The Role of Vitamin D3 in Pediatric Bronchiectasis Severity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-03-20

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Cystic Fibrosis and Non CF Bronchiectasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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vitamin D 3

oral vitamin D3 drops and tablets

Group Type EXPERIMENTAL

Cholecalciferol (vitaminD3)

Intervention Type DRUG

Theraputic vitamin D3 for CF and non CF bronchiectasis children

Interventions

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Cholecalciferol (vitaminD3)

Theraputic vitamin D3 for CF and non CF bronchiectasis children

Intervention Type DRUG

Eligibility Criteria

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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

* 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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No