bronchiectasis Severity
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